HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 02JAN25:16:26:0502JAN25:16:26:05 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS ADDV SASDATA 6.06 02JAN25:16:26:0502JAN25:16:26:05 Deviation Analysis Dataset HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000006500000000000000000000 STUDYID Study Identifier USUBJID Unique Subject Identifier  SUBJID Subject Identifier for the Study 'SITEID Study Site Identifier 0COUNTRY Country 5AGE Age BEST  8AGEU Age Units @AGEGR1 Pooled Age Group 1 E AGEGR1N Pooled Age Group 1 (N) BEST  W AGEGR2 Pooled Age Group 2 _ AGEGR2N Pooled Age Group 2 (N) BEST  r SEX Sex z) RACE Race {'RACESPY Race Specify ETHNIC Ethnicity RANDFL Randomized Population Flag SAFFL Safety Population Flag FASBABFLFull Analysis Set bAb Population Flag FASNABFLFull Analysis Set nAb Population Flag PPBABFL Per Protocol bAb Population Flag PPNABFL Per Protocol nAb Population Flag PPBD29FLPer Protocol bAb Day 29 Flag PPBD57FLPer Protocol bAb Day 57 Flag PBD209FLPer Protocol bAb Day 209 Flag PPND29FLPer Protocol nAb Day 29 Flag PPND57FLPer Protocol nAb Day 57 Flag PND209FLPer Protocol nAb Day 209 Flag SAR1FL First Solicited Safety Population Flag SAR2FL Second Solicited Safety Population Flag SARAFL Solicited Safety Population Flag FASNA2FLFAS nAb 2 Population Flag  PPNAB2FLPP nAb 2 Population Flag !PN2D29FLPer Protocol nAb 2 Day 29 Flag "PN2D57FLPer Protocol nAb 2 Day 57 Flag #PN2209FLPer Protocol nAb 2 Day 209 Flag $DVBABFL Deviation Impact bAb Flag %DVNABFL Deviation Impact nAb Flag &DOSE1FL Vaccination 1 Flag 'DOSE2FL Vaccination 2 Flag (DOSEROFLDosing Error Flag  )COV19BL Baseline COVID Infection *ELECSBL Baseline Elecsys SARS CoV-2 Assay +COV19FL COVID Infection Flag ,SENTLFL Sentinel Participant Flag -D29W7DFLDay 29 Out of 7-Day Window Flag  .TRT01P Planned Treatment for Period 01  /TRT01PN Planned Treatment for Period 01 (N) BEST  0TRT01A Actual Treatment for Period 01 "1TRT01AN Actual Treatment for Period 01 (N) BEST  22TR01SDT Date of First Exposure in Period 01 DATE  :3TR01SDTMDatetime of First Exposure in Period 01 DATETIME B4TR01EDT Date of Last Exposure in Period 01 DATE  J5TR01EDTMDatetime of Last Exposure in Period 01 DATETIME R6TRTSDTM Datetime of First Exposure to Treatment DATETIME Z7TRTEDTM Datetime of Last Exposure to Treatment DATETIME b8DOSE2DT Date of Dose 2 DATE  j9DOS2DTM Datetime of Dose 2 DATETIME r:DVSEQ Sequence Number BEST  z;DVCAT Category for Protocol Deviation DVSTDY Study Day of Start of Deviation BEST  ?DVTERM Protocol Deviation Term @DVTERM1 Protocol Deviation Term 1 ADVSIG Significant Protocol Deviation 0 HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201mRNA-1273-P201-US201-1043US2011043US201USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FMULTIPLE (b)(6) HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVOHqɳ HqHqɳ DVOHqɳ AProtocol DeviationStudy Procedures/Assessments 2020-09-28BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1043US2011043US201USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FMULTIPLE (b)(6) HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVOHqɳ HqHqɳ DVOHqɳ A Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1075US2041075US204USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MMULTIPLE (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq:DDVQHqmHq:DHqmDVQHqmAProtocol DeviationVisit Scheduling 2020-07-13B*P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1075US2041075US204USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MMULTIPLE (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq:DDVQHqmHq:DHqmDVQHqmA Protocol DeviationVisit Scheduling 2020-07-21B2P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1059US2021059US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq DVRHq͜Hq Hq͜DVRHq͜AProtocol DeviationStudy Procedures/Assessments 2021-01-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1059US2021059US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq DVRHq͜Hq Hq͜DVRHq͜A Protocol DeviationVisit Scheduling 2021-02-18C`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqYAProtocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqYA Protocol DeviationStudy Procedures/Assessments 2020-10-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqYA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqYA@Protocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1166US2021166US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FOTHER (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq:DVWHqYHq:HqYDVWHqYAPProtocol DeviationVisit Scheduling 2021-02-22CpP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1004US2011004US201USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqhHqHqhDVOHqhAProtocol DeviationStudy Procedures/Assessments 2020-09-30BzP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1004US2011004US201USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqhHqHqhDVOHqhA Protocol DeviationStudy Procedures/Assessments 2021-03-05C`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1004US2011004US201USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqhHqHqhDVOHqhA0Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1007US2011007US201USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq dDVOHqHq dHqDVOHqAProtocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1009US2011009US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq!DVOHq 0Hq!Hq 0DVOHq 0AProtocol DeviationStudy Procedures/Assessments 2020-09-28BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1009US2011009US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq!DVOHq 0Hq!Hq 0DVOHq 0A Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1011US2011011US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0Hq$DVLHqlHq$HqlDVLHqlA0Protocol DeviationConcomitant Medication 2021-03-04CP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1011US2011011US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0Hq$DVLHqlHq$HqlDVLHqlAProtocol DeviationStudy Procedures/Assessments 2020-05-29AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1011US2011011US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0Hq$DVLHqlHq$HqlDVLHqlA Protocol DeviationStudy Procedures/Assessments 2020-08-27B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1011US2011011US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0Hq$DVLHqlHq$HqlDVLHqlA@Protocol DeviationVisit Scheduling 2020-12-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1012US2011012US201USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqQHqHqQDVPHqQAProtocol DeviationStudy Procedures/Assessments 2020-09-29ByP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1012US2011012US201USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqQHqHqQDVPHqQA Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1012US2011012US201USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqQHqHqQDVPHqQA0Protocol DeviationVisit Scheduling 2021-02-19CP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1014US2011014US201USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVOHqɟHqHqɟDVOHqɟAProtocol DeviationStudy Procedures/Assessments 2020-10-01B{P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1014US2011014US201USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVOHqɟHqHqɟDVOHqɟA Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1018US2011018US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq-DVPHqu\Hq-Hqu\DVPHqu\AProtocol DeviationStudy Procedures/Assessments 2020-09-30BzP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1018US2011018US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq-DVPHqu\Hq-Hqu\DVPHqu\A Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1018US2011018US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq-DVPHqu\Hq-Hqu\DVPHqu\A0Protocol DeviationVisit Scheduling 2021-02-25CP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1019US2011019US201USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqaDVRHqͺHqaHqͺDVRHqͺAProtocol DeviationStudy Procedures/Assessments 2020-09-29BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1019US2011019US201USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqaDVRHqͺHqaHqͺDVRHqͺA Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1020US2011020US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVQHq̦ HqHq̦ DVQHq̦ AProtocol DeviationStudy Procedures/Assessments 2020-09-30BzP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1020US2011020US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVQHq̦ HqHq̦ DVQHq̦ A Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1023US2011023US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV4HqwDVRHqHqwHqDVRHqAProtocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1028US2011028US201USAB<YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɦxHqHqɦxDVOHqɦxAProtocol DeviationStudy Procedures/Assessments 2021-02-24CP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1028US2011028US201USAB<YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɦxHqHqɦxDVOHqɦxA Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1029US2011029US201USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq4<DVOHqXHq4<HqXDVOHqXAProtocol DeviationStudy Procedures/Assessments 2020-09-28BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1029US2011029US201USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq4<DVOHqXHq4<HqXDVOHqXA Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1030US2011030US201USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq%DVPHqHq%HqDVPHqAProtocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1032US2011032US201USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqM|DVQHq́@HqM|Hq́@DVQHq́@AProtocol DeviationStudy Procedures/Assessments 2020-09-29BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1032US2011032US201USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqM|DVQHq́@HqM|Hq́@DVQHq́@A Protocol DeviationStudy Procedures/Assessments 2021-03-05CPP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1032US2011032US201USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqM|DVQHq́@HqM|Hq́@DVQHq́@A0Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1039US2011039US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq'DVOHqHq'HqDVOHqAProtocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq(DVOHqɿHq(HqɿDVOHqɿA Protocol DeviationConcomitant Medication 2021-01-26BP09.1 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (IMMUNOSUPPRESSANTS OR OTHER IMMUNE-MODIFYING DRUGS ADMINISTERED CHRONICALLY (IE, MORE THAN 14 DAYS IN TOTAL) DURING THE STUDY PERIOD. FOR CORTICOSTEROIDS, THIS WILL MEAN THAT PREDNISONE = 20 MG/DAY OR THE EQUIVALENT IS NOT PERMITTED. ) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT)SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq(DVOHqɿHq(HqɿDVOHqɿAProtocol DeviationStudy Treatment Admin/Dispense2020-06-29BP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER CONTRA-INDICATION, ETC.) BUT IP DETERMINED ACCEPTABLE FOR USE AND NO IMPACT TO SUBJECT SAFETY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq(DVOHqɿHq(HqɿDVOHqɿA0Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1041US2011041US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%hDVPHq.XHq%hHq.XDVPHq.XA Protocol DeviationMissing Endpoint Assessments 2020-06-10AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1041US2011041US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%hDVPHq.XHq%hHq.XDVPHq.XA0Protocol DeviationMissing Endpoint Assessments 2020-07-07B$P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1041US2011041US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%hDVPHq.XHq%hHq.XDVPHq.XAProtocol DeviationMissing Endpoint Assessments 2020-12-29BP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1041US2011041US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%hDVPHq.XHq%hHq.XDVPHq.XA@Protocol DeviationStudy Procedures/Assessments 2020-10-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1041US2011041US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%hDVPHq.XHq%hHq.XDVPHq.XAPProtocol DeviationStudy Procedures/Assessments 2021-03-04C@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1041US2011041US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%hDVPHq.XHq%hHq.XDVPHq.XA`Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1042US2011042US201USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqDVVHqCHqHqCDVVHqCAProtocol DeviationMissing Endpoint Assessments 2020-07-13B$P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1042US2011042US201USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqDVVHqCHqHqCDVVHqCA Protocol DeviationVisit Scheduling 2020-12-21BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1046US2011046US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqdDVQHq̙dHqdHq̙dDVQHq̙dAProtocol DeviationStudy Procedures/Assessments 2020-10-01BzP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1046US2011046US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqdDVQHq̙dHqdHq̙dDVQHq̙dA Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1046US2011046US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqdDVQHq̙dHqdHq̙dDVQHq̙dA0Protocol DeviationVisit Scheduling 2021-01-23BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1048US2011048US201USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq$DVOHqɹHq$HqɹDVOHqɹAProtocol DeviationStudy Procedures/Assessments 2020-09-02B^P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1048US2011048US201USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq$DVOHqɹHq$HqɹDVOHqɹA Protocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1048US2011048US201USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq$DVOHqɹHq$HqɹDVOHqɹA0Protocol DeviationVisit Scheduling 2021-01-22BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1048US2011048US201USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq$DVOHqɹHq$HqɹDVOHqɹA@Protocol DeviationVisit Scheduling 2021-02-19CP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1050US2011050US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɭHqHqɭDVOHqɭAProtocol DeviationVisit Scheduling 2020-12-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1050US2011050US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɭHqHqɭDVOHqɭA Protocol DeviationVisit Scheduling 2021-01-22BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1050US2011050US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHqɭHqHqɭDVOHqɭA0Protocol DeviationVisit Scheduling 2021-02-19CP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq"AProtocol DeviationStudy Procedures/Assessments 2020-09-01B\P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq"A Protocol DeviationStudy Procedures/Assessments 2020-10-12BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq"A0Protocol DeviationStudy Procedures/Assessments 2021-02-01BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1051US2011051US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqqDVVHq"HqqHq"DVVHq"A@Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1055US2011055US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq}DVPHq[XHq}Hq[XDVPHq[XAProtocol DeviationMissing Endpoint Assessments 2020-07-07B$P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1055US2011055US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq}DVPHq[XHq}Hq[XDVPHq[XA Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1056US2011056US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq@DVPHqhHq@HqhDVPHqhAProtocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1057US2011057US201USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqZDVPHqHqZHqDVPHqAProtocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1059US2011059US201USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVPHqHqHqDVPHqAProtocol DeviationStudy Procedures/Assessments 2020-06-30BP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1059US2011059US201USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVPHqHqHqDVPHqA Protocol DeviationStudy Procedures/Assessments 2020-09-30ByP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1059US2011059US201USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVPHqHqHqDVPHqA0Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1060US2011060US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq@ DVPHqb$Hq@ Hqb$DVPHqb$AProtocol DeviationStudy Procedures/Assessments 2020-09-28BwP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1060US2011060US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq@ DVPHqb$Hq@ Hqb$DVPHqb$A Protocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1061US2011061US201USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVRHq@HqHq@DVRHq@AProtocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1064US2011064US201USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq<$DVQHq̌Hq<$Hq̌DVQHq̌AProtocol DeviationStudy Procedures/Assessments 2020-09-28BwP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1064US2011064US201USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq<$DVQHq̌Hq<$Hq̌DVQHq̌A Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1065US2011065US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqFDVPHqCHqFHqCDVPHqCAProtocol DeviationStudy Procedures/Assessments 2020-09-29BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1065US2011065US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqFDVPHqCHqFHqCDVPHqCA Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4AProtocol DeviationStudy Procedures/Assessments 2020-10-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4A@Protocol DeviationVisit Scheduling 2020-06-10AP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4A Protocol DeviationVisit Scheduling 2020-09-29BwP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVWHq4HqHq4DVWHq4A0Protocol DeviationVisit Scheduling 2020-12-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1068US2011068US201USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqhDVPHq,HqhHq,DVPHq,AProtocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1069US2011069US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqDVPHq=HqHq=DVPHq=AProtocol DeviationStudy Procedures/Assessments 2020-10-01BzP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1069US2011069US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqDVPHq=HqHq=DVPHq=A Protocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1070US2011070US201USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADV7HqDVVHqHqHqDVVHqAProtocol DeviationMissing Endpoint Assessments 2020-06-10A`P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1070US2011070US201USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADV7HqDVVHqHqHqDVVHqA Protocol DeviationMissing Endpoint Assessments 2020-06-12AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1070US2011070US201USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADV7HqDVVHqHqHqDVVHqA@Protocol DeviationVisit Scheduling 2020-06-12AP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1070US2011070US201USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADV7HqDVVHqHqHqDVVHqA0Protocol DeviationVisit Scheduling 2020-09-03B[P10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1080US2011080US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDVQHq̟HqHq̟DVQHq̟AProtocol DeviationStudy Procedures/Assessments 2021-01-29BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1080US2011080US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDVQHq̟HqHq̟DVQHq̟A Protocol DeviationStudy Procedures/Assessments 2021-03-02CP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1080US2011080US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDVQHq̟HqHq̟DVQHq̟A0Protocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1084US2011084US201USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq DVPHqHq HqDVPHqAProtocol DeviationVisit Scheduling 2021-01-09BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1085US2011085US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq DVQHq̷(Hq Hq̷(DVQHq̷(AProtocol DeviationStudy Procedures/Assessments 2020-09-29BwP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1085US2011085US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq DVQHq̷(Hq Hq̷(DVQHq̷(A Protocol DeviationStudy Procedures/Assessments 2021-03-05C@P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1085US2011085US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq DVQHq̷(Hq Hq̷(DVQHq̷(A0Protocol DeviationVisit Scheduling 2021-01-10BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1086US2011086US201USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMBLACK OR AFRICAN AMERICAN HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4HqPDVPHqHqPHqDVPHqAProtocol DeviationVisit Scheduling 2021-01-09BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1087US2011087US201USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̭PHqHq̭PDVQHq̭PAProtocol DeviationMissing Endpoint Assessments 2020-07-08B$P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1087US2011087US201USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̭PHqHq̭PDVQHq̭PA Protocol DeviationStudy Procedures/Assessments 2020-09-30BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1087US2011087US201USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̭PHqHq̭PDVQHq̭PA0Protocol DeviationStudy Procedures/Assessments 2020-10-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1087US2011087US201USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̭PHqHq̭PDVQHq̭PA@Protocol DeviationVisit Scheduling 2020-12-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9AProtocol DeviationMissing Endpoint Assessments 2020-07-14B)P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9A Protocol DeviationStudy Procedures/Assessments 2020-09-02B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9A0Protocol DeviationStudy Procedures/Assessments 2020-10-01BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9A@Protocol DeviationStudy Procedures/Assessments 2020-10-28BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9APProtocol DeviationStudy Procedures/Assessments 2021-02-02BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq9HqHq9DVWHq9A`Protocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzhAProtocol DeviationStudy Procedures/Assessments 2020-09-03B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzhA Protocol DeviationStudy Procedures/Assessments 2020-10-02BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzhA0Protocol DeviationStudy Procedures/Assessments 2020-10-30BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzhA@Protocol DeviationStudy Procedures/Assessments 2021-02-22CpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1089US2011089US201USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqDVZHqzhHqHqzhDVZHqzhAPProtocol DeviationVisit Scheduling 2021-01-08BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1090US2011090US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqͲhHqHqͲhDVRHqͲhAProtocol DeviationStudy Procedures/Assessments 2020-09-30BwP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1090US2011090US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqͲhHqHqͲhDVRHqͲhA Protocol DeviationVisit Scheduling 2021-01-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqրAProtocol DeviationStudy Procedures/Assessments 2020-09-30BwP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1091US2011091US201USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqրHqHqրDVRHqրA Protocol DeviationVisit Scheduling 2021-01-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1092US2011092US201USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqRDVWHqԂHqRHqԂDVWHqԂAProtocol DeviationStudy Procedures/Assessments 2020-09-01BYP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1092US2011092US201USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqRDVWHqԂHqRHqԂDVWHqԂA Protocol DeviationStudy Procedures/Assessments 2020-10-02BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1092US2011092US201USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqRDVWHqԂHqRHqԂDVWHqԂA0Protocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1093US2011093US201USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq,DVVHqHq,HqDVVHqAProtocol DeviationVisit Scheduling 2021-01-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1093US2011093US201USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq,DVVHqHq,HqDVVHqA Protocol DeviationVisit Scheduling 2021-01-30BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1093US2011093US201USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq,DVVHqHq,HqDVVHqA0Protocol DeviationVisit Scheduling 2021-02-27CP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO AProtocol DeviationStudy Procedures/Assessments 2020-10-01BwP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1095US2011095US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYNYYNYNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqYDVVHqO HqYHqO DVVHqO A Protocol DeviationVisit Scheduling 2021-01-12BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1102US2011102US201USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVVHqHqHqDVVHqAProtocol DeviationStudy Procedures/Assessments 2020-10-02BuP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1102US2011102US201USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVVHqHqHqDVVHqA Protocol DeviationVisit Scheduling 2021-01-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1103US2011103US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq?DVWHqԕ`Hq?Hqԕ`DVWHqԕ`AProtocol DeviationMissing Endpoint Assessments 2020-07-07BP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1103US2011103US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq?DVWHqԕ`Hq?Hqԕ`DVWHqԕ`A Protocol DeviationVisit Scheduling 2020-12-21BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1103US2011103US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq?DVWHqԕ`Hq?Hqԕ`DVWHqԕ`A0Protocol DeviationVisit Scheduling 2021-02-26CP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1109US2011109US201USABLYEARS>=55 Years A >=55 Years A@FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYN NNNPlacebo APlacebo ADVLHq޼DVhHqHq޼HqDVhHqAProtocol DeviationStudy Procedures/Assessments 2020-09-30BaP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1109US2011109US201USABLYEARS>=55 Years A >=55 Years A@FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYN NNNPlacebo APlacebo ADVLHq޼DVhHqHq޼HqDVhHqA Protocol DeviationStudy Procedures/Assessments 2020-10-23BxP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1109US2011109US201USABLYEARS>=55 Years A >=55 Years A@FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYN NNNPlacebo APlacebo ADVLHq޼DVhHqHq޼HqDVhHqA0Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1109US2011109US201USABLYEARS>=55 Years A >=55 Years A@FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYN NNNPlacebo APlacebo ADVLHq޼DVhHqHq޼HqDVhHqA@Protocol DeviationStudy Procedures/Assessments 2021-03-02BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1113US2011113US201USAB?YEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqhDVnHqHqhHqDVnHqAProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1114US2011114US201USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqؤDVhHqHqؤHqDVhHqAProtocol DeviationStudy Procedures/Assessments 2020-09-24B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1114US2011114US201USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqؤDVhHqHqؤHqDVhHqA Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1114US2011114US201USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqؤDVhHqHqؤHqDVhHqA0Protocol DeviationStudy Procedures/Assessments 2021-03-04BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1116US2011116US201USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVMHq.DVkHqɨHq.HqɨDVkHqɨAProtocol DeviationStudy Procedures/Assessments 2020-09-25B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1116US2011116US201USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVMHq.DVkHqɨHq.HqɨDVkHqɨA Protocol DeviationVisit Scheduling 2021-01-09BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1117US2011117US201USABOYEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq$DVhHq8Hq$Hq8DVhHq8AProtocol DeviationStudy Procedures/Assessments 2020-09-22BYP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1117US2011117US201USABOYEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq$DVhHq8Hq$Hq8DVhHq8A Protocol DeviationVisit Scheduling 2021-01-08BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1118US2011118US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqTDVhHqHqTHqDVhHqAProtocol DeviationStudy Procedures/Assessments 2020-09-28B_P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1118US2011118US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqTDVhHqHqTHqDVhHqA Protocol DeviationStudy Procedures/Assessments 2021-03-04BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1118US2011118US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqTDVhHqHqTHqDVhHqA0Protocol DeviationVisit Scheduling 2021-01-08BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1120US2011120US201USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVMHq'DVkHqHq'HqDVkHqAProtocol DeviationStudy Procedures/Assessments 2020-09-29B_P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1120US2011120US201USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVMHq'DVkHqHq'HqDVkHqA Protocol DeviationStudy Procedures/Assessments 2020-10-21BuP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1120US2011120US201USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVMHq'DVkHqHq'HqDVkHqA0Protocol DeviationStudy Procedures/Assessments 2021-03-02BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1120US2011120US201USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVMHq'DVkHqHq'HqDVkHqA@Protocol DeviationVisit Scheduling 2021-01-09BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVnHqHqHqDVnHqA Protocol DeviationStudy Procedures/Assessments 2020-09-29BZP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVnHqHqHqDVnHqAProtocol DeviationStudy Treatment Admin/Dispense2020-07-30BP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER CONTRA-INDICATION, ETC.) BUT IP DETERMINED ACCEPTABLE FOR USE AND NO IMPACT TO SUBJECT SAFETY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVnHqHqHqDVnHqA0Protocol DeviationVisit Scheduling 2021-01-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŭDVhHqPHqŭHqPDVhHqPA Protocol DeviationStudy Procedures/Assessments 2020-09-24B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŭDVhHqPHqŭHqPDVhHqPA0Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŭDVhHqPHqŭHqPDVhHqPA@Protocol DeviationStudy Procedures/Assessments 2021-03-05BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŭDVhHqPHqŭHqPDVhHqPAProtocol DeviationVisit Scheduling 2020-08-21B9P07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŭDVhHqPHqŭHqPDVhHqPAPProtocol DeviationVisit Scheduling 2020-08-21B9P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1123US2011123US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq Hq Hq DVhHq AProtocol DeviationStudy Procedures/Assessments 2020-09-30BaP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1123US2011123US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq Hq Hq DVhHq A Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1123US2011123US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq Hq Hq DVhHq A0Protocol DeviationVisit Scheduling 2021-02-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1124US2011124US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHq HqHq DVhHq AProtocol DeviationMissing Endpoint Assessments 2020-07-31B$P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1124US2011124US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHq HqHq DVhHq A Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1125US2011125US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHq DVmHqHq HqDVmHqAProtocol DeviationStudy Procedures/Assessments 2020-09-29BZP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1125US2011125US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHq DVmHqHq HqDVmHqA Protocol DeviationVisit Scheduling 2021-01-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1126US2011126US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqŻDVhHqꭌHqŻHqꭌDVhHqꭌAProtocol DeviationStudy Procedures/Assessments 2020-09-24B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1126US2011126US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqŻDVhHqꭌHqŻHqꭌDVhHqꭌA Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1126US2011126US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqŻDVhHqꭌHqŻHqꭌDVhHqꭌA0Protocol DeviationVisit Scheduling 2021-02-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1127US2011127US201USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq԰Hq Hq԰DVhHq԰AProtocol DeviationStudy Procedures/Assessments 2020-09-23BZP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1127US2011127US201USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq԰Hq Hq԰DVhHq԰A Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1127US2011127US201USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVhHq԰Hq Hq԰DVhHq԰A0Protocol DeviationVisit Scheduling 2021-02-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1128US2011128US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHqDDVmHqR,HqDHqR,DVmHqR,AProtocol DeviationStudy Procedures/Assessments 2020-06-30AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1128US2011128US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHqDDVmHqR,HqDHqR,DVmHqR,A Protocol DeviationStudy Procedures/Assessments 2020-09-29B\P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1128US2011128US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHqDDVmHqR,HqDHqR,DVmHqR,A0Protocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1130US2011130US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqdHqHqdDVhHqdAProtocol DeviationStudy Procedures/Assessments 2020-09-26B]P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1130US2011130US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqdHqHqdDVhHqdA Protocol DeviationVisit Scheduling 2021-01-08BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1131US2011131US201USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqHqHqDVhHqAProtocol DeviationStudy Procedures/Assessments 2020-09-24B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1131US2011131US201USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqHqHqDVhHqA Protocol DeviationStudy Procedures/Assessments 2020-10-21BvP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1131US2011131US201USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqHqHqDVhHqA0Protocol DeviationStudy Procedures/Assessments 2021-03-05BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1131US2011131US201USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVhHqHqHqDVhHqA@Protocol DeviationVisit Scheduling 2021-01-08BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1137US2011137US201USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqųDVhHqꚐHqųHqꚐDVhHqꚐAProtocol DeviationStudy Procedures/Assessments 2020-09-24B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1137US2011137US201USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqųDVhHqꚐHqųHqꚐDVhHqꚐA Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1137US2011137US201USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqųDVhHqꚐHqųHqꚐDVhHqꚐA0Protocol DeviationStudy Procedures/Assessments 2021-03-05BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1138US2011138US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVMHq DVkHqPHq HqPDVkHqPAProtocol DeviationStudy Procedures/Assessments 2020-09-29B_P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1138US2011138US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVMHq DVkHqPHq HqPDVkHqPA Protocol DeviationStudy Procedures/Assessments 2020-10-22BvP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1138US2011138US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVMHq DVkHqPHq HqPDVkHqPA0Protocol DeviationVisit Scheduling 2021-01-14BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1139US2011139US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVhHqHqHqDVhHqAProtocol DeviationStudy Procedures/Assessments 2020-09-23BZP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1142US2011142US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq,DVkHqHHq,HqHDVkHqHAProtocol DeviationStudy Procedures/Assessments 2020-10-06BdP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1142US2011142US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq,DVkHqHHq,HqHDVkHqHA Protocol DeviationStudy Procedures/Assessments 2021-03-05BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1142US2011142US201USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq,DVkHqHHq,HqHDVkHqHA0Protocol DeviationVisit Scheduling 2021-01-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1145US2011145US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqPDVhHq¤HqPHq¤DVhHq¤AProtocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1149US2011149US201USABJYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqDVkHqlHqHqlDVkHqlAProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1152US2011152US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq4DVkHqHq4HqDVkHqAProtocol DeviationStudy Procedures/Assessments 2020-09-29B]P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1152US2011152US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHq4DVkHqHq4HqDVkHqA Protocol DeviationVisit Scheduling 2021-01-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1153US2011153US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqDVkHqHqHqDVkHqAProtocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1155US2011155US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHqK,DVlHq-HqK,Hq-DVlHq-AProtocol DeviationStudy Procedures/Assessments 2020-09-29B\P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1155US2011155US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHqK,DVlHq-HqK,Hq-DVlHq-A Protocol DeviationVisit Scheduling 2021-01-12BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1156US2011156US201USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHq5`DVlHqHq5`HqDVlHqA0Protocol DeviationConcomitant Medication 2021-03-06BP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1156US2011156US201USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHq5`DVlHqHq5`HqDVlHqA Protocol DeviationStudy Procedures/Assessments 2020-09-29B\P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1156US2011156US201USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHq5`DVlHqHq5`HqDVlHqAProtocol DeviationStudy Treatment Admin/Dispense2020-07-28BP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER CONTRA-INDICATION, ETC.) BUT IP DETERMINED ACCEPTABLE FOR USE AND NO IMPACT TO SUBJECT SAFETY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1156US2011156US201USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHq5`DVlHqHq5`HqDVlHqA@Protocol DeviationVisit Scheduling 2021-01-12BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1157US2011157US201USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHqoDVlHqYHqoHqYDVlHqYAProtocol DeviationStudy Procedures/Assessments 2020-09-28B[P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1157US2011157US201USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHqoDVlHqYHqoHqYDVlHqYA Protocol DeviationVisit Scheduling 2021-01-12BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1159US2011159US201USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqϴDVnHqHqϴHqDVnHqAProtocol DeviationStudy Procedures/Assessments 2020-09-29BZP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1159US2011159US201USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqϴDVnHqHqϴHqDVnHqA Protocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNNNYYYNNNNNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq:AProtocol DeviationStudy Procedures/Assessments 2020-07-01PP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNNNYYYNNNNNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqIDVrHq:HqIHq:DVrHq:A Protocol DeviationVisit Scheduling 2021-01-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqTAICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqTApICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqTA Protocol DeviationStudy Procedures/Assessments 2020-09-15BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqTA0Protocol DeviationStudy Procedures/Assessments 2020-10-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqTA@Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqTAPProtocol DeviationStudy Procedures/Assessments 2021-01-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq+XDVPHqTHq+XHqTDVPHqTA`Protocol DeviationStudy Procedures/Assessments 2021-03-15C0P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1004US2021004US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVLHqŻHqHqŻDVLHqŻAICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1004US2021004US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVLHqŻHqHqŻDVLHqŻA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1004US2021004US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVLHqŻHqHqŻDVLHqŻA Protocol DeviationVisit Scheduling 2021-02-15CpP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1007US2021007US202USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq$DVOHqɱ@Hq$Hqɱ@DVOHqɱ@AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1007US2021007US202USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq$DVOHqɱ@Hq$Hqɱ@DVOHqɱ@A ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THE TASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1011US2021011US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq#$DVLHqHq#$HqDVLHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1011US2021011US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq#$DVLHqHq#$HqDVLHqA ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1012US2021012US202USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVOHqɷXHqHqɷXDVOHqɷXAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1012US2021012US202USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVOHqɷXHqHqɷXDVOHqɷXA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1015US2021015US202USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0HqXDVLHqŽtHqXHqŽtDVLHqŽtAICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1015US2021015US202USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0HqXDVLHqŽtHqXHqŽtDVLHqŽtA ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq`AICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq`ApICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq`A Protocol DeviationStudy Procedures/Assessments 2020-08-24BXP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq`A0Protocol DeviationStudy Procedures/Assessments 2020-10-15BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq`A@Protocol DeviationStudy Procedures/Assessments 2020-11-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq`A`Protocol DeviationVisit Scheduling 2020-07-13B.P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDV]Hq`HqHq`DV]Hq`APProtocol DeviationVisit Scheduling 2021-01-18BP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHqA`ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHqA Protocol DeviationStudy Procedures/Assessments 2020-09-15BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHqA0Protocol DeviationStudy Procedures/Assessments 2020-10-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHqA@Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1019US2021019US202USAB;YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVRHqHqHqDVRHqAPProtocol DeviationVisit Scheduling 2021-01-19BP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqHqHqDVPHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqHqHqDVPHqA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqHqHqDVPHqA Protocol DeviationStudy Procedures/Assessments 2020-10-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1021US2021021US202USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0Hq,DVLHqſHq,HqſDVLHqſAICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1021US2021021US202USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV0Hq,DVLHqſHq,HqſDVLHqſA ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHqApICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHqA Protocol DeviationStudy Procedures/Assessments 2020-09-07BcP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHqA0Protocol DeviationStudy Procedures/Assessments 2020-09-21BqP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHqA@Protocol DeviationStudy Procedures/Assessments 2020-10-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHqAPProtocol DeviationStudy Procedures/Assessments 2020-11-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1022US2021022US202USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq\DVVHqHq\HqDVVHqA`Protocol DeviationVisit Scheduling 2021-01-20BP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1031US2021031US202USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq%DVOHqHq%HqDVOHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1031US2021031US202USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq%DVOHqHq%HqDVOHqA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - STEPS IN THE DOSE ADMINISTRATION AND PREPARATION WORKSHEETS CONTAINS THE INITIALS OF THE VERIFIER INSTEAD OF THE INITIALS OF THE INDIVIDUAL WHO COMPETED THETASK. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1043US2021043US202USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq"lDVRHqͳXHq"lHqͳXDVRHqͳXAProtocol DeviationStudy Procedures/Assessments 2020-10-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1043US2021043US202USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3Hq"lDVRHqͳXHq"lHqͳXDVRHqͳXA Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68AProtocol DeviationStudy Procedures/Assessments 2020-08-20BMP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68A Protocol DeviationStudy Procedures/Assessments 2020-09-09BaP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68A0Protocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1058US2021058US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq PDVWHq68Hq PHq68DVWHq68A@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1063US2021063US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq0 HqHq0 DVWHq0 AProtocol DeviationStudy Procedures/Assessments 2020-09-21BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1063US2021063US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq0 HqHq0 DVWHq0 A Protocol DeviationStudy Procedures/Assessments 2020-10-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1063US2021063US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq0 HqHq0 DVWHq0 A0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1063US2021063US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq0 HqHq0 DVWHq0 A@Protocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq(AProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq(A Protocol DeviationStudy Procedures/Assessments 2020-10-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq(A0Protocol DeviationStudy Procedures/Assessments 2020-11-24BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq(A@Protocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1064US2021064US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHq(HqHq(DVYHq(APProtocol DeviationVisit Scheduling 2021-02-24C`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1067US2021067US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq4(DVVHqHq4(HqDVVHqAProtocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1067US2021067US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq4(DVVHqHq4(HqDVVHqA Protocol DeviationStudy Procedures/Assessments 2020-10-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1067US2021067US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq4(DVVHqHq4(HqDVVHqA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1067US2021067US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq4(DVVHqHq4(HqDVVHqA@Protocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1068US2021068US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqxDVQHq̳,HqxHq̳,DVQHq̳,AProtocol DeviationStudy Procedures/Assessments 2021-01-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1068US2021068US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqxDVQHq̳,HqxHq̳,DVQHq̳,A Protocol DeviationVisit Scheduling 2021-02-18C`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1074US2021074US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVWHq}<HqHq}<DVWHq}<AProtocol DeviationStudy Procedures/Assessments 2020-09-21BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1074US2021074US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVWHq}<HqHq}<DVWHq}<A Protocol DeviationStudy Procedures/Assessments 2020-10-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1074US2021074US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVWHq}<HqHq}<DVWHq}<A0Protocol DeviationStudy Procedures/Assessments 2020-11-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1074US2021074US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVWHq}<HqHq}<DVWHq}<A@Protocol DeviationStudy Procedures/Assessments 2021-02-18C`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ AProtocol DeviationStudy Procedures/Assessments 2020-09-09BaP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ A Protocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ A0Protocol DeviationStudy Procedures/Assessments 2020-10-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ A@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1080US2021080US202USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqVDVXHqՉ HqVHqՉ DVXHqՉ APProtocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqMAProtocol DeviationStudy Procedures/Assessments 2020-09-21BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqMA Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1082US2021082US202USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqzDVWHqMHqzHqMDVWHqMA0Protocol DeviationStudy Procedures/Assessments 2020-11-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1084US2021084US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hqh0DVWHqFdHqh0HqFdDVWHqFdAProtocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1084US2021084US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hqh0DVWHqFdHqh0HqFdDVWHqFdA Protocol DeviationStudy Procedures/Assessments 2020-10-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1084US2021084US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hqh0DVWHqFdHqh0HqFdDVWHqFdA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1089US2021089US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqE@DVXHq HqE@Hq DVXHq AProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1089US2021089US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqE@DVXHq HqE@Hq DVXHq A Protocol DeviationStudy Procedures/Assessments 2020-10-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1089US2021089US202USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqE@DVXHq HqE@Hq DVXHq A0Protocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1090US2021090US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVVHq|HqHq|DVVHq|AProtocol DeviationStudy Procedures/Assessments 2020-09-21BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1090US2021090US202USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVVHq|HqHq|DVVHq|A Protocol DeviationStudy Procedures/Assessments 2020-11-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1093US2021093US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqmDVVHqHqmHqDVVHqAProtocol DeviationStudy Procedures/Assessments 2020-09-11BeP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1093US2021093US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqmDVVHqHqmHqDVVHqA Protocol DeviationStudy Procedures/Assessments 2020-09-21BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1093US2021093US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqmDVVHqHqmHqDVVHqA0Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1093US2021093US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqmDVVHqHqmHqDVVHqA@Protocol DeviationStudy Procedures/Assessments 2020-11-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1093US2021093US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqmDVVHqHqmHqDVVHqAPProtocol DeviationStudy Procedures/Assessments 2021-01-24BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1093US2021093US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqmDVVHqHqmHqDVVHqA`Protocol DeviationStudy Procedures/Assessments 2021-02-22CP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYNNNNNNNNNYNYYNNNNYYYNNNot Detected YNNPlacebo APlacebo ADV7Hq[DV7Hq[Hq[Hq[..AProtocol DeviationVisit Scheduling 2020-07-06B P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYNNNNNNNNNYNYYNNNNYYYNNNot Detected YNNPlacebo APlacebo ADV7Hq[DV7Hq[Hq[Hq[..A Protocol DeviationVisit Scheduling 2020-07-15B)P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYNNNNNNNNNYNYYNNNNYYYNNNot Detected YNNPlacebo APlacebo ADV7Hq[DV7Hq[Hq[Hq[..A0Protocol DeviationVisit Scheduling 2020-07-17B+P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYNNNNNNNNNYNYYNNNNYYYNNNot Detected YNNPlacebo APlacebo ADV7Hq[DV7Hq[Hq[Hq[..A@Protocol DeviationVisit Scheduling 2020-08-06B?P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1096US2021096US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hq DVRHq<Hq Hq<DVRHq<AProtocol DeviationStudy Procedures/Assessments 2020-11-15BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqhAProtocol DeviationStudy Procedures/Assessments 2020-09-14BcP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqhA Protocol DeviationStudy Procedures/Assessments 2020-09-18BgP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqhA0Protocol DeviationStudy Procedures/Assessments 2020-10-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqhA@Protocol DeviationStudy Procedures/Assessments 2020-11-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqhAPProtocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1101US2021101US202USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq'|DVYHqhHq'|HqhDVYHqhA`Protocol DeviationVisit Scheduling 2021-02-25CpP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1107US2021107US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hq^DVRHq͟0Hq^Hq͟0DVRHq͟0AProtocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1114US2021114US202USABCYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŷDVmHqCHqŷHqCDVmHqCAProtocol DeviationStudy Procedures/Assessments 2020-09-15BRP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1114US2021114US202USABCYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŷDVmHqCHqŷHqCDVmHqCA Protocol DeviationStudy Procedures/Assessments 2020-10-20BuP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1114US2021114US202USABCYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŷDVmHqCHqŷHqCDVmHqCA0Protocol DeviationStudy Procedures/Assessments 2020-12-09BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1114US2021114US202USABCYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŷDVmHqCHqŷHqCDVmHqCA@Protocol DeviationVisit Scheduling 2020-11-16BP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1115US2021115US202USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq@DVoHqHq@HqDVoHqAProtocol DeviationStudy Procedures/Assessments 2020-09-21BXP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1115US2021115US202USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq@DVoHqHq@HqDVoHqA Protocol DeviationStudy Procedures/Assessments 2020-10-14BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1115US2021115US202USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq@DVoHqHq@HqDVoHqA0Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1115US2021115US202USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq@DVoHqHq@HqDVoHqA@Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1121US2021121US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq\DVQHqc|Hq\Hqc|DVQHqc|AProtocol DeviationStudy Procedures/Assessments 2020-12-11BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq$DVmHqVdHq$HqVdDVmHqVdAProtocol DeviationStudy Procedures/Assessments 2020-09-25B\P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq$DVmHqVdHq$HqVdDVmHqVdA Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1130US2021130US202USABPYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq$DVmHqVdHq$HqVdDVmHqVdA0Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1133US2021133US202USABKYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq$DVmHqfTHq$HqfTDVmHqfTAProtocol DeviationStudy Procedures/Assessments 2020-09-14BQP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1133US2021133US202USABKYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq$DVmHqfTHq$HqfTDVmHqfTA Protocol DeviationStudy Procedures/Assessments 2020-10-14BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1133US2021133US202USABKYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq$DVmHqfTHq$HqfTDVmHqfTA0Protocol DeviationStudy Procedures/Assessments 2020-11-12BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1133US2021133US202USABKYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq$DVmHqfTHq$HqfTDVmHqfTA@Protocol DeviationStudy Procedures/Assessments 2020-12-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1135US2021135US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqhDVWHqJ`HqhHqJ`DVWHqJ`AProtocol DeviationMissing Endpoint Assessments 2020-06-06A P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1135US2021135US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqhDVWHqJ`HqhHqJ`DVWHqJ`A Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1135US2021135US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqhDVWHqJ`HqhHqJ`DVWHqJ`A0Protocol DeviationVisit Scheduling 2021-01-26BP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1135US2021135US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqhDVWHqJ`HqhHqJ`DVWHqJ`A@Protocol DeviationVisit Scheduling 2021-02-22CpP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘlAProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘlA Protocol DeviationStudy Procedures/Assessments 2020-11-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘlA0Protocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘlA@Protocol DeviationVisit Scheduling 2020-07-15B&P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘlAPProtocol DeviationVisit Scheduling 2020-07-21B,P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘlApProtocol DeviationVisit Scheduling 2020-08-18BHP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNNNYYYYYNNNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq[ DVWHqԘlHq[ HqԘlDVWHqԘlA`Protocol DeviationVisit Scheduling 2021-02-24C`P10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1138US2021138US202USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6Hq,DVVHqHq,HqDVVHqAProtocol DeviationStudy Procedures/Assessments 2020-09-21BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1138US2021138US202USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6Hq,DVVHqHq,HqDVVHqA Protocol DeviationStudy Procedures/Assessments 2020-10-09BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1138US2021138US202USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6Hq,DVVHqHq,HqDVVHqA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqxAProtocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqxA Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqxA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqxA@Protocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7Hq"XDVVHqxHq"XHqxDVVHqxAPProtocol DeviationVisit Scheduling 2020-08-10BCP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1145US2021145US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVYHq HqHq DVYHq AProtocol DeviationStudy Procedures/Assessments 2020-09-15BhP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1145US2021145US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVYHq HqHq DVYHq A Protocol DeviationStudy Procedures/Assessments 2020-09-21BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1145US2021145US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVYHq HqHq DVYHq A0Protocol DeviationStudy Procedures/Assessments 2020-10-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1145US2021145US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVYHq HqHq DVYHq A@Protocol DeviationStudy Procedures/Assessments 2020-11-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1145US2021145US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVYHq HqHq DVYHq APProtocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1145US2021145US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVYHq HqHq DVYHq A`Protocol DeviationVisit Scheduling 2021-02-24CP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1147US2021147US202USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqQtDVWHqԤHqQtHqԤDVWHqԤAProtocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1147US2021147US202USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqQtDVWHqԤHqQtHqԤDVWHqԤA Protocol DeviationStudy Procedures/Assessments 2020-10-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1147US2021147US202USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqQtDVWHqԤHqQtHqԤDVWHqԤA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1147US2021147US202USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqQtDVWHqԤHqQtHqԤDVWHqԤA@Protocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%dAProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%dA Protocol DeviationStudy Procedures/Assessments 2020-10-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%dA0Protocol DeviationStudy Procedures/Assessments 2020-11-24BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1151US2021151US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqa`DVYHq%dHqa`Hq%dDVYHq%dA@Protocol DeviationStudy Procedures/Assessments 2021-01-29BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘAProtocol DeviationStudy Procedures/Assessments 2020-09-22BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘA Protocol DeviationStudy Procedures/Assessments 2020-10-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1154US2021154US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqLLDVXHqԘHqLLHqԘDVXHqԘA@Protocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1155US2021155US202USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqnDV]HqwHqnHqwDV]HqwAProtocol DeviationStudy Procedures/Assessments 2020-09-13BbP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1155US2021155US202USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqnDV]HqwHqnHqwDV]HqwA Protocol DeviationStudy Procedures/Assessments 2020-09-27BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1155US2021155US202USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqnDV]HqwHqnHqwDV]HqwA0Protocol DeviationStudy Procedures/Assessments 2020-10-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1155US2021155US202USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqnDV]HqwHqnHqwDV]HqwA@Protocol DeviationStudy Procedures/Assessments 2020-12-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1161US2021161US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqiDVWHqBhHqiHqBhDVWHqBhAProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1162US2021162US202USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:Hq(DV:Hq(Hq(Hq(..AProtocol DeviationVisit Scheduling 2020-06-16AP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1162US2021162US202USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:Hq(DV:Hq(Hq(Hq(..A Protocol DeviationVisit Scheduling 2020-06-23BP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1162US2021162US202USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:Hq(DV:Hq(Hq(Hq(..A0Protocol DeviationVisit Scheduling 2020-07-13B$P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDVXHq՝HHqHq՝HDVXHq՝HAProtocol DeviationStudy Procedures/Assessments 2020-10-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDVXHq՝HHqHq՝HDVXHq՝HA Protocol DeviationStudy Procedures/Assessments 2020-11-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDVXHq՝HHqHq՝HDVXHq՝HA0Protocol DeviationVisit Scheduling 2020-08-07B=P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1167US2021167US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq DVWHqԀHq HqԀDVWHqԀAProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1167US2021167US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq DVWHqԀHq HqԀDVWHqԀA Protocol DeviationStudy Procedures/Assessments 2020-11-30BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1167US2021167US202USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq DVWHqԀHq HqԀDVWHqԀA0Protocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձAProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձA Protocol DeviationStudy Procedures/Assessments 2020-11-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1175US2021175US202USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqBpDVXHqձHqBpHqձDVXHqձA0Protocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇAProtocol DeviationStudy Procedures/Assessments 2020-09-14BcP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇA Protocol DeviationStudy Procedures/Assessments 2020-09-29BrP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇA0Protocol DeviationStudy Procedures/Assessments 2020-10-23BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇA@Protocol DeviationStudy Procedures/Assessments 2020-11-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1179US2021179US202USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqLDVWHqԇHqLHqԇDVWHqԇAPProtocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ(AProtocol DeviationStudy Procedures/Assessments 2020-09-29BrP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ(A Protocol DeviationStudy Procedures/Assessments 2020-10-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ(A0Protocol DeviationStudy Procedures/Assessments 2020-11-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1180US2021180US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqgDVXHqՐ(HqgHqՐ(DVXHqՐ(A@Protocol DeviationStudy Procedures/Assessments 2021-01-27BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1182US2021182US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq DVWHq=Hq Hq=DVWHq=AProtocol DeviationStudy Procedures/Assessments 2021-02-24C`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1182US2021182US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq DVWHq=Hq Hq=DVWHq=A Protocol DeviationVisit Scheduling 2020-12-18BP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1185US2021185US202USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADVLHqDVoHq?HqHq?DVoHq?AProtocol DeviationStudy Procedures/Assessments 2020-10-16BqP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1185US2021185US202USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADVLHqDVoHq?HqHq?DVoHq?A Protocol DeviationStudy Procedures/Assessments 2020-11-12BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1185US2021185US202USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADVLHqDVoHq?HqHq?DVoHq?A0Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1186US2021186US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVkHqHHqHqHDVkHqHAProtocol DeviationStudy Procedures/Assessments 2020-09-17BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1186US2021186US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVkHqHHqHqHDVkHqHA Protocol DeviationStudy Procedures/Assessments 2020-10-15BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1186US2021186US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVkHqHHqHqHDVkHqHA0Protocol DeviationStudy Procedures/Assessments 2020-11-12BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1186US2021186US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVkHqHHqHqHDVkHqHA@Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1186US2021186US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVkHqHHqHqHDVkHqHAPProtocol DeviationVisit Scheduling 2020-08-07B+P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1189US2021189US202USABKYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqtDVkHqHqtHqDVkHqAProtocol DeviationStudy Procedures/Assessments 2020-09-17BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1189US2021189US202USABKYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqtDVkHqHqtHqDVkHqA Protocol DeviationStudy Procedures/Assessments 2020-10-15BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1189US2021189US202USABKYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqtDVkHqHqtHqDVkHqA0Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1190US2021190US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq`DVmHqpHq`HqpDVmHqpAProtocol DeviationStudy Procedures/Assessments 2020-09-07BJP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1190US2021190US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq`DVmHqpHq`HqpDVmHqpA Protocol DeviationStudy Procedures/Assessments 2020-09-21BXP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1190US2021190US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq`DVmHqpHq`HqpDVmHqpA0Protocol DeviationStudy Procedures/Assessments 2020-10-20BuP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1190US2021190US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq`DVmHqpHq`HqpDVmHqpA@Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1190US2021190US202USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq`DVmHqpHq`HqpDVmHqpAPProtocol DeviationStudy Procedures/Assessments 2021-02-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1192US2021192US202USAB>YEARS>=55 Years A >=55 Years A@MASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqųDVkHqHHqųHqHDVkHqHAProtocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1192US2021192US202USAB>YEARS>=55 Years A >=55 Years A@MASIAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqųDVkHqHHqųHqHDVkHqHA Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1196US2021196US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHq;\DVrHq(Hq;\Hq(DVrHq(AProtocol DeviationStudy Procedures/Assessments 2020-09-21BRP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1196US2021196US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHq;\DVrHq(Hq;\Hq(DVrHq(A Protocol DeviationStudy Procedures/Assessments 2020-09-22BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1196US2021196US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHq;\DVrHq(Hq;\Hq(DVrHq(A0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1196US2021196US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHq;\DVrHq(Hq;\Hq(DVrHq(A@Protocol DeviationStudy Procedures/Assessments 2020-12-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1198US2021198US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVOHq@DVsHq0Hq@Hq0DVsHq0AProtocol DeviationStudy Procedures/Assessments 2020-09-21BUP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1198US2021198US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVOHq@DVsHq0Hq@Hq0DVsHq0A Protocol DeviationStudy Procedures/Assessments 2020-09-22BVP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1198US2021198US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVOHq@DVsHq0Hq@Hq0DVsHq0A0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1198US2021198US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVOHq@DVsHq0Hq@Hq0DVsHq0A@Protocol DeviationStudy Procedures/Assessments 2020-12-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1198US2021198US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVOHq@DVsHq0Hq@Hq0DVsHq0APProtocol DeviationVisit Scheduling 2020-08-04B%P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHqAProtocol DeviationStudy Procedures/Assessments 2020-09-21BXP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHqA Protocol DeviationStudy Procedures/Assessments 2020-09-22BYP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHqA0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHqA@Protocol DeviationStudy Procedures/Assessments 2020-12-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1205US2021205US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq DVoHqHq HqDVoHqAPProtocol DeviationStudy Procedures/Assessments 2021-02-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1206US2021206US202USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqǀDVsHq4$HqǀHq4$DVsHq4$AProtocol DeviationStudy Procedures/Assessments 2020-09-21BRP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1206US2021206US202USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHqǀDVsHq4$HqǀHq4$DVsHq4$A Protocol DeviationStudy Procedures/Assessments 2020-10-19BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1207US2021207US202USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVLHqDVuHqhHqHqhDVuHqhAProtocol DeviationVisit Scheduling 2020-08-06B*P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq0A Protocol DeviationVisit Scheduling 2020-08-05B$P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̨DVmHq0Hq̨Hq0DVmHq0AProtocol DeviationVisit Scheduling 2020-08-19B2P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1230US2021230US202USABDYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHq=PDVrHqHq=PHqDVrHqAProtocol DeviationConcomitant Medication 2021-02-17BP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1002US2031002US203USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq<DVOHqɚHq<HqɚDVOHqɚAProtocol DeviationStudy Procedures/Assessments 2020-10-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1002US2031002US203USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq<DVOHqɚHq<HqɚDVOHqɚA Protocol DeviationStudy Procedures/Assessments 2021-01-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVOHqɮpHqHqɮpDVOHqɮpAProtocol DeviationStudy Procedures/Assessments 2020-10-15BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1004US2031004US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVOHqɮpHqHqɮpDVOHqɮpA Protocol DeviationStudy Procedures/Assessments 2021-01-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1011US2031011US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq'\DVQHqnHq'\HqnDVQHqnAProtocol DeviationStudy Procedures/Assessments 2020-10-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1011US2031011US203USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq'\DVQHqnHq'\HqnDVQHqnA Protocol DeviationStudy Procedures/Assessments 2021-01-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1014US2031014US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0HqDVOHqHqHqDVOHqAProtocol DeviationStudy Procedures/Assessments 2020-10-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1014US2031014US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0HqDVOHqHqHqDVOHqA Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1014US2031014US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0HqDVOHqHqHqDVOHqA0Protocol DeviationStudy Procedures/Assessments 2021-01-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1016US2031016US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq\DVRHqͭ@Hq\Hqͭ@DVRHqͭ@AProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1020US2031020US203USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq DVQHqIHq HqIDVQHqIAProtocol DeviationStudy Procedures/Assessments 2020-10-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1020US2031020US203USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq DVQHqIHq HqIDVQHqIA Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1020US2031020US203USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq DVQHqIHq HqIDVQHqIA0Protocol DeviationStudy Procedures/Assessments 2021-01-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1022US2031022US203USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0HqDVOHqHqHqDVOHqAProtocol DeviationStudy Procedures/Assessments 2020-10-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1023US2031023US203USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0Hq4DVRHqHHq4HqHDVRHqHAProtocol DeviationStudy Procedures/Assessments 2020-10-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1023US2031023US203USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0Hq4DVRHqHHq4HqHDVRHqHA Protocol DeviationStudy Procedures/Assessments 2021-01-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq4DVWHq.|Hq4Hq.|DVWHq.|AProtocol DeviationStudy Procedures/Assessments 2020-09-21BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq4DVWHq.|Hq4Hq.|DVWHq.|A Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq4DVWHq.|Hq4Hq.|DVWHq.|A0Protocol DeviationStudy Procedures/Assessments 2020-11-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1029US2031029US203USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq4DVWHq.|Hq4Hq.|DVWHq.|A@Protocol DeviationStudy Procedures/Assessments 2021-01-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1030US2031030US203USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq_xDVQHq[HHq_xHq[HDVQHq[HAProtocol DeviationStudy Procedures/Assessments 2020-08-29BXP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1038US2031038US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hqk0DVRHqHqk0HqDVRHqAProtocol DeviationStudy Procedures/Assessments 2021-01-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1038US2031038US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hqk0DVRHqHqk0HqDVRHqA Protocol DeviationStudy Procedures/Assessments 2021-02-19C`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1040US2031040US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVPHqHqHqDVPHqAProtocol DeviationStudy Procedures/Assessments 2020-09-18BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1040US2031040US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVPHqHqHqDVPHqA Protocol DeviationStudy Procedures/Assessments 2020-11-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1040US2031040US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVPHqHqHqDVPHqA0Protocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1040US2031040US203USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVPHqHqHqDVPHqA@Protocol DeviationStudy Procedures/Assessments 2021-02-17C`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1042US2031042US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVVHq-HqHq-DVVHq-AProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1043US2031043US203USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6Hq)DVRHqxHq)HqxDVRHqxAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1056US2031056US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqVHqHqVDVPHqVAProtocol DeviationStudy Procedures/Assessments 2020-09-18BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1056US2031056US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqVHqHqVDVPHqVA Protocol DeviationStudy Procedures/Assessments 2020-10-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1056US2031056US203USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqDVPHqVHqHqVDVPHqVA0Protocol DeviationStudy Procedures/Assessments 2020-11-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1060US2031060US203USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqlDVRHqHqlHqDVRHqAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1062US2031062US203USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq"hDVRHq Hq"hHq DVRHq AProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1071US2031071US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6Hq(DVRHq͊Hq(Hq͊DVRHq͊AProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq`AProtocol DeviationStudy Procedures/Assessments 2020-08-23BRP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq`A Protocol DeviationStudy Procedures/Assessments 2020-09-21BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq`A0Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq`A@Protocol DeviationStudy Procedures/Assessments 2020-11-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1072US2031072US203USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq`HqHq`DVVHq`APProtocol DeviationStudy Procedures/Assessments 2021-01-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1079US2031079US203USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq$DVRHqͳXHq$HqͳXDVRHqͳXAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1080US2031080US203USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVRHqHqHqDVRHqAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1081US2031081US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVRHqͥ HqHqͥ DVRHqͥ AProtocol DeviationStudy Procedures/Assessments 2020-08-03B=P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1086US2031086US203USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŬDVkHq\HqŬHq\DVkHq\AProtocol DeviationStudy Procedures/Assessments 2020-10-14BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1086US2031086US203USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŬDVkHq\HqŬHq\DVkHq\A Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1100US2031100US203USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̦DVrHq3Hq̦Hq3DVrHq3AProtocol