HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 Linux 07DEC21:22:31:4407DEC21:22:31:44 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS DV SASDATA 9.4 Linux 07DEC21:22:31:4407DEC21:22:31:44 Protocol Deviations HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000001100000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier DVSEQ Sequence Number  DVSPID Sponsor-Defined Identifier (DVTERM Protocol Deviation Term 1DVDECOD Protocol Deviation Coded Term  DVCAT Category for Protocol Deviation  EPOCH Epoch  DVSTDTC Start Date/Time of Deviation 1 DVSTDY Study Day of Start of Deviation ; HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001DVC4591001 1005 10051317A1-1Z9W1BYUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1005 10051328A1-1Z9W1F3Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1005 10051339A01-1Z9W1F6Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1005 10051339A1-1XEAMG1Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-04BC4591001DVC4591001 1005 10051339A 1-1XU5CQNProcedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-06-09BC4591001DVC4591001 1005 10051413A1-1USCBW1Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-04-01BmC4591001DVC4591001 1005 10051414A 1-1OT8117Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1005 10051414A01-1YY0VDAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-25BC4591001DVC4591001 1005 10051414A1-1XMBFVLProcedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1005 10051417A1-1ZGA15PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-13BC4591001DVC4591001 1005 10051419A01-1XK5AREVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-06-02BC4591001DVC4591001 1005 10051419A 1-1OT811BVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1005 10051419A1-1UEHGUJOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-02-24BGC4591001DVC4591001 1005 10051420A01-1VNE4OGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BxC4591001DVC4591001 1005 10051420A1-1ZH24PKNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-31BjC4591001DVC4591001 1005 10051420A 1-1ZHJ095Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1005 10051420A@1-1Z70K1JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1005 10051421A 1-1Z9VJW3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-19BC4591001DVC4591001 1005 10051421A1-1XMBFVOProcedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1005 10051422A1-1Z9VJW6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-19BC4591001DVC4591001 1005 10051424A01-1VIS4UEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-16BxC4591001DVC4591001 1005 10051424A 1-1SZFK08Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-19B\C4591001DVC4591001 1005 10051424A1-1OTC10GVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-08BC4591001DVC4591001 1005 10051425A1-1ZH24PNNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-03BkC4591001DVC4591001 1005 10051425A 1-1ZHUSS7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-09BqC4591001DVC4591001 1005 10051427A01-1OTC0WAProcedure not performed as part of vital signs. Procedures/Tests Non-ImportantVACCINATION 2021-01-08BC4591001DVC4591001 1005 10051427AP1-1RVVF3JVisit conducted when not required per protocol Visit Schedule Non-ImportantVACCINATION 2021-02-04B.C4591001DVC4591001 1005 10051427A@1-1XRTK89Procedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1005 10051427A 1-1SSTN91Nasal swab collected at a visit where it was not required Laboratory Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1005 10051427A`1-1RVVUHHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-11BQC4591001DVC4591001 1005 10051427A1-1R54FU9Lab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-03-11BQC4591001DVC4591001 1005 10051431A1-1UEIK9LOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-09B2C4591001DVC4591001 1005 10051438A1-1XMBFVRProcedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1005 10051445A 1-1ZH2CQFNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-11BC4591001DVC4591001 1005 10051445A`1-1ZHUSSEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1005 10051445A1-1ZH24PQNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-14BrC4591001DVC4591001 1005 10051445AP1-1ZHUSSBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-22BzC4591001DVC4591001 1005 10051445A@1-1Y8SL8EProcedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-06-16BC4591001DVC4591001 1005 10051445A01-1XMBFVUProcedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1005 10051447A 1-1OS2TLQOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1005 10051447A1-1OS2TLKOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1005 10051448A 1-1UEIVHJOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-01B2C4591001DVC4591001 1005 10051448A01-1YW5EXQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1005 10051448A@1-1ZH2CQJNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-02BRC4591001DVC4591001 1005 10051448A1-1OS2TM2Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1005 10051448AP1-1UIIRQ1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BUC4591001DVC4591001 1005 10051450A01-1WTN7QNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-26BjC4591001DVC4591001 1005 10051450A 1-1Y8SL8JProcedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1005 10051450A1-1XMBFW7Procedure not performed by a medically qualified individual at specified visits Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1005 10051451A1-1OTTAVCProcedure/Test not performed per protocol Procedures/Tests Non-ImportantSCREENING 2021-01-11C4591001DVC4591001 1006 10061183A01-1OS305PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-07B'C4591001DVC4591001 1006 10061183A 1-1OT811HVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-07B'C4591001DVC4591001 1006 10061183A1-1POJ18NProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-09BHC4591001DVC4591001 1006 10061190A01-1YCOMHGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-15BC4591001DVC4591001 1006 10061190A1-1ZIM22LNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1006 10061190A 1-1XOV7IRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-24BC4591001DVC4591001 1006 10061201A1-1Z4PJFHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1006 10061203A 1-1YCQC4RVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1006 10061203A1-1OSO0CLVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1006 10061203A01-1ZMMT2FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1006 10061209A1-1ZMMT2JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-25BC4591001DVC4591001 1006 10061214A 1-1XNGGW5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1006 10061214A1-1ZHUT27Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1006 10061214A01-1YNZMAVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-21BC4591001DVC4591001 1006 10061219A01-1ZMMT2MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1006 10061219A 1-1Y29BS2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1006 10061219A1-1ORCDBKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-24BC4591001DVC4591001 1006 10061219A@1-1ZCT7K7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-30BC4591001DVC4591001 1006 10061224A1-1ZMMT8JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1006 10061224A 1-1Z6G6W8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-08BC4591001DVC4591001 1006 10061230A1-1OVP24TNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2020-12-31BC4591001DVC4591001 1006 10061230A 1-1ZQO1UVNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-10BC4591001DVC4591001 1006 10061231A1-1ZHUT2AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1006 10061232A1-1ZHUT2DVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BC4591001DVC4591001 1006 10061233A1-1OT811QVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1006 10061241A1-1YV6XRJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1006 10061247A 1-1ZH10SVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-12BC4591001DVC4591001 1006 10061247A1-1PAG6XISerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-01-28B2C4591001DVC4591001 1006 10061249A1-1ZMMT8MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1006 10061250A1-1Y55S2VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06BC4591001DVC4591001 1006 10061250A 1-1YY0VDNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-28BC4591001DVC4591001 1006 10061254A1-1P85LFLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-02B6C4591001DVC4591001 1006 10061256A1-1ZMMT8SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1006 10061256A 1-1ZMMT8PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-12BC4591001DVC4591001 1006 10061258A1-1ZMN4C1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1006 10061259A1-1VGEQO9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-04-13ByC4591001DVC4591001 1006 10061261A1-1ZMN4C4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1006 10061262A1-1Z4PJFLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-07BC4591001DVC4591001 1006 10061267A 1-1QZSYM3Other lab deviation Laboratory Non-ImportantVACCINATION 2021-01-22B'C4591001DVC4591001 1006 10061267A1-1PG7JLHNasal swab not collected by site staff prior to vaccination. Laboratory Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1006 10061267A01-1PG76QCProcedure not performed as part of vital signs. Procedures/Tests Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1006 10061269A01-1ZMN4C7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1006 10061269A 1-1VRXXYCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-27BC4591001DVC4591001 1006 10061269A1-1PFF411Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-10B:C4591001DVC4591001 1006 10061269A@1-1YY0VDQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1006 10061272A1-1OXOQ5YParticipant met exclusion criterion #01 (participant having other medical or psychiatric condition) Inclusion/Exclusion Important VACCINATION 2020-12-16AC4591001DVC4591001 1006 10061274A1-1ZD1VOBNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1006 10061274A 1-1YBCOE9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-25BC4591001DVC4591001 1006 10061274A01-1YV6XRNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1006 10061276A1-1YCQC4VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-11BC4591001DVC4591001 1006 10061277A1-1ZE8TSOSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-12BVC4591001DVC4591001 1006 10061278A1-1R1DHHZNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1006 10061280A1-1Z2PN6TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1006 10061282A1-1XOV7IVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-13BC4591001DVC4591001 1006 10061284A1-1YZ24R2Subject/LAR did not sign the ICD but gave verbal consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-15BC4591001DVC4591001 1006 10061286A1-1Z7HG8IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1006 10061287A 1-1Y71SMXReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1006 10061287A1-1Y71SN1Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1006 10061299A1-1Z7HG8MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1007 10071409A 1-1ZZ4D95Procedure not recorded in source documentation as having been performed. Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1007 10071409A1-1X12I7NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1007 10071409Ap1-1OE7S8MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2020-12-15B7C4591001DVC4591001 1007 10071409A@1-1ZZ4DCYProcedure not recorded in source documentation as having been performed. Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1007 10071409AP1-1ZBKAZ3Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1007 10071409A`1-1O6HZE1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-01B)C4591001DVC4591001 1007 10071409A01-1ZZ4DCVProcedure not recorded in source documentation as having been performed. Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1007 10071409A1-1ZZ4D8ZProcedure not recorded in source documentation as having been performed. Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1007 10071414A01-1YBCOECVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1007 10071414A1-1YHI2APOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071414A 1-1WTN7QVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BC4591001DVC4591001 1007 10071415A`1-1OSO0FDVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-10B2C4591001DVC4591001 1007 10071415Ap1-1OT9EZAVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantFOLLOW-UP 2021-01-07BNC4591001DVC4591001 1007 10071415AP1-1OSO0FAVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-10B2C4591001DVC4591001 1007 10071415A1-1Z33ZY0Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant SCREENING 2020-06-03C4591001DVC4591001 1007 10071415A01-1O4BQN6Subject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantVACCINATION 2020-11-06BC4591001DVC4591001 1007 10071415A@1-1OFD7VRProcedure not performed as part of vital signs. Procedures/Tests Non-ImportantVACCINATION 2020-12-10B2C4591001DVC4591001 1007 10071415A 1-1X6ZYPNReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071428A 1-1Z340H3Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-05BC4591001DVC4591001 1007 10071428A01-1ZBKAZ6Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071428A1-1Z33ZY3Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant FOLLOW-UP 2021-05-05BC4591001DVC4591001 1007 10071429A 1-1Z340H6Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071429A1-1Y71SN4Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071471A1-1ZQ9454Other Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1007 10071471A 1-1ZQ945KOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1007 10071472A1-1WTN7QYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08BC4591001DVC4591001 1007 10071475A1-1ORZHPEOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-19B3C4591001DVC4591001 1007 10071475A 1-1ORZHQYOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-19B3C4591001DVC4591001 1007 10071478A@1-1P947RYRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B@C4591001DVC4591001 1007 10071478A1-1P947RROther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B@C4591001DVC4591001 1007 10071478A 1-1P947RZOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B@C4591001DVC4591001 1007 10071478A01-1P947RQRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B@C4591001DVC4591001 1007 10071480AP1-1XEB7B8Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071480A@1-1XEB7B2Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071480A01-1XEB7ACOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071480A 1-1XEB7A6Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071480A1-1ZQ94OLOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-11-30AC4591001DVC4591001 1007 10071481A 1-1ZQOYGKOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1007 10071481A01-1ZQP122Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1007 10071481A@1-1ZQP12IOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1007 10071481A1-1ZQP13IICD signed by subject/LAR had not received IRB/IEC approval Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1007 10071482A1-1Z9OU88Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1007 10071482A 1-1Z6VKZXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1007 10071483A01-1WZ6Y09Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-03-30BxC4591001DVC4591001 1007 10071483A 1-1WZ6XY0Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-26B9C4591001DVC4591001 1007 10071483A1-1WZ6CUNOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-26B9C4591001DVC4591001 1007 10071484A`1-1XEB7C6Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071484A01-1XEB7BEOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071484AP1-1XEB7C0Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071484A1-1UEGOPQOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-26B9C4591001DVC4591001 1007 10071484A@1-1XEB7BUOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071484A 1-1UEGOQ6Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-26B9C4591001DVC4591001 1007 10071492A 1-1XSXJDXReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071492A1-1Z340H9Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071496AP1-1XEBGY5Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071496A@1-1XEBGXZOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071496A01-1XEBGQVOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071496A 1-1XEBGQPOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071496A1-1XEB5K9Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-02AC4591001DVC4591001 1007 10071497A1-1YBCOEGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071499A 1-1Z35AVMReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1007 10071499A1-1X6ZYZRReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071500A1-1ZQUFJ0Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1007 10071505A 1-1P947RIOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B9C4591001DVC4591001 1007 10071505A01-1O9K7TRAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1007 10071505A1-1P947R2Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B9C4591001DVC4591001 1007 10071508A1-1P947S5Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-28B5C4591001DVC4591001 1007 10071508A 1-1P947SBOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-01-28B5C4591001DVC4591001 1007 10071509A1-1PNQNFWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-17BIC4591001DVC4591001 1007 10071511A01-1XGLXTKOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071511A 1-1XGLXTEOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071511A@1-1XGLXTQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071511A1-1XGLXT8Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071515A 1-1YYPA1BReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-05BC4591001DVC4591001 1007 10071515A01-1P947SUOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20B,C4591001DVC4591001 1007 10071515A@1-1P947T0Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20B,C4591001DVC4591001 1007 10071515A1-1XSXJE0Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1007 10071518A1-201T7WVRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-01-26B2C4591001DVC4591001 1007 10071519A1-1UEHIZ7Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-03-31BrC4591001DVC4591001 1007 10071521A1-201VBCZOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1007 10071522A@1-1XM5NTWOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071522A01-1XM5NTQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071522A 1-1XM5NTKOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071522A1-1XM5NTEOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071523A1-1YGGO8HIncorrect serology sample volume collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1007 10071524A01-1YLJ7SARevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-02-25BPC4591001DVC4591001 1007 10071524A1-1P947TAOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-02-01B8C4591001DVC4591001 1007 10071524A 1-1P947TGOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-02-01B8C4591001DVC4591001 1007 10071524A@1-1PDX794Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-03B:C4591001DVC4591001 1007 10071525A1-1PDX799Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-03B:C4591001DVC4591001 1007 10071528A1-1Z35AVSReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071528A 1-1Z35B5LReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071529A 1-1YBCOEJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071529A1-1OAL5G0Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-09AC4591001DVC4591001 1007 10071530A1-1XK3Y7FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-01BC4591001DVC4591001 1007 10071531A`1-1XK3Y7IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1007 10071531A@1-1XM73FIOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071531A1-1ZCDLPJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-28BC4591001DVC4591001 1007 10071531Ap1-1YV6XRQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-22BC4591001DVC4591001 1007 10071531AP1-1PNR0W3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-17BGC4591001DVC4591001 1007 10071531A 1-1XM7388Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071531A01-1XM738EOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071531A1-1XM737SOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071533A1-1XMBBEUOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071533A 1-1XMBBFKOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071533A01-1XMBBGUOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071533A@1-1XMBBH0Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071536A1-1YBCOEMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1007 10071536A 1-1Z6G6WBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1007 10071537A 1-1OT8120Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantFOLLOW-UP 2021-01-29B4C4591001DVC4591001 1007 10071537A1-1OTC5LJVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1007 10071539A1-1Y5U9OORevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-02BC4591001DVC4591001 1007 10071540A01-1YGE03FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-02BC4591001DVC4591001 1007 10071540A 1-1WYEJXDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-12BC4591001DVC4591001 1007 10071540A1-1YG8TD7Serology sample not collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-02BC4591001DVC4591001 1007 10071541A1-1YHI2ITRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-02-09B?C4591001DVC4591001 1007 10071542A1-1YBCOEZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071543A01-1YG8TDASerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1007 10071543A 1-1Y24OS3Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071543A1-1X6ZYZUReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071547AP1-1XKP13IOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071547A01-1XKP136Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071547A 1-1XKP12QOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071547A@1-1XKP13COther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071547A1-1XKP12AOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071551A`1-1PP8P75Nasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2020-12-26BC4591001DVC4591001 1007 10071551Ap1-1R2MXMQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-02BSC4591001DVC4591001 1007 10071551A1-1YG8U0FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-22BC4591001DVC4591001 1007 10071551AP1-1XKP16KOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071551A@1-1XKP16EOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071551A1-1XKP15MOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071551A 1-1XKP15SOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071551A01-1XKP168Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071552A1-1XMBBHQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071552A@1-1XMBBKQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071552A01-1XMBBJGOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071552A 1-1XMBBJAOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071554A 1-1Z35B5OReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1007 10071554A1-1XD2IB4Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-22BC4591001DVC4591001 1007 10071555A1-1XGK0G5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1007 10071555A 1-1Z4VSKLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1007 10071557A1-1ZBB9L3Serology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-22BC4591001DVC4591001 1007 10071557A01-1ZB3SZXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-22BC4591001DVC4591001 1007 10071557A 1-1YBEU83Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1007 10071559A 1-1PFSWK5Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21B'C4591001DVC4591001 1007 10071559AP1-1XMBBO4Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071559A1-1PFSWJZOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21B'C4591001DVC4591001 1007 10071559A`1-1XMBBOAOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071559A@1-1XMBBNYOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071559A01-1XMBBNSOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071560A01-1XGL7BKOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071560AP1-1UEHUXJRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-14B[C4591001DVC4591001 1007 10071560A@1-1XGL7BQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071560A 1-1XGL7B4Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071560A1-1XGL7AYOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071560A`1-1UEHUXPRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-16B]C4591001DVC4591001 1007 10071562A 1-1XGL7CCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071562A@1-1XGL7DSOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071562A1-1XGL7C6Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071562A01-1XGL7DCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071563A01-1XGL7EKOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071563A@1-1XGL7EQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071563A1-1XGL7DYOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071563A 1-1XGL7EEOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071564A1-1ONNA3KOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071564A@1-1TE4I2PVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071564A 1-1ONNA3QOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071564A01-1OT812GVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071564AP1-1PFF365Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-08B9C4591001DVC4591001 1007 10071565A 1-1ONN9K3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071565A1-1ONN9JXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071565A01-1OT812JVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071566A1-1YYQVO9Serology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1007 10071566A01-1P2RFXFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-01B2C4591001DVC4591001 1007 10071566A@1-1Z3S3BPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071566A 1-1ZE8TVSSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1007 10071567A1-1ONN9K9Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071567A 1-1ONO00XOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071568A 1-1XSZQDTRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071568A1-1XSZQCJRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071569A1-1ONO04POther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071569A 1-1ONO04VOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071570A 1-1ONO057Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071570A1-1ONO051Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071571A01-1Z3S3BTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071571A1-1ONO05NOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071571A 1-1ONO05TOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071572A 1-1ONO08ZOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071572A1-1ONO061Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1007 10071573A1-1XSXJK7Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071574A1-1UEHV0TRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantREPEAT SCREENING 1 2021-03-13BXC4591001DVC4591001 1007 10071574A@1-1Z2PN6XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1007 10071574A 1-1VITA5CParticipant entered into asymptomatic swabbing part of study after they were unblinded Other Non-ImportantREPEAT SCREENING 1 2021-03-17B\C4591001DVC4591001 1007 10071574A01-1YBEU87Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071575A 1-1ONO0HDOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071575A1-1ONO0H7Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071576A 1-1XSZQCDRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071576A1-1XSZQBDRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071577A 1-1ONO0HPOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-01-06BC4591001DVC4591001 1007 10071577A1-1ONO0HJOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-01-06BC4591001DVC4591001 1007 10071577A01-1WZ7GVDOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-04-19B}C4591001DVC4591001 1007 10071578A`1-1XKVLDHOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071578A@1-1XKVLCBOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071578A1-1ONO0IFOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071578A 1-1ONO0ILOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071578AP1-1XKVLD1Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071578A01-1XKVLC5Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071579A01-1Z4VSKOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-16BC4591001DVC4591001 1007 10071579A 1-1ONO0JROther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071579A1-1ONO0IROther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071580A1-1ONO0JXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071580A 1-1ONO0KXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1007 10071581A01-1XKVLDNOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071581A@1-1XKVLENOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071581A`1-1XKVLEZOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071581AP1-1XKVLETOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071581A 1-1ONO0LJOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071581A1-1ONO0LDOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071582AP1-1YV6XRTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1007 10071582A 1-1ONO0MFOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071582A1-1ONO0M9Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071582A@1-1Z3A98TSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-08BC4591001DVC4591001 1007 10071582A01-1XQ1WEJNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1007 10071583A@1-1XGLZ4ROther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071583A01-1XGLXUZOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071583AP1-1XGLZ4XOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071583A 1-1ONOEJLOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071583A`1-1XGLZ53Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071583A1-1ONO0MVOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071584A 1-1ONOEKROther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071584A1-1ONOEJROther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071585A`1-1XGLXQCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071585AP1-1XGLXPMOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071585A01-1XGLXP0Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071585A 1-1ONOEUTOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071585A1-1ONOEKXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071585A@1-1XGLXP6Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071586A1-1ONOEYLOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071586A 1-1ONOEYROther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071587A1-1ONOF8EOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071587A 1-1ONOF8KOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1007 10071588A01-1XTPZXZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071588A 1-1OS17X3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071588A1-1OS17WXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071589A 1-1ORAYUUOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071589A`1-1XGLZ5ROther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071589A01-1XGLZ59Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071589AP1-1XGLZ5LOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071589A@1-1XGLZ5FOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071589A1-1ORAYSGOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071591A 1-1ZA1F4URevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-02BC4591001DVC4591001 1007 10071591A1-1ORAYW0Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071592A01-1QYQAN1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24B;C4591001DVC4591001 1007 10071592A1-1ORBV52Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071592A 1-1ORBV58Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071592A@1-1XTPZY3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071593A1-1QZCJI9Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant VACCINATION 2021-01-21BC4591001DVC4591001 1007 10071593A 1-1T5A5N5Blind broken outside of IRT when not permitted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-02-12B/C4591001DVC4591001 1007 10071594A 1-1OROZMHOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1007 10071594A1-1OROZM3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1007 10071594A01-1YV6XRWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1007 10071595A`1-1XGOXS9Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071595A 1-1ORBVGPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071595A@1-1XGOXRXOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071595A01-1XGOXRROther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071595AP1-1XGOXS3Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071595A1-1ORBV5FOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071596A`1-1XM737HOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071596A01-1XM5FNNOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071596AP1-1XM5FNZOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071596A 1-1OVTH5YOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071596A@1-1XM5FNTOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1007 10071596A1-1OVTH5SOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071597A01-1YBEU8AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1007 10071597A 1-1OS17ZFOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071597A1-1OS17Z9Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071599AP1-1ZHUT2GVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1007 10071599A@1-1XTPZY6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-06BC4591001DVC4591001 1007 10071599A 1-1ORBVHPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071599A01-1ZIM294Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1007 10071599A1-1ORBVH1Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071600A 1-1ORC2NKOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071600A01-1YJ4OMAOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1007 10071600AP1-1Z6VL01Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-14BC4591001DVC4591001 1007 10071600A1-1ORBVHWOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071600A@1-1YD7IBXSerology sample not collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1007 10071601A`1-1ZCDLPNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1007 10071601A@1-1Z4WZO6Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-16BOC4591001DVC4591001 1007 10071601AP1-1SMY9AMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-16BOC4591001DVC4591001 1007 10071601A1-1YBYR3OReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071601A 1-1OS17ZMOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071601A01-1OS17ZSOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071602A01-1YBEU8NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071602A 1-1OS189XOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071602A1-1OS189QOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071603A01-1OS1U2GOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071603A 1-1OS1U2AOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071603A1-1XSXJKAReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-05BC4591001DVC4591001 1007 10071604A1-1Z4VTMYReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071604A01-1OS1U2NOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071604A@1-1OS1U3DOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071604A 1-1Z4VTN1Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-12BC4591001DVC4591001 1007 10071605A1-1ORC2O1Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071605A01-1YBEU8QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1007 10071605A 1-1ORC2O7Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071606A 1-1OS1U4UOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071606AP1-1Z8JZKXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-18BC4591001DVC4591001 1007 10071606A01-1R24MVTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-04BBC4591001DVC4591001 1007 10071606A@1-1YV6XRZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1007 10071606A1-1OS1U4OOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071607A1-1YG8TEQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-21BC4591001DVC4591001 1007 10071607A`1-1XEB7E3Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071607AP1-1XEB7DIOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071607A@1-1XEB7CIOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071607A01-1XEB7CCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071607A1-1OS1U7JOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071607A 1-1OS1U7POther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071607Ap1-1QYQPR7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24B:C4591001DVC4591001 1007 10071608A1-1QYQPRBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24B:C4591001DVC4591001 1007 10071608A`1-1XEB7FGOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071608AP1-1XEB7FAOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071608Ap1-1X75PELLab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1007 10071608A01-1XEB7E9Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071608A 1-1OS29Q4Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071608A@1-1XEB7EFOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071608A1-1OS1U7WOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071609A@1-1WTN7R4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28ByC4591001DVC4591001 1007 10071609A01-1WTN7R1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28ByC4591001DVC4591001 1007 10071609A 1-1OS29UXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071609A1-1OS29UROther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071609AP1-1XTQ01LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071610A1-1OVTT3BOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071610A 1-1OVTT3HOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071612A`1-1YBEU8TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071612Ap1-1ZHUT51Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1007 10071612AP1-1QZP5B3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-25B;C4591001DVC4591001 1007 10071612A01-1U7XBCALab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-03-29B[C4591001DVC4591001 1007 10071612A 1-1OS2K9GOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071612A1-1OS2K9AOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071612A@1-1ZIM297Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-10BC4591001DVC4591001 1007 10071613A`1-1XEB7XNOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071613AP1-1XEB7XHOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071613A@1-1XEB7XBOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071613Ap1-1YCQC4YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31B]C4591001DVC4591001 1007 10071613A01-1XEB7FMOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071613A1-1OS2KA7Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071613A 1-1OS2KADOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071614AP1-1XEBGM3Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071614Ap1-1YV6XS2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-28BC4591001DVC4591001 1007 10071614A@1-1XEBGLNOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071614A01-1XEBGKXOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071614A`1-1XEBGMJOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1007 10071614A 1-1ORC1XZOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071614A1-1ORC1XTOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071615A@1-1YBEU8WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1007 10071615AP1-1Z499HLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-08BC4591001DVC4591001 1007 10071615A 1-1OS2KEWOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071615A01-1XNE0EFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-02BC4591001DVC4591001 1007 10071615A1-1OS2KAKOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071616A@1-1ZCDLPQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1007 10071616A 1-1OS2KFJOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071616A01-1YBEUAXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071616A1-1OS2KFDOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071617A1-1OVTT4IOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071617A 1-1OVTT58Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071618A`1-1QYQPREVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24B:C4591001DVC4591001 1007 10071618A@1-1ORC1YCOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071618AP1-1XQC5GNNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-01BC4591001DVC4591001 1007 10071618A01-1ORC1Y6Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1007 10071618A 1-1XSXJKDReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071618A1-1XSXJKGReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1007 10071619A 1-1OS2KG6Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071619A1-1OS2KG0Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071619A01-1XTQ01OVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071620AP1-1ZHW9RZVisit not done Visit Schedule Non-ImportantVACCINATION 2021-02-05B&C4591001DVC4591001 1007 10071620A@1-1TB4AGZSAE report delayed or not reported to Sponsor Safety Reporting Non-ImportantFOLLOW-UP 2021-03-16BMC4591001DVC4591001 1007 10071620A 1-1V8MALINasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-16BMC4591001DVC4591001 1007 10071620A1-1R1DOTBNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-02-05B&C4591001DVC4591001 1007 10071620A01-1QO6A4ISAE report delayed or not reported to Sponsor Safety Reporting Non-ImportantVACCINATION 2021-02-01B"C4591001DVC4591001 1007 10071621A 1-1OVTTRDOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071621A1-1OVTTR7Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071622A1-1OVU6X8Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071622A 1-1OVU6X6Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071622A01-1PPEUWTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-18B3C4591001DVC4591001 1007 10071623A@1-1OVVC3MOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071623AP1-1ZE8TVVSerology sample not collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1007 10071623A1-1OROZMNOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1007 10071623A01-1OVVC18Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071623A 1-1OROZMUOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1007 10071624A@1-1XEBGQJOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071624AP1-1OVVC8OVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1007 10071624A01-1XEBGNVOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071624A 1-1XEBGNPOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071624A1-1XEBGN9Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071625Ap1-1OZPL53Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1007 10071625A`1-1XGOY6DOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071625A@1-1XGOY61Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071625A01-1XGOY0BOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071625AP1-1XGOY67Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1007 10071625A 1-1OZPL52Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1007 10071625A1-1OZPL4WOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1007 10071626A1-1OS2KGPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071626A01-1XTQ01RVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071626A 1-1OS2KGVOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071627A@1-1XTQ01UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071627A 1-1OROZNMOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1007 10071627A01-1XT1VKJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071627A1-1OROZN8Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1007 10071628A`1-1ZCT7KBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1007 10071628A@1-1ZIM291Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1007 10071628A01-1ZIM22UNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-10BC4591001DVC4591001 1007 10071628A1-1OZPL49Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071628A 1-1OZPL4NOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071628AP1-1Z3S3BWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1007 10071629A1-1OS2KJ9Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071629A 1-1OS2KJFOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071630A`1-1XM73GGOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1007 10071630AP1-1XM73GAOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1007 10071630A@1-1XM73G4Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1007 10071630A01-1XM73FOOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1007 10071630A 1-1OS2KKCOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071630A1-1OS2KJWOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1007 10071631A 1-1OZPL3NOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071631A1-1OZPL3HOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071632AP1-1XGOXZPOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071632A`1-1XGOY05Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071632A@1-1XGOXZJOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071632A01-1XGOXSFOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1007 10071632A 1-1OZPL2QOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071632A1-1OZPL2KOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071633A 1-1OZPL2DOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071633A01-1XTQ01XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071633A1-1OZPL27Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1007 10071634A 1-1OZPL20Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071634A1-1OZPL1UOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071635A01-1OZPL1NOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071635A1-1XD2IB7Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1007 10071635A 1-1OZPL1HOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071636A1-1XTQ020Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1007 10071638A@1-1Z499HPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-08BC4591001DVC4591001 1007 10071638A01-1Z4VZVTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1007 10071638A 1-1OZPDFIOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071638A1-1OZPDF2Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071639A@1-1ZHUT54Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BsC4591001DVC4591001 1007 10071639A01-1ZIM22PNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-19BjC4591001DVC4591001 1007 10071639A1-1OZP63AOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071639A 1-1OZP63GOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071640A1-1R0CRESVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-02B:C4591001DVC4591001 1007 10071641A`1-1ZFDTHSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-09BC4591001DVC4591001 1007 10071641A@1-1XTQ023Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071641AP1-1ZB3T01Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1007 10071641A01-1XD2IEMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1007 10071641A 1-1OXAG9COther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1007 10071641A1-1OXAG96Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1007 10071642A01-1QSQ8I6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22B2C4591001DVC4591001 1007 10071642A1-1OWKIN5Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1007 10071642A 1-1OWKINBOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1007 10071643Ap1-1QTCECTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22B2C4591001DVC4591001 1007 10071643A@1-1XMBBOMOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071643A01-1XMBBOGOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071643A`1-1XMBBOYOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071643A1-1OWJJMQOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1007 10071643A 1-1OWJJOAOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1007 10071643AP1-1XMBBOSOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-27BC4591001DVC4591001 1007 10071644A 1-1OWJJMJOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071644A1-1OWJJM3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071644A01-1XTQ026Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071645A`1-1XMBBNMOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071645AP1-1XMBBNGOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071645A01-1XMBBKWOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071645A 1-1OWJJL2Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071645A1-1OWJJKWOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071645A@1-1XMBBN0Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1007 10071646A1-1OWJJI1Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071646A 1-1OWJJJ1Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071647A01-1Z3S3BZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071647A 1-1OWJJHUOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071647A1-1OWJJG2Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1007 10071648A1-1ON6MQCOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071648A 1-1ON6MQIOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071649A 1-1ON6M4EOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071649A1-1ON619EOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071650A1-1WTN7RRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-26BpC4591001DVC4591001 1007 10071650A1-1X3BCY0Lab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-04-26BpC4591001DVC4591001 1007 10071650A1-1ON6MIOProcedure/Test not performed per protocol Procedures/Tests Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071650A`1-1XMBBPMOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071650AP1-1XMBBPGOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071650A@1-1XMBBPAOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071650A 1-1ON6MINOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071650Ap1-1P1ZHV1Subject was vaccinated despite meeting temporary delay criterion #1 (current febrile illness or other acute illness within 48 hrs before study intervention administration. Includes current symptoms Investigational ProductNon-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071650A1-1ON6MIHOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071650A01-1XMBBP4Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071651A01-1XTQ029Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071651A 1-1ON6MR5Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071651A1-1ON6MQZOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1007 10071652Ap1-1YV6XSFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-21BC4591001DVC4591001 1007 10071652A`1-1WTN7RUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-20BjC4591001DVC4591001 1007 10071652AP1-1X3BCY3Lab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-04-26BpC4591001DVC4591001 1007 10071652A@1-1XM5NSXOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071652A01-1XM5NSROther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071652A 1-1XM5NSLOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071652A1-1XM5NRVOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1007 10071653A1-1XTQ02CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071654A01-1QW05STSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-23B2C4591001DVC4591001 1007 10071654A@1-1ZCJ1HFSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-22BC4591001DVC4591001 1007 10071654A1-1XSYJV7Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1007 10071654A 1-1OV1ORANasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1007 10071655A`1-1ZE8TWISerology sample not collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071655A@1-1XGLXQUOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071655AP1-1XGLXR0Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071655A01-1XGLXQOOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071655A 1-1XGLXQIOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071655A1-1Z3A9BFSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantOPEN LABEL TREATMENT2021-07-02BC4591001DVC4591001 1007 10071656A1-1YBEUB2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1007 10071658A@1-1XGLXT2Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071658A 1-1XGLXRCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071658AP1-1YGUX98Nasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-08BC4591001DVC4591001 1007 10071658A01-1XGLXSWOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071658A1-1XGLXR6Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1007 10071659A01-1XTQ02FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071659A1-1X3BCPSNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-28BRC4591001DVC4591001 1007 10071659A 1-1YEE5NZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08B]C4591001DVC4591001 1007 10071660A 1-1YEE5O3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08B]C4591001DVC4591001 1007 10071660A1-1X3BCXXNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-28BRC4591001DVC4591001 1007 10071661A1-1XTQ02IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1007 10071662A1-1XSYJVAReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-05BC4591001DVC4591001 1007 10071662A 1-1ZH2UHGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-12BC4591001DVC4591001 1008 10081751A1-1XDA5EFIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081752A 1-1WKF774Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-19BC4591001DVC4591001 1008 10081752A1-1XDA5EJIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081753A1-1WKF777Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-19BC4591001DVC4591001 1008 10081756A1-1YL1U1ARevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-12BC4591001DVC4591001 1008 10081756A01-1XDA5EMIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-04-22BC4591001DVC4591001 1008 10081756A 1-1YL1U48Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-12BC4591001DVC4591001 1008 10081757A1-1XDA5FJIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081758A1-1WTN7S0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-29BC4591001DVC4591001 1008 10081761A1-1XDA5FMIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-04-05BxC4591001DVC4591001 1008 10081763A1-1R5SPMOOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-12B`C4591001DVC4591001 1008 10081763A 1-1P9LCCZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-25B2C4591001DVC4591001 1008 10081764A1-1P9LCD3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-25B2C4591001DVC4591001 1008 10081767A1-1XDA5FPIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081769A1-1R7E1VZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-23BNC4591001DVC4591001 1008 10081773A1-1XDA5FSIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081774A1-1YM02Z7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1008 10081775A1-1YNZMAZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-18BC4591001DVC4591001 1008 10081780A1-1XDA5HJIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081788A1-1XDA5HMIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081790A1-1XDA5HPIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081793A1-1XDA5KAIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081794A1-1XDA5KDIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081796A 1-1WNXXE5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BxC4591001DVC4591001 1008 10081796A1-1XDA5KGIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081798A1-1XDA5LNIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081799A01-1ZHUT58Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1008 10081799A 1-1OCN9STUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1008 10081799A1-1ZIM2A4Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1008 10081801A 1-1ZE8TWLSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-22B`C4591001DVC4591001 1008 10081801A1-1XDA5LQIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081803A1-1XDA5LTIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-04-09BrC4591001DVC4591001 1008 10081804A1-1XDA5OFIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081805A 1-1ZHUT9RVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-01BC4591001DVC4591001 1008 10081805A1-1YXHVRASerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1008 10081807A1-1XDA5OIIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081808A1-1XDA5OLIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081809A 1-1Z6G6WHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-14BC4591001DVC4591001 1008 10081809A1-1XDA5OOIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081811A1-1OFAVJLOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1008 10081811A01-1XSGB0VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-01BC4591001DVC4591001 1008 10081811A 1-1XPVX9KLab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-01BC4591001DVC4591001 1008 10081812A1-1XDA5QZIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081817A 1-1PLVAJEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-12B9C4591001DVC4591001 1008 10081817A1-1XDA5R2Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081818A1-1XT0RCTNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-25BC4591001DVC4591001 1008 10081819A1-1XDA5R5Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1008 10081821A1-1PF862JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-08B2C4591001DVC4591001 1008 10081822A1-1XDA5R8Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081825A1-1XDA5RBIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081826A1-1YD7IC0Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1008 10081828A01-1Y1PBIBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-08BC4591001DVC4591001 1008 10081828A 1-1PDX79CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-22B!C4591001DVC4591001 1008 10081828A1-1XDA5REIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081831A1-1VISO3TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-20BxC4591001DVC4591001 1008 10081832A1-1ZIW26QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-20BC4591001DVC4591001 1008 10081833A1-1XDA5RRIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081836A 1-1QTCECWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-23B@C4591001DVC4591001 1008 10081836A1-1XDA5RUIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081837A1-1ZMN4EIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1008 10081838A01-1YBEUBHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1008 10081838A 1-1YBEUBEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1008 10081838A1-1YBEUBBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1008 10081839A@1-1YM02ZBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-20BC4591001DVC4591001 1008 10081839A 1-1YM02ZEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1008 10081839A1-1XK42SNLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1008 10081839A01-1YM0301Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1008 10081840A1-1XDA5RXIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081842A1-1QW7RGHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-19B;C4591001DVC4591001 1008 10081843A1-1YV6XSIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1008 10081845A1-1XDA5S0Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081845A 1-1ZE8TWOSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-04-05BhC4591001DVC4591001 1008 10081849A 1-1XDA5S3Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081849A1-1YXG8IVSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantOPEN LABEL TREATMENT2021-06-30BC4591001DVC4591001 1008 10081851A1-1XDA5S6Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1008 10081852A1-1XDA5S9Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1008 10081854A1-1Z499HSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1008 10081861A1-1XDA5SDIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081862A1-1ZHEE05Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-06BC4591001DVC4591001 1008 10081863A1-1XDA5SGIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081864A1-1ZH2CQMNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-24BC4591001DVC4591001 1008 10081866A1-1XDA5SJIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081867A1-1XDA5VYIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081868A1-1ZHUT9UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1008 10081869A1-1XDA5W1Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081870AP1-1Z499SPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1008 10081870A@1-1YV6XT8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1008 10081870A1-1ZF2K25Other lab deviation Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1008 10081870A01-1YV6XSLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1008 10081870A 1-1WTN7T0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-09BfC4591001DVC4591001 1008 10081871A 1-1QW7RGLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-16B1C4591001DVC4591001 1008 10081871A1-1XDA5W4Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081872Ap1-1WTN7SXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-02B|C4591001DVC4591001 1008 10081872AP1-1XK2YZMNasal swab collected at a visit where it was not required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-02B|C4591001DVC4591001 1008 10081872A`1-1XK2YZSNasal swab collected at a visit where it was not required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1008 10081872A01-1XDAWC5Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-09BC4591001DVC4591001 1008 10081872A 1-1UIL84USubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantOPEN LABEL TREATMENT2021-04-09BeC4591001DVC4591001 1008 10081872A1-1UIL7TCSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantOPEN LABEL TREATMENT2021-04-09BeC4591001DVC4591001 1008 10081872A@1-1XK1TL9Nasal swab collected at a visit where it was not required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-04-23BsC4591001DVC4591001 1008 10081873A 1-1ZHUT9XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1008 10081873A1-1ZIM2A7Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-30BC4591001DVC4591001 1008 10081873A01-1ZCDLQ3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-30BC4591001DVC4591001 1008 10081874A 1-1ZIM2EKNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-13BC4591001DVC4591001 1008 10081874A@1-1ZHUTBYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1008 10081874A1-1ZIM2ABNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1008 10081874A01-1XNE0EIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1008 10081875A 1-1XNE0FZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-03BC4591001DVC4591001 1008 10081875A1-1XDAWC8Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081876A1-1VIRO0XNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-27BXC4591001DVC4591001 1008 10081876A 1-1WH6QCHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-17BNC4591001DVC4591001 1008 10081877A1-1XDAWCBIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081878A1-1ZIM2EZNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-11BC4591001DVC4591001 1008 10081879A@1-1XE4MVBNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-02B|C4591001DVC4591001 1008 10081879A01-1V9SUKYNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-29BZC4591001DVC4591001 1008 10081879A 1-1YBSBMIReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-12BC4591001DVC4591001 1008 10081879A1-1XGCGK3Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1008 10081880A1-1XDAWCEIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1008 10081881A1-1XDAWCHIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1008 10081882A1-1ZHEE09Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-16BC4591001DVC4591001 1008 10081883A1-1Z3S3C2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1008 10081884A@1-1Z499SSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-09BC4591001DVC4591001 1008 10081884A01-1QW7RGOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-19B3C4591001DVC4591001 1008 10081884A 1-1ZE8TX1Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-19BOC4591001DVC4591001 1008 10081884A1-1XDAWCKIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081885A1-1WTN7T3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BaC4591001DVC4591001 1008 10081885A 1-1ZMN4ELVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-12BC4591001DVC4591001 1008 10081887A1-1XDAWCOIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081888A1-1XDAWLDIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081891A1-1XDAWLGIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1008 10081892A 1-1WNXXECVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-22BNC4591001DVC4591001 1008 10081892A1-1WNXXE9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03B;C4591001DVC4591001 1008 10081893A1-1ZHUTC1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1008 10081894A 1-1ZE8TX4Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-04-06B]C4591001DVC4591001 1008 10081894A@1-1Z8JZL1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-17BC4591001DVC4591001 1008 10081894A1-1ZIM2ENNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-05BC4591001DVC4591001 1008 10081894A01-1ZHUTC4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-20BC4591001DVC4591001 1008 10081896A1-1XDAWLJIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081897A 1-1ZHVGD3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1008 10081897A1-1ZIM2EQNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1008 10081898A 1-1WTNENVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BcC4591001DVC4591001 1008 10081898A1-1XDAWQWIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081899A1-1XDAWQZIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081899A 1-1WTNENYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BcC4591001DVC4591001 1008 10081900A1-1ZHVGD6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-18BC4591001DVC4591001 1008 10081902A1-1XDAWR3Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081902A 1-1P19HPPAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1008 10081903A1-1Z6VL04Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1008 10081904A1-1XDAWR6Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081905A01-1Z6VL07Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1008 10081905A 1-1ZHVGD9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1008 10081905A1-1ZIM2ETNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-13BC4591001DVC4591001 1008 10081906A 1-1Z499SVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1008 10081906A1-1VM3J5ZNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-18BgC4591001DVC4591001 1008 10081907A1-1XDAWR9Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081909A1-1TVW3JCNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-08B>C4591001DVC4591001 1008 10081909A 1-1YV6XTBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BxC4591001DVC4591001 1008 10081911A1-1XDAWRCIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081912A1-1ZH2CTRNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-20BC4591001DVC4591001 1008 10081913A1-1XDAWRPIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081914A 1-1QW7RL7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-12B&C4591001DVC4591001 1008 10081914A1-1XDAWRSIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1008 10081919A1-1OT9IF1Procedure not performed as part of vital signs. Procedures/Tests Non-ImportantSCREENING 2020-11-01CC4591001DVC4591001 1008 10081920A01-1ZHVGDCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1008 10081920A1-1ZIM2EWNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1008 10081920A 1-1XTRH45Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-05BC4591001DVC4591001 1008 10081921A01-1XDAWRVIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-04-26BnC4591001DVC4591001 1008 10081921A1-1YLH3L5Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081921A 1-1YLH3MPRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081923A1-1XDAWRYIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B~C4591001DVC4591001 1008 10081924A 1-1XDAWSBIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081924A1-1QZOQHUSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantVACCINATION 2021-02-11B#C4591001DVC4591001 1008 10081926A01-1WOKKODNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-18BeC4591001DVC4591001 1008 10081926A 1-1XDAWSEIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081926A1-1ZIZBL2Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1008 10081930A1-1XDAWSHIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B{C4591001DVC4591001 1008 10081933A1-1XDAWSUIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081934A1-1Z499SYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1008 10081935A1-1R0XVKGSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantVACCINATION 2021-02-25B.C4591001DVC4591001 1008 10081935A 1-1ZG7WSKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-13BC4591001DVC4591001 1008 10081936A1-1XDAWSXIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14B|C4591001DVC4591001 1008 10081937A1-1YV6XTEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1008 10081938A1-1XDAWT0Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1008 10081941A1-1XDAWT3Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14B{C4591001DVC4591001 1008 10081942A1-1XDAWT6Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14B{C4591001DVC4591001 1009 10091204A1-1ZBKUC7Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1009 10091205A 1-1ZMN4EOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-18BC4591001DVC4591001 1009 10091205A1-1YGSKODNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-10BC4591001DVC4591001 1009 10091209A1-1ZBKUCAUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1009 10091212A1-1O05DG4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-11-16B C4591001DVC4591001 1009 10091213A01-1OEKRU1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2020-12-16B>C4591001DVC4591001 1009 10091213A 1-1RVVF7LVisit conducted when not required per protocol Visit Schedule Non-ImportantFOLLOW-UP 2021-01-04BQC4591001DVC4591001 1009 10091213A1-1RVVUQANasal swab collected at a visit where it was not required Laboratory Non-ImportantVACCINATION 2020-12-02B0C4591001DVC4591001 1009 10091216A1-1ZBKUCDUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1009 10091218A1-1ZBKUCGUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1009 10091220A1-1WTNEO1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-18BC4591001DVC4591001 1009 10091221A 1-1WH6QCLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-18BC4591001DVC4591001 1009 10091221A1-1NR3P0BUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-10-19AC4591001DVC4591001 1009 10091223A1-1ZBKUD3Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1009 10091229A 1-1O4AHO2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-11-23B#C4591001DVC4591001 1009 10091229A1-1ZK3KGBSubject was vaccinated despite the site being instructed to discontinue further vaccination Investigational ProductImportant FOLLOW-UP 2021-03-18BC4591001DVC4591001 1009 10091231A1-1ZBKUD6Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1009 10091233A1-1ZBKUD9Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-18BC4591001DVC4591001 1009 10091234A1-1XSGB0YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-15BC4591001DVC4591001 1009 10091237A1-1ZBKUDCUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-05-13BC4591001DVC4591001 1009 10091240A1-1ZBKUDFUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1009 10091246A 1-1ZBKUDIUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1009 10091246A1-1OCOVQRSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantVACCINATION 2020-12-07B/C4591001DVC4591001 1009 10091272A1-1ZHWDGHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-10BC4591001DVC4591001 1009 10091274A1-1OS50NSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1009 10091275A1-1OS50NVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1009 10091277A 1-1YM0304Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-07BC4591001DVC4591001 1009 10091277A1-1OS50NYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1009 10091280A1-1ZBKUE5Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1009 10091281A1-1ZMN4LFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1009 10091283A 1-1ZBKUE8Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1009 10091283A1-1ZE8TX7Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-30BvC4591001DVC4591001 1009 10091284A1-1ZBKUEBUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1009 10091296A1-1SSS0N0Potential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-03B;C4591001DVC4591001 1009 10091304A1-1Z03K9HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1009 10091312A1-1YV6XU1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-25BC4591001DVC4591001 1009 10091314A1-1ZHEE0CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-02BC4591001DVC4591001 1009 10091315A1-1WTNEV2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-26BC4591001DVC4591001 1009 10091317A1-1ZBKUEEUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1009 10091319A1-1WTNEV5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-26BC4591001DVC4591001 1009 10091320A 1-1YV6XU4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-28BC4591001DVC4591001 1009 10091320A1-1PJ91L5Participant met exclusion criterion #01 (participant having other medical or psychiatric condition) Inclusion/Exclusion Important VACCINATION 2020-12-10AC4591001DVC4591001 1009 10091324A1-1XSGB11Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-19BC4591001DVC4591001 1009 10091326Ap1-1YV6XU7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-25BC4591001DVC4591001 1009 10091326A`1-1XSGB14Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1009 10091326AP1-1WTNEWFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-23BC4591001DVC4591001 1009 10091326A@1-1WTNEV8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-04BsC4591001DVC4591001 1009 10091326A01-200C94RVisit not done Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-09BC4591001DVC4591001 1009 10091326A 1-1ZJTC4DRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL FOLLOW-UP2021-08-10BC4591001DVC4591001 1009 10091326A1-1ZJTC3XRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL FOLLOW-UP2021-08-10BC4591001DVC4591001 1009 10091330A01-1YY0VDTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-26BC4591001DVC4591001 1009 10091330A 1-1ZBKUF1Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1009 10091330A1-1Z63DGCSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-25BiC4591001DVC4591001 1009 10091331A1-1Y55S32Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1009 10091335A1-1XDAH01Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-02-22BJC4591001DVC4591001 1009 10091336A1-1XSGB17Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-31BC4591001DVC4591001 1009 10091338A1-1OTC0L3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-18B$C4591001DVC4591001 1009 10091339A1-1PDX7EPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-18B$C4591001DVC4591001 1009 10091340A1-1YV6XUAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1009 10091344A1-1ZBJNERNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-07-30BC4591001DVC4591001 1009 10091347A1-1ZH2UNXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-05BC4591001DVC4591001 1009 10091350A1-1ZALCUNOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-07-06BC4591001DVC4591001 1009 10091351A1-1ZE8U0XSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-22BaC4591001DVC4591001 1009 10091355A1-1ZD1VOFNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-08BC4591001DVC4591001 1009 10091356A1-1PKDRMGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-10B9C4591001DVC4591001 1009 10091358A1-1YV6XUXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1009 10091360A1-1YBEUBNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1009 10091361A1-1Z7HG8PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-19BC4591001DVC4591001 1009 10091362A1-1PAQ0TFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1009 10091363AP1-1ZMN4LIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-27BC4591001DVC4591001 1009 10091363A@1-1PDYN65Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-09B7C4591001DVC4591001 1009 10091363A01-1PDX7ESVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1009 10091363A 1-1ZD1VOINasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-12BC4591001DVC4591001 1009 10091363A1-1OS1Q5BLab performed out of window Laboratory Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1009 10091364A 1-1Z6VL0AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-12BC4591001DVC4591001 1009 10091364A1-1OVT3GIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-19B"C4591001DVC4591001 1009 10091365A01-1ZJNOUTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-19BC4591001DVC4591001 1009 10091365A 1-1OVT3GMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-19B"C4591001DVC4591001 1009 10091365A1-1ZB90CKOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1009 10091366A`1-1XSGB1AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-22BC4591001DVC4591001 1009 10091366AP1-1RVXPUNUrine pregnancy test not performed. Laboratory Non-ImportantFOLLOW-UP 2021-03-04BNC4591001DVC4591001 1009 10091366A@1-1QZSYN3Urine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1009 10091366A01-1ZJ22XRNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-28BC4591001DVC4591001 1009 10091366A 1-1ZNNH4TRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-08-10BC4591001DVC4591001 1009 10091366A1-1ZK3KGFSubject was vaccinated despite the site being instructed to discontinue further vaccination Investigational ProductImportant FOLLOW-UP 2021-02-26BHC4591001DVC4591001 1009 10091380A1-1ZIUMM3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-18BC4591001DVC4591001 1009 10091382A1-1ZNKP23Nasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-07-08BC4591001DVC4591001 1009 10091387A1-1R1RFRNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-05B;C4591001DVC4591001 1009 10091390A1-1ZCT7KEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-27BC4591001DVC4591001 1009 10091394A 1-1ZMN4LLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BvC4591001DVC4591001 1009 10091394A1-1WTNEWIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-27BoC4591001DVC4591001 1009 10091395A 1-1ZKZNV1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BvC4591001DVC4591001 1009 10091395A1-1WTNEWLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-27BoC4591001DVC4591001 1009 10091396A1-1ZH2UO0Potential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-11BC4591001DVC4591001 1009 10091399A1-1ZB3T04Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-20BC4591001DVC4591001 1009 10091400A01-1QZ3TPRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-12B$C4591001DVC4591001 1009 10091400A 1-1ZMN4LOLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-07-28BC4591001DVC4591001 1009 10091400A1-1YWWQWWLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-06-18BC4591001DVC4591001 1009 10091404A1-1ZB3T07Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1009 10091406A1-1SSS10VPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1009 10091407AP1-1ZHWDGKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1009 10091407A@1-1Z499TBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1009 10091407A01-1ZHVLXGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BqC4591001DVC4591001 1009 10091407A 1-1ZD1VPINasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-31BC4591001DVC4591001 1009 10091407A1-1ZD1VPFNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1009 10091408A 1-1ZB3T0AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-20BC4591001DVC4591001 1009 10091408A1-1YK0FBJNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-24BC4591001DVC4591001 1009 10091409A1-1ZB3T0DVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-20BC4591001DVC4591001 1009 10091410A 1-1YBECDLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1009 10091410A1-1PAG7MTVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-01BC4591001DVC4591001 1009 10091412A01-1YY0VDWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-02BC4591001DVC4591001 1009 10091412A 1-1T8K11VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-15B?C4591001DVC4591001 1009 10091412A1-1ZE8U10Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-29BMC4591001DVC4591001 1009 10091413A1-1Z9VPFJNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-27BC4591001DVC4591001 1013 10131821A1-1P02XECICD signed by unauthorized site personnel Informed Consent Non-ImportantFOLLOW-UP 2021-01-27B;C4591001DVC4591001 1013 10131823A 1-1ZJQFESSite staff training missing/incomplete Other Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1013 10131823A125453201IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1013 10131824A1-1OTC3LSSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-01-19B2C4591001DVC4591001 1013 10131828A 1-1Y55S3FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1013 10131828A1-1OI3QA0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1013 10131830AP1-1ZMNWARVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-22BC4591001DVC4591001 1013 10131830A@1-1PDYT7DVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-18B0C4591001DVC4591001 1013 10131830A01-1OT48B1Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantFOLLOW-UP 2021-01-18B0C4591001DVC4591001 1013 10131830A 1-1OTC5ONVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1013 10131830A1-1PO9518Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-01-28B:C4591001DVC4591001 1013 10131835A1-1OTBW9SVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1013 10131839A01-1Z6W3C1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1013 10131839A 1-1P6MT44Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-19B1C4591001DVC4591001 1013 10131839A1-1ZA0E4VReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1013 10131841A 1-1OTBW9VVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1013 10131841A1-1QZCEMEProcedure/Test not performed per protocol Procedures/Tests Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1013 10131842AP1-1ZB3T13Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-20BC4591001DVC4591001 1013 10131842A@1-1YM00WRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BC4591001DVC4591001 1013 10131842A01-1WTQAQPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05B}C4591001DVC4591001 1013 10131842A 1-1OTC5OZVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1013 10131842A1-1OTBW9YVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1013 10131843A`1-1Z6W3C4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1013 10131843AP1-1YNZMB8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06BC4591001DVC4591001 1013 10131843A@1-1YNZMB5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BC4591001DVC4591001 1013 10131843A01-1PDYT7GVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-27B9C4591001DVC4591001 1013 10131843A 1-1ZF2K6RNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-16BC4591001DVC4591001 1013 10131843A1-1ZF2K28Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-02BC4591001DVC4591001 1013 10131844A01-1YV6XV3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-14BC4591001DVC4591001 1013 10131844A 1-1YV6XV0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06BC4591001DVC4591001 1013 10131844A1-1PDYTCTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-27B9C4591001DVC4591001 1013 10131845A@1-1ZMNWAUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-29BC4591001DVC4591001 1013 10131845A01-1WTQAQSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-22BnC4591001DVC4591001 1013 10131845A 1-1OTBWA1Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1013 10131845A1-1QZCEMIProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-01-21B2C4591001DVC4591001 1013 10131850A01-1YNZMBBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1013 10131850A 1-1WNXXF8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-23BSC4591001DVC4591001 1013 10131850A1-1OTC5P5Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1013 10131851A 1-1ZSWS68Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-31CC4591001DVC4591001 1013 10131851A1-1ZH10SYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-26BC4591001DVC4591001 1013 10131856A1-1PLVATBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-08B>C4591001DVC4591001 1013 10131858A 1-1Z6G6WZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-15BC4591001DVC4591001 1013 10131858A1-1WTQAQVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BqC4591001DVC4591001 1013 10131859A@1-201SLGJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-13BC4591001DVC4591001 1013 10131859A01-1ZIM2GCNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-09BC4591001DVC4591001 1013 10131859A 1-1ZIM2G9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1013 10131859A1-1ZIM2F2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-03BtC4591001DVC4591001 1013 10131861A 1-1ZNJA6OVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-25C0C4591001DVC4591001 1013 10131861A1-1OS50V9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1013 10131865A 1-1ZHVRQTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BC4591001DVC4591001 1013 10131865A1-1ZIM2GFNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-11BwC4591001DVC4591001 1013 10131866A 1-1ZHVRQXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BC4591001DVC4591001 1013 10131866A1-1ZIM2GSNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-11BwC4591001DVC4591001 1013 10131867AP1-1YY0VE2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-30BC4591001DVC4591001 1013 10131867A@1-1Z3S3C8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BC4591001DVC4591001 1013 10131867A01-1WNXXFLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-10BTC4591001DVC4591001 1013 10131867A 1-1OTBWA7Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1013 10131867A1-1V8LW61Lab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-03-16BZC4591001DVC4591001 1013 10131868A126429301IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1013 10131869A1-1PG5YQ1Participant randomized into incorrect age stratum in Impala Randomization Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1013 10131870A126429501IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1013 10131872A 1-1SST1U8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-17BWC4591001DVC4591001 1013 10131872A126429401IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1013 10131873A01-1PF862OVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-03B,C4591001DVC4591001 1013 10131873A 1-1ZHJ099Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-18BC4591001DVC4591001 1013 10131873A1-1ZF2K6UNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-16BC4591001DVC4591001 1013 10131874A 1-1ZMNWCLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-19BC4591001DVC4591001 1013 10131874A1-1PF862RVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-03B,C4591001DVC4591001 1013 10131877A01-1R163EXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-01BEC4591001DVC4591001 1013 10131877A 1-1ZF2K6XNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-05BC4591001DVC4591001 1013 10131877A126525801IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1013 10131878A 1-1ZMNWCOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-22ByC4591001DVC4591001 1013 10131878A1-1XE9KW3Potential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1013 10131880A@1-1YNZMBEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1013 10131880A01-1WTQAQYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-22BZC4591001DVC4591001 1013 10131880A 1-1WNXXFOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03BGC4591001DVC4591001 1013 10131880A1-1ZAYZKBNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-31BC4591001DVC4591001 1013 10131882A 1-1WTQARLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03B@C4591001DVC4591001 1013 10131882A1-1WNXXFRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-23B8C4591001DVC4591001 1013 10131883A 1-1ZKZNV5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-21BpC4591001DVC4591001 1013 10131883A1-1XA31YTUrine pregnancy test not performed. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1013 10131884A1-1ZIUMM7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-18BC4591001DVC4591001 1013 10131885A127000101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1016 10161307A 1-1WNXXFXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-25BC4591001DVC4591001 1016 10161307A1-1ZBKUF7Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161308A1-1ZBKUGYUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161310A1-1ZBKUH1Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161311A1-1WZ8A6TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-11BC4591001DVC4591001 1016 10161314A1-1ZBKUH4Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1016 10161314A 1-1WH6QX9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24BC4591001DVC4591001 1016 10161315A01-1WH6QXMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-09BuC4591001DVC4591001 1016 10161315A 1-1ZBKUI1Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1016 10161315A1-1PFGQHRLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-02-09BuC4591001DVC4591001 1016 10161316A1-1O4N1URVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-11-13BC4591001DVC4591001 1016 10161318A1-1ZBKUI4Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161319A1-1ZBKUI7Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-18BC4591001DVC4591001 1016 10161320A1-1ZBKUIAUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1016 10161322A1-1ZBKUIXUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161323A1-1ZBKUJ0Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161324A1-1ZBKUJ3Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161325A1-1ZBKUJGUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161326A1-1ZBKUJJUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161327A1-1ZBKPG3Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161329A1-1ZBKPG7Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1016 10161330A1-1ZBKPGAUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161331A 1-1ZBKPNBUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-18BC4591001DVC4591001 1016 10161331A1-1ZHW9QZNasal swab collected at a visit where it was not required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-08-09C`C4591001DVC4591001 1016 10161332A1-1ZBKPNEUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1016 10161334A1-1ZBKPNHUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1016 10161335A 1-1WTQARUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BC4591001DVC4591001 1016 10161335A1-1ZBKPNKUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1016 10161336A01-1WTQARXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BC4591001DVC4591001 1016 10161336A 1-1ZBL5IHUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1016 10161336A1-1ZBAIRMOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-05C C4591001DVC4591001 1016 10161338A01-1OSSM9YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2020-12-28BDC4591001DVC4591001 1016 10161338A 1-1ZBL5IKUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1016 10161338A1-1OESW8DIncorrect serology sample volume collected Laboratory Non-ImportantVACCINATION 2020-10-22AC4591001DVC4591001 1016 10161339A1-1ZBL5INUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1016 10161340A1-1ZBL5JAUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1016 10161343A1-1ZBL5JDUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1016 10161344A1-1ZBL5JGUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1016 10161350A1-1YBECDPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1016 10161351A1-1Z6G6X2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-12BC4591001DVC4591001 1016 10161356A1-1ZMNWCRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1016 10161357A1-1WTQAS0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BC4591001DVC4591001 1016 10161361A1-1WTQAS3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-12BcC4591001DVC4591001 1016 10161362A 1-1ZMNWCUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1016 10161362A1-1OS8YWUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1016 10161363A 1-1WH6QXPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-23BNC4591001DVC4591001 1016 10161363A1-1SXW32MPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantVACCINATION 2021-01-08B C4591001DVC4591001 1016 10161364A@1-1YV6XVJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1016 10161364A01-1YV6XVGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-28BC4591001DVC4591001 1016 10161364A 1-1WTQAS9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-20BC4591001DVC4591001 1016 10161364A1-1WTQAS6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-26BlC4591001DVC4591001 1016 10161366A@1-1Z3S3CBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-07BC4591001DVC4591001 1016 10161366A01-1UCOGAQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BqC4591001DVC4591001 1016 10161366A 1-1QTCH4NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-17BAC4591001DVC4591001 1016 10161366A1-1ZBAISZOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-07-06BC4591001DVC4591001 1016 10161369A1-1PI38GEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1016 10161370AP1-1Z6W3CKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1016 10161370A@1-1Z6W3CHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-17BC4591001DVC4591001 1016 10161370A01-1WTQASCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06B]C4591001DVC4591001 1016 10161370A 1-1OQLI4GSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1016 10161370A1-1OQLI4ASubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1016 10161376A 1-1Z6W3CNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1016 10161376A1-1YM00WVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1016 10161377A 1-1Z6W3CQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1016 10161377A1-1YM00WYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1016 10161378A1-1ZCJKLIUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1016 10161379A01-1YV6XVMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-28BC4591001DVC4591001 1016 10161379A 1-1YP0QZZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-28BC4591001DVC4591001 1016 10161379A1-1PDYTCWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-05BC4591001DVC4591001 1016 10161381A1-1ZHW9ODVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-04BC4591001DVC4591001 1016 10161382A1-1Z8JZN5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1016 10161384A01-1YV6XW2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1016 10161384A 1-1YV6XVZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12B}C4591001DVC4591001 1016 10161384A1-1WH6QXSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-17B)C4591001DVC4591001 1039 10391250A 1-1YXOAEWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1039 10391250A1-1Z3S3JIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1039 10391251A1-1OTLH1DVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1039 10391252A1-1V9RO1QAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-04-15BC4591001DVC4591001 1039 10391255A1-1Z4EZ0HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1039 10391256A01-1XK8VV6Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391256A 131647801Other IP deviation Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391256A131632401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391258A01-1XO2U2GIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391258A 131862401IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1039 10391258A131633601IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391259A01-1XO2U2OIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391259A 131739301Other IP deviation Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391259A131737001IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391260A1-1ZE7IL5Other Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1039 10391264A@1-1R0TGKPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-01BTC4591001DVC4591001 1039 10391264A01-1XA0FOFAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1039 10391264A 1-1XO2U2RIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1039 10391264A131862301IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1039 10391265A1-1R0TGKSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-01BTC4591001DVC4591001 1039 10391266A1-1XO2U2UIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391268A 1-1XO2U2XIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391268A131632501IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391270A 1-1XO2U30Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391270A131632601IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391271A 1-1XO2U33Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391271A131633301IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391273A 1-1XO2U36Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391273A131633401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391274A1-1XO2U39Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391277A 1-1XO2U3CIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391277A131632701IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391279A 1-1X4R37JAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1039 10391279A1-1XO2U3FIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1039 10391280A1-1XO2U3IIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391281A1-1Z9VPFMNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-23BC4591001DVC4591001 1039 10391283A1-1XO2U3LIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391285A01-1Z4H7FBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-12BC4591001DVC4591001 1039 10391285A 1-1XO2U3OIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391285A131675401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391286A@1-1ZIM2HENasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1039 10391286A01-1ZIM2HBNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1039 10391286A 1-1ZIM2GYNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1039 10391286A1-1ZIM2GVNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1039 10391287A 1-1XO2U3RIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391287A131632301IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391292A1-1XO2U48Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391294A 1-1XO2U4BIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391294A131675301IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391296A01-1Y76TP1Assessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-06-04BC4591001DVC4591001 1039 10391296A 1-1XO2U4EIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391296A131675801Other IP deviation Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391297A 1-1OUFGFZVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1039 10391297A1-1QW05QOSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-22B8C4591001DVC4591001 1039 10391299A1-1XO2U4HIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391300A1-1QT350LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22B8C4591001DVC4591001 1039 10391301A01-1Z4WZJQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-13BC4591001DVC4591001 1039 10391301A 1-1XO2U4KIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391301A131633501IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391303A1-1XO2U4NIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1039 10391304A1-1QZ3TQBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24B:C4591001DVC4591001 1039 10391305A 1-1Z4EZ0NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-12BC4591001DVC4591001 1039 10391305A1-1XO2U4QIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391307A 1-1XO2U4TIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391307A131737101IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391308A1-1OT9E0ZUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1039 10391309A01-1Z8JZNBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1039 10391309A 1-1XO2U4WIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1039 10391309A131737501IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1039 10391310A01-1Y1PBIFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1039 10391310A 1-1XO2U4ZIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391310A131737201IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391311A1-1Z9VJW9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1039 10391312A1-1ZGKJ9SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-10BC4591001DVC4591001 1039 10391313A 1-1XO2U52Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391313A131675701IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391314A 1-1XO2U55Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1039 10391314A131737401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1039 10391317A01-1R2N24TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-26B3C4591001DVC4591001 1039 10391317A 1-1S02Y4LNasal swab collected at a visit where it was not required Laboratory Non-ImportantFOLLOW-UP 2021-03-02B7C4591001DVC4591001 1039 10391317A1-1XO2U58Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1039 10391318A 1-1ZEM9G4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-09BC4591001DVC4591001 1039 10391318A1-1ZNKOP9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-23BC4591001DVC4591001 1039 10391319A01-1XO2U7JIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1039 10391319A 131873801IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1039 10391319A131861901IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1039 10391320A01-1ZJE4GTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-23BC4591001DVC4591001 1039 10391320A 1-1Z7FGYKReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-13BC4591001DVC4591001 1039 10391320A1-1X6ZZ00Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1039 10391321A 1-1P93YSNUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1039 10391321A1-1XO2U7MIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1039 10391325A1-1XO2U7PIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B{C4591001DVC4591001 1039 10391327A 1-1Y24OS7Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-05BC4591001DVC4591001 1039 10391327A1-1X70YRLReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-15B}C4591001DVC4591001 1039 10391328A 1-1XO2U7SIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14B|C4591001DVC4591001 1039 10391328A131675601IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-14B|C4591001DVC4591001 1039 10391329A01-1XOLIALIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1039 10391329A 131874101IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1039 10391329A131862001IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1039 10391330A1-1ZH29RPPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1039 10391333A01-1XOLIAOIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1039 10391333A 131862101IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1039 10391333A131951301IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1039 10391334A 1-1XOLIARIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1039 10391334A131862201IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1039 10391337A1-1XOLIAUIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14B{C4591001DVC4591001 1039 10391339A 1-1XOLIAXIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1039 10391339A131737701IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1044 10441251A 1-1ZHVRR0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1044 10441251A1-1ZIM2HHNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-31BC4591001DVC4591001 1044 10441252A1-1XI77XOIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441253A1-1YRZ2LMSurveillance for asymptomatic SARS-CoV-2 infection is performed after Visit-4 Other Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1044 10441255A1-1OEJ3JOOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1044 10441256A 1-1XF78UQIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441256A1-1OEJNTGOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1044 10441257A1-1PF8637Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-19B2C4591001DVC4591001 1044 10441260A1-1X4317RIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441261A 1-1OS3076Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-18B1C4591001DVC4591001 1044 10441261A1-1XIEIZLIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441264A 1-1ZJNOUXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-23C@C4591001DVC4591001 1044 10441264A1-1ZGMKN9Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-08BC4591001DVC4591001 1044 10441265A1-1XF78UNIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441266A1-1YG8TBELab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-01BC4591001DVC4591001 1044 10441267A1-1XF78UKIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441270A01-1X44111Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1044 10441270A 1-1X4410VRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1044 10441270A1-1P4J85ROther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1044 10441271A01-1P4JVCXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1044 10441271A 1-1Z4VTNYReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1044 10441271A1-1Z64ZDTReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1044 10441275A1-1XF78UHIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441276A1-1PF863AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-25B0C4591001DVC4591001 1044 10441277A1-1XF6VNYIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441278A 1-1YS04S7Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1044 10441278A1-1YS04S1Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1044 10441280A1-1PFEZ97Other Informed Consent Informed Consent Non-ImportantSCREENING 2020-10-29)C4591001DVC4591001 1044 10441281A1-1P4JVE2Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-09AC4591001DVC4591001 1044 10441284A1-1X4I040Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1044 10441285A 1-1P9A3XZOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1044 10441285A1-1P4JVENOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1044 10441286A 1-1X5U5HWIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441286A1-1X5SA8QOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1044 10441288A1-1YIQUTKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1044 10441289A1-1OTLH1HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1044 10441292A129890401IP documentation error IP preparation form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-04-01BjC4591001DVC4591001 1044 10441293A@1-1YSDS0RVisit not done Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1044 10441293A01-1XI77XHIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441293A 1-1X5U65HOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441293A1-1YBSBOMReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant OPEN LABEL TREATMENT2021-06-04BC4591001DVC4591001 1044 10441294A@1-1YSDS0VVisit not done Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1044 10441294A01-1XF6VNVIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441294A 1-1X5U66MOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441294A1-1YXG8J2Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant OPEN LABEL TREATMENT2021-06-04BC4591001DVC4591001 1044 10441295A 1-1ZBK2CTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1044 10441295A1-1ZHJ07RNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-11BC4591001DVC4591001 1044 10441301A1-1ZC5VQSSubject/LAR did not sign the ICD but gave verbal consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1044 10441302A1-1XF6VNRIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441303A 1-1P6MY2NOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1044 10441303A1-1P6MY0JOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1044 10441308A1-1XEWESTIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441309A1-1XSWW3XOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-04-29ByC4591001DVC4591001 1044 10441312A1-1XEWESQIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441315A1-1XIIUESIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441317A1-1XEWESNIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441318A1-1XEWESJIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441319A1-1ZHJ07VNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-01BC4591001DVC4591001 1044 10441320A1-1XEW3HOIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441322A1-1YBPIORSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-02B9C4591001DVC4591001 1044 10441323A1-1XIMI20Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441324A1-1XEW3HLIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441326A1-1XEW3H8Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441327A1-1XEW3H5Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441328A1-1ZHW9OHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1044 10441329A1-1ZH2UOPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-10BC4591001DVC4591001 1044 10441330A1-1XEW3H2Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441331A1-1P4HDGOOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1044 10441332A 1-1XA5OHXIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1044 10441332A1-1P4H28YOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1044 10441333A1-1QZDT2QOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-26B4C4591001DVC4591001 1044 10441334A1-1R25YIQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-05B:C4591001DVC4591001 1044 10441335A01-1Z39HM9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-07-08BC4591001DVC4591001 1044 10441335A 1-1XEW3DXIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1044 10441335A1-1P4HS1AOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1044 10441336A1-1ZHJ07YNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1044 10441337A1-1XEW3DUIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441338A1-1P4HS7ZOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1044 10441339A1-1P4IE6BOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1044 10441340A 1-1X4I0PAIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B~C4591001DVC4591001 1044 10441340A1-1P9A429Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1044 10441341A1-1XA5OC7Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B~C4591001DVC4591001 1044 10441344A1-1SSQJNGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-03-16BCC4591001DVC4591001 1044 10441345A1-1XEW3DRIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441346A1-1P4J31POther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-09AC4591001DVC4591001 1044 10441348A1-1XEW3DOIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441350A 1-1PG6OK3Participant randomized into incorrect age stratum in Impala Randomization Non-ImportantVACCINATION 2021-01-09AC4591001DVC4591001 1044 10441350A1-1P4J39AOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-09AC4591001DVC4591001 1044 10441351A 1-1ZCT7M4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1044 10441351A1-1P4J39WOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-10AC4591001DVC4591001 1044 10441353A1-1ZBRT3RICD signed by subject/LAR had not received IRB/IEC approval Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1044 10441354A1-1XEW3DLIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1044 10441355A1-1ZAED6SOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1044 10441356A01-1ZBRTAHICD signed by subject/LAR had not received IRB/IEC approval Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1044 10441356A 1-1ZDSNTRReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1044 10441356A1-1ZDSNTUReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14B}C4591001DVC4591001 1044 10441357A 1-1XEW3DIIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1044 10441357A1-1P9NP45Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-10AC4591001DVC4591001 1044 10441358A 1-1WZ7WX7Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B7C4591001DVC4591001 1044 10441358A1-1P4KWCQOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-10AC4591001DVC4591001 1044 10441359A01-1QZ3TQEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-25B.C4591001DVC4591001 1044 10441359A 1-1QZSEWUUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441359A1-1ZAED7OOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1044 10441360A 1-1QZ3TQHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-25B.C4591001DVC4591001 1044 10441360A1-1XEW3DFIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1044 10441361A1-1ZMOHA4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1044 10441362A1-1XIEISIIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B{C4591001DVC4591001 1044 10441363A 1-1XA5OC4Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14B|C4591001DVC4591001 1044 10441363A1-1P4LJ88Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441365A01-1XIIUEXIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B{C4591001DVC4591001 1044 10441365A 1-1P4LJCJOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441365A1-1P4LJC3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441366A 1-1P4M1FPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441366A1-1P4LJCPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441367A 1-1P4M1H6Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441367A1-1P4M1FVOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441368A130185201IP documentation error IP preparation form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-03-30BOC4591001DVC4591001 1044 10441369A@1-1ZHW9OKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1044 10441369A01-1ZB3T7EVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1044 10441369A 1-1P4MDNAOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441369A1-1P4MDN4Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441370A 1-1P4MDRAOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441370A1-1P4MDQ0Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441372A1-1P4NM1COther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1044 10441373A1-1XEW3D2Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17B~C4591001DVC4591001 1044 10441374A1-1P4ME7UOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441375A1-1ZBRTCCICD signed by subject/LAR had not received IRB/IEC approval Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1044 10441376A01-1P4N75WOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441376A 1-1P4N756Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441376A1-1ZBRTE2ICD signed by subject/LAR had not received IRB/IEC approval Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1044 10441377A01-1Z6W3DNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1044 10441377A 1-1QVZNTNVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-22BC4591001DVC4591001 1044 10441377A1-1ZIM2HKNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1044 10441378A 1-1P4MZXNOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441378A1-1P4MZWXOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441380A 1-1XEW3CZIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BzC4591001DVC4591001 1044 10441380A1-1P4MZYOOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441381A01-1Y55S3IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-11BC4591001DVC4591001 1044 10441381A 1-1XIEIS9Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17B~C4591001DVC4591001 1044 10441381A1-1P4NLRNOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441382A01-1XI77XLIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BzC4591001DVC4591001 1044 10441382A 1-1P4NLWFOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441382A1-1P4NLVPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441383A01-1ZCT7MRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1044 10441383A 1-1P4NLXVOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441383A1-1P4NLWLOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1044 10441384A1-1XEW3CVIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1057 10571376A 1-1OTLT2ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1057 10571376A1-1OJOITMOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1057 10571379A1-1Z3S3JRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-06BC4591001DVC4591001 1057 10571380A1-1OTLT32Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1057 10571382A1-1OTLT35Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1057 10571383A1-1Y55S3LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-11BC4591001DVC4591001 1057 10571388A01-1Z7HZD4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1057 10571388A 1-1Z3S3JUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1057 10571388A1-1PFBCGFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-03B9C4591001DVC4591001 1057 10571389A01-1OTLT38Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1057 10571389A 1-1Z7FGZAReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-12BC4591001DVC4591001 1057 10571389A1-1Z7FGZ7Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-23BC4591001DVC4591001 1057 10571391A 1-1UCOGATVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-04-07BxC4591001DVC4591001 1057 10571391A1-1QYIC26Procedure/Test not performed per protocol Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-02-24BNC4591001DVC4591001 1057 10571394A1-1XIHFPAOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1057 10571395A@1-1OS3079Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-14B%C4591001DVC4591001 1057 10571395A01-1OTC13WVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-14B%C4591001DVC4591001 1057 10571395A 1-1ZIMKN3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1057 10571395A1-1QYVAY5Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-17BGC4591001DVC4591001 1057 10571396A@1-1Z3S3JXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1057 10571396A01-1PPEUYFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-11B@C4591001DVC4591001 1057 10571396A 1-1OTMNKTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1057 10571396A1-1Z7WAR7Nasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1057 10571398A1-1XSGB35Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-03BC4591001DVC4591001 1057 10571399A1-1R1TIWJNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-02-08B=C4591001DVC4591001 1057 10571400A 1-1ZJNOV0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-04BC4591001DVC4591001 1057 10571400A1-1QAG8QGNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-01-19B(C4591001DVC4591001 1057 10571401A 1-1YY0VE6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1057 10571401A1-1OJNEENOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1057 10571402A1-1R0XBYWProcedure/Test not performed per protocol Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-03-03BPC4591001DVC4591001 1057 10571404A@1-1QW7RLAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-16B?C4591001DVC4591001 1057 10571404A01-1OTBWAQVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1057 10571404A 1-1POJ18UProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-16B?C4591001DVC4591001 1057 10571404A1-1ZIM2M3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-13BwC4591001DVC4591001 1057 10571408A 132107401IP documentation error IP preparation form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1057 10571408A1-1XIHFRVOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1057 10571409A1-1ZIM2M6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-13BC4591001DVC4591001 1057 10571411A1-1YV7391Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1057 10571412A@1-1ZB3T7UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1057 10571412A01-1XSHVNPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-28BC4591001DVC4591001 1057 10571412A 1-1XSGB38Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-29BC4591001DVC4591001 1057 10571412A1-1ZIM2M9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1057 10571413A1-1QYDAN9Randomization done out of sequence Randomization Non-ImportantSCREENING 2020-12-21AC4591001DVC4591001 1057 10571414A1-1TVTP2UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-26B`C4591001DVC4591001 1057 10571415A@1-1Z7HZD8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-09BC4591001DVC4591001 1057 10571415A01-1ROCW9BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-12BRC4591001DVC4591001 1057 10571415A 1-1OS307CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-14BC4591001DVC4591001 1057 10571415A1-1OQ3W62Subject/LAR signed consent but did not date it Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1057 10571416A 1-1TB0ZMOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-21B[C4591001DVC4591001 1057 10571416A1-1U10WZ0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-19BYC4591001DVC4591001 1057 10571417A@1-1YV7395Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1057 10571417A01-1X5VTP1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1057 10571417A 1-1QW7RLDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-16B:C4591001DVC4591001 1057 10571417A1-1V9SP86Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-08BmC4591001DVC4591001 1057 10571418A1-1OSO0CPVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1057 10571419A1-1QW99BDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-16B9C4591001DVC4591001 1057 10571420A1-1OTC5PEVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-23AC4591001DVC4591001 1057 10571422A 1-1OSE3Z2Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1057 10571422A1-1QZCK4QProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-10B2C4591001DVC4591001 1057 10571423A1-1YGVR68Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-28B~C4591001DVC4591001 1057 10571426A01-1PFBCGJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1057 10571426A 1-1R0XW3CSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-03BFC4591001DVC4591001 1057 10571426A1-1T4K572Nasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1057 10571427A@1-1ZHFDYBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1057 10571427A01-1P99Q83Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1057 10571427A 1-1ZIMKLANasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1057 10571427A1-1R1TIWMNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1057 10571428A01-1ZHW9ONVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1057 10571428A 1-1P85LUEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-03B*C4591001DVC4591001 1057 10571428A1-1PFBUHTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1057 10571429A01-1ZHFDYFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1057 10571429A 1-1PFBUHWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1057 10571429A1-1ZIMKLDNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1057 10571431A1-1YY0VE9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-21BC4591001DVC4591001 1057 10571432A1-1PG5AYAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-11B,C4591001DVC4591001 1057 10571434A 1-1PPEV1AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-18B2C4591001DVC4591001 1057 10571434A1-1YGVRK7Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1057 10571436A01-1ZHW9OQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-17BC4591001DVC4591001 1057 10571436A 133628501IP documentation error IP preparation form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-07-22BC4591001DVC4591001 1057 10571436A1-1ZU7VTAOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1057 10571437A1-1ZU6STVOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1057 10571438A 1-1WNXXHAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06B]C4591001DVC4591001 1057 10571438A1-1ZIMKLGNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1057 10571440A1-1Z8JZNEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1057 10571441A 1-1X5XE3DVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1057 10571441A1-1P9Y0UZVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1057 10571442A01-1ZCT7NUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-22BC4591001DVC4591001 1057 10571442A 1-1P9Y0X2Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-29BC4591001DVC4591001 1057 10571442A133628701IP documentation error IP preparation form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-07-22BC4591001DVC4591001 1057 10571443A 1-1ZHW9OTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-11BC4591001DVC4591001 1057 10571443A1-1ZIMKMONasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-06BC4591001DVC4591001 1057 10571444A 1-1ZHW9OWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-11BC4591001DVC4591001 1057 10571444A1-1ZIMKMRNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-06BC4591001DVC4591001 1057 10571445A1-1ZIMKMUNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-04BrC4591001DVC4591001 1057 10571446A1-1PAG7MWVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-01BC4591001DVC4591001 1057 10571447A 1-1ZMOHIDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BxC4591001DVC4591001 1057 10571447A1-1PAGL3FVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-01BC4591001DVC4591001 1057 10571448A@1-1YV7398Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1057 10571448A01-1YV739LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BxC4591001DVC4591001 1057 10571448A 1-1PAGL3IVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-01BC4591001DVC4591001 1057 10571448A1-1ZIMKN6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1057 10571451A01-1Z9VJWFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1057 10571451A 1-1YY0VECVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1057 10571451A1-1YGVRKANasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-14B{C4591001DVC4591001 1057 10571452A1-1ZIMKMXNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1057 10571453A1-1P9Y0NXNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-02-01BC4591001DVC4591001 1057 10571454A 1-1ZIMKN0Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1057 10571454A127406501IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2021-02-03BC4591001DVC4591001 1066 10661394AP1-1YBECEPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-15BC4591001DVC4591001 1066 10661394A@1-1ZKZNV8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-16BC4591001DVC4591001 1066 10661394A01-1OCQ6GOVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-09AC4591001DVC4591001 1066 10661394A 1-1X6A31BOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1066 10661394A1-1UCYA9VOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1066 10661395A 1-1YM0M5KVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1066 10661395A1-1YM0M5HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-13BC4591001DVC4591001 1066 10661397A1-1OS307ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-18B1C4591001DVC4591001 1066 10661401A@1-1WNXXHDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BxC4591001DVC4591001 1066 10661401A01-1R2N12MLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-03-10BcC4591001DVC4591001 1066 10661401A 1-1R2N1FBOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-03B\C4591001DVC4591001 1066 10661401A1-1OJPYDLOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-21BC4591001DVC4591001 1066 10661402A1-1R069XLOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-02B[C4591001DVC4591001 1066 10661403A 1-1P17VXSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-28B9C4591001DVC4591001 1066 10661403A1-1X6A31MOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1066 10661404A 1-1P2Q1X6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-28B9C4591001DVC4591001 1066 10661404A1-1R2N1BTOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-04B\C4591001DVC4591001 1066 10661407A1-1OJPYE0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1066 10661409A1-1P2QYJIOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1066 10661410A1-1P2QYVSOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1066 10661411A1-1OJPYEPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1066 10661412A 1-1Z8JZNRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1066 10661412A1-1Z7JCRFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1066 10661414A1-1ZMOHJNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-24BC4591001DVC4591001 1066 10661415A 1-1ZMOHJQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-26BC4591001DVC4591001 1066 10661415A1-1RU8TTOOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-08BUC4591001DVC4591001 1066 10661417A1-1ZHU0P6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-18BC4591001DVC4591001 1066 10661418A1-1YLIKXXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-17BC4591001DVC4591001 1066 10661419A1-1Z7HZDBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1066 10661421A1-1Z6GSJBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-17BC4591001DVC4591001 1066 10661423A 1-1YBECESVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1066 10661423A1-1P17W3SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1066 10661425A01-1ZMOHJTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1066 10661425A 1-1ZH29XAPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1066 10661425A1-1R2N1HFOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-02B9C4591001DVC4591001 1066 10661427A 1-1ZHVRW3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1066 10661427A1-1ZIMKNUNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-13BC4591001DVC4591001 1066 10661430A01-1ZHW9OZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1066 10661430A 1-1YNLIHVNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-16BC4591001DVC4591001 1066 10661430A1-1YDS916Lab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1066 10661431A1-1Z6W3DQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1066 10661432A01-1ZMP80PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1066 10661432A 1-1R06A0PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03B8C4591001DVC4591001 1066 10661432A1-1R06A0NOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-03B8C4591001DVC4591001 1066 10661433A 1-1WNXXHGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BaC4591001DVC4591001 1066 10661433A1-1WKGILOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BYC4591001DVC4591001 1066 10661434A 1-1ZHVRW6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1066 10661434A1-1Z7WBFSNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-03BC4591001DVC4591001 1066 10661435A 1-1ZHVRW9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1066 10661435A1-1Z7X8NWNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-03BC4591001DVC4591001 1077 10771275A1-1OTC5PKVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1077 10771277A 1-1OTC5Q0Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1077 10771277A1-1YWMHO1Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1077 10771278A1-1OTC5Q3Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1077 10771282A1-1X70YTBReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-15BC4591001DVC4591001 1077 10771284A1-1YV739OVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1077 10771287A1-1QZ3TQKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-15B?C4591001DVC4591001 1077 10771288A 1-1OTC5Q6Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1077 10771288A1-1OTBWD0Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1077 10771289A1-1XND6C8Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1077 10771290A1-1XND6CBReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1077 10771292A1-1OTBWD3Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1077 10771294A 1-1YNZMC0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-18BC4591001DVC4591001 1077 10771294A1-1Y7HCTIOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-22B9C4591001DVC4591001 1077 10771295A1-1YXAU31Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-02-25B<C4591001DVC4591001 1077 10771296A1-1Z3S3LKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1084 10841543A 1-1ZHVRWCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-30BC4591001DVC4591001 1084 10841543A132057201Other IP deviation Investigational ProductImportant OPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1084 10841545AP1-1Z499THVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-06BC4591001DVC4591001 1084 10841545A@1-1WTQAUFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-17BZC4591001DVC4591001 1084 10841545A01-1ZBAKVGPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1084 10841545A 1-1YGW4W6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1084 10841545A126305601IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-21A@C4591001DVC4591001 1084 10841548A1-1YVJHODNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1084 10841550A126305501IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1084 10841551AP1-1ZHFDYIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1084 10841551A@1-1ZHW9S5Visit not done Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08BmC4591001DVC4591001 1084 10841551A01-1ZIMKOANasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1084 10841551A 1-1ZIMKO7Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-20BC4591001DVC4591001 1084 10841551A1-1V8MAM9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-08BmC4591001DVC4591001 1084 10841552A 1-1YBECEYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-11BC4591001DVC4591001 1084 10841552A131731301IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1084 10841555A 1-1ZIMKOGNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1084 10841555A1-1ZIMKODNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-16BC4591001DVC4591001 1084 10841556A1-1SKY4UJRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-22B9C4591001DVC4591001 1084 10841560AP1-1YV739RVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-21BC4591001DVC4591001 1084 10841560A@1-1PFCI2HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-22BC4591001DVC4591001 1084 10841560A0132130401IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-28BC4591001DVC4591001 1084 10841560A 1-1VIRPIFOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-25B<C4591001DVC4591001 1084 10841560A1-1VIR1CSOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-25B<C4591001DVC4591001 1084 10841561A1-1ZBJNEVNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1084 10841562A 1-1YV739UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1084 10841562A1-1YNZMC3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-20BC4591001DVC4591001 1084 10841563A 1-1ZHW3RXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1084 10841563A1-1ZIMKNXNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1084 10841564A 1-1ZHFDZZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-05BC4591001DVC4591001 1084 10841564A1-1YJ08MCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1084 10841565A1-1Z49RQKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-07BC4591001DVC4591001 1084 10841566AP1-1Z49RQNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1084 10841566A@1-1OTTUDRVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-18BC4591001DVC4591001 1084 10841566A01-1OTBWD6Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1084 10841566A 1-1ZIMKY8Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1084 10841566A1-1ZIMKY5Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-22BC4591001DVC4591001 1084 10841567A 1-1ZHW3S0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06BC4591001DVC4591001 1084 10841567A1-1QZKYT1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24B9C4591001DVC4591001 1084 10841568A1-1R6YX5XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-08BEC4591001DVC4591001 1084 10841569A 1-1Z49RQQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-07BC4591001DVC4591001 1084 10841569A1-1Z3UG3SOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1084 10841570A1-1Z49RRXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-07BC4591001DVC4591001 1084 10841571A 1-1ZGPU9HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-04BC4591001DVC4591001 1084 10841571A1-1ZJPZBOSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantFOLLOW-UP 2021-05-07BC4591001DVC4591001 1084 10841572A 1-1PG6OT7Participant randomized into incorrect age stratum in Impala Randomization Non-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1084 10841572A132130601IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-28BC4591001DVC4591001 1084 10841575A1-1YV73A7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-06-30BC4591001DVC4591001 1084 10841578A 1-1ZIMKY2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1084 10841578A1-1ZIMKOJNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-18BC4591001DVC4591001 1084 10841579A1-1XD2IBCReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1084 10841582A1-1ZHW3S3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1084 10841586A01-1Z49RS0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-07BC4591001DVC4591001 1084 10841586A 1-1ZHW3U4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-22BiC4591001DVC4591001 1084 10841586A1-1ZIMKO0Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-12B_C4591001DVC4591001 1084 10841588A 1-1Z49XQDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-07BC4591001DVC4591001 1084 10841588A131731501IP Documentation Error - Confirmation of Treatment - Received Form errors Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1084 10841591A1-1OT3RASUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-11A@C4591001DVC4591001 1084 10841593A@1-1ZHW3U7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-07BxC4591001DVC4591001 1084 10841593A01-1WOTDBDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BvC4591001DVC4591001 1084 10841593A 1-1ZIMKO3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-27BnC4591001DVC4591001 1084 10841593A1-1Z8R4YLOther Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-23BC4591001DVC4591001 1084 10841594A01-1ZE57WTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-03BC4591001DVC4591001 1084 10841594A 1-1ZJO3SBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1084 10841594A1-1Z8R4P4Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1091 10911394A1-1OU3MTLParticipant randomized into incorrect age stratum in Impala Randomization Non-ImportantVACCINATION 2021-01-12B*C4591001DVC4591001 1091 10911396A 1-1OTC5QCVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-21BC4591001DVC4591001 1091 10911396A1-1YXHKDGSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantOPEN LABEL TREATMENT2021-06-25BC4591001DVC4591001 1091 10911399A 1-1ZB3TC5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1091 10911399A1-1OTOAG7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-07B#C4591001DVC4591001 1091 10911400A@1-1ZL0455Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-24CC4591001DVC4591001 1091 10911400A01-1Z2PN7QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-06BC4591001DVC4591001 1091 10911400A 1-1OTOAGBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1091 10911400A126403201IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1091 10911403A 1-1ZMQLYDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BC4591001DVC4591001 1091 10911403A1-1YGWXYANasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1091 10911404A 1-1Z65R7FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1091 10911404A1-1PLVATHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-09BAC4591001DVC4591001 1091 10911406A 1-1YBFWRQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-14BC4591001DVC4591001 1091 10911406A1-1ZGN0A6Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1091 10911412A 1-1YNZMC6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-22BC4591001DVC4591001 1091 10911412A1-1ZGN0A9Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1091 10911413A1-1OTOAIZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1091 10911414A 1-1OTOAJ2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1091 10911414A1-1QZCK4UProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-09B?C4591001DVC4591001 1091 10911415A 1-1OTBWDCVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1091 10911415A126403401IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1091 10911416A1-1OTBWDFVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1091 10911417A@1-1ZHFE02Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-04BC4591001DVC4591001 1091 10911417A01-1OTBWDIVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1091 10911417A 1-1X7QZHCUrine pregnancy test not performed. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1091 10911417A1-1X70Z4SLab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1091 10911423A1-1XN7T8VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-26BC4591001DVC4591001 1091 10911424A126403501IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1091 10911426A1-1Y77ZLBNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1091 10911427A1-1SSSYKILab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-03-12BWC4591001DVC4591001 1091 10911429A1-1WKGQ2XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-04-27BC4591001DVC4591001 1091 10911430A 1-1Y1PBIIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1091 10911430A1-1XA0G0ZUrine pregnancy test not performed. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1091 10911431A 1-1YY0VEFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-01BC4591001DVC4591001 1091 10911431A1-1OTOAJ5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-12BC4591001DVC4591001 1091 10911432A 1-1Y55S3XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1091 10911432A1-1PFCI2KVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-02B0C4591001DVC4591001 1091 10911437A126619801IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1091 10911439A1-1OTC113Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-08BC4591001DVC4591001 1091 10911443A 1-1ZHFE05Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-12BC4591001DVC4591001 1091 10911443A1-1OS3082Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-15BC4591001DVC4591001 1091 10911445A 1-1YBFWRTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1091 10911445A1-1QZ5JVJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22B@C4591001DVC4591001 1091 10911447A 1-1U6JECJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-04-01BeC4591001DVC4591001 1091 10911447A1-1R1U4A4Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-02-16B9C4591001DVC4591001 1091 10911450A126619901IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1091 10911451A 1-1OLFHVMRandomization done out of sequence Randomization Non-ImportantSCREENING 2020-12-22AC4591001DVC4591001 1091 10911451A127396801IP documentation error IP preparation form errors Investigational ProductNon-ImportantSCREENING 2020-12-22AC4591001DVC4591001 1091 10911452A 1-1YBFWSGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1091 10911452A126620101IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1091 10911453A1-1QW99BHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-17B:C4591001DVC4591001 1091 10911455A01-1QZ5JVNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-26B<C4591001DVC4591001 1091 10911455A 1-1ZHXSRUReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1091 10911455A1-1ZHXSRRReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1091 10911456A 1-1Z65DB9Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1091 10911456A1-1Z65DBCReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1091 10911459A1-1QWNWLZSerology sample not labeled properly and had to discarded Laboratory Non-ImportantFOLLOW-UP 2021-02-18B4C4591001DVC4591001 1091 10911461A0126701301IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2021-01-19BC4591001DVC4591001 1091 10911461A 1-1ZC6C32Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1091 10911461A1-1Z4WHQLReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1091 10911464A 1-1ZMQLYGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1091 10911464A1-1Z66YV6Procedure/Test performed out of window Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1091 10911466A1-1ZB3TC8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1123 11231422A 1-1WKGQ3PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-12BC4591001DVC4591001 1123 11231422A126573301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21BC4591001DVC4591001 1123 11231425A 1-1OAE2C8Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-02AC4591001DVC4591001 1123 11231425A1-1Z0DRESSurveillance for asymptomatic SARS-CoV-2 infection is performed after Visit-4 Other Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1123 11231431A 1-1X5V207Incorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-08B_C4591001DVC4591001 1123 11231431A126573401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1123 11231434A126573601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1123 11231438A@1-1Z49XQIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1123 11231438A01-1XSHVP7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-15BC4591001DVC4591001 1123 11231438A 1-1OTP359Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1123 11231438A126573701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1123 11231439A01-1YV73AJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1123 11231439A 1-1XSHVPAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1123 11231439A1-1OTP35CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1123 11231440A1-1Z7WBEWNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1123 11231441A 1-1OTP35FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1123 11231441A126574301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1123 11231442A@1-1YY0VN4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-24BC4591001DVC4591001 1123 11231442A01-1YO3CTDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-22BC4591001DVC4591001 1123 11231442A 1-1OTP35IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1123 11231442A126574501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1123 11231443A1-1OTP35VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1123 11231445A126574601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1123 11231446A1-1XK2B4FUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-02-15BEC4591001DVC4591001 1123 11231447A1-1YY0VN7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1123 11231448A 1-1VKCCUVPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-15B~C4591001DVC4591001 1123 11231448A126574701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1123 11231449A 1-1YBFWTIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-30BC4591001DVC4591001 1123 11231449A1-1ZNKOPCNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-27C@C4591001DVC4591001 1123 11231450A01-1YO3CTGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BC4591001DVC4591001 1123 11231450A 1-1WKGQ3SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-27BkC4591001DVC4591001 1123 11231450A126575001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1123 11231453A 1-1ZCT7OCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1123 11231453A1-1YV73AMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1123 11231456A1-1X5V21RIncorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-17B\C4591001DVC4591001 1123 11231457A1-1X5V201Incorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-16B[C4591001DVC4591001 1123 11231458A 1-1ZCT7OPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1123 11231458A1-1WNXXJDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BwC4591001DVC4591001 1123 11231462A1-1ZIH3YNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1123 11231463A1-1YDATG7Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-16BYC4591001DVC4591001 1123 11231466A 1-1YV73BJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1123 11231466A1-1WNYMPBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08BpC4591001DVC4591001 1123 11231467A01-1Z7FGGPNasal swab collected at a visit where it was not required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-31BC4591001DVC4591001 1123 11231467A 1-1Z63DG8Nasal swab collected at a visit where it was not required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-17BC4591001DVC4591001 1123 11231467A1-1X5UAEJIncorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-08BNC4591001DVC4591001 1123 11231468A 1-1ZNKP1XNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-08-13BC4591001DVC4591001 1123 11231468A1-1V8CKLHNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-30BdC4591001DVC4591001 1123 11231469A1-1ZBPCS9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1123 11231472A1-1YY0VNAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-01BC4591001DVC4591001 1123 11231473A1-1X5V22SIncorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-16BVC4591001DVC4591001 1123 11231474A 1-1ZD1SFNNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-18BC4591001DVC4591001 1123 11231474A1-1Z4VF88Other Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1123 11231475A1-1ZD1SFRNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-18BC4591001DVC4591001 1123 11231476A`1-1XSHW3PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1123 11231476AP1-1XSHW3MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-20ByC4591001DVC4591001 1123 11231476A@1-1XSHW3JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-30BdC4591001DVC4591001 1123 11231476A01-1X5UAEMIncorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-08BNC4591001DVC4591001 1123 11231476A 1-1XMG4FCRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-02BC4591001DVC4591001 1123 11231476A1-1XMG4CWRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-02BC4591001DVC4591001 1123 11231477A@1-1ZCT7OSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-15BC4591001DVC4591001 1123 11231477A01-1Z5ZOC3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1123 11231477A 1-1XT0RDGSerology samples processed incorrectly Laboratory Non-ImportantFOLLOW-UP 2021-02-08B2C4591001DVC4591001 1123 11231477A1-1XE4MVINasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-05BC4591001DVC4591001 1123 11231481A 1-1ZHFE08Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1123 11231481A1-1ZL0458Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-30BC4591001DVC4591001 1123 11231482A 1-1Z6W3DTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1123 11231482A1-1XSHW42Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1123 11231484A1-1YY0VNNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1123 11231485A 1-1XSVK3KVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BC4591001DVC4591001 1123 11231485A1-1YJNEMNOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-06-23BC4591001DVC4591001 1123 11231486A1-1XSHW45Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-11BC4591001DVC4591001 1123 11231488A 1-1YY0VNQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1123 11231488A1-1SSTSU2Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-05BJC4591001DVC4591001 1123 11231489A01-1ZNH9IPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1123 11231489A 1-1ZMUK1JNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-25BC4591001DVC4591001 1123 11231489A1-1ZD1SFVNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1123 11231491A 1-1XSHW48Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1123 11231491A1-1WKGQ3VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-26B_C4591001DVC4591001 1123 11231492A1-1X5V21OIncorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-19BWC4591001DVC4591001 1123 11231493A 1-1YY0VNTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1123 11231493A1-1YV73BMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1123 11231494A01-1YV73BPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1123 11231494A 1-1ZIMKYENasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1123 11231494A1-1ZIMKYBNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1123 11231497A1-1PFGS6PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1123 11231499A1-1X5V204Incorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-04-06BdC4591001DVC4591001 1123 11231501A01-1R7E22GVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-18B5C4591001DVC4591001 1123 11231501A 1-1QVZNTQVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-18B5C4591001DVC4591001 1123 11231501A1-1ZEO98JSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-22BUC4591001DVC4591001 1123 11231504A@1-1YY0VNWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-18BC4591001DVC4591001 1123 11231504A01-1YBFWVTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-28BC4591001DVC4591001 1123 11231504A 1-1Z3T77VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BlC4591001DVC4591001 1123 11231504A1-1ZD1SGINasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1123 11231506A 1-1YY1KH9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1123 11231506A1-1XSHW4BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1123 11231507A1-1XTRH4LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-08BC4591001DVC4591001 1123 11231508A1-1R27M2XOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-19B6C4591001DVC4591001 1123 11231509A1-1YGWY06Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1123 11231513A1-1YBR2OOSerology sample not collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-11BC4591001DVC4591001 1123 11231514A1-1ZL045BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BxC4591001DVC4591001 1123 11231518A1-1ZIH3YRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1123 11231519A1-1Z49XQLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1123 11231520A1-1UGA2G4Potential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-22BSC4591001DVC4591001 1123 11231521A 1-1OTBORWUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-04A`C4591001DVC4591001 1123 11231521A1-1XT0RDJSerology samples processed incorrectly Laboratory Non-ImportantFOLLOW-UP 2021-02-15B0C4591001DVC4591001 1123 11231522A1-1X8NVUROther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1123 11231523A 1-1X5V21UIncorrect serology sample volume collected Laboratory Non-ImportantFOLLOW-UP 2021-03-10BAC4591001DVC4591001 1123 11231523A1-1X8NVVCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1123 11231524A01-1Z4A0XOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1123 11231524A 1-1P9Y0WDVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-29BC4591001DVC4591001 1123 11231524A1-1QZCKCPProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-25B4C4591001DVC4591001 1123 11231525A@1-1ZL045EVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1123 11231525A01-1Z4A0XRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-01BC4591001DVC4591001 1123 11231525A 1-1YBFWVWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1123 11231525A1-1P9Y0X5Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-29BC4591001DVC4591001 1123 11231526A 1-1ZMUK3KVisit not done Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10B{C4591001DVC4591001 1123 11231526A1-1P9Y0X8Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-29BC4591001DVC4591001 1124 11241236A@1-1R1QHLDProcedure/Test not performed per protocol Procedures/Tests Non-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1124 11241236A01-1XRQ1J5Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantFOLLOW-UP 2021-03-10BWC4591001DVC4591001 1124 11241236A 1-1WXMUSWSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1124 11241236A1-1OHE227Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1124 11241238A1-1R1QHLGProcedure/Test not performed per protocol Procedures/Tests Non-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1124 11241239A 1-1XROYO3Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1124 11241239A1-1XRMY2DRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1124 11241242A 1-1XRQPY7Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1124 11241242A1-1XRQ1Z8Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1124 11241243A1-1OTBWDOVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1124 11241245A1-1QZ5JZ9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-11B;C4591001DVC4591001 1124 11241246A 1-1QZ5JZCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-11B;C4591001DVC4591001 1124 11241246A1-1PLTDO9Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-11B;C4591001DVC4591001 1124 11241247A1-1PJVT0SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-10B9C4591001DVC4591001 1124 11241249A1-1Z91JB5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1124 11241253A1-1Z9VJX1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-23BC4591001DVC4591001 1124 11241254A1-1ZCDVUEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-30BC4591001DVC4591001 1124 11241255A 1-1PLU8K6Subject/LAR signed and dated ICD after screen/enroll date Informed Consent Non-ImportantVACCINATION 2021-01-22B$C4591001DVC4591001 1124 11241255A1-1ORZGE4Subject/LAR did not sign the ICD but gave verbal consent Informed Consent Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1124 11241258A1-1QZSEOZVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-14BC4591001DVC4591001 1124 11241262A 1-1QZ5JZFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-17B9C4591001DVC4591001 1124 11241262A1-1OTC116Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1124 11241265A1-1OTBWDRVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1124 11241268A1-1P9Y0VCVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1124 11241271A1-1P2SC9WVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-26BC4591001DVC4591001 1124 11241272A1-1P9Y0VFVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1124 11241275A 1-1ZH2W41Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-11BC4591001DVC4591001 1124 11241275A1-1P9Y0VIVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1125 11251246A01-1OTC3JVVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1125 11251246A 1-1PNNGCRProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-01-27B1C4591001DVC4591001 1125 11251246A1-1OCMPICOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1125 11251249A1-1OCMPJROther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1125 11251252A1-1PFGS6VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1125 11251253A 1-1XIJLDOOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-05-09BC4591001DVC4591001 1125 11251253A1-1XII77OOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-05-09BC4591001DVC4591001 1126 11261230A 1-1ZNJADQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-26CC4591001DVC4591001 1126 11261230A1-1ZHJ09CNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1126 11261239A 1-1ZNH9ITVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1126 11261239A1-1WTQAVEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-18BC4591001DVC4591001 1126 11261240A 1-1ZL04FHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1126 11261240A1-1WTQAVHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-18BC4591001DVC4591001 1126 11261246A1-1ZNH9IWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1126 11261250A1-1Z6HTNEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-15BC4591001DVC4591001 1126 11261255A 128934801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1126 11261255A128934701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1126 11261258A 128934101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1126 11261258A128934001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1126 11261262A 128933501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1126 11261262A128933401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1126 11261263A 128933701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1126 11261263A128933601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1126 11261264A 128933901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1126 11261264A128933801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1126 11261265A 1-1Z6HTPZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1126 11261265A128935501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1126 11261266A 1-1Z6HTQ2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1126 11261266A1-1OTBWDXVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1126 11261267A128935601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1126 11261268A 128935801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1126 11261268A128935701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1126 11261269AP1-1ZNISRVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1126 11261269A@1-1YV73CSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1126 11261269A01-1YV73CPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1126 11261269A 128936001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1126 11261269A128935901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1126 11261270A 1-1WZ8AA7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1126 11261270A128936101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1126 11261271A01-1Z7HZGCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1126 11261271A 128935001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1126 11261271A128935101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1126 11261273A 128935301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1126 11261273A128935201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1126 11261274A128935401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1126 11261275A1-1ZL0IAZNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-08-26BC4591001DVC4591001 1126 11261277A1-1ZNISRYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1126 11261278A1-1ZNISS1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1126 11261281A1-1QZKYVMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-12B;C4591001DVC4591001 1126 11261282A1-1YO3CTJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1126 11261286A 1-1PE33HVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1126 11261286A1-1OS3088Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1126 11261287A01-1OS308BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1126 11261287A 1-1R1DW8BVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-10B9C4591001DVC4591001 1126 11261287A1-1OSQUCWProcedure not performed as part of vital signs. Procedures/Tests Non-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1126 11261288A 1-1Z3A98WSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1126 11261288A1-1PAGL8XSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-04B3C4591001DVC4591001 1126 11261289A 1-1R054QWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03BMC4591001DVC4591001 1126 11261289A1-1R29WY3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-03BMC4591001DVC4591001 1126 11261290A1-1Z8JZNXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-16BC4591001DVC4591001 1126 11261293A1-1ZGP8WQNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-17BC4591001DVC4591001 1126 11261295A1-1ZNIT6KVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1126 11261302A1-1R7E22JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1126 11261304A@1-1VS0QE2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-02B_C4591001DVC4591001 1126 11261304A01-1ZF0ONPSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-04-02B_C4591001DVC4591001 1126 11261304A 1-1ZEA8WWSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-04-02B_C4591001DVC4591001 1126 11261304A1-1V9T0HYNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-02B_C4591001DVC4591001 1126 11261307A 1-1YV73CVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1126 11261307A1-1WPLKQJNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-29BUC4591001DVC4591001 1126 11261308A01-1YO3CTMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06B{C4591001DVC4591001 1126 11261308A 1-1WTQAVKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-27BrC4591001DVC4591001 1126 11261308A1-1V8MVSJNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-13BdC4591001DVC4591001 1126 11261309A1-1YV73D8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1126 11261311A1-1Z9VPG2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-07-22BC4591001DVC4591001 1126 11261312A1-1ZL04FKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10B~C4591001DVC4591001 1126 11261314A1-1U6JP1UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03B9C4591001DVC4591001 1126 11261315A 1-1ZB3TCEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1126 11261315A1-1ZNIT6NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BxC4591001DVC4591001 1126 11261317A1-1WTQAVNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08B\C4591001DVC4591001 1126 11261318AP1-1ZHW9P3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-05BC4591001DVC4591001 1126 11261318A@1-1Z6WODJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-07BC4591001DVC4591001 1126 11261318A01-1YO3CTPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-14BC4591001DVC4591001 1126 11261318A 1-1R7P24WVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-25B2C4591001DVC4591001 1126 11261318A1-1P9Y0VVVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1126 11261323A01-1ZB3TD1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1126 11261323A 1-1XSHW4EVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-31BC4591001DVC4591001 1126 11261323A1-1R29WY6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-01-25BC4591001DVC4591001 1126 11261324A 1-1ZB3TD4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1126 11261324A1-1XTRFM9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-31BC4591001DVC4591001 1126 11261325A1-1P9Y0ZTVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-29BC4591001DVC4591001 1131 11311277A 1-1YBFWYDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-01BC4591001DVC4591001 1131 11311277A1-1WTQAW9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BxC4591001DVC4591001 1131 11311278A 1-1XN7TAIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-18BC4591001DVC4591001 1131 11311278A1-1WTQAWMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08BzC4591001DVC4591001 1131 11311279A`1-1QSRI5UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-02-17B;C4591001DVC4591001 1131 11311279AP1-1PG5YB7Participant randomized into incorrect age stratum in Impala Randomization Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1131 11311279A@1-1OTC119Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1131 11311279A01-1POJ1BZProcedure/Test not performed per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-02-17B;C4591001DVC4591001 1131 11311279A 1-1Z4Z0FZICD was lost, no copy available Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1131 11311279A1-1Z4Z0EFICD was lost, no copy available Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1131 11311280A01-1ZHFEIXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-03BC4591001DVC4591001 1131 11311280A 1-1WTQAWPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BoC4591001DVC4591001 1131 11311280A1-1ZBC4JQOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-07-08BC4591001DVC4591001 1131 11311283A01-1XN7TALVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1131 11311283A 1-1OTC11CVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1131 11311283A1-1POJ1C3Procedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-15B8C4591001DVC4591001 1131 11311285A 1-1ZBC4KHOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-07-07BC4591001DVC4591001 1131 11311285A1-1QSOZ6XOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-12B4C4591001DVC4591001 1131 11311286A1-1Z5BC3BSerology samples processed incorrectly Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1131 11311287A1-1QSQ8CUNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-02-15B1C4591001DVC4591001 1131 11311290A1-1WTQAWSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-29BZC4591001DVC4591001 1131 11311292A@1-1ZQ5CZHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-30BC4591001DVC4591001 1131 11311292A01-1XN7TB8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-26BC4591001DVC4591001 1131 11311292A 1-1ZHW9S8Visit not done Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BxC4591001DVC4591001 1131 11311292A1-1TB2XNGUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-03-01B9C4591001DVC4591001 1131 11311293A01-1WTQAXFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06B]C4591001DVC4591001 1131 11311293A 1-1OTBOSFUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-05A C4591001DVC4591001 1131 11311293A1-1ZBC4KYOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-07-13BC4591001DVC4591001 1131 11311294A1-1YBFWYGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1131 11311295A1-1YBFX0RVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1131 11311297A 1-1ZHW9P6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1131 11311297A1-1YV73DEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1131 11311301A 1-1ZHW9P9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-09BC4591001DVC4591001 1131 11311301A1-1PAQ0A3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-05BC4591001DVC4591001 1131 11311302A1-1WNYMRVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-07BWC4591001DVC4591001 1139 11391144AP1-1WTQB57Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-01BpC4591001DVC4591001 1139 11391144A@1-1WTQB4SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-11B[C4591001DVC4591001 1139 11391144A01-1WTQB4PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03BSC4591001DVC4591001 1139 11391144A 125911401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391144A125895301IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391145A1-1YV73DRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1139 11391145A1-1ZHW9SMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1139 11391145Ap1-1WTQB5AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-24BrC4591001DVC4591001 1139 11391145A`1-1O5FM3GUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1139 11391145AP1-1ZJ0QAXNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-24BC4591001DVC4591001 1139 11391145A@125858901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21BC4591001DVC4591001 1139 11391145A0125911501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1139 11391145A 125896201IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-21BC4591001DVC4591001 1139 11391145A125895901IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1139 11391151A 125912101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391151A125900501IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391152A@1-1PI2W6VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1139 11391152A01-1X45HFSIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1139 11391152A 125912201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391152A125900701IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391154A@1-1PI2W85Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1139 11391154A01-1X45HFPIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1139 11391154A 125912401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391154A125930001IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391155A1-1Z6WJCVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-08BC4591001DVC4591001 1139 11391155A1-1ZHW9SPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1139 11391155Ap1-1WTQB5DVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-03-02BYC4591001DVC4591001 1139 11391155A`1-1YVJHOWNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1139 11391155AP1-1ZJ0QB6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1139 11391155A@125912501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391155A0125930101IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1139 11391155A 1-1TT1O1DOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-26B6C4591001DVC4591001 1139 11391155A1-1P1VYB3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-26B6C4591001DVC4591001 1139 11391156Ap1-1ZHW9T5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1139 11391156A`1-1ZHW9SSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BC4591001DVC4591001 1139 11391156AP1-1ZJ0QBGNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1139 11391156A@1-1ZJ0QBCNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-01BC4591001DVC4591001 1139 11391156A01-1ZJ0QB9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-05BxC4591001DVC4591001 1139 11391156A 125912601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1139 11391156A125930301IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1139 11391157A01-1YEE5WHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-04-09B{C4591001DVC4591001 1139 11391157A 125912701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391157A125930401IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391158A 125912801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391158A125930501IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391159AP1-1ZIGGBJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1139 11391159A@1-1PFEHH6Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-01-29B5C4591001DVC4591001 1139 11391159A0125912901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391159A 125930601IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391159A1-1R0DGYQOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-29BC4591001DVC4591001 1139 11391161A 125913101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391161A125930801IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391162A`1-1ZHW9TBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1139 11391162AP1-1ZHW9T8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-10BC4591001DVC4591001 1139 11391162A@1-1ZJ0QC6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1139 11391162A01-1ZJ0QC3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-04-30BC4591001DVC4591001 1139 11391162A 125913201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391162A125930901IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391163A 125913501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391163A125931101IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1139 11391165A01-1Y1PBIOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1139 11391165A 125934701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391165A125931301IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391166AP1-1QVJDJDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-09B=C4591001DVC4591001 1139 11391166A@1-1Q8QOFQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-09B=C4591001DVC4591001 1139 11391166A01-1S02Y00Visit conducted when not required per protocol Visit Schedule Non-ImportantFOLLOW-UP 2021-02-09B=C4591001DVC4591001 1139 11391166A 125934901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391166A125931401IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391168AP1-1ZHFEJ0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1139 11391168A@1-1ZHW9TFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-30BnC4591001DVC4591001 1139 11391168A01-1ZJ0QC9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-20BdC4591001DVC4591001 1139 11391168A 125935401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391168A125931701IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1139 11391169AP1-1PI2W88Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-14BC4591001DVC4591001 1139 11391169A@125935601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391169A0125931801IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391169A 1-1ZHXSR6Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-01BC4591001DVC4591001 1139 11391169A1-1ZHXSR3Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant FOLLOW-UP 2021-05-11BC4591001DVC4591001 1139 11391170A01-1PI2W8BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-14BC4591001DVC4591001 1139 11391170A 125935801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391170A125931901IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391171A1-1ZNOH7TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-27CC4591001DVC4591001 1139 11391171A1-1YBGC6LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-02BC4591001DVC4591001 1139 11391171A1-1Z4YDI4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1139 11391171A1-1R6ZZG1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-10BVC4591001DVC4591001 1139 11391171A1-1ZLQIC2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1139 11391171A1-1ZLQIBYNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1139 11391171Ap1-1ZLQIBVNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-15BzC4591001DVC4591001 1139 11391171A`1-1ZJ0QCCNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-28BhC4591001DVC4591001 1139 11391171AP125937301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391171A@125932001IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391171A01-1X5XJ4HRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-10BVC4591001DVC4591001 1139 11391171A 1-1Z39G6EReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1139 11391171A1-1Z39G6HReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1139 11391172A01-1OCN9T0Urine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391172A 125937501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391172A125932101IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391173AP1-1Z6WJCZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1139 11391173A@1-1YEE5WKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1139 11391173A01-1ZJ0QCLNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1139 11391173A 125937701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391173A125932201IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391174Ap1-1Z6WJD2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-16BC4591001DVC4591001 1139 11391174A`1-1ZHW9TIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-16BC4591001DVC4591001 1139 11391174AP1-1YG8TDDSerology sample not collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-18BC4591001DVC4591001 1139 11391174A@1-1ZJ0QDBNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-11BC4591001DVC4591001 1139 11391174A01-1ZJ0QD8Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-24BC4591001DVC4591001 1139 11391174A 125937801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391174A125932301IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391175A@1-1XT1A76Other lab deviation Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-03BC4591001DVC4591001 1139 11391175A01-1OCOVZ3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391175A 125937901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391175A125932401IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1139 11391177AP1-1YBGC6SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1139 11391177A@1-1YBGC6PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1139 11391177A01-1PI2W8EVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-15BC4591001DVC4591001 1139 11391177A 125938001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1139 11391177A125932501IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1139 11391178A@1-1OTBOSIUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391178A01-1OT3RBQUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391178A 125938101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391178A125932601IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391180A01-1WTQB5TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BC4591001DVC4591001 1139 11391180A 125938201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391180A125932701IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391181A01-1PGIV4FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-03B0C4591001DVC4591001 1139 11391181A 125938301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391181A125932801IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391182AP1-1WHGZ8CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-26BcC4591001DVC4591001 1139 11391182A@1-1OQYPEDUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-08BC4591001DVC4591001 1139 11391182A01-1OTBOSVUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1139 11391182A 125938501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391182A125932901IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391183A1-1ZHW9TLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-10BC4591001DVC4591001 1139 11391183A1-1YBHJF2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1139 11391183A1-1YBHJEZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-01BC4591001DVC4591001 1139 11391183Ap1-1Z4YDI7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-24BC4591001DVC4591001 1139 11391183A`1-1ZLQIDNNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-28BC4591001DVC4591001 1139 11391183AP1-1ZLQIDJNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-10BrC4591001DVC4591001 1139 11391183A@1-1ZJ0QDENasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-23B`C4591001DVC4591001 1139 11391183A0125938701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391183A 125933001IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391183A1-1ZGM78JOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391185A`1-1ZHW9TOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BC4591001DVC4591001 1139 11391185AP1-1PI2W8HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-12BC4591001DVC4591001 1139 11391185A@1-1ZJ0QJ6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-25BC4591001DVC4591001 1139 11391185A01-1X45HK7Incorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1139 11391185A 125938801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391185A125933101IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1139 11391186A@1-1ZHW9TRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-13BSC4591001DVC4591001 1139 11391186A01-1ZJ0QIHNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-02BHC4591001DVC4591001 1139 11391186A 125938901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1139 11391186A125933201IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1139 11391187A1-1ZHFEJ3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1139 11391187Ap1-1ZHW9TUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-11BC4591001DVC4591001 1139 11391187A`1-1ZMNRBBNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-20BC4591001DVC4591001 1139 11391187AP1-1ZMNRB8Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-02BC4591001DVC4591001 1139 11391187A@1-1ZMNQXJNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-14BsC4591001DVC4591001 1139 11391187A01-1ZJ0QIKNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-27BaC4591001DVC4591001 1139 11391187A 125939101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1139 11391187A125933301IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1139 11391188A@1-1YEE64FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-29BcC4591001DVC4591001 1139 11391188A01-1ZJ0QINNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-19BYC4591001DVC4591001 1139 11391188A 125939301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1139 11391188A125933401IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1139 11391189A 1-1OTC0YVProcedure not performed as part of vital signs. Procedures/Tests Non-ImportantVACCINATION 2021-01-08BC4591001DVC4591001 1139 11391189A1-1OTBOSYUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1139 11391191A01-1ZHXSM5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-23BC4591001DVC4591001 1139 11391191A 1-1WTQB5WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-01BGC4591001DVC4591001 1139 11391191A1-1ZJ0QK5Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-18BC4591001DVC4591001 1139 11391193A01-1OTBOT1Urine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-22A C4591001DVC4591001 1139 11391193A 1-1OT3RBTUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-22A C4591001DVC4591001 1139 11391193A1-1X43STFIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1139 11391195A 1-1ZNIT6QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-27BC4591001DVC4591001 1139 11391195A1-1YBHJF5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-11BC4591001DVC4591001 1139 11391196A1-1ZB3TDDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-27BC4591001DVC4591001 1139 11391197A 1-1ZHXSM8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1139 11391197A1-1ZNJ9S1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1139 11391198A 1-1ZHFY3MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-13BC4591001DVC4591001 1139 11391198A1-1PI2W8KVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1139 11391199A01-1ZHXSMBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-23B{C4591001DVC4591001 1139 11391199A 1-1R0TUVWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-26BCC4591001DVC4591001 1139 11391199A1-1ZJ0QJ9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-13BqC4591001DVC4591001 1139 11391202A01-1ZHFY3PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1139 11391202A 1-1XD5Z2KVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1139 11391202A1-1YEE64IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1139 11391203A1-1PNQCL3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-16B9C4591001DVC4591001 1139 11391204A1-1PNQCL6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-16B9C4591001DVC4591001 1139 11391205A@1-1Z6WJG7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-16BC4591001DVC4591001 1139 11391205A01-1R54Q1XOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-10B3C4591001DVC4591001 1139 11391205A 1-1P186TIOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1139 11391205A1-1OH12IDOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1139 11391207A1-1ZHFY3SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1139 11391208A1-1ZHFYGNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1139 11391209A`1-1ZCT7T0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1139 11391209AP1-1Z6WJGAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1139 11391209A@1-1Z2PN7WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1139 11391209A01-1YEE64LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1139 11391209A 1-1ZJ0QKBNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-20BC4591001DVC4591001 1139 11391209A1-1ZJ0QK8Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-02BC4591001DVC4591001 1139 11391210A01-1ZHFYGQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-12BC4591001DVC4591001 1139 11391210A 1-1WTQB5ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BcC4591001DVC4591001 1139 11391210A1-1OTC3L3Procedure not performed as part of vital signs. Procedures/Tests Non-ImportantVACCINATION 2021-01-12BC4591001DVC4591001 1139 11391211A 1-1YEE651Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1139 11391211A1-1ZJ0QKENasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-29BC4591001DVC4591001 1139 11391212A 1-1T3NSM3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-03-15BNC4591001DVC4591001 1139 11391212A1-1R2NLM5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-02-19B6C4591001DVC4591001 1139 11391213A 1-1ZHXSMEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1139 11391213A1-1ZJ22U6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1139 11391214A1-1PI2W8NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1139 11391216A1-1ZHFYGTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-04BC4591001DVC4591001 1139 11391216Ap1-1ZIK17TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1139 11391216A`1-1ZHXSMHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-13BC4591001DVC4591001 1139 11391216AP1-1ZJ0QKKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BjC4591001DVC4591001 1139 11391216A@1-1WHGZ8FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BbC4591001DVC4591001 1139 11391216A01-1ZJ22M7Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1139 11391216A 1-1ZJ0QKNNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-01BC4591001DVC4591001 1139 11391216A1-1ZJ0QKHNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-29BC4591001DVC4591001 1139 11391218A1-1ZJ22W2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-11BC4591001DVC4591001 1139 11391219A`1-1VS0QE8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-26BwC4591001DVC4591001 1139 11391219AP1-1ZHXSMKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BkC4591001DVC4591001 1139 11391219A@1-1ZHW9SBVisit not done Visit Schedule Non-ImportantFOLLOW-UP 2021-03-22BTC4591001DVC4591001 1139 11391219A01-1X42MJZIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1139 11391219A 1-1X43CI8Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1139 11391219A1-1X43CC8Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-13BC4591001DVC4591001 1139 11391220A 1-1ZHFYGWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-13BC4591001DVC4591001 1139 11391220A1-1P1RA86Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-21BC4591001DVC4591001 1139 11391221AP1-1ZHXSMNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1139 11391221A@1-1YBHJF8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-09BC4591001DVC4591001 1139 11391221A01-1YEE64YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-07B^C4591001DVC4591001 1139 11391221A 1-1ZJ0QCINasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-11BC4591001DVC4591001 1139 11391221A1-1ZJ0QCFNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-28BTC4591001DVC4591001 1139 11391222A01-1ZHGC4XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-13BC4591001DVC4591001 1139 11391222A 1-1WTQB6FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-21BlC4591001DVC4591001 1139 11391222A1-1WTQB6CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-29BUC4591001DVC4591001 1139 11391223AP1-1ZHXSMQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-17BC4591001DVC4591001 1139 11391223A@1-1YV73DUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-01BC4591001DVC4591001 1139 11391223A01-1YEE654Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BdC4591001DVC4591001 1139 11391223A 1-1ZJ22MPNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1139 11391223A1-1ZJ22MMNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-19BC4591001DVC4591001 1139 11391225AP1-1ZHXSMTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-18BC4591001DVC4591001 1139 11391225A@1-1WHGZ9CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-12BDC4591001DVC4591001 1139 11391225A01-1R2GD0YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-05B=C4591001DVC4591001 1139 11391225A 1-1R0TUWTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-28BC4591001DVC4591001 1139 11391225A1-1ZJ22MSNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-08BC4591001DVC4591001 1139 11391226A`1-1ZHXSMWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-05BC4591001DVC4591001 1139 11391226AP1-1YEE661Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-20BC4591001DVC4591001 1139 11391226A@1-1ZMPMRFNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-30BC4591001DVC4591001 1139 11391226A01-1ZMPMRCNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1139 11391226A 1-1ZJ22MYNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1139 11391226A1-1ZJ22MANasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-11BC4591001DVC4591001 1139 11391228A1-1ZHGC50Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-13BC4591001DVC4591001 1139 11391229A1-1ZHGC53Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-13BC4591001DVC4591001 1139 11391230A1-1ZJ22WSNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-17BC4591001DVC4591001 1139 11391232A1-1ZJO3SEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-23BC4591001DVC4591001 1139 11391233A 1-1ZHXSNTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1139 11391233A1-1ZJE20RRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-20BC4591001DVC4591001 1139 11391235A1-1UIIMZ3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1139 11391236A@1-1ZHXSNXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1139 11391236A01-1ZE63ZRVisit conducted when not required per protocol Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1139 11391236A 1-1ZJ22U2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1139 11391236A1-1ZJ22TZNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-06BC4591001DVC4591001 1139 11391238A 1-1Z6WJGDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1139 11391238A1-1ZJ22VJNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1139 11391239A01-1ZIK17XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-16BC4591001DVC4591001 1139 11391239A 1-1R0TUWWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22B/C4591001DVC4591001 1139 11391239A1-1YY56QSNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-07-02BC4591001DVC4591001 1139 11391240A@1-1ZQ5CZLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-30BC4591001DVC4591001 1139 11391240A01-1YV73DXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1139 11391240A 1-1OSE41HUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-19AC4591001DVC4591001 1139 11391240A1-1ZJ22WPNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1139 11391241A@1-1ZIK180Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-16BC4591001DVC4591001 1139 11391241A01-1ZHXSO0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-07BxC4591001DVC4591001 1139 11391241A 1-1WHGZ9FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-09B\C4591001DVC4591001 1139 11391241A1-1ZJ0QJWNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-27BnC4591001DVC4591001 1139 11391242A01-1ZHXSO3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-23BjC4591001DVC4591001 1139 11391242A 1-1OSE42EUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-19AC4591001DVC4591001 1139 11391242A1-1ZJ0QJZNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-13B`C4591001DVC4591001 1139 11391244A@1-1ZIGGBNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-18BC4591001DVC4591001 1139 11391244A01-1ZQ77EWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-06BC4591001DVC4591001 1139 11391244A 1-1YVHD23Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1139 11391244A1-1ZMUK3NNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-27BC4591001DVC4591001 1139 11391245A 1-1ZHGCA6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-11BC4591001DVC4591001 1139 11391245A1-1PI2W8QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-02BC4591001DVC4591001 1139 11391246A 1-1ZIK1C9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-16BC4591001DVC4591001 1139 11391246A1-1OSE3YWProcedure not performed as part of vital signs. Procedures/Tests Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1139 11391248A01-1Z7HZOAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1139 11391248A 1-1U1QPK3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-22BJC4591001DVC4591001 1139 11391248A1-1ZF0ONVSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-22BJC4591001DVC4591001 1139 11391249AP1-1ZNOH7ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-25BC4591001DVC4591001 1139 11391249A@1-1ZCT7TDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1139 11391249A01-1YO3CU2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1139 11391249A 1-1YO3CTZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1139 11391249A1-1ZQOKMLSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-25BC4591001DVC4591001 1139 11391250A@1-1ZHWRHHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-04-20BdC4591001DVC4591001 1139 11391250A01-1ZMPMZYNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-17BaC4591001DVC4591001 1139 11391250A 1-1ZMPMRINasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-30BOC4591001DVC4591001 1139 11391250A1-1ZJ0QIQNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-12B=C4591001DVC4591001 1139 11391251AP1-1ZHXSO9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1139 11391251A@1-1ZHXSO6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1139 11391251A01-1ZJ22VZNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1139 11391251A 1-1ZJ22MDNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-23BC4591001DVC4591001 1139 11391251A1-1XPXJ63Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1139 11391252A@1-1X5GWLWIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-13B{C4591001DVC4591001 1139 11391252A01-1ZGXFZ7Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-13B{C4591001DVC4591001 1139 11391252A 1-1OR7PRVOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1139 11391252A1-1OR7PRPOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1139 11391253A1-1ZQ77EZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1139 11391253A1-1YEE667Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1139 11391253Ap1-1YEE664Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-22BfC4591001DVC4591001 1139 11391253A`1-1R0TUWZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-26B/C4591001DVC4591001 1139 11391253AP1-1ZMQLJ7Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-24BC4591001DVC4591001 1139 11391253A@1-1ZJ22VWNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1139 11391253A01-1ZJ22MGNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1139 11391253A 1-1ZMPN01Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-17BaC4591001DVC4591001 1139 11391253A1-1ZJ0QJ3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-30BOC4591001DVC4591001 1139 11391254A 1-1ZB3TDGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-23BC4591001DVC4591001 1139 11391254A1-1R0TUXWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-26B/C4591001DVC4591001 1139 11391256A 1-1ZHXSOCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-20BC4591001DVC4591001 1139 11391256A1-1ZJ22WVNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-11BC4591001DVC4591001 1139 11391257A1-1ZIK1CCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-16BC4591001DVC4591001 1139 11391258A1-1ZB3TE3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-23BC4591001DVC4591001 1139 11391259AP1-1ZIK1CFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1139 11391259A@1-1YFMT1TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-19BbC4591001DVC4591001 1139 11391259A01-1ZJ22VGNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1139 11391259A 1-1ZJ22VDNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-03BC4591001DVC4591001 1139 11391259A1-1ZJ0QK2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-09BXC4591001DVC4591001 1139 11391260A 1-1ZIK1CIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-16BC4591001DVC4591001 1139 11391260A1-1R0DH08Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1139 11391261A1-1R0TUXZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-24B,C4591001DVC4591001 1139 11391262A@1-1ZCTHF0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-27BC4591001DVC4591001 1139 11391262A01-1YFMT1XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-13BzC4591001DVC4591001 1139 11391262A 1-1ZJ22MJNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-03BpC4591001DVC4591001 1139 11391262A1-1R0MJNWOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-12AC4591001DVC4591001 1140 11401323A@1-1OO7QB3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-09BC4591001DVC4591001 1140 11401323A0126678901IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-09BC4591001DVC4591001 1140 11401323A 1-1ORBYN3Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1140 11401323A1-1OCW0SASubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1140 11401324AP1-1TVTP2XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-24BiC4591001DVC4591001 1140 11401324A@1-1OO7QB7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-09BC4591001DVC4591001 1140 11401324A01-1OCW0U9Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1140 11401324A 1-1SMGXUGOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-05BVC4591001DVC4591001 1140 11401324A1-1SKVL46Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-05BVC4591001DVC4591001 1140 11401325A 1-1OO7QBBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1140 11401325A1-1OCW0TOSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1140 11401326A01-1OO7QBYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1140 11401326A 126677101IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1140 11401326A1-1OCW0VESubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1140 11401327A@1-1OO7QC1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1140 11401327A01-1OS7O4NRandomization done out of sequence Randomization Non-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1140 11401327A 1-1OT9ECJNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2020-12-30BC4591001DVC4591001 1140 11401327A1-1OE37U2Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1140 11401328A 126674501IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1140 11401328A1-1OE6HZGSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1140 11401329A 126674601IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1140 11401329A1-1OE6HZUSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1140 11401330A 1-1OE6I0MSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1140 11401330A1-1OE6IJAOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1140 11401331A01-1ZHGCAAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1140 11401331A 1-1ZML3P2Other lab deviation Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1140 11401331A126676001IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1140 11401332A@1-1ZHGCADVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1140 11401332A01-1WXBD4WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1140 11401332A 1-1VNE5FSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-15ByC4591001DVC4591001 1140 11401332A126675801IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1140 11401333A 1-1OE6I1YSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1140 11401333A1-1OE6I1ASubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1140 11401334A 1-1OE6I2QSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1140 11401334A1-1OE6I2CSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1140 11401335A01-1ZNJ9S4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1140 11401335A 1-1OE6I4WSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401335A1-1OE6I48Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401336A0126677401IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-08BC4591001DVC4591001 1140 11401336A 1-1OE6I86Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401336A1-1OE6I78Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401337A@1-1WNYMVMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-19B|C4591001DVC4591001 1140 11401337A0126675101IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-05BC4591001DVC4591001 1140 11401337A 1-1OE6ID4Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401337A1-1OE6IBCSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401338A01-1OE6IHSSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401338A 1-1OE6IH4Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1140 11401338A1-1R7BT1MOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-08BRC4591001DVC4591001 1140 11401340A 1-1OGJIR4Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1140 11401340A1-1OGJIQYSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1140 11401343AP1-1ZNJ9S7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1140 11401343A@1-1WXBD4ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BkC4591001DVC4591001 1140 11401343A01-1ZIML0BNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1140 11401343A 1-1TVU1ISOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-18BXC4591001DVC4591001 1140 11401343A1-1TVU1DWOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-18BXC4591001DVC4591001 1140 11401344A01-1ZNJ9SAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1140 11401344A 1-1WNYMX3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BkC4591001DVC4591001 1140 11401344A1-1ZIML0FNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-11BC4591001DVC4591001 1140 11401348A1-1X675VHAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1140 11401352A1-1OLV4YPSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1140 11401353A 1-1OLVNV9Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1140 11401353A1-1OLVNV2Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1140 11401354A@1-1YVHD26Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-16BC4591001DVC4591001 1140 11401354A01-1QBEI0BSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-15B7C4591001DVC4591001 1140 11401354A 1-1XRPLQUOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-17BUC4591001DVC4591001 1140 11401354A1-1XRPLQNOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-17BUC4591001DVC4591001 1140 11401357AP1-1OTC11PVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1140 11401357A@1-1ZH3UMYReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1140 11401357A01-1ZF0ZY1Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1140 11401357A 1-1ZH3U6RReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1140 11401357A1-1ZF0ZWJReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1140 11401358A01-1YCOMCLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-02BC4591001DVC4591001 1140 11401358A 1-1ZNJA3AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1140 11401358A1-1ZNJA37Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-07BC4591001DVC4591001 1140 11401359A 1-1WNYMX6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-10BmC4591001DVC4591001 1140 11401359A1-1VOT04NLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-04-10BmC4591001DVC4591001 1140 11401361A 126616701IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1140 11401361A128480801Blind compromised Investigational ProductNon-ImportantFOLLOW-UP 2021-02-18B5C4591001DVC4591001 1140 11401362A 1-1VOTH7OLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-04-14BlC4591001DVC4591001 1140 11401362A1-1SMGXVGSubject/LAR signed consent but did not date it Informed Consent Non-ImportantFOLLOW-UP 2021-03-10BIC4591001DVC4591001 1140 11401363A 1-1R2GD32Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-26B=C4591001DVC4591001 1140 11401363A1-1R0ME4EOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-26B=C4591001DVC4591001 1140 11401364A01-1ZNJA3DVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1140 11401364A 1-1UFPEJ4Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-31B^C4591001DVC4591001 1140 11401364A1-1UFPEFARevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-31B^C4591001DVC4591001 1140 11401365A 1-1ZCE9RHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-30BC4591001DVC4591001 1140 11401365A126616801IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1140 11401366A01-1ZNJA6IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1140 11401366A 1-1UFPEOWRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-31B^C4591001DVC4591001 1140 11401366A1-1UFPEL3Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-31B^C4591001DVC4591001 1140 11401367A126616901IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-29A C4591001DVC4591001 1140 11401370AP1-1YCOMCOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1140 11401370A@1-1ZIMKYKNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1140 11401370A01-1ZIMKYHNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1140 11401370A 126617001IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1140 11401370A128480401Blind compromised Investigational ProductNon-ImportantFOLLOW-UP 2021-02-18B4C4591001DVC4591001 1140 11401371A126617101IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1140 11401373A126617701IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1140 11401375A1-1OMCT77Other Informed Consent Informed Consent Non-ImportantSCREENING 2020-12-28C4591001DVC4591001 1140 11401376A01-1ZNJA6LVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1140 11401376A 126618101IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1140 11401376A1-1OMD5JVOther Informed Consent Informed Consent Non-ImportantSCREENING 2020-12-28C4591001DVC4591001 1140 11401378A126618201IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1140 11401379A`1-1XT0S1QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1140 11401379AP1-1T3NT87Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-16BMC4591001DVC4591001 1140 11401379A@1-1OZPULKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1140 11401379A01-1T3RBWDVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1140 11401379A 1-1P9Y0WQVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1140 11401379A1-1ZA0V0ZSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-16BMC4591001DVC4591001 1140 11401380A`1-1ZCT7TMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1140 11401380AP1-1Z4A0XUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1140 11401380A@1-1YY1KHHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1140 11401380A01-1YY1KHEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-23BC4591001DVC4591001 1140 11401380A 1-1R2GD35Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-05BBC4591001DVC4591001 1140 11401380A126618401IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1140 11401381A01-1R01D7AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03B@C4591001DVC4591001 1140 11401381A 126618501IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1140 11401381A1-1SMGXWQOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-10BGC4591001DVC4591001 1140 11401382A126618601IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1140 11401385A1-1UFPEPLOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-04-10B_C4591001DVC4591001 1140 11401386A01-1ONCAHTVisit 1 procedures not performed per protocol specified sequence with respect to randomization. Procedures/Tests Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1140 11401386A 1-1ONQ363Other Informed Consent Informed Consent Non-ImportantSCREENING 2020-12-30`C4591001DVC4591001 1140 11401386A1-1ONQ35XOther Informed Consent Informed Consent Non-ImportantSCREENING 2020-12-30`C4591001DVC4591001 1140 11401388A1-1WZ8ABQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10B~C4591001DVC4591001 1140 11401390A126674701IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1140 11401391A`1-1Z6WJLMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1140 11401391AP1-1YY1KI7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-16BC4591001DVC4591001 1140 11401391A@1-1YY1KI4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1140 11401391A01-1YY1KIAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-15BdC4591001DVC4591001 1140 11401391A 126675501IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1140 11401391A1-1R7CPQSOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-08B>C4591001DVC4591001 1140 11401392A01-1YY1KINVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-01BC4591001DVC4591001 1140 11401392A 1-1WNYMXXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BqC4591001DVC4591001 1140 11401392A1-1WNYMXAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BZC4591001DVC4591001 1140 11401393A01-1Z6WJLPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1140 11401393A 1-1V8MALFLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-04-12BaC4591001DVC4591001 1140 11401393A126675201IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1140 11401394Ap1-1ZHGLIYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-06BC4591001DVC4591001 1140 11401394A`1-1Z6WZXKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1140 11401394AP1-1YY1KIQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-12BC4591001DVC4591001 1140 11401394A@1-1YY1KITVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BwC4591001DVC4591001 1140 11401394A01-1P9Y0WTVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-28BC4591001DVC4591001 1140 11401394A 1-1ZIML0INasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-25BC4591001DVC4591001 1140 11401394A126675301IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1140 11401395A01-1R2N265Nasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-02-25B2C4591001DVC4591001 1140 11401395A 1-1RUGYW5Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-12BAC4591001DVC4591001 1140 11401395A1-1R0ME2XOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-01B6C4591001DVC4591001 1140 11401397A01-1R290ICVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantFOLLOW-UP 2021-03-01B5C4591001DVC4591001 1140 11401397A 1-1P9Y0WWVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-28BC4591001DVC4591001 1140 11401397A1-1RVJD5QOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-09B=C4591001DVC4591001 1140 11401398A@1-1ZHW9POVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1140 11401398A01-1Z6WZXNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1140 11401398A 1-1YCOMCRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-06BC4591001DVC4591001 1140 11401398A126678501IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1140 11401399A@1-1Z6WZXQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-09BC4591001DVC4591001 1140 11401399A01-1YY1KIWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-19BC4591001DVC4591001 1140 11401399A 1-1ZIML8NNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-27BC4591001DVC4591001 1140 11401399A126678601IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1140 11401400A01-1ZHGLJ1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-04BC4591001DVC4591001 1140 11401400A 1-1X97ZMESerology sample collected after vaccination at vaccination visits. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1140 11401400A1-1X97ZMBNasal swab not collected by site staff prior to vaccination. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1140 11401401A@1-1Z7HZODVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1140 11401401A01-1R2GD38Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-05B9C4591001DVC4591001 1140 11401401A 1-1P1RA7ZProcedure not performed as part of vital signs. Procedures/Tests Non-ImportantSCREENING 2021-01-050C4591001DVC4591001 1140 11401401A126677201IP administered prior to Almac authorizing it for use Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1140 11401402A1-1R0ME67Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-26B2C4591001DVC4591001 1140 11401403A1-1R0MEBJOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-26B2C4591001DVC4591001 1142 11421319A1-1ZCKEFEUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-16BC4591001DVC4591001 1142 11421321A1-1QWANCJOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-02B?C4591001DVC4591001 1142 11421323A@1-1ZCKEG4Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1142 11421323A01-1PG66KJSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-10BFC4591001DVC4591001 1142 11421323A 1-1OTUAC8Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-01-22B3C4591001DVC4591001 1142 11421323A1-1U6IAIVOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-10BFC4591001DVC4591001 1142 11421324A 1-1ZCKEG7Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1142 11421324A1-1XNJQX5Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1142 11421325A01-1WXBDJSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-25BqC4591001DVC4591001 1142 11421325A 1-1UCOSTTNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-20BlC4591001DVC4591001 1142 11421325A1-1XNJRCWOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B=C4591001DVC4591001 1142 11421326A@1-1WXBDJVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-25BqC4591001DVC4591001 1142 11421326A01-1UI3ZQXNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-21BmC4591001DVC4591001 1142 11421326A 1-1XNKCEVRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-24BC4591001DVC4591001 1142 11421326A1-1XBUONKOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B=C4591001DVC4591001 1142 11421327A 1-1WZH1GGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1142 11421327A1-1ZCKEGAUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1142 11421329A01-1ZHW8Z1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-10BC4591001DVC4591001 1142 11421329A 1-1WXBDL8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-19BC4591001DVC4591001 1142 11421329A1-1WXBDLBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-12BC4591001DVC4591001 1142 11421330A@1-1Z91JBBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1142 11421330A01-1WXBDLEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-19BC4591001DVC4591001 1142 11421330A 1-1WXBDLHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-12BC4591001DVC4591001 1142 11421330A1-1ZGPHW4Nasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1142 11421333A@1-1OE55I2Serology sample not collected Laboratory Non-ImportantSCREENING 2020-12-04C4591001DVC4591001 1142 11421333A01-1ZG93FXNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1142 11421333A 1-1ZA0V12Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-12BC4591001DVC4591001 1142 11421333A1-1OE55I5Nasal swab not collected for the visit where it is required Laboratory Non-ImportantSCREENING 2020-12-04C4591001DVC4591001 1142 11421335A01-1X92JEMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-21BC4591001DVC4591001 1142 11421335A 1-1XN7TBBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-16BC4591001DVC4591001 1142 11421335A1-1ZCKEMNUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1142 11421340A 1-1WHGZ9IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22BNC4591001DVC4591001 1142 11421340A1-1ZCKEMQUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-06BC4591001DVC4591001 1142 11421341A 1-1WNYMY3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-01BUC4591001DVC4591001 1142 11421341A1-1WHGZ9VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22BNC4591001DVC4591001 1142 11421342AP1-1ZBK2DCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-06-11BC4591001DVC4591001 1142 11421342A@1-1WNYMYQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22BNC4591001DVC4591001 1142 11421342A01-1YERU6CRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-12B`C4591001DVC4591001 1142 11421342A 1-1WKEYNFRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-12B`C4591001DVC4591001 1142 11421342A1-1U6KP1SOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-03B;C4591001DVC4591001 1142 11421344A01-1YVHD29Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1142 11421344A 1-1QWB8DAOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B8C4591001DVC4591001 1142 11421344A1-1OPSIQ0Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1142 11421345A 1-1YVHD2NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1142 11421345A1-1QWB8H2Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B8C4591001DVC4591001 1142 11421346A1-1ZCKEMTUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1142 11421348A1-1QWB8P1Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-02B7C4591001DVC4591001 1142 11421349A1-1ZCKEMZUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1142 11421351A1-1ZCKEPKUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-28BC4591001DVC4591001 1142 11421352A`1-1YVHD2QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-22BC4591001DVC4591001 1142 11421352AP1-1ZNJADUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BoC4591001DVC4591001 1142 11421352A@1-1WHGZ9YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-20BHC4591001DVC4591001 1142 11421352A01-1OTQ4MPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1142 11421352A 1-1ZCKEPNUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1142 11421352A1-1WKF7DENasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-14B}C4591001DVC4591001 1142 11421353A 1-1YBHJHWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1142 11421353A1-1WOKL36Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-23BC4591001DVC4591001 1142 11421354A 1-1YCOMCUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-07BC4591001DVC4591001 1142 11421354A1-1T3QF3GNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-11B[C4591001DVC4591001 1142 11421355A1-1ZCKEPQUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1142 11421356A1-1ZCKEPTUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1142 11421358A1-1ZHW9PIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1142 11421358Ap1-1WXBDLKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-09BUC4591001DVC4591001 1142 11421358A`1-1OTC3JMVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1142 11421358AP1-1XK2Z5SNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1142 11421358A@1-1Z8RQKMLab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1142 11421358A01-1WLITFRSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1142 11421358A 1-1WLITERSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1142 11421358A1-1QWCRSGOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-04B4C4591001DVC4591001 1142 11421359A`1-1Y55SB3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-09BC4591001DVC4591001 1142 11421359AP1-201SLGMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-16B\C4591001DVC4591001 1142 11421359A@1-1WHGZA1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22BFC4591001DVC4591001 1142 11421359A01-1RHZC29Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-08BTC4591001DVC4591001 1142 11421359A 1-1WLITG3Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1142 11421359A1-1WLITFXSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1142 11421360AP1-1ZHW9PLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-13BC4591001DVC4591001 1142 11421360A@1-1WHGZA4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22BFC4591001DVC4591001 1142 11421360A01-1RHZC2CSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-08BTC4591001DVC4591001 1142 11421360A 1-1WLITGPSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1142 11421360A1-1WLITGJSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1142 11421361A@1-1ZCKEPWUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1142 11421361A01-1WLITH1Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1142 11421361A 1-1WLITGVSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1142 11421361A1-1U7T8IOOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-01B0C4591001DVC4591001 1142 11421362AP1-1YVHD2TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-18BC4591001DVC4591001 1142 11421362A@1-1YCOMD7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1142 11421362A01-1SL24ETLab performed out of window Laboratory Non-ImportantFOLLOW-UP 2021-02-23BFC4591001DVC4591001 1142 11421362A 1-1WLITIHSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1142 11421362A1-1WLITI1Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1142 11421363A`1-1ZQSKQSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-30C C4591001DVC4591001 1142 11421363AP1-1QWB4OQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-03B2C4591001DVC4591001 1142 11421363A@1-1PFE8L2Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-03B2C4591001DVC4591001 1142 11421363A01-1ZQ7GX7Serology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-30C C4591001DVC4591001 1142 11421363A 1-1WLITJDSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1142 11421363A1-1WLITINSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1142 11421364A 1-1WLITJPSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1142 11421364A1-1WLITJJSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1142 11421365Ap1-1ZNJN1AVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-16BC4591001DVC4591001 1142 11421365A`1-1ZBK2DFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-07BC4591001DVC4591001 1142 11421365AP1-1WXBDLNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03BLC4591001DVC4591001 1142 11421365A@1-1ZHW9SEVisit not done Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1142 11421365A01-1R3H3R3Site staff training missing/incomplete Other Non-ImportantFOLLOW-UP 2021-03-03BLC4591001DVC4591001 1142 11421365A 1-1WLITKBSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1142 11421365A1-1WLITK5Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1142 11421366Ap1-1ZCKEPZUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1142 11421366A`1-1WM8MKNSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421366AP1-1WM8MITSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421366A@1-1ZK009HRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421366A01-1ZK009BRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421366A 1-1ZK008VRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421366A1-1ZK004JRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421367A01-1ZCKEQ2Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1142 11421367A 1-1WM8ML0Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421367A1-1WM8MKUSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421368Ap1-1ZK07X7Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421368A`1-1ZK07X1Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421368AP1-1WM8MMQSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421368A@1-1WM8MMKSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421368A01-1ZK07XJRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421368A 1-1ZK07XDRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421368A1-1XQ8VY1Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1142 11421369AP1-1OTQ4MSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-15BC4591001DVC4591001 1142 11421369A@1-1ZDSO7MNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-22BC4591001DVC4591001 1142 11421369A01-1WM8MO6Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421369A 1-1WM8MO0Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421369A1-1XQ9ZB7Other Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1142 11421370A`1-1ZNJN1EVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-27BC4591001DVC4591001 1142 11421370AP1-1SK9U7ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-17BWC4591001DVC4591001 1142 11421370A@1-1XK2Z5VNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-06BC4591001DVC4591001 1142 11421370A01-1WMOAN5Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421370A 1-1WM8MOMSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421370A1-1U7TT47Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-08B2C4591001DVC4591001 1142 11421371A01-1Z8PSBGIncorrect serology sample volume collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1142 11421371A 1-1WMOAURSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421371A1-1WMOAU1Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1142 11421372Ap1-1ZNJN1HVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-19BwC4591001DVC4591001 1142 11421372A`1-1WXBDM0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-02BGC4591001DVC4591001 1142 11421372AP1-1R3H3RCSite staff training missing/incomplete Other Non-ImportantFOLLOW-UP 2021-03-02BGC4591001DVC4591001 1142 11421372A@1-1Z94BDKSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1142 11421372A01-1YYTKPXNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-31BC4591001DVC4591001 1142 11421372A 1-1WMOAVDSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421372A1-1WMOAUXSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421373A01-1ZH2CRUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-13BC4591001DVC4591001 1142 11421373A 1-1WMOAVPSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421373A1-1WMOAVJSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421374A@1-1YYTKQ0Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1142 11421374A01-1ZGPI5ENasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1142 11421374A 1-1WMOAW1Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421374A1-1WMOAVVSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421375AP1-1ZNJN3SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-11BC4591001DVC4591001 1142 11421375A@1-1YYSSUWProcedure/Test not performed per protocol Procedures/Tests Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421375A01-1X66W73Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-04BhC4591001DVC4591001 1142 11421375A 1-1WN0T93Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421375A1-1WN0SR7Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421376A01-1UGC9J6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08BlC4591001DVC4591001 1142 11421376A 1-1WN0T9FSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421376A1-1WN0T99Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421377A`1-1ZBK2DIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-11BC4591001DVC4591001 1142 11421377AP1-1U1RKVSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BdC4591001DVC4591001 1142 11421377A@1-1XN7TBEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-19BXC4591001DVC4591001 1142 11421377A01-1WN1MEPSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421377A 1-1WN1MDZSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1142 11421377A1-1XRNUCBOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-11B4C4591001DVC4591001 1142 11421379A01-1WN1MFLSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1142 11421379A 1-1WN1MEVSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1142 11421379A1-1XSWW3POther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-04-29B{C4591001DVC4591001 1142 11421380Ap1-1Z6XAPVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-14BC4591001DVC4591001 1142 11421380A`1-1YBHJHZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-06BC4591001DVC4591001 1142 11421380AP1-1YYTKQ3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-20BC4591001DVC4591001 1142 11421380A@1-1WN1MGHSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1142 11421380A01-1WN1MGBSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1142 11421380A 1-1WN1MH3Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-23B:C4591001DVC4591001 1142 11421380A1-1WN1MGXRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-23B:C4591001DVC4591001 1142 11421383A@1-1YYTKQ6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-28BC4591001DVC4591001 1142 11421383A01-1WOKL39Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-05BCC4591001DVC4591001 1142 11421383A 1-1WN1MKBSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1142 11421383A1-1WN1MJVSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1142 11421384A01-1ZHGLJ4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-05BC4591001DVC4591001 1142 11421384A 1-1WN1MLRSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1142 11421384A1-1WN1MLLSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1142 11421385A`1-1Z7X5NYNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1142 11421385AP1-1ZD1SGLNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1142 11421385A@1-1WN1MMXSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-31AC4591001DVC4591001 1142 11421385A01-1WN1MMRSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-31AC4591001DVC4591001 1142 11421385A 1-1WN1MN9Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-22B6C4591001DVC4591001 1142 11421385A1-1WN1MN3Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-22B6C4591001DVC4591001 1142 11421386AP1-1ZBK2E5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1142 11421386A@1-1WN1MNVSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-31AC4591001DVC4591001 1142 11421386A01-1WN1MNFSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-31AC4591001DVC4591001 1142 11421386A 1-1WN1MOHRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-22B6C4591001DVC4591001 1142 11421386A1-1WN1MO1Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-22B6C4591001DVC4591001 1142 11421388A1-1ZNJN3VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-08B^C4591001DVC4591001 1142 11421388Ap1-1T3P3R3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-17BHC4591001DVC4591001 1142 11421388A`1-1SK9U82Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-17BHC4591001DVC4591001 1142 11421388AP1-1ZF2FU7Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-03-17BHC4591001DVC4591001 1142 11421388A@1-1XT0RD0Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-22BlC4591001DVC4591001 1142 11421388A01-1Z94BDENasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-20BC4591001DVC4591001 1142 11421388A 1-1WN1MPZSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1142 11421388A1-1WN1MPTSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1142 11421389A@1-1VM3J66Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-05BZC4591001DVC4591001 1142 11421389A01-1VM3J63Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-22BLC4591001DVC4591001 1142 11421389A 1-1WN1MQLSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1142 11421389A1-1WN1MQFSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1142 11421390A1-1Z6XAPZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-07BC4591001DVC4591001 1142 11421390Ap1-1ZK07ZUSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1142 11421390A`1-1ZK07ZOSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1142 11421390AP1-1WKFUZFRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-24B2C4591001DVC4591001 1142 11421390A@1-1WKFUQNRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-24B2C4591001DVC4591001 1142 11421390A01-1ZK0806Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1142 11421390A 1-1ZK0800Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1142 11421390A1-1ZK0816Other Informed Consent Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-20BC4591001DVC4591001 1142 11421391A01-1QZZX5ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-23B1C4591001DVC4591001 1142 11421391A 1-1WKFV0CRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-23B1C4591001DVC4591001 1142 11421391A1-1WKFUZLRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-23B1C4591001DVC4591001 1142 11421392A 1-1WKFV0ORevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B9C4591001DVC4591001 1142 11421392A1-1WKFV0IRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B9C4591001DVC4591001 1142 11421393A1-1ZNJN3YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-28BoC4591001DVC4591001 1142 11421393Ap1-1ZHFHBAPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-05BC4591001DVC4591001 1142 11421393A`1-1XE4N3NNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-12B}C4591001DVC4591001 1142 11421393AP1-1XQCFYYSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1142 11421393A@1-1XQCFYSSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1142 11421393A01-1WKFV10Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-26B2C4591001DVC4591001 1142 11421393A 1-1WKFV0URevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-02-26B2C4591001DVC4591001 1142 11421393A1-1QWCS4LOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-02-02BC4591001DVC4591001 1142 11421394AP1-1PFEHMJSerology sample not collected Laboratory Non-ImportantVACCINATION 2021-02-08BC4591001DVC4591001 1142 11421394A@1-1XQCG4KSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1142 11421394A01-1XQCFZ4Subject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1142 11421394A 1-1WKFV1CRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-09B:C4591001DVC4591001 1142 11421394A1-1WKFV16Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-09B:C4591001DVC4591001 1142 11421395A@1-1XQHBYBSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1142 11421395A01-1XQHBTZSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1142 11421395A 1-1WKFV1ORevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-03B4C4591001DVC4591001 1142 11421395A1-1WKFV1IRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-03B4C4591001DVC4591001 1142 11421396Ap1-1WXBDM3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-30BOC4591001DVC4591001 1142 11421396A`1-1ZF2K70Serology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1142 11421396AP1-1XQHC6FSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1142 11421396A@1-1XQHBYHSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1142 11421396A01-1WKFV2ARevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-01B2C4591001DVC4591001 1142 11421396A 1-1WKFV1URevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-01B2C4591001DVC4591001 1142 11421396A1-1XRQKV8Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-02-01BC4591001DVC4591001 1147 11471263A1-1PGIV5FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-06B@C4591001DVC4591001 1147 11471264A 1-1OPUKCKProcedure/Test not performed per protocol Procedures/Tests Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1147 11471264A1-1YWWQYKLab performed out of window Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-23BC4591001DVC4591001 1147 11471271A1-1O91Z5BSerology sample not collected Laboratory Non-ImportantVACCINATION 2020-12-05AC4591001DVC4591001 1147 11471274A 1-1VM4BZ3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-22BC4591001DVC4591001 1147 11471274A1-1O91Z5FSerology sample not collected Laboratory Non-ImportantVACCINATION 2020-12-05AC4591001DVC4591001 1147 11471275A 1-1Z7IGBBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-08BBC4591001DVC4591001 1147 11471275A1-1OTC3JCVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1147 11471277A1-1Z3X4SMSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1147 11471279A1-1Z7FGGSNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1147 11471282A1-1Z2PN8JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1147 11471283A1-1Z3T79GVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1147 11471284A01-1ZGLOMCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-09BC4591001DVC4591001 1147 11471284A 1-1ZGLOXOReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1147 11471284A1-1ZGLOXLReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-30BC4591001DVC4591001 1147 11471285A1-1XTRFMTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-05-31BC4591001DVC4591001 1147 11471290A 1-1PKJ0OLSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-06B2C4591001DVC4591001 1147 11471291A01-1R01D7WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-03BKC4591001DVC4591001 1147 11471291A 1-1OH6W9TSubject/LAR signed a superseded/outdated version of the ICD Informed Consent Non-ImportantVACCINATION 2020-12-19AC4591001DVC4591001 1147 11471291A1-1ZP3JNIRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-04-28BC4591001DVC4591001 1147 11471296A1-1Z2PN8MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1147 11471300A@1-1ZHW9PFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-17BC4591001DVC4591001 1147 11471300A01-1YBHJI2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1147 11471300A 1-1XKAPZ9Visit not done Visit Schedule Non-ImportantFOLLOW-UP 2021-04-02BiC4591001DVC4591001 1147 11471300A1-1PG66KMSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-10B6C4591001DVC4591001 1147 11471301A 1-1XD5Z2NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1147 11471301A1-1PG66KPSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-10B6C4591001DVC4591001 1147 11471307A1-1YWWQYNLab performed out of window Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-19BC4591001DVC4591001 1147 11471308A1-1YVHD2WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-01BC4591001DVC4591001 1147 11471309A1-1Z2PN8PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1147 11471310A 1-1ZBK2F0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-19BC4591001DVC4591001 1147 11471310A1-1QT6M9JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22B@C4591001DVC4591001 1147 11471311A1-1ZBK2F3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1147 11471313A01-1ZGP4BNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-13BC4591001DVC4591001 1147 11471313A 1-1Z2PN8SVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1147 11471313A1-1YIR5JCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1147 11471314A1-1OT46YOSerology sample not collected Laboratory Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1147 11471315A1-1QY6FK9Serology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-22B2C4591001DVC4591001 1147 11471318A1-1Z3T79TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-28BC4591001DVC4591001 1147 11471321A1-1ZBK2F6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-13BC4591001DVC4591001 1147 11471322A`1-1U1RUSTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-08B?C4591001DVC4591001 1147 11471322AP1-1ZE8ETFProcedure/Test not performed per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-08-06BC4591001DVC4591001 1147 11471322A@1-1R1TFSFSerology sample not collected Laboratory Non-ImportantVACCINATION 2021-02-26B5C4591001DVC4591001 1147 11471322A01-1ZHGWCJNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-06BC4591001DVC4591001 1147 11471322A 1-1ZZ5Q2JReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1147 11471322A1-1X92J3TReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1147 11471323A 1-1Z94B1JReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1147 11471323A1-1X92J3WReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-14BC4591001DVC4591001 1147 11471324A1-1QWNWKMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-25B4C4591001DVC4591001 1147 11471327A01-1QZCKCSProcedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-25B4C4591001DVC4591001 1147 11471327A 1-1ZHXSQZReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1147 11471327A1-1ZHXSQVReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-07B{C4591001DVC4591001 1147 11471328A01-1ZIGGBQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-18BC4591001DVC4591001 1147 11471328A 1-1Z6704HProcedure/Test not performed per protocol Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-07-19BC4591001DVC4591001 1147 11471328A1-1Z6704FSubject/LAR signed and dated ICD after screen/enroll date Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-07-01BC4591001DVC4591001 1147 11471330A 1-1YBHJI5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1147 11471330A1-1Z07BD1Urine pregnancy test not performed. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-14BC4591001DVC4591001 1147 11471332A 1-1ZBK2FJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-16BC4591001DVC4591001 1147 11471332A1-1ZQO1V2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-08-17BC4591001DVC4591001 1147 11471333A1-1R7E23CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-02-03BC4591001DVC4591001 1147 11471334A 1-1YVHD2ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1147 11471334A1-1ZIML8SNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-10BC4591001DVC4591001 1147 11471335A01-1ZHW9SHVisit not done Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-07BzC4591001DVC4591001 1147 11471335A 1-1Z94B33Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1147 11471335A1-1Z94B1MReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-20BC4591001DVC4591001 1147 11471336A01-1ZBJFDNLab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1147 11471336A 1-1ZHXSRAReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-08-12BC4591001DVC4591001 1147 11471336A1-1ZHXSRDReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-07-22BC4591001DVC4591001 1147 11471337A1-1Z2PN8VVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1147 11471338A 1-1ZIML95Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-18BC4591001DVC4591001 1147 11471338A1-1QZR7VPOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-01B7C4591001DVC4591001 1147 11471340A@1-1XKAPZCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-03BvC4591001DVC4591001 1147 11471340A01-1ZIML9BNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-13BC4591001DVC4591001 1147 11471340A 1-1ZIML98Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1147 11471340A1-1YWUHXELab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1147 11471341A1-1ZGO9CGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-04BC4591001DVC4591001 1147 11471342A1-1ZGO9CBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-04BC4591001DVC4591001 1147 11471344A1-1P93Z07Subject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantVACCINATION 2021-01-13AC4591001DVC4591001 1147 11471345A1-1ZBK2FMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-16BC4591001DVC4591001 1147 11471346A1-1SJSPLJSerology sample not collected Laboratory Non-ImportantFOLLOW-UP 2021-02-26B4C4591001DVC4591001 1150 11501118A01-1X206YJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-07BC4591001DVC4591001 1150 11501118A 1-1ZCKER9Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1150 11501118A1-1NUUOMEOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-10-15AC4591001DVC4591001 1150 11501120A1-1NUTN4OOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-10-15AC4591001DVC4591001 1150 11501121A1-1ZCKERCUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1150 11501125A1-1P9XMA1Procedure/Test not performed per protocol Procedures/Tests Non-ImportantFOLLOW-UP 2020-12-20B?C4591001DVC4591001 1150 11501126A1-1NPX56QUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-10-19AC4591001DVC4591001 1150 11501127A1-1NUUWVWOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-10-19AC4591001DVC4591001 1150 11501129AP1-1Z3T873Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-07CPC4591001DVC4591001 1150 11501129A@1-1X20LTSVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-23BC4591001DVC4591001 1150 11501129A01-1X20LTPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-17BC4591001DVC4591001 1150 11501129A 1-1X206YMVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-09BC4591001DVC4591001 1150 11501129A1-1NNFIZPUrine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-10-20AC4591001DVC4591001 1150 11501132A 1-1UCO558Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BC4591001DVC4591001 1150 11501132A1-1ZAMFPJOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-09BqC4591001DVC4591001 1150 11501134A1-1ZCKERFUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1150 11501135A1-1ZCKERSUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-13BC4591001DVC4591001 1150 11501168A01-1YBHJIVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-11BC4591001DVC4591001 1150 11501168A 1-1P9XMBOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-01B>C4591001DVC4591001 1150 11501168A1-1XA1US1Participant entered into asymptomatic swabbing part of study after they were unblinded Other Non-ImportantREPEAT SCREENING 1 2021-05-20BC4591001DVC4591001 1150 11501171A1-1ZZ5Q2MReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-09-01CC4591001DVC4591001 1150 11501183A1-1Z67CGFSerology sample not collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-25BC4591001DVC4591001 1150 11501187A1-1Z9VJXEVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-23BC4591001DVC4591001 1150 11501189A1-1X20LTVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-07BwC4591001DVC4591001 1150 11501190A1-1X20LTYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-07BwC4591001DVC4591001 1150 11501191A1-1X20LW9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-19BHC4591001DVC4591001 1150 11501193A1-1OAY4GMOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1150 11501195A 1-1X20LWFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-15B~C4591001DVC4591001 1150 11501195A1-1X20LWCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BuC4591001DVC4591001 1150 11501196A 1-1X20LX5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-15B~C4591001DVC4591001 1150 11501196A1-1X20LX2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-06BuC4591001DVC4591001 1150 11501200A1-1ZNJNARVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BtC4591001DVC4591001 1150 11501201A1-1X20LX8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BtC4591001DVC4591001 1150 11501203A1-1YIQWD8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-10BC4591001DVC4591001 1150 11501205A1-1PKTXS8Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1150 11501209A1-1YM0M5NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1150 11501214A 1-1Y29BTBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-11BC4591001DVC4591001 1150 11501214A1-1OTBWEIVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-07BC4591001DVC4591001 1150 11501221A1-1YO3CUCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1150 11501228A1-1XSHW4KVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-03BC4591001DVC4591001 1150 11501233A1-1ZBK2FPVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1150 11501237A01-1X20M03Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-22B@C4591001DVC4591001 1150 11501237A 1-1XD90VXOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1150 11501237A1-1ONF58GOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1150 11501238A01-1ZHW9QWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-17BC4591001DVC4591001 1150 11501238A 1-1ZIK1D5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-13BC4591001DVC4591001 1150 11501238A1-1ONFNDSOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1150 11501239A1-1X20M06Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-13BqC4591001DVC4591001 1150 11501240A1-1R1PD1HOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-02-26BCC4591001DVC4591001 1150 11501242A1-1VI83AXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-04-05BhC4591001DVC4591001 1150 11501245A1-1SK9ULRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-17BPC4591001DVC4591001 1150 11501246A01-1ZHGW7XVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-11BC4591001DVC4591001 1150 11501246A 1-1T3Q4BUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-12BKC4591001DVC4591001 1150 11501246A1-1PJ7AMQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-29B!C4591001DVC4591001 1150 11501247A1-1YE2OTTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1150 11501250A1-1ONY5KBOther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1150 11501252A1-1Z2PN8YVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-05BC4591001DVC4591001 1150 11501256A1-1OW74D1Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1150 11501258A1-1XE2UPOOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1150 11501259A1-1XE2URNOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-19BC4591001DVC4591001 1150 11501262A1-1ZHGW81Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-05BC4591001DVC4591001 1150 11501263A1-1OW74ILOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1150 11501268A1-1XFTTSAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-15BC4591001DVC4591001 1150 11501269A1-1ZHGW84Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-04BC4591001DVC4591001 1150 11501276A1-1Z97VPRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-08BC4591001DVC4591001 1150 11501278A1-1YO3CUFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-21BC4591001DVC4591001 1150 11501280A 126899801IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1150 11501280A1-1T5WLA4Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-03-02B8C4591001DVC4591001 1150 11501285A1-1P23R7GOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1150 11501286A1-1P25HU7Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1150 11501289A01-1X7PJ13Subject/LAR signed consent but did not date it Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1150 11501289A 1-1X7PJ4LOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1150 11501289A1-1P25I70Other Informed Consent Informed Consent Non-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1150 11501293A 1-1P29DM0Subject was vaccinated despite meeting temporary delay criterion #3 (anticipation of receiving seasonal or pandemic influenza vaccine within 14 days or any other non-study vaccine within 28 days afterInvestigational ProductNon-ImportantVACCINATION 2021-01-15APC4591001DVC4591001 1150 11501293A1-1P93Z1CSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantVACCINATION 2021-01-15APC4591001DVC4591001 1150 11501295A1-1ZBK2GCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-20BC4591001DVC4591001 1150 11501296A1-1X20M09Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-07BWC4591001DVC4591001 1150 11501298A1-1X20M0CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BTC4591001DVC4591001 1152 11521604A 128265901Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-21BC4591001DVC4591001 1152 11521604A128259601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-02AC4591001DVC4591001 1152 11521605A128259701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-02AC4591001DVC4591001 1152 11521607A 128266701Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1152 11521607A128264301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521608A128362901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521611A128363201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521612A@1-1ZQN69BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-25CC4591001DVC4591001 1152 11521612A01-1ZLQIC3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-25CC4591001DVC4591001 1152 11521612A 128267301Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1152 11521612A128363301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521613A01-1ZLQIC7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-08-25CC4591001DVC4591001 1152 11521613A 128267501Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-22BC4591001DVC4591001 1152 11521613A128363501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521614A128363601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521615A01-1XN7TO0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-05BC4591001DVC4591001 1152 11521615A 1-1YLW4O5Nasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-01BC4591001DVC4591001 1152 11521615A128363701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521617A@1-1Z7IG17Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1152 11521617A01-1Z6ZZNBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1152 11521617A 1-1PJ7AMTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1152 11521617A128364001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521619A128364301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-03AC4591001DVC4591001 1152 11521625A 1-1ZCKEYZUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1152 11521625A128258301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1152 11521626A 1-1ZCKEZ2Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1152 11521626A128258401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1152 11521628A128258601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1152 11521629AP1-1PGIV5OVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-01-05B!C4591001DVC4591001 1152 11521629A@1-1ZBJNGVNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL FOLLOW-UP2021-07-16BC4591001DVC4591001 1152 11521629A0128724801Other IP deviation Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-01-05B!C4591001DVC4591001 1152 11521629A 128706301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-01-27B7C4591001DVC4591001 1152 11521629A128258701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-04AC4591001DVC4591001 1152 11521633A01-1ZH2NMRVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-28BC4591001DVC4591001 1152 11521633A 128269301Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521633A128256201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521635A128256601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521636A 1-1ZGN7TEUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-08-11BC4591001DVC4591001 1152 11521636A128256701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521637A01-1X20M20Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-21BC4591001DVC4591001 1152 11521637A 128269701Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521637A128256801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521638A 128269901Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521638A128257001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521639A 128270101Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521639A128257301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521640A01-1YFMT20Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-12BC4591001DVC4591001 1152 11521640A 1-1ZH2NOVNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1152 11521640A127767501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-22B/C4591001DVC4591001 1152 11521641AP1-1YFMT5ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-09BC4591001DVC4591001 1152 11521641A@1-1P2RFY8Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-01-29B6C4591001DVC4591001 1152 11521641A01-1ZH2NOYNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1152 11521641A 1-1PE4QAKNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2020-12-09A0C4591001DVC4591001 1152 11521641A127767401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-22B/C4591001DVC4591001 1152 11521642A 128270501Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521642A127767301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521644A 1-1ZCKEZ8Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1152 11521644A127767001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1152 11521645Ap1-1YFMT62Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-25BC4591001DVC4591001 1152 11521645A`1-1WHGZB0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-15BFC4591001DVC4591001 1152 11521645AP1-1ZCKEZBUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-29BC4591001DVC4591001 1152 11521645A@1-1Z7FGVQNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-17BC4591001DVC4591001 1152 11521645A01-1Z7FGVNNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-03BC4591001DVC4591001 1152 11521645A 128270701Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521645A127766901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521646A 1-1ZHGWCMNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1152 11521646A127766701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521647A01-1PAF1X5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-05B<C4591001DVC4591001 1152 11521647A 1-1P9Y85JVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-06BC4591001DVC4591001 1152 11521647A127766601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-22B.C4591001DVC4591001 1152 11521648A127766501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521649A01-1YBHJIYVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-26BC4591001DVC4591001 1152 11521649A 128271001Other IP deviation Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521649A127766301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521650A127766201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521651A127766101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521652A 1-1Z4A0YAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-08BC4591001DVC4591001 1152 11521652A127765801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1152 11521653A127765701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-09AC4591001DVC4591001 1152 11521654A127765601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-09AC4591001DVC4591001 1152 11521655A127765501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-09AC4591001DVC4591001 1152 11521656A 1-1PJL1GIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1152 11521656A127760801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521657A 1-1X20M2NVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BpC4591001DVC4591001 1152 11521657A127760601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521658A01-1Z7XVN1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-07-19BC4591001DVC4591001 1152 11521658A 1-1X20M2QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BpC4591001DVC4591001 1152 11521658A127760301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521659A01-1YFMT65Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06BC4591001DVC4591001 1152 11521659A 1-1ZH2NP1Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-26BC4591001DVC4591001 1152 11521659A127760201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521660A 1-1PJL1GLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-04BC4591001DVC4591001 1152 11521660A127760001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521661A127759601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521662A127759401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521663A@1-1YO3V93Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-21BC4591001DVC4591001 1152 11521663A01-1YFMT68Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-02BC4591001DVC4591001 1152 11521663A 1-1ZH2NRWNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-24BC4591001DVC4591001 1152 11521663A127759301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-10AC4591001DVC4591001 1152 11521664A01-1YFMTD9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-25BiC4591001DVC4591001 1152 11521664A 1-1ZH2NRZNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-08BXC4591001DVC4591001 1152 11521664A127759101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1152 11521665A01-1ZHXSOIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-05BtC4591001DVC4591001 1152 11521665A 1-1ZH2NS2Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-21BeC4591001DVC4591001 1152 11521665A127758601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1152 11521666A 1-1Q8RCHFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-04B8C4591001DVC4591001 1152 11521666A127758401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1152 11521667A127758001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1152 11521668A127757801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1152 11521669A127757701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1152 11521670A 1-1ZHHG6VNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-05BC4591001DVC4591001 1152 11521670A127757601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-11AC4591001DVC4591001 1152 11521671A127757501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1152 11521672A@1-1ZHW9R2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-16BC4591001DVC4591001 1152 11521672A01-1Y75BQ4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-16BC4591001DVC4591001 1152 11521672A 1-1WHGZB3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-10B;C4591001DVC4591001 1152 11521672A127757401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1152 11521673A01-1WHGZB6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-10B;C4591001DVC4591001 1152 11521673A 1-1ZNKP20Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-13BC4591001DVC4591001 1152 11521673A127757301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1152 11521674A 1-1PJVT0MVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-08BC4591001DVC4591001 1152 11521674A127757201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1152 11521675A01-1ZH2NMUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-30BC4591001DVC4591001 1152 11521675A 1-1XN7TO3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-04BC4591001DVC4591001 1152 11521675A127522101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1152 11521676A01-1QWB4OWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-18BCC4591001DVC4591001 1152 11521676A 128706601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1152 11521676A127756901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-14AC4591001DVC4591001 1152 11521677A 1-1ZCTHF3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-26BC4591001DVC4591001 1152 11521677A127756701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521678A 1-1WHGZC4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-07BrC4591001DVC4591001 1152 11521678A127756601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521679A 1-1U1RKY3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BkC4591001DVC4591001 1152 11521679A127756501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521680A 1-1XTOOXBIncorrect serology sample volume collected Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1152 11521680A127756401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521681A1-1ZLQID7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-27CC4591001DVC4591001 1152 11521681Ap1-1ZLQICAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-27CC4591001DVC4591001 1152 11521681A`1-1ZHXSOLVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-28BC4591001DVC4591001 1152 11521681AP1-1YFMTDCVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-04BC4591001DVC4591001 1152 11521681A@1-1X20M2TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-28BhC4591001DVC4591001 1152 11521681A01-1ZIYNPYNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-22BC4591001DVC4591001 1152 11521681A 1-1ZIYNPVNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-02BC4591001DVC4591001 1152 11521681A127756301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521682AP1-1ZHXSOOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-07-07BC4591001DVC4591001 1152 11521682A@1-1YFMTDFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-04BC4591001DVC4591001 1152 11521682A01-1X20M2WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-29BiC4591001DVC4591001 1152 11521682A 1-1ZIYZCNNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-02BC4591001DVC4591001 1152 11521682A127756201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521683A127756101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521684A01-1ZHXSORVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1152 11521684A 1-1ZIYZCQNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-12BC4591001DVC4591001 1152 11521684A127756001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521685A@1-1ZHXSOUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-01BC4591001DVC4591001 1152 11521685A01-1ZCKEZEUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-02BC4591001DVC4591001 1152 11521685A 1-1ZJ0Q9LNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-22BC4591001DVC4591001 1152 11521685A127755901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-15AC4591001DVC4591001 1152 11521686A@1-1ZHXSOFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-08-16BC4591001DVC4591001 1152 11521686A01-1QWH42CVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-19BBC4591001DVC4591001 1152 11521686A 1-1PJVT0PVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-11BC4591001DVC4591001 1152 11521686A127755701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521687A127755601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521688A127755501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521689A127755401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521690A127755301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521691A 1-1YVHD35Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-24BC4591001DVC4591001 1152 11521691A127755201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521692A01-1X20M2ZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-20B~C4591001DVC4591001 1152 11521692A 1-1X20M32Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-12BvC4591001DVC4591001 1152 11521692A127755101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521693A 1-1Z7XVN5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-20BC4591001DVC4591001 1152 11521693A127755001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521694A127754901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521695A 132185801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantOPEN LABEL TREATMENT2021-05-28BC4591001DVC4591001 1152 11521695A127754801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-16AC4591001DVC4591001 1152 11521696A127754701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-17AC4591001DVC4591001 1152 11521697A127754601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1152 11521698A01-1XN7TO6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1152 11521698A 127754501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1152 11521698A1-1X70YY4Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-15BC4591001DVC4591001 1152 11521699A01-1YO3V96Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-11BC4591001DVC4591001 1152 11521699A 1-1ZJ0QAANasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-07BC4591001DVC4591001 1152 11521699A127754401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1152 11521700A@1-1X20M35Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-29BC4591001DVC4591001 1152 11521700A01-1XBRTTBVisit not done Visit Schedule Non-ImportantFOLLOW-UP 2021-04-09BqC4591001DVC4591001 1152 11521700A 1-1ZJ0Q9PNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-28BeC4591001DVC4591001 1152 11521700A127754301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1152 11521701A127754201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-18AC4591001DVC4591001 1152 11521702A127754101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1152 11521703A 1-1YVHD38Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-28BC4591001DVC4591001 1152 11521703A127754001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1152 11521704A127753901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1152 11521705A127753801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1152 11521706A127753701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1152 11521707A`1-1ZHXSOXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-18BC4591001DVC4591001 1152 11521707AP1-1YFMTECVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1152 11521707A@1-1ZJ0Q9YNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-15BC4591001DVC4591001 1152 11521707A01-1ZJ0Q9VNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-28BC4591001DVC4591001 1152 11521707A 1-1ZJ0Q9SNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-01BC4591001DVC4591001 1152 11521707A127753601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1152 11521708A127753501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-21AC4591001DVC4591001 1152 11521709A01-1ZBK2GIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-27BC4591001DVC4591001 1152 11521709A 1-1X20M38Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-16BtC4591001DVC4591001 1152 11521709A127753401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1152 11521710A127753301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1152 11521711A 1-1Y7KZCTAssessment of acute reaction for protocol specified timeframe after study intervention administration not performed at the vaccination visits. Procedures/Tests Non-ImportantFOLLOW-UP 2021-02-22B?C4591001DVC4591001 1152 11521711A127753201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1152 11521712A 1-1ZCDVSBVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-28BC4591001DVC4591001 1152 11521712A127753101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-22AC4591001DVC4591001 1152 11521713A01-1Z2PN9BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-24BC4591001DVC4591001 1152 11521713A 1-1X20M3BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-21BxC4591001DVC4591001 1152 11521713A127753001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-23AC4591001DVC4591001 1152 11521714A127752901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-23AC4591001DVC4591001 1152 11521715A127752801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-28A`C4591001DVC4591001 1152 11521716A127752701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1152 11521717A127752601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-28AC4591001DVC4591001 1152 11521718A127752401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1152 11521719A@1-1Y1PBIUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL TREATMENT2021-06-07BC4591001DVC4591001 1152 11521719A01-1R79ZJXNasal swab not collected for the visit where it is required Laboratory Non-ImportantVACCINATION 2021-02-05B'C4591001DVC4591001 1152 11521719A 127752301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1152 11521719A1-1XA3PHCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-14BC4591001DVC4591001 1152 11521720A 1-1ZBKHL1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-19BC4591001DVC4591001 1152 11521720A127752201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1152 11521721A 1-1ZCDVSFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-28BC4591001DVC4591001 1152 11521721A127752001IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-29AC4591001DVC4591001 1152 11521722A01-1ZQN69FVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-31BC4591001DVC4591001 1152 11521722A 1-1X20M3EVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-23BsC4591001DVC4591001 1152 11521722A127751701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1152 11521723A@1-1ZHXSP0Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-10BfC4591001DVC4591001 1152 11521723A01-1ZJ0QA1Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-05BaC4591001DVC4591001 1152 11521723A 1-1Z2H9WUNasal swab not collected by site staff prior to vaccination. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-18BC4591001DVC4591001 1152 11521723A127751501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-22BC4591001DVC4591001 1152 11521724A127751301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1152 11521725A127751101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1152 11521726A 127750901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-30AC4591001DVC4591001 1152 11521726A1-1YBSBTWReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-06-12BC4591001DVC4591001 1152 11521727A127750701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1152 11521728A 1-1Z7FGVTNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1152 11521728A127750601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1152 11521729A127750401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1152 11521730A 1-1X20M3RVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-17BhC4591001DVC4591001 1152 11521730A127749901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1152 11521731A127749701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-04AC4591001DVC4591001 1152 11521732A127749601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1152 11521733A127749401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1152 11521734A@1-1YBHJJ1Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-08BC4591001DVC4591001 1152 11521734A01-1YFMTEFVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-09B}C4591001DVC4591001 1152 11521734A 1-1ZJ0QA4Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-22BlC4591001DVC4591001 1152 11521734A127749201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1152 11521735A@1-1YBHJJ4Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-08BC4591001DVC4591001 1152 11521735A01-1YFMTEIVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-09B}C4591001DVC4591001 1152 11521735A 1-1ZJ0QA7Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-22BlC4591001DVC4591001 1152 11521735A127748801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1152 11521736A127748401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-05AC4591001DVC4591001 1152 11521737A 1-1ZHGWCDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1152 11521737A127748201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1152 11521738A 1-1ZHHG6ZNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-07-13BC4591001DVC4591001 1152 11521738A127747901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-06AC4591001DVC4591001 1152 11521739A 1-1P9Y0WZVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-28BC4591001DVC4591001 1152 11521739A127747301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1152 11521740A127747101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1152 11521741A127746701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1152 11521742A 1-1YBHJJ7Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1152 11521742A127742101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521743A127741701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521744A127741501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521745A127741301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521746A127741201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521747A@1-1XN7TOJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-14BaC4591001DVC4591001 1152 11521747A01-1R1PP7IVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-08B<C4591001DVC4591001 1152 11521747A 127740901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521747A1-1Z94B36Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant OPEN LABEL TREATMENT2021-07-20BC4591001DVC4591001 1152 11521748A@1-1ZNJNAUVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-15BbC4591001DVC4591001 1152 11521748A01-1YLW4O9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-17BC4591001DVC4591001 1152 11521748A 127740801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521748A1-1ZA1EUNICD signed by unauthorized site personnel Informed Consent Non-ImportantREPEAT SCREENING 1 2021-07-21BC4591001DVC4591001 1152 11521749A127740501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521750A127740301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-08AC4591001DVC4591001 1152 11521751A 127739901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1152 11521751A1-1X70YZLReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-17BC4591001DVC4591001 1152 11521752A127739701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1152 11521753A127739501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1152 11521754A 127739301IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1152 11521754A1-1X92J3ZReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant REPEAT SCREENING 1 2021-05-20BC4591001DVC4591001 1152 11521755A@1-1ZQ77F2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-07BC4591001DVC4591001 1152 11521755A01-1YVHD3BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1152 11521755A 1-1ZH2CTWNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-23BC4591001DVC4591001 1152 11521755A127739101IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1152 11521756AP1-1X20M3UVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-12B\C4591001DVC4591001 1152 11521756A@1-1SXXBFDPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantVACCINATION 2021-01-21AC4591001DVC4591001 1152 11521756A01-1Z7FGYENasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1152 11521756A 1-1Z7FGYHNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-31BC4591001DVC4591001 1152 11521756A127738901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1152 11521757A127738601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2021-01-11AC4591001DVC4591001 1156 11561243A 1-201RHG7Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1156 11561243A1-1X8OK5QSurveillance for asymptomatic SARS-CoV-2 infection is performed after Visit-4 Other Non-ImportantFOLLOW-UP 2021-05-14BC4591001DVC4591001 1156 11561244A@1-1ZCKEZTUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1156 11561244A01-1X8OK5TSurveillance for asymptomatic SARS-CoV-2 infection is performed after Visit-4 Other Non-ImportantFOLLOW-UP 2021-05-14BC4591001DVC4591001 1156 11561244A 124747101IP documentation error IP preparation form errors Investigational ProductNon-ImportantVACCINATION 2020-11-03BC4591001DVC4591001 1156 11561244A1-1XNKQ73Other Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1156 11561245A01-1ZCKEZXUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-21BC4591001DVC4591001 1156 11561245A 1-1X8OK5WSurveillance for asymptomatic SARS-CoV-2 infection is performed after Visit-4 Other Non-ImportantFOLLOW-UP 2021-05-14BC4591001DVC4591001 1156 11561245A1-1NLVZNROther Informed Consent Informed Consent Non-ImportantVACCINATION 2020-10-15AC4591001DVC4591001 1156 11561246A1-1Z4A0YDVisit performed outside of protocol specified window. Visit Schedule Non-ImportantOPEN LABEL FOLLOW-UP2021-07-08C@C4591001DVC4591001 1156 11561247A1-1ZCKF00Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-27BC4591001DVC4591001 1156 11561249A1-1ZCKF0XUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1156 11561250A1-1ZCKF10Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1156 11561253A1-1ZCKF13Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-03BC4591001DVC4591001 1156 11561254A1-1ZCKF16Unblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1156 11561255A1-1NPPBB3Other Informed Consent Informed Consent Non-ImportantVACCINATION 2020-10-20AC4591001DVC4591001 1156 11561257A1-1X25EOVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-08BC4591001DVC4591001 1156 11561259A1-1ZCKSDJUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1156 11561263A 1-1YEWDZCOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-25BC4591001DVC4591001 1156 11561263A1-1Z4WHQPSubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantFOLLOW-UP 2021-05-10BC4591001DVC4591001 1156 11561265A1-1PNR0ZKVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-02-16BvC4591001DVC4591001 1156 11561303A 1-1ZCKSDPUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1156 11561303A126222601IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-11-30AC4591001DVC4591001 1156 11561304A126222801IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-11-30AC4591001DVC4591001 1156 11561306A 1-1ZCKSEMUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-22BC4591001DVC4591001 1156 11561306A126222901IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1156 11561307A126224201IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-02A C4591001DVC4591001 1156 11561308A126224401IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1156 11561310A01-1X25EX3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-11BC4591001DVC4591001 1156 11561310A 126224501IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-01AC4591001DVC4591001 1156 11561310A1-1OT3QYESubject received allowable non-study vaccine within 28 days prior to or 28 days after the administration of IP. Concomitant MedicationsNon-ImportantVACCINATION 2020-12-08AC4591001DVC4591001 1156 11561311A@1-1PJ7AIVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-05B#C4591001DVC4591001 1156 11561311A01-1ZCUBUVUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1156 11561311A 1-1ZIYNPSNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-07-01BC4591001DVC4591001 1156 11561311A126224701IP documentation error - IRT Confirmation Report Error Investigational ProductNon-ImportantVACCINATION 2020-12-02AC4591001DVC4591001 1156 11561312A1-200B3LTOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-07-06BC4591001DVC4591001 1156 11561316A1-1PJ7AIZVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1156 11561317A1-1PJ7AJ2Visit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2020-12-28BC4591001DVC4591001 1156 11561318A1-1PJ7ALNVisit performed outside of protocol specified window. Visit Schedule Non-ImportantVACCINATION 2021-01-05B!C4591001DVC4591001 1156 11561319A1-1ZCKSEPUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-06-23BC4591001DVC4591001 1156 11561320A1-1OTBWEOVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2020-12-23BC4591001DVC4591001 1156 11561322AP1-1ZHWCY9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-16BC4591001DVC4591001 1156 11561322A@1-1ZHWCY5Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-26BC4591001DVC4591001 1156 11561322A01-1ZIYNH3Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-14BC4591001DVC4591001 1156 11561322A 1-1ZIYNAMNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-24BC4591001DVC4591001 1156 11561322A126225701IP documentation error - IPAL error Investigational ProductNon-ImportantVACCINATION 2020-12-07AC4591001DVC4591001 1156 11561323A`1-1ZHWCYTVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-16BC4591001DVC4591001 1156 11561323AP1-1ZHWCYQVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-26BC4591001DVC4591001 1156 11561323A@1-1ZHWCYCProcedure/Test not performed per protocol Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1156 11561323A01-1ZIYNH9Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-05-14BC4591001DVC4591001 1156 11561323A 1-1ZIYNH6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-24BC4591001DVC4591001 1156 11561323A1-1Y6D8AOOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-18BC4591001DVC4591001 1156 11561324A1-1X25EX6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-08B\C4591001DVC4591001 1156 11561325A 1-1YFN96QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-07BC4591001DVC4591001 1156 11561325A1-1ZIYNHCNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-30BC4591001DVC4591001 1156 11561328A01-1ZL0IAVVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-18BC4591001DVC4591001 1156 11561328A 1-1ZHWCYWVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-14BC4591001DVC4591001 1156 11561328A1-1ZIYNLBNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-04BC4591001DVC4591001 1156 11561335A 1-1OSE3Z5Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-13BC4591001DVC4591001 1156 11561335A1-1ZCKSESUnblinding procedure for identification of participants to transition from placebo to active not conducted per protocol Procedures/Tests Non-ImportantREPEAT SCREENING 1 2021-07-16BC4591001DVC4591001 1156 11561336A 1-1XSYJXTReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant FOLLOW-UP 2021-06-03BC4591001DVC4591001 1156 11561336A1-1XSYJXQReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant FOLLOW-UP 2021-05-13BC4591001DVC4591001 1156 11561337A 1-1YFN96TVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06BC4591001DVC4591001 1156 11561337A1-1ZIYNLENasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-26B~C4591001DVC4591001 1156 11561339A 1-1ZNJNAXVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-21BsC4591001DVC4591001 1156 11561339A1-1OTBOU7Urine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2020-12-29A C4591001DVC4591001 1156 11561344A1-1ZHGWCGVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-03BC4591001DVC4591001 1156 11561348A1-1X25EX9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-07B=C4591001DVC4591001 1156 11561351A1-1OT3RC5Urine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1156 11561353A 1-1P9Y0VYVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1156 11561353A1-1Z65DIVReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant OPEN LABEL TREATMENT2021-06-10BC4591001DVC4591001 1156 11561354A 1-1ZJO3SHVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-19BC4591001DVC4591001 1156 11561354A1-1P9Y0W1Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1156 11561357A01-1YFN96WVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-19BgC4591001DVC4591001 1156 11561357A 1-1OT3RC8Urine pregnancy test not performed. Laboratory Non-ImportantVACCINATION 2021-01-08A C4591001DVC4591001 1156 11561357A1-1ZIYNLHNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-11B_C4591001DVC4591001 1156 11561358A1-1T3RBZ3Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-12BAC4591001DVC4591001 1156 11561359A1-1Z39G6KReceipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. Concomitant MedicationsImportant VACCINATION 2021-01-08AC4591001DVC4591001 1156 11561363A@1-1ZHWD53Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-06-16BC4591001DVC4591001 1156 11561363A01-1ZF3H7RProcedure/Test not performed per protocol Procedures/Tests Non-ImportantOPEN LABEL TREATMENT2021-07-30BC4591001DVC4591001 1156 11561363A 1-1ZIYNM4Nasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-06-01BC4591001DVC4591001 1156 11561363A1-1PH241HOther Informed Consent Informed Consent Non-ImportantVACCINATION 2021-02-02BC4591001DVC4591001 1156 11561364A1-1YO3VA6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1156 11561370A1-1ZIUMMAVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-18BC4591001DVC4591001 1156 11561373A 1-1ZHWD56Visit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-03-31BOC4591001DVC4591001 1156 11561373A1-1ZIYNMANasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-03-08B8C4591001DVC4591001 1156 11561375A 1-1YFN9CJVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-06BsC4591001DVC4591001 1156 11561375A1-1ZIYNPPNasal swab not collected for the visit where it is required Laboratory Non-ImportantFOLLOW-UP 2021-04-26BiC4591001DVC4591001 1223 12231267A01-1Z8PQX6Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-23BC4591001DVC4591001 1223 12231267A 1-1P9Y0W4Vaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-27BC4591001DVC4591001 1223 12231267A1-1ZE5VWINasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-12BC4591001DVC4591001 1223 12231268AP1-1ZB8USYPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-13BC4591001DVC4591001 1223 12231268A@1-1Z9KUITPotential COVID-19 illness visit not done when required per protocol. Visit Schedule Non-ImportantFOLLOW-UP 2021-05-13BC4591001DVC4591001 1223 12231268A01-1YKK1G6Nasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-05-19BC4591001DVC4591001 1223 12231268A 1-1Z94BE7Nasal swab collected at a visit where it was not required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-26BC4591001DVC4591001 1223 12231268A1-1YWW2LMLab performed out of window Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1223 12231269A01-1XA31Z0Urine pregnancy test not performed. Laboratory Non-ImportantOPEN LABEL TREATMENT2021-05-20BC4591001DVC4591001 1223 12231269A 127783801IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1223 12231269A1-1VM28TORevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B:C4591001DVC4591001 1223 12231270A1-1Z8PQX9Visit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-07-14BC4591001DVC4591001 1223 12231270A1-1ZIML9ENasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-04BC4591001DVC4591001 1223 12231270A1-1Z63Z5FNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-16BC4591001DVC4591001 1223 12231270Ap1-1ZNK705Nasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-25BC4591001DVC4591001 1223 12231270A`1-1ZMUK1MNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-12BC4591001DVC4591001 1223 12231270AP1-1ZE4R2IIncorrect serology sample volume collected Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-02BC4591001DVC4591001 1223 12231270A@127784101IP documentation error - Confirmation of blind error Investigational ProductNon-ImportantVACCINATION 2021-01-07AC4591001DVC4591001 1223 12231270A01-1XGB56LSubject/LAR did not sign the ICD but gave verbal consent Informed Consent Non-ImportantFOLLOW-UP 2021-04-07B[C4591001DVC4591001 1223 12231270A 1-1VM2R21Revised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B:C4591001DVC4591001 1223 12231270A1-1VM2R1VRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B:C4591001DVC4591001 1223 12231271A`1-1YVHD4BVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-05-26BC4591001DVC4591001 1223 12231271AP1-1Z63Z5INasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-30BC4591001DVC4591001 1223 12231271A@1-1ZMUK1PNasal swab collected at a visit where it was not required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-09BC4591001DVC4591001 1223 12231271A01-1Y8IT2TLab performed out of window Laboratory Non-ImportantREPEAT SCREENING 1 2021-06-15BC4591001DVC4591001 1223 12231271A 1-1XGB58SRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B9C4591001DVC4591001 1223 12231271A1-1VM2R6RRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-05B9C4591001DVC4591001 1223 12231272A1-1XGB59HOther Informed Consent Informed Consent Non-ImportantOPEN LABEL TREATMENT2021-05-21BC4591001DVC4591001 1223 12231273A01-1P9Y0ZWVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-01-29BC4591001DVC4591001 1223 12231273A 1-1YKK1GTNasal swab not collected for the visit where it is required Laboratory Non-ImportantOPEN LABEL TREATMENT2021-06-13BC4591001DVC4591001 1223 12231273A1-1XGB5HQOther Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-04-01BSC4591001DVC4591001 1223 12231274A`1-1ZL04FOVisit performed outside of protocol specified window. Visit Schedule Non-ImportantREPEAT SCREENING 1 2021-08-24BC4591001DVC4591001 1223 12231274AP1-1ZIQVVRNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-08-16BC4591001DVC4591001 1223 12231274A@1-1ZIQVVONasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-29BC4591001DVC4591001 1223 12231274A01-1ZIQVVLNasal swab not collected for the visit where it is required Laboratory Non-ImportantREPEAT SCREENING 1 2021-07-11BC4591001DVC4591001 1223 12231274A 1-1XGCVBWRevised ICD not signed at the first subject visits after the revised/approved ICD was available at site Informed Consent Non-ImportantFOLLOW-UP 2021-03-31BRC4591001DVC4591001 1223 12231274A1-1XGCVC2Other Informed Consent Informed Consent Non-ImportantFOLLOW-UP 2021-04-01BSC4591001DVC4591001 1223 12231275A1-1YM0M5QVisit performed outside of protocol specified window. Visit Schedule Non-ImportantFOLLOW-UP 2021-04-27BmC4591001DVC4591001 1223 12231275Ap1-1PDKG7CVaccination diary not completed at all during required 7-day post vaccination period. Procedures/Tests Non-ImportantVACCINATION 2021-02-02BC4591001DVC4591001 1223 12231275A`1-1ZJQ0QQNasal swab