DeviationStudy Procedures/Assessments 2020-09-21BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1100US2031100US203USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̦DVrHq3Hq̦Hq3DVrHq3A Protocol DeviationStudy Procedures/Assessments 2020-10-19BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1101US2031101US203USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqDVrHq=HqHq=DVrHq=AProtocol DeviationVisit Scheduling 2020-07-20BP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1106US2031106US203USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVmHqPHqHqPDVmHqPAProtocol DeviationStudy Procedures/Assessments 2020-09-15BRP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1106US2031106US203USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVmHqPHqHqPDVmHqPA Protocol DeviationStudy Procedures/Assessments 2020-10-14BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1106US2031106US203USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVmHqPHqHqPDVmHqPA0Protocol DeviationStudy Procedures/Assessments 2020-11-10BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1106US2031106US203USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVmHqPHqHqPDVmHqPA@Protocol DeviationStudy Procedures/Assessments 2020-12-08BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1108US2031108US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq)(DVrHqHq)(HqDVrHqAProtocol DeviationStudy Procedures/Assessments 2020-08-20B.P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1112US2031112US203USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqlDVkHqHqlHqDVkHqAProtocol DeviationVisit Scheduling 2020-09-02BEP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1116US2031116US203USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVOHqɡDVnHqHqɡHqDVnHqAProtocol DeviationStudy Procedures/Assessments 2020-08-27B<P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1131US2031131US203USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq8DVoHqHq8HqDVoHqAProtocol DeviationStudy Procedures/Assessments 2020-10-19BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1003US2041003US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqjDVPHqSHqjHqSDVPHqSAProtocol DeviationStudy Procedures/Assessments 2021-04-01CP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1003US2041003US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqjDVPHqSHqjHqSDVPHqSA Protocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1005US2041005US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0Hq|DVLHq8Hq|Hq8DVLHq8AProtocol DeviationStudy Procedures/Assessments 2021-02-19CP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1006US2041006US204USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVRHqʹ HqHqʹ DVRHqʹ AProtocol DeviationStudy Procedures/Assessments 2020-09-19BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1007US2041007US204USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3HqLDVOHqŤHqLHqŤDVOHqŤAProtocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1008US2041008US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVQHq̩THqHq̩TDVQHq̩TAProtocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1008US2041008US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVQHq̩THqHq̩TDVQHq̩TA Protocol DeviationVisit Scheduling 2020-08-11BHP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1010US2041010US204USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqDVOHqɢ@HqHqɢ@DVOHqɢ@AProtocol DeviationConcomitant Medication 2021-02-19CP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1010US2041010US204USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqDVOHqɢ@HqHqɢ@DVOHqɢ@A Protocol DeviationVisit Scheduling 2020-12-12BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1011US2041011US204USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVQHqF0HqHqF0DVQHqF0AProtocol DeviationStudy Procedures/Assessments 2021-01-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1011US2041011US204USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVQHqF0HqHqF0DVQHqF0A Protocol DeviationStudy Procedures/Assessments 2021-02-17C`P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1011US2041011US204USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVQHqF0HqHqF0DVQHqF0A@Protocol DeviationVisit Scheduling 2020-06-15AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1011US2041011US204USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVQHqF0HqHqF0DVQHqF0APProtocol DeviationVisit Scheduling 2020-08-17BNP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1011US2041011US204USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVQHqF0HqHqF0DVQHqF0A0Protocol DeviationVisit Scheduling 2020-12-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1012US2041012US204USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVWHqw`HqHqw`DVWHqw`AProtocol DeviationStudy Procedures/Assessments 2020-10-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1012US2041012US204USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVWHqw`HqHqw`DVWHqw`A Protocol DeviationStudy Procedures/Assessments 2020-11-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1013US2041013US204USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq+XDVOHq<Hq+XHq<DVOHq<AProtocol DeviationStudy Procedures/Assessments 2020-10-13BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1013US2041013US204USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq+XDVOHq<Hq+XHq<DVOHq<A Protocol DeviationVisit Scheduling 2020-12-10BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1014US2041014US204USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0Hq!DVLHqŻHq!HqŻDVLHqŻA Protocol DeviationVisit Scheduling 2020-07-08B)P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1014US2041014US204USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV0Hq!DVLHqŻHq!HqŻDVLHqŻAProtocol DeviationVisit Scheduling 2020-12-13BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1016US2041016US204USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected YNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HquTDV^HqݨHquTHqݨDV^HqݨAProtocol DeviationStudy Procedures/Assessments 2020-10-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1016US2041016US204USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected YNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HquTDV^HqݨHquTHqݨDV^HqݨA Protocol DeviationStudy Procedures/Assessments 2020-11-16BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1016US2041016US204USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected YNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HquTDV^HqݨHquTHqݨDV^HqݨA0Protocol DeviationVisit Scheduling 2020-07-06B#P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1019US2041019US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq]DVPHq8Hq]Hq8DVPHq8AProtocol DeviationMissing Endpoint Assessments 2020-08-31B[P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1019US2041019US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq]DVPHq8Hq]Hq8DVPHq8A0Protocol DeviationVisit Scheduling 2020-07-28B9P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1019US2041019US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV4Hq]DVPHq8Hq]Hq8DVPHq8A Protocol DeviationVisit Scheduling 2020-12-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1022US2041022US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq7pDVVHqHq7pHqDVVHqAProtocol DeviationConcomitant Medication 2021-02-12BP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1023US2041023US204USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq$DVOHqHq$HqDVOHqAProtocol DeviationVisit Scheduling 2020-12-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1026US2041026US204USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqtDVPHq>HqtHq>DVPHq>AProtocol DeviationStudy Procedures/Assessments 2020-08-12BHP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1026US2041026US204USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqtDVPHq>HqtHq>DVPHq>A Protocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1027US2041027US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq@DVOHqɿHq@HqɿDVOHqɿAProtocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1029US2041029US204USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqDVOHqtHqHqtDVOHqtAProtocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1030US2041030US204USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq DVPHqFHq HqFDVPHqFAProtocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1034US2041034US204USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV3HqhDVRHqHqhHqDVRHqAProtocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1046US2041046US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVRHq͡LHqHq͡LDVRHq͡LA Protocol DeviationVisit Scheduling 2020-09-01BZP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1046US2041046US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVRHq͡LHqHq͡LDVRHq͡LAProtocol DeviationVisit Scheduling 2020-12-19BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1047US2041047US204USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqDVPHqHqHqDVPHqAProtocol DeviationVisit Scheduling 2020-12-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1048US2041048US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%,DVQHq̦Hq%,Hq̦DVQHq̦AProtocol DeviationVisit Scheduling 2020-11-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1048US2041048US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq%,DVQHq̦Hq%,Hq̦DVQHq̦A Protocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1049US2041049US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDV^HqHqHqDV^HqAICH/GCP Deviation Other GCP Deviation 2021-02-17C0P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1049US2041049US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDV^HqHqHqDV^HqA Protocol DeviationVisit Scheduling 2020-07-08B#P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1049US2041049US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDV^HqHqHqDV^HqA0Protocol DeviationVisit Scheduling 2020-09-11BdP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1051US2041051US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4HqUtDVPHq HqUtHq DVPHq AProtocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1055US2041055US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYNNNNNNNNNNYNYNNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqzlDV5HqzlHqzlHqzl..AProtocol DeviationVisit Scheduling 2020-06-25BP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1055US2041055US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYNNNNNNNNNNYNYNNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqzlDV5HqzlHqzlHqzl..A Protocol DeviationVisit Scheduling 2020-07-07B#P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1056US2041056US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADV4HqODVPHq4HqOHq4DVPHq4AProtocol DeviationMissing Endpoint Assessments 2020-06-30BP07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION (POST VACCINATION) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1058US2041058US204USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNNNYNYNNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDV5HqHqHq..AProtocol DeviationVisit Scheduling 2020-07-07B#P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1059US2041059US204USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYNNNNNNNNNNYNYNNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV4Hqm DV4Hqm Hqm Hqm ..AProtocol DeviationVisit Scheduling 2020-07-06B#P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqlDVQHqNdHqlHqNdDVQHqNdAICH/GCP Deviation ICF Process/Timing 2020-09-02B]I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqlDVQHqNdHqlHqNdDVQHqNdA0Protocol DeviationVisit Scheduling 2020-09-02B]P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqlDVQHqNdHqlHqNdDVQHqNdA Protocol DeviationVisit Scheduling 2021-04-13CP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1061US2041061US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqpDVVHq (HqpHq (DVVHq (AProtocol DeviationVisit Scheduling 2020-09-02B]P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1064US2041064US204USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqcDV^HqфHqcHqфDV^HqфAProtocol DeviationVisit Scheduling 2020-07-13B$P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1064US2041064US204USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqcDV^HqфHqcHqфDV^HqфA Protocol DeviationVisit Scheduling 2020-09-24BmP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1071US2041071US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq DVVHqHHq HqHDVVHqHAProtocol DeviationStudy Procedures/Assessments 2020-10-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1071US2041071US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq DVVHqHHq HqHDVVHqHA Protocol DeviationStudy Procedures/Assessments 2020-11-18BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1076US2041076US204USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq6 DVVHqHq6 HqDVVHqAProtocol DeviationVisit Scheduling 2021-02-05BP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1077US2041077US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqLDVQHqe\HqLHqe\DVQHqe\AProtocol DeviationMissing Endpoint Assessments 2020-07-01BP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1078US2041078US204USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqXDVQHq_HqXHq_DVQHq_AProtocol DeviationMissing Endpoint Assessments 2020-07-01BP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1088US2041088US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqMDVZHqj<HqMHqj<DVZHqj<AProtocol DeviationVisit Scheduling 2021-01-29BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1089US2041089US204USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqdDVZHq28HqdHq28DVZHq28AProtocol DeviationStudy Procedures/Assessments 2020-09-25BnP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1090US2041090US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqRDVZHqqHqRHqqDVZHqqAProtocol DeviationStudy Procedures/Assessments 2020-07-14B%P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1090US2041090US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqRDVZHqqHqRHqqDVZHqqA Protocol DeviationStudy Procedures/Assessments 2020-08-12BBP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1090US2041090US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqRDVZHqqHqRHqqDVZHqqA0Protocol DeviationStudy Procedures/Assessments 2020-12-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1091US2041091US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV<HqdDVZHqmHqdHqmDVZHqmAProtocol DeviationStudy Procedures/Assessments 2020-08-12B@P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1091US2041091US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV<HqdDVZHqmHqdHqmDVZHqmA Protocol DeviationVisit Scheduling 2021-01-31BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqY,DV^Hqݥ8HqY,Hqݥ8DV^Hqݥ8AProtocol DeviationStudy Procedures/Assessments 2020-08-28BRP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqY,DV^Hqݥ8HqY,Hqݥ8DV^Hqݥ8A Protocol DeviationStudy Procedures/Assessments 2020-09-28BqP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqY,DV^Hqݥ8HqY,Hqݥ8DV^Hqݥ8A0Protocol DeviationStudy Procedures/Assessments 2020-11-24BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqY,DV^Hqݥ8HqY,Hqݥ8DV^Hqݥ8A@Protocol DeviationVisit Scheduling 2020-07-13B$P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1094US2041094US204USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq`DVhHq8Hq`Hq8DVhHq8AProtocol DeviationVisit Scheduling 2020-08-11B/P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1096US2041096US204USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɘhDVlHqHqɘhHqDVlHqAProtocol DeviationVisit Scheduling 2020-11-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1102US2041102US204USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqū,DVhHqtHqū,HqtDVhHqtAProtocol DeviationVisit Scheduling 2020-12-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1103US2041103US204USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqlDVhHqxHqlHqxDVhHqxAProtocol DeviationVisit Scheduling 2020-12-10BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1104US2041104US204USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq״DVhHqHq״HqDVhHqAProtocol DeviationVisit Scheduling 2020-12-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1104US2041104US204USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq״DVhHqHq״HqDVhHqA Protocol DeviationVisit Scheduling 2021-01-19BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1107US2041107US204USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqlDVkHqHqlHqDVkHqA Protocol DeviationVisit Scheduling 2020-07-09AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1107US2041107US204USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqlDVkHqHqlHqDVkHqAProtocol DeviationVisit Scheduling 2020-12-10BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1108US2041108US204USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŷDVkHqHqŷHqDVkHqAProtocol DeviationStudy Procedures/Assessments 2020-10-14BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1108US2041108US204USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYYNNNYYYYYNYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŷDVkHqHqŷHqDVkHqA Protocol DeviationStudy Procedures/Assessments 2020-11-12BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1109US2041109US204USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVkHqHqHqDVkHqAProtocol DeviationStudy Procedures/Assessments 2020-11-12BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1109US2041109US204USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVkHqHqHqDVkHqA Protocol DeviationVisit Scheduling 2020-12-12BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1112US2041112US204USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqHDVlHqD,HqHHqD,DVlHqD,A Protocol DeviationVisit Scheduling 2020-08-18B6P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1112US2041112US204USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqHDVlHqD,HqHHqD,DVlHqD,AProtocol DeviationVisit Scheduling 2020-12-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1113US2041113US204USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq DVlHq*Hq Hq*DVlHq*AProtocol DeviationMissing Endpoint Assessments 2020-07-07AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1113US2041113US204USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq DVlHq*Hq Hq*DVlHq*A Protocol DeviationMissing Endpoint Assessments 2020-07-28BP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1113US2041113US204USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq DVlHq*Hq Hq*DVlHq*A0Protocol DeviationStudy Procedures/Assessments 2020-10-08BeP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1114US2041114US204USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVLHqDVrHqHqHqDVrHqA Protocol DeviationVisit Scheduling 2020-08-03B'P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1114US2041114US204USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVLHqDVrHqHqHqDVrHqAProtocol DeviationVisit Scheduling 2020-12-10BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1115US2041115US204USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̅<DVsHqC`Hq̅<HqC`DVsHqC`AProtocol DeviationStudy Procedures/Assessments 2020-09-22BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1115US2041115US204USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̅<DVsHqC`Hq̅<HqC`DVsHqC`A Protocol DeviationStudy Procedures/Assessments 2020-10-20BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1115US2041115US204USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̅<DVsHqC`Hq̅<HqC`DVsHqC`A0Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1117US2041117US204USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DVlHqEHq HqEDVlHqEAProtocol DeviationVisit Scheduling 2020-12-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1118US2041118US204USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqXDVlHq$HqXHq$DVlHq$AProtocol DeviationVisit Scheduling 2021-01-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1119US2041119US204USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq#LDVsHq*LHq#LHq*LDVsHq*LAProtocol DeviationVisit Scheduling 2021-01-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1121US2041121US204USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̣<DVoHqHq̣<HqDVoHqAProtocol DeviationVisit Scheduling 2020-10-21BqP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1121US2041121US204USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̣<DVoHqHq̣<HqDVoHqA Protocol DeviationVisit Scheduling 2020-11-18BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1121US2041121US204USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq̣<DVoHqHq̣<HqDVoHqA0Protocol DeviationVisit Scheduling 2021-01-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1123US2041123US204USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŵDVhHqHqŵHqDVhHqAProtocol DeviationVisit Scheduling 2020-12-10BP10: PART A SAFETY CALL/VISIT CONDUCTED POST PARTICIPANT DECISION VISIT - NOT EXPECTED PER PART B SCHEDULE OF EVENTS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1125US2041125US204USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqDVlHqL$HqHqL$DVlHqL$AProtocol DeviationVisit Scheduling 2020-10-20BrP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1125US2041125US204USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqDVlHqL$HqHqL$DVlHqL$A Protocol DeviationVisit Scheduling 2021-01-15BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1126US2041126US204USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqLDVlHqDHqLHqDDVlHqDAProtocol DeviationStudy Procedures/Assessments 2020-09-17BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1126US2041126US204USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqLDVlHqDHqLHqDDVlHqDA Protocol DeviationStudy Procedures/Assessments 2020-10-15BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1126US2041126US204USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqLDVlHqDHqLHqDDVlHqDA0Protocol DeviationStudy Procedures/Assessments 2020-11-12BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1126US2041126US204USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqLDVlHqDHqLHqDDVlHqDA@Protocol DeviationVisit Scheduling 2020-12-12BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1127US2041127US204USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHq4DVhHq`Hq4Hq`DVhHq`AProtocol DeviationVisit Scheduling 2020-12-10BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1131US2041131US204USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqDVyHrHqHrDVyHrA Protocol DeviationVisit Scheduling 2020-08-10B+P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1131US2041131US204USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqDVyHrHqHrDVyHrAProtocol DeviationVisit Scheduling 2021-01-13BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1132US2041132US204USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqŮ8DVkHq`HqŮ8Hq`DVkHq`AProtocol DeviationStudy Procedures/Assessments 2020-08-13B1P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1132US2041132US204USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqŮ8DVkHq`HqŮ8Hq`DVkHq`A Protocol DeviationVisit Scheduling 2020-12-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1132US2041132US204USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqŮ8DVkHq`HqŮ8Hq`DVkHq`A0Protocol DeviationVisit Scheduling 2021-01-10BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1136US2041136US204USAB8YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqpDVrHq"dHqpHq"dDVrHq"dAProtocol DeviationStudy Procedures/Assessments 2020-12-15BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1136US2041136US204USAB8YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqpDVrHq"dHqpHq"dDVrHq"dA Protocol DeviationVisit Scheduling 2020-11-21BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1139US2041139US204USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqDVlHq<HqHq<DVlHq<AProtocol DeviationVisit Scheduling 2021-01-13BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1142US2041142US204USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVRHqLDVoHqHqLHqDVoHqAProtocol DeviationVisit Scheduling 2020-11-19BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1144US2041144US204USABAYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq$DVlHq Hq$Hq DVlHq AProtocol DeviationVisit Scheduling 2020-12-11BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1145US2041145US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVoHqHqHqDVoHqAProtocol DeviationVisit Scheduling 2020-11-19BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1145US2041145US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVoHqHqHqDVoHqA Protocol DeviationVisit Scheduling 2020-12-17BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1146US2041146US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq DVoHqHq HqDVoHqAProtocol DeviationVisit Scheduling 2020-11-19BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1146US2041146US204USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq DVoHqHq HqDVoHqA Protocol DeviationVisit Scheduling 2021-01-16BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1149US2041149US204USABAYEARS>=55 Years A >=55 Years A@FAMERICAN INDIAN OR ALASKA NATIVE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHq@\DVrHq Hq@\Hq DVrHq AProtocol DeviationVisit Scheduling 2020-11-23BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1150US2041150US204USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVQHqg<DVrHqנHqg<HqנDVrHqנAProtocol DeviationStudy Procedures/Assessments 2020-10-24BtP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1150US2041150US204USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVQHqg<DVrHqנHqg<HqנDVrHqנA Protocol DeviationStudy Procedures/Assessments 2020-12-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1150US2041150US204USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVQHqg<DVrHqנHqg<HqנDVrHqנA0Protocol DeviationVisit Scheduling 2020-11-20BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1151US2041151US204USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHq3DVsHq<Hq3Hq<DVsHq<AProtocol DeviationVisit Scheduling 2020-11-23BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1155US2041155US204USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq;DVrHqdHq;HqdDVrHqdAProtocol DeviationStudy Procedures/Assessments 2020-10-08B_P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1155US2041155US204USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq;DVrHqdHq;HqdDVrHqdA Protocol DeviationVisit Scheduling 2020-12-02BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1155US2041155US204USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHq;DVrHqdHq;HqdDVrHqdA0Protocol DeviationVisit Scheduling 2021-01-20BP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1166US2041166US204USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHq(DVrHqHq(HqDVrHqAProtocol DeviationStudy Procedures/Assessments 2020-11-23BP08: PROCEDURE COMPLETED BUT NOT REQUIRED PER PROTOCOL (ANY PROCEDURE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1001US2051001US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqHDVRHq͟lHqHHq͟lDVRHq͟lAICH/GCP Deviation ICF Process/Timing 2020-05-26I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1001US2051001US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqHDVRHq͟lHqHHq͟lDVRHq͟lA Protocol DeviationStudy Procedures/Assessments 2021-01-22BP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1001US2051001US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqHDVRHq͟lHqHHq͟lDVRHq͟lA0Protocol DeviationStudy Procedures/Assessments 2021-01-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1002US2051002US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDXDVRHqͭHqDXHqͭDVRHqͭAICH/GCP Deviation ICF Process/Timing 2020-05-26pI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1003US2051003US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYYNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq \DVIHqݔHq \HqݔDVIHqݔAICH/GCP Deviation ICF Process/Timing 2020-05-260I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1003US2051003US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYYNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq \DVIHqݔHq \HqݔDVIHqݔA Protocol DeviationMissing Endpoint Assessments 2020-06-11AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1003US2051003US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYYNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq \DVIHqݔHq \HqݔDVIHqݔA0Protocol DeviationStudy Treatment Admin/Dispense2020-05-29AVACCINATION IS NOT ACCORDING TO THE PROTOCOL - DAY 1 VISIT DOSING PROCEDURE WAS NOT PERFORMED ACCORDING TO THE PHARMACY MANUAL AND DOSING WORKSHEET INSTRUCTION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1008US2051008US205USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVPHq`HqHq`DVPHq`AICH/GCP Deviation ICF Process/Timing 2020-05-260I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1008US2051008US205USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0HqDVPHq`HqHq`DVPHq`A Protocol DeviationMissing Endpoint Assessments 2020-06-11AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1009US2051009US205USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq#DVPHqHq#HqDVPHqAICH/GCP Deviation ICF Process/Timing 2020-05-27`I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1011US2051011US205USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq0DVWHqEHq0HqEDVWHqEAProtocol DeviationVisit Scheduling 2020-07-17B-P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1011US2051011US205USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq0DVWHqEHq0HqEDVWHqEA Protocol DeviationVisit Scheduling 2020-07-29B9P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1012US2051012US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq[DVQHqrHq[HqrDVQHqrAProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1017US2051017US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqADVWHq<HqAHq<DVWHq<AProtocol DeviationVisit Scheduling 2020-11-04BP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1020US2051020US205USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq,DVRHqHq,HqDVRHqAProtocol DeviationStudy Procedures/Assessments 2021-01-22BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1022US2051022US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqeTDVWHq;HqeTHq;DVWHq;AProtocol DeviationStudy Procedures/Assessments 2020-06-03AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1022US2051022US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqeTDVWHq;HqeTHq;DVWHq;A Protocol DeviationVisit Scheduling 2020-11-04BP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1024US2051024US205USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNNNYYYYYNNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq&XDVWHqMlHq&XHqMlDVWHqMlAProtocol DeviationVisit Scheduling 2020-11-04BP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1025US2051025US205USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq0,DVYHqHHq0,HqHDVYHqHAProtocol DeviationVisit Scheduling 2020-11-04BP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1026US2051026US205USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq"DVPHqHq"HqDVPHqAProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1026US2051026US205USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq"DVPHqHq"HqDVPHqA Protocol DeviationStudy Procedures/Assessments 2020-06-25BP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1027US2051027US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq0(DVWHqSHq0(HqSDVWHqSAProtocol DeviationVisit Scheduling 2020-11-04BP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1028US2051028US205USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MASIAN NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqXDV6HqXHqXHqX..AProtocol DeviationStudy Treatment Admin/Dispense2020-09-08BaP05.04: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN ) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1029US2051029US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq͐DVYHqHq͐HqDVYHqAProtocol DeviationVisit Scheduling 2020-11-04BP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1030US2051030US205USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqjDVVHqHqjHqDVVHqAProtocol DeviationMissing Endpoint Assessments 2020-09-24BrP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT PROCESSED AS OUTLINED IN LAB MANUAL) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1032US2051032US205USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq*DVPHq|Hq*Hq|DVPHq|AProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1032US2051032US205USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq*DVPHq|Hq*Hq|DVPHq|A Protocol DeviationStudy Procedures/Assessments 2020-06-25BP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1032US2051032US205USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq*DVPHq|Hq*Hq|DVPHq|A0Protocol DeviationStudy Procedures/Assessments 2020-07-27B8P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq DVWHqBHq HqBDVWHqBAProtocol DeviationVisit Scheduling 2020-07-17B,P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq DVWHqBHq HqBDVWHqBA Protocol DeviationVisit Scheduling 2020-07-28B7P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1035US2051035US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVXHqHqHqDVXHqAProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1035US2051035US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVXHqHqHqDVXHqA Protocol DeviationVisit Scheduling 2020-07-17B,P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1035US2051035US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVXHqHqHqDVXHqA0Protocol DeviationVisit Scheduling 2020-07-30B9P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1042US2051042US205USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq4DVQHq̅xHq4Hq̅xDVQHq̅xAProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1042US2051042US205USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq4DVQHq̅xHq4Hq̅xDVQHq̅xA Protocol DeviationStudy Procedures/Assessments 2021-01-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1043US2051043US205USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVQHq̣HqHq̣DVQHq̣AProtocol DeviationMissing Endpoint Assessments 2020-06-11AP07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION (POST VACCINATION) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1044US2051044US205USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqHDVVHqHqHHqDVVHqAProtocol DeviationVisit Scheduling 2020-07-17B+P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1044US2051044US205USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqHDVVHqHqHHqDVVHqA Protocol DeviationVisit Scheduling 2020-07-28B6P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1059US2051059US205USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqDVkHq,HqHq,DVkHq,AProtocol DeviationVisit Scheduling 2020-08-18B6P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1071US2051071US205USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqxDVkHq,HqxHq,DVkHq,AProtocol DeviationConcomitant Medication 2020-08-25B:P09: ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1072US2051072US205USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYNNYNNYYYYYYNNNNYYNNot Detected YNNPlacebo APlacebo ADVVHqEDVrHq HqEHq DVrHq AProtocol DeviationVisit Scheduling 2020-09-09BBP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1084US2051084US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqt DVmHqHqt HqDVmHqAProtocol DeviationConcomitant Medication 2020-08-11B*P09: ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1111US2051111US205USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqADVsHqnDHqAHqnDDVsHqnDAProtocol DeviationVisit Scheduling 2020-11-04BzP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqsAProtocol DeviationStudy Procedures/Assessments 2020-08-25BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqsA Protocol DeviationStudy Procedures/Assessments 2020-09-22BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqsA0Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqsA@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqsAPProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqsApProtocol DeviationVisit Scheduling 2020-07-10B%P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq1,DVZHqsHq1,HqsDVZHqsA`Protocol DeviationVisit Scheduling 2020-08-19BMP10: MISSED VISIT: SAFETY CALL NOT COMPLETED AS OUTLINED IN SOE BEGINNING DAY 85 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1003US2061003US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVVHqHqHqDVVHqAProtocol DeviationStudy Procedures/Assessments 2020-08-25BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1003US2061003US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVVHqHqHqDVVHqA Protocol DeviationStudy Procedures/Assessments 2020-09-22BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1003US2061003US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVVHqHqHqDVVHqA0Protocol DeviationStudy Procedures/Assessments 2020-10-20BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1003US2061003US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVVHqHqHqDVVHqA@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1003US2061003US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV6HqDVVHqHqHqDVVHqAPProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1006US2061006US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqnxDVQHqwHqnxHqwDVQHqwAProtocol DeviationMissing Endpoint Assessments 2020-07-03BP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1006US2061006US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqnxDVQHqwHqnxHqwDVQHqwA Protocol DeviationVisit Scheduling 2020-06-10AP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHqAProtocol DeviationStudy Procedures/Assessments 2020-06-04A P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHqA Protocol DeviationStudy Procedures/Assessments 2020-08-25BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHqA0Protocol DeviationStudy Procedures/Assessments 2020-09-21BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHqA@Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHqAPProtocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq<DVVHqHq<HqDVVHqA`Protocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1009US2061009US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq$DVWHqzHq$HqzDVWHqzAProtocol DeviationStudy Procedures/Assessments 2020-08-25BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1009US2061009US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq$DVWHqzHq$HqzDVWHqzA Protocol DeviationStudy Procedures/Assessments 2020-09-21BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1009US2061009US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq$DVWHqzHq$HqzDVWHqzA0Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1009US2061009US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq$DVWHqzHq$HqzDVWHqzA@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1009US2061009US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq$DVWHqzHq$HqzDVWHqzAPProtocol DeviationVisit Scheduling 2020-08-19BNP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1010US2061010US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqjDVXHqՇ|HqjHqՇ|DVXHqՇ|AProtocol DeviationStudy Procedures/Assessments 2020-08-25BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1010US2061010US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqjDVXHqՇ|HqjHqՇ|DVXHqՇ|A Protocol DeviationStudy Procedures/Assessments 2020-09-21BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1010US2061010US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqjDVXHqՇ|HqjHqՇ|DVXHqՇ|A0Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1010US2061010US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqjDVXHqՇ|HqjHqՇ|DVXHqՇ|A@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1010US2061010US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqjDVXHqՇ|HqjHqՇ|DVXHqՇ|APProtocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1010US2061010US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqjDVXHqՇ|HqjHqՇ|DVXHqՇ|A`Protocol DeviationVisit Scheduling 2020-08-19BNP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1011US2061011US206USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq0lHqHq0lDVVHq0lAProtocol DeviationStudy Procedures/Assessments 2020-08-25BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1011US2061011US206USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq0lHqHq0lDVVHq0lA Protocol DeviationStudy Procedures/Assessments 2020-09-21BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1011US2061011US206USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq0lHqHq0lDVVHq0lA0Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1011US2061011US206USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq0lHqHq0lDVVHq0lA@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1011US2061011US206USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq0lHqHq0lDVVHq0lAPProtocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1011US2061011US206USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqDVVHq0lHqHq0lDVVHq0lA`Protocol DeviationVisit Scheduling 2020-08-19BNP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1013US2061013US206USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq<DVVHq+Hq<Hq+DVVHq+AProtocol DeviationStudy Procedures/Assessments 2020-08-25BRP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1013US2061013US206USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq<DVVHq+Hq<Hq+DVVHq+A Protocol DeviationStudy Procedures/Assessments 2020-09-23BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1013US2061013US206USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq<DVVHq+Hq<Hq+DVVHq+A0Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1013US2061013US206USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq<DVVHq+Hq<Hq+DVVHq+A@Protocol DeviationStudy Procedures/Assessments 2020-11-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1013US2061013US206USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq<DVVHq+Hq<Hq+DVVHq+APProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1015US2061015US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVVHq-$HqHq-$DVVHq-$AProtocol DeviationStudy Procedures/Assessments 2020-08-25BTP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1015US2061015US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVVHq-$HqHq-$DVVHq-$A Protocol DeviationStudy Procedures/Assessments 2020-09-23BqP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1015US2061015US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVVHq-$HqHq-$DVVHq-$A0Protocol DeviationStudy Procedures/Assessments 2020-10-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1015US2061015US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVVHq-$HqHq-$DVVHq-$A@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1015US2061015US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVVHq-$HqHq-$DVVHq-$APProtocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1018US2061018US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7HqoDVXHqՈHqoHqՈDVXHqՈAProtocol DeviationStudy Procedures/Assessments 2020-08-26BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1018US2061018US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7HqoDVXHqՈHqoHqՈDVXHqՈA Protocol DeviationStudy Procedures/Assessments 2020-09-23BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1018US2061018US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7HqoDVXHqՈHqoHqՈDVXHqՈA0Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1018US2061018US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7HqoDVXHqՈHqoHqՈDVXHqՈA@Protocol DeviationStudy Procedures/Assessments 2020-11-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1019US2061019US206USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq|DVQHq̔<Hq|Hq̔<DVQHq̔<A Protocol DeviationVisit Scheduling 2020-07-21B1P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1019US2061019US206USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq|DVQHq̔<Hq|Hq̔<DVQHq̔<AProtocol DeviationVisit Scheduling 2020-08-19BNP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1020US2061020US206USAB6YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqvDVWHq5 HqvHq5 DVWHq5 AProtocol DeviationMissing Endpoint Assessments 2020-07-14B%P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1021US2061021US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVRHqHqHqDVRHqAProtocol DeviationStudy Procedures/Assessments 2020-08-31BYP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1021US2061021US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVRHqHqHqDVRHqA Protocol DeviationVisit Scheduling 2020-07-21B0P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHqAProtocol DeviationStudy Procedures/Assessments 2020-08-26BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHqA Protocol DeviationStudy Procedures/Assessments 2020-09-24BpP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHqA0Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHqA@Protocol DeviationStudy Procedures/Assessments 2020-11-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1023US2061023US206USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq%DVVHqHq%HqDVVHqAPProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1024US2061024US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYYNot Detected NNNmRNA-1273 100 ugA0Placebo ADV5Hq˄DVRHqHq˄HqDVRHqA0Protocol DeviationStudy Treatment Admin/Dispense2020-06-03AVACCINATION IS NOT ACCORDING TO THE PROTOCOL - SUBJECT WAS RANDOMIZED TO 100 MCG TREATMENT ARM AT DAY 1 BUT RECEIVED PLACEBO SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1024US2061024US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYYNot Detected NNNmRNA-1273 100 ugA0Placebo ADV5Hq˄DVRHqHq˄HqDVRHqA Protocol DeviationVisit Scheduling 2020-07-22B2P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1024US2061024US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYYNot Detected NNNmRNA-1273 100 ugA0Placebo ADV5Hq˄DVRHqHq˄HqDVRHqAProtocol DeviationVisit Scheduling 2020-08-19BNP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1025US2061025US206USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNNNYYYNot Detected NNNPlacebo AmRNA-1273 100 ugA0DV5HqPDVQHq̠HqPHq̠DVQHq̠AProtocol DeviationStudy Procedures/Assessments 2020-12-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1025US2061025US206USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNNNYYYNot Detected NNNPlacebo AmRNA-1273 100 ugA0DV5HqPDVQHq̠HqPHq̠DVQHq̠A0Protocol DeviationStudy Treatment Admin/Dispense2020-06-03AVACCINATION IS NOT ACCORDING TO THE PROTOCOL - SUBJECT US206-1025 WAS RANDOMIZED TO PLACEBO TREATMENT ARM BUT RECEIVED 100 MCG DOSE AT DAY 1 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1025US2061025US206USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNNNYYYNot Detected NNNPlacebo AmRNA-1273 100 ugA0DV5HqPDVQHq̠HqPHq̠DVQHq̠A Protocol DeviationVisit Scheduling 2020-08-19BNP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqRAProtocol DeviationStudy Procedures/Assessments 2020-08-26BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqRA Protocol DeviationStudy Procedures/Assessments 2020-09-23BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqRA0Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqRA@Protocol DeviationStudy Procedures/Assessments 2020-11-17BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqRAPProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq#HDVWHqRHq#HHqRDVWHqRA`Protocol DeviationVisit Scheduling 2020-08-19BLP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1027US2061027US206USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqTDVXHqՈHqTHqՈDVXHqՈAProtocol DeviationStudy Procedures/Assessments 2020-08-31BXP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1027US2061027US206USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqTDVXHqՈHqTHqՈDVXHqՈA Protocol DeviationStudy Procedures/Assessments 2020-09-23BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1027US2061027US206USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqTDVXHqՈHqTHqՈDVXHqՈA0Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1027US2061027US206USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqTDVXHqՈHqTHqՈDVXHqՈA@Protocol DeviationStudy Procedures/Assessments 2020-11-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1027US2061027US206USAB,YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqTDVXHqՈHqTHqՈDVXHqՈAPProtocol DeviationStudy Procedures/Assessments 2021-01-26BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1032US2061032US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqdDVWHqԒHqdHqԒDVWHqԒAProtocol DeviationStudy Procedures/Assessments 2020-09-23BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1032US2061032US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqdDVWHqԒHqdHqԒDVWHqԒA Protocol DeviationStudy Procedures/Assessments 2020-10-21BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1032US2061032US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqdDVWHqԒHqdHqԒDVWHqԒA0Protocol DeviationStudy Procedures/Assessments 2020-11-19BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1032US2061032US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqdDVWHqԒHqdHqԒDVWHqԒA@Protocol DeviationStudy Procedures/Assessments 2021-01-25BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1032US2061032US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqdDVWHqԒHqdHqԒDVWHqԒAPProtocol DeviationVisit Scheduling 2020-08-19BLP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1035US2061035US206USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected YNNPlacebo APlacebo ADVLHqDVdHqepHqHqepDVdHqepAProtocol DeviationStudy Treatment Admin/Dispense2020-07-20BP05.02: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (VACCINATION GIVEN OUT OF WINDOW EXCEPT IN THE CASES OF RESTRICTIONS DUE TO COVID-19 PANDEMIC, WHERE 2ND DOSE WILL BE ALLOWED UP TO +21 DAYS WINDOW. ) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1036US2061036US206USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqHDVkHqdHqHHqdDVkHqdAProtocol DeviationStudy Procedures/Assessments 2020-09-16BSP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1036US2061036US206USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqHDVkHqdHqHHqdDVkHqdA Protocol DeviationStudy Procedures/Assessments 2020-10-14BoP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1037US2061037US206USAB8YEARS>=55 Years A >=55 Years A@FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER NOT HISPANIC OR LATINOYYYYYYYYNYNNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŻDVmHq8HqŻHq8DVmHq8AProtocol DeviationStudy Procedures/Assessments 2020-09-19BVP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1037US2061037US206USAB8YEARS>=55 Years A >=55 Years A@FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER NOT HISPANIC OR LATINOYYYYYYYYNYNNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŻDVmHq8HqŻHq8DVmHq8A Protocol DeviationStudy Procedures/Assessments 2020-10-16BqP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1037US2061037US206USAB8YEARS>=55 Years A >=55 Years A@FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER NOT HISPANIC OR LATINOYYYYYYYYNYNNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŻDVmHq8HqŻHq8DVmHq8A0Protocol DeviationStudy Procedures/Assessments 2020-11-11BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1051US2061051US206USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVPHqdDVnHq8HqdHq8DVnHq8AICH/GCP Deviation ICF Process/Timing 2020-06-30AI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1063US2061063US206USAB8YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHqhDVlHqGtHqhHqGtDVlHqGtAProtocol DeviationVisit Scheduling 2020-08-11B+P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1064US2061064US206USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq^(DVlHq4<Hq^(Hq4<DVlHq4<AProtocol DeviationStudy Procedures/Assessments 2020-09-24BWP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1064US2061064US206USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq^(DVlHq4<Hq^(Hq4<DVlHq4<A Protocol DeviationStudy Procedures/Assessments 2020-10-20BqP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqDVoHqlHqHqlDVoHqlAProtocol DeviationStudy Procedures/Assessments 2020-12-14BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqDVoHqlHqHqlDVoHqlA Protocol DeviationVisit Scheduling 2020-08-11B+P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqDVoHqlHqHqlDVoHqlA0Protocol DeviationVisit Scheduling 2020-08-25B9P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1001US2071001US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq+DVPHq7Hq+Hq7DVPHq7AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11328 (50 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:APICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:A Protocol DeviationStudy Procedures/Assessments 2020-06-05APP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:A0Protocol DeviationStudy Procedures/Assessments 2020-07-16B.P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVPHq:HqHq:DVPHq:A@Protocol DeviationStudy Procedures/Assessments 2020-07-27B9P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1003US2071003US207USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq\DVPHq9 Hq\Hq9 DVPHq9 AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02A I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1003US2071003US207USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq\DVPHq9 Hq\Hq9 DVPHq9 A ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02A SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVXHqՆHqHqՆDVXHqՆAProtocol DeviationInformed Consent 2020-08-20BNP03.01: RECONSENT NOT COLLECTED FOR NEW ICF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1005US2071005US207USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4Hq DVVHq0Hq Hq0DVVHq0AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18BI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1005US2071005US207USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4Hq DVVHq0Hq Hq0DVVHq0A@ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18BSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE PLACEBO DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1005US2071005US207USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4Hq DVVHq0Hq Hq0DVVHq0A ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BJI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1005US2071005US207USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4Hq DVVHq0Hq Hq0DVVHq0A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BJSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVQHqN(HqHqN(DVQHqN(AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVQHqN(HqHqN(DVQHqN(A ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVQHqN(HqHqN(DVQHqN(A`ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE BPO DOSE NUMBER WAS NOT ENTERED CORRECTLY BY PI. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVQHqN(HqHqN(DVQHqN(ApICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVQHqN(HqHqN(DVQHqN(A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12BHI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVQHqN(HqHqN(DVQHqN(APICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12BHSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - DISCREPANCY NOTED IN THE TIMINGS OF DOSE PREPARATION AND DOSE SYRINGE FILLING. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqDVQHqN(HqHqN(DVQHqN(A@Protocol DeviationMissing Endpoint Assessments 2020-07-07B$P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1007US2071007US207USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq0lDVWHqHHq0lHqHDVWHqHAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1007US2071007US207USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq0lDVWHqHHq0lHqHDVWHqHA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1012US2071012US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqDVWHqsHqHqsDVWHqsAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BII10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1012US2071012US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqDVWHqsHqHqsDVWHqsA Protocol DeviationInformed Consent 2020-08-20BOP03.01: RECONSENT NOT COLLECTED FOR NEW ICF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1012US2071012US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV5HqDVWHqsHqHqsDVWHqsA0Protocol DeviationInv Record Keeping Source Docs2020-08-14BISOURCE DOCUMENTATION DOSE NOT MEET ALCOA - DISCREPANCY NOTED IN THE TIMINGS OF THE FILLING OF SYRINGE AND ADMINSTRATION OF IP. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1013US2071013US207USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NYYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqYDVYHq)`HqYHq)`DVYHq)`AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1013US2071013US207USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NYYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqYDVYHq)`HqYHq)`DVYHq)`A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1013US2071013US207USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NYYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqYDVYHq)`HqYHq)`DVYHq)`A Protocol DeviationVisit Scheduling 2020-07-09B&P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1014US2071014US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hq|DVVHq$Hq|Hq$DVVHq$AICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BII10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1014US2071014US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5Hq|DVVHq$Hq|Hq$DVVHq$A ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BISOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1016US2071016US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDVXHqչhHqHqչhDVXHqչhAProtocol DeviationStudy Procedures/Assessments 2020-08-03B>P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1016US2071016US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDVXHqչhHqHqչhDVXHqչhA Protocol DeviationStudy Procedures/Assessments 2020-08-03B>P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1017US2071017US207USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNPlacebo APlacebo ADV4Hq~DVQHq̑lHq~Hq̑lDVQHq̑lAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-30BI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1017US2071017US207USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNPlacebo APlacebo ADV4Hq~DVQHq̑lHq~Hq̑lDVQHq̑lA Protocol DeviationExclusion Criteria 2020-08-24BTP03.01: EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1017US2071017US207USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNPlacebo APlacebo ADV4Hq~DVQHq̑lHq~Hq̑lDVQHq̑lA0Protocol DeviationVisit Scheduling 2020-08-18BNP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1022US2071022US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVRHqʹHqHqʹDVRHqʹAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BII10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1022US2071022US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV5HqDVRHqʹHqHqʹDVRHqʹA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BISOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1026US2071026US207USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqT@DV]HqkdHqT@HqkdDV]HqkdAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-08AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-12AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$A ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$ApICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - SITE DID NOT NOTE THE INJECTION SITE INFORMATION ON THE 50UG DOSE PREPARATION AND ADMINSTRATION WORKSHEET. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE INJECTION TIME FOR UNBLINDED SUBJECT WAS NOTED TO BE MISSING ON THE DOSE PREPARATION AND ADMINSITRATION WORKSHEET. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$A@Protocol DeviationMissing Endpoint Assessments 2020-07-10B$P07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$APProtocol DeviationMissing Endpoint Assessments 2020-08-05B>P07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$A0Protocol DeviationStudy Treatment Admin/Dispense2020-07-10B$P05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqrDDVZHqؑ$HqrDHqؑ$DVZHqؑ$A`Protocol DeviationVisit Scheduling 2020-09-01BYP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVVHqSHqPHqSDVVHqSAICH/GCP Deviation Inv Record Keeping Source Docs2020-07-23B3I10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVVHqSHqPHqSDVVHqSA Protocol DeviationVisit Scheduling 2020-08-11BFP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5HqPDVVHqSHqPHqSDVVHqSA0Protocol DeviationVisit Scheduling 2020-08-11BFP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1032US2071032US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq~DVZHq"HHq~Hq"HDVZHq"HAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1032US2071032US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq~DVZHq"HHq~Hq"HDVZHq"HA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1033US2071033US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHqHqHqDVYHqA Protocol DeviationMissing Endpoint Assessments 2020-07-07BP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1033US2071033US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqDVYHqHqHqDVYHqAProtocol DeviationStudy Treatment Admin/Dispense2020-07-09B P05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1037US2071037US207USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq|DVWHqvHq|HqvDVWHqvAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1037US2071037US207USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq|DVWHqvHq|HqvDVWHqvA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - IP ACCOUNTABILITY LOG WAS MISSING ENTRY OF "DATE USED" NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1038US2071038US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqXDV]HqHqXHqDV]HqAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1038US2071038US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqXDV]HqHqXHqDV]HqA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1038US2071038US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqXDV]HqHqXHqDV]HqA@ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1038US2071038US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqXDV]HqHqXHqDV]HqA Protocol DeviationVisit Scheduling 2020-07-13B(P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqoDV]HqqHqoHqqDV]HqqAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqoDV]HqqHqoHqqDV]HqqA@ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqoDV]HqqHqoHqqDV]HqqA Protocol DeviationStudy Procedures/Assessments 2020-06-05AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqoDV]HqqHqoHqqDV]HqqA0Protocol DeviationVisit Scheduling 2020-07-13B'P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4HqHDVRHq͕HqHHq͕DVRHq͕AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4HqHDVRHq͕HqHHq͕DVRHq͕A ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4HqHDVRHq͕HqHHq͕DVRHq͕A@ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4HqHDVRHq͕HqHHq͕DVRHq͕APICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WERE NOT BEING FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YYNPlacebo APlacebo ADV4HqHDVRHq͕HqHHq͕DVRHq͕A0Protocol DeviationMissing Endpoint Assessments 2020-11-06BP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1042US2071042US207USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVYHqHqHqDVYHqAProtocol DeviationVisit Scheduling 2020-07-21B0P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1042US2071042US207USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVYHqHqHqDVYHqA Protocol DeviationVisit Scheduling 2020-07-21B0P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1049US2071049US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6Hq$DVXHqՉHq$HqՉDVXHqՉAProtocol DeviationInformed Consent 2020-08-20BNP03.01: RECONSENT NOT COLLECTED FOR NEW ICF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1050US2071050US207USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq<DVWHqWDHq<HqWDDVWHqWDAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BGI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1050US2071050US207USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq<DVWHqWDHq<HqWDDVWHqWDA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BGSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1059US2071059US207USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqY,DVWHqԎXHqY,HqԎXDVWHqԎXAProtocol DeviationStudy Treatment Admin/Dispense2020-07-07BP05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL , (IP (INCLUDING DILUENT AND SALINE) GIVEN THAT WAS NOT APPROPRIATE FOR USE (EXPIRED, TEMPERATURE DEVIATED UNREPORTED / QUARANTINED IP ETC), WRONGOR UNKNOWN ROUTE OF ADMINSTRATION, OR RECEIVED 2ND DOSE DESPITE CONTRAINDICATION); IP DETERMINED TO BE NOT ACCEPTABLE FOR USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1064US2071064US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqY0DVYHqAHqY0HqADVYHqAAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BGI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1064US2071064US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqY0DVYHqAHqY0HqADVYHqAA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BGSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1064US2071064US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV7HqY0DVYHqAHqY0HqADVYHqAA Protocol DeviationInclusion Criteria 2020-10-14BP02: SUBJECT DOES NOT MEET ENTRY CRITERIA (INC#) (INCLUSION CRITERIA NOT MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1066US2071066US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqDVXHq̠HqHq̠DVXHq̠AICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BCI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1066US2071066US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqDVXHq̠HqHq̠DVXHq̠A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BCSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1066US2071066US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqDVXHq̠HqHq̠DVXHq̠A Protocol DeviationStudy Procedures/Assessments 2020-08-03B8P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1067US2071067US207USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYYNNYYYYYYNYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq/xDVXHqHq/xHqDVXHqAProtocol DeviationVisit Scheduling 2020-08-13BFP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1068US2071068US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq_DDVXHqhHq_DHqhDVXHqhAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1068US2071068US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq_DDVXHqhHq_DHqhDVXHqhA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1069US2071069US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDV]Hq1HqHq1DV]Hq1AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1069US2071069US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDV]Hq1HqHq1DV]Hq1A ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1070US2071070US207USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:Hq4DVWHq.|Hq4Hq.|DVWHq.|AProtocol DeviationMissing Endpoint Assessments 2020-06-15AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1071US2071071US207USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq7DVWHqY$Hq7HqY$DVWHqY$AProtocol DeviationExclusion Criteria 2020-06-05AP03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1072US2071072US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq:@DVVHq4Hq:@Hq4DVVHq4AICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BGI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1072US2071072US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV7Hq:@DVVHq4Hq:@Hq4DVVHq4A ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14BGSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT COMPLETED CORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1073US2071073US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq!dDVWHqGTHq!dHqGTDVWHqGTAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1073US2071073US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq!dDVWHqGTHq!dHqGTDVWHqGTA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1074US2071074US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq?DVYHqHq?HqDVYHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1074US2071074US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq?DVYHqHq?HqDVYHqA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1081US2071081US207USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqeDVWHqԑHqeHqԑDVWHqԑAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1081US2071081US207USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:HqeDVWHqԑHqeHqԑDVWHqԑA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS NOT COMPLETED IN ITS ENTIRETY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1082US2071082US207USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqPDVlHqHqPHqDVlHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1082US2071082US207USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqPDVlHqHqPHqDVlHqA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - WORKSHEET "THAWING" SECTION NOT COMPLETED PROPERLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHqA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO CONFIRMED BY INITIALS WERE MISSING IN THE DOSE PREPARATION WORKSHEET. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHqA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL EXPIRATION DATE NOT ADDED. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqŨDVeHqHqŨHqDVeHqA@ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1084US2071084US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq`DVkHqLHq`HqLDVkHqLAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1084US2071084US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHq`DVkHqLHq`HqLDVkHqLA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO FORM NOT COMPLETELY PROPERLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1086US2071086US207USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVmHqIDHqHqIDDVmHqIDAICH/GCP Deviation Inv Record Keeping Source Docs2020-07-09AI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1086US2071086US207USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVmHqIDHqHqIDDVmHqIDA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1086US2071086US207USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVmHqIDHqHqIDDVmHqIDA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1087US2071087US207USABQYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq޼DVnHq8Hq޼Hq8DVnHq8AICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1087US2071087US207USABQYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq޼DVnHq8Hq޼Hq8DVnHq8A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - US2071087/US2071082 - WORKSHEET PAGE 1 NOT COMPLETED PROPERLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1087US2071087US207USABQYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq޼DVnHq8Hq޼Hq8DVnHq8A Protocol DeviationMissing Endpoint Assessments 2020-07-06AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1088US2071088US207USABFYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVkHqHqHqDVkHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1088US2071088US207USABFYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVkHqHqHqDVkHqA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1088US2071088US207USABFYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqDVkHqHqHqDVkHqA Protocol DeviationVisit Scheduling 2020-07-27B P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) , THAT IS THE ONE WE CAN USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1089US2071089US207USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŹDVmHqHqŹHqDVmHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1089US2071089US207USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŹDVmHqHqŹHqDVmHqA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1090US2071090US207USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqDVmHqlHqHqlDVmHqlAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B-I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1090US2071090US207USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqDVmHqlHqHqlDVmHqlA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B-SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1091US2071091US207USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DVkHqHq HqDVkHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1091US2071091US207USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DVkHqHq HqDVkHqA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B0SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - VIAL REGISTRATION IS MISSING FROM THE SUBJECT SOURCE. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1091US2071091US207USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHq DVkHqHq HqDVkHqA Protocol DeviationVisit Scheduling 2020-10-05BfP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) , THAT IS THE ONE WE CAN USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1092US2071092US207USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADVLHqπDVeHqXHqπHqXDVeHqXAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1092US2071092US207USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADVLHqπDVeHqXHqπHqXDVeHqXA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B2SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1092US2071092US207USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADVLHqπDVeHqXHqπHqXDVeHqXA Protocol DeviationInclusion Criteria 2020-10-29B~P02: SUBJECT DOES NOT MEET ENTRY CRITERIA (INC#) (INCLUSION CRITERIA NOT MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1093US2071093US207USABCYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɺDVmHqEHqɺHqEDVmHqEAProtocol DeviationMissing Endpoint Assessments 2020-06-29AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1094US2071094US207USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHq DVsHqQHq HqQDVsHqQAProtocol DeviationStudy Procedures/Assessments 2020-08-04BP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1094US2071094US207USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVVHq DVsHqQHq HqQDVsHqQA Protocol DeviationStudy Procedures/Assessments 2020-08-04BP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1096US2071096US207USAB7YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVtHqHqHqDVtHqAICH/GCP Deviation Inv Record Keeping Source Docs2020-08-05B#I10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1096US2071096US207USAB7YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVtHqHqHqDVtHqA Protocol DeviationExclusion Criteria 2020-06-24P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1098US2071098US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNPlacebo APlacebo ADVQHq^TDVtHq҄Hq^THq҄DVtHq҄AICH/GCP Deviation Inv Record Keeping Source Docs2020-08-05B$I10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1098US2071098US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNPlacebo APlacebo ADVQHq^TDVtHq҄Hq^THq҄DVtHq҄A ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B-I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1098US2071098US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNPlacebo APlacebo ADVQHq^TDVtHq҄Hq^THq҄DVtHq҄A@ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-14B-SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - BPO DOCUMENT HAS DOSE 2 NOT MARKED. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1098US2071098US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNPlacebo APlacebo ADVQHq^TDVtHq҄Hq^THq҄DVtHq҄A0Protocol DeviationExclusion Criteria 2020-08-24B7P03.01: EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqqHDVsHqr@HqqHHqr@DVsHqr@AICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B%I10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqqHDVsHqr@HqqHHqr@DVsHqr@APICH/GCP Deviation Inv Record Keeping Source Docs2020-08-12B%SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - EXPIRATION DATE MISSING FOR THE NACL NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqqHDVsHqr@HqqHHqr@DVsHqr@A Protocol DeviationExclusion Criteria 2020-07-07AP03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqqHDVsHqr@HqqHHqr@DVsHqr@A@Protocol DeviationMissing Endpoint Assessments 2020-08-11B$P07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION (POST VACCINATION) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqqHDVsHqr@HqqHHqr@DVsHqr@A0Protocol DeviationStudy Treatment Admin/Dispense2020-08-04BP05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER CONTRA-INDICATION, ETC.) BUT IP DETERMINED ACCEPTABLE FOR USE AND NO IMPACT TO SUBJECT SAFETY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1101US2071101US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqDVrHqLHqHqLDVrHqLAProtocol DeviationExclusion Criteria 2020-08-24B9P03.01: EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1101US2071101US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqDVrHqLHqHqLDVrHqLA Protocol DeviationStudy Treatment Admin/Dispense2020-08-31B@P05.01: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1101US2071101US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqDVrHqLHqHqLDVrHqLA0Protocol DeviationVisit Scheduling 2020-08-12B-P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1104US2071104US207USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqDVyHrHqHrDVyHrAICH/GCP Deviation Inv Record Keeping Source Docs2020-07-21BI10: ECRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM..A0Protocol DeviationConcomitant Medication 2021-03-17BP09.01 ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION (ANY INVESTIGATIONAL DRUG OR VACCINE OTHER THAN THE STUDY IP) (PROHIBITED CONCOMITANT MEDICATION OR VACCINE RECEIVED BY SUBJECT) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM..A Protocol DeviationStudy Procedures/Assessments 2020-07-15AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM..AProtocol DeviationStudy Treatment Admin/Dispense2020-09-28BUP05.02: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (VACCINATION GIVEN OUT OF WINDOW EXCEPT IN THE CASES OF RESTRICTIONS DUE TO COVID-19 PANDEMIC, WHERE 2ND DOSE WILL BE ALLOWED UP TO +21 DAYS WINDOW. ) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM..APProtocol DeviationVisit Scheduling 2020-07-27BP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM..A@Protocol DeviationVisit Scheduling 2020-08-10B$P10.01: SUBJECT DID NOT COMPLY WITH BLOOD DRAW SCHEDULE (VISIT PERFORMED OUF OF WINDOW - SAFETY LABS NOT COLLECTED AT D29, D57) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM..A`Protocol DeviationVisit Scheduling 2020-08-10B$P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1106US2071106US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqMDVVHqMHqMHqM..ApProtocol DeviationVisit Scheduling 2020-08-17B+P10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1001US2081001US208USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqDVJHq HqHq DVJHq AICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1001US2081001US208USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqDVJHq HqHq DVJHq A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11320 AND 11319 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1001US2081001US208USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqDVJHq HqHq DVJHq A ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02API10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA mRNA-1273-P201mRNA-1273-P201-US208-1002US2081002US208USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqXDVKHq`HqXHq`DVKHq`AICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1002US2081002US208USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqXDVKHq`HqXHq`DVKHq`A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11317 AND 11318 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1002US2081002US208USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0HqXDVKHq`HqXHq`DVKHq`A Protocol DeviationVisit Scheduling 2020-11-29BP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq$DVOHqɮHq$HqɮDVOHqɮAICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq$DVOHqɮHq$HqɮDVOHqɮAPICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11312 (50 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq$DVOHqɮHq$HqɮDVOHqɮA0Protocol DeviationMissing Endpoint Assessments 2020-06-11AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq$DVOHqɮHq$HqɮDVOHqɮA Protocol DeviationStudy Treatment Admin/Dispense2020-07-27B<P05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER CONTRA-INDICATION, ETC.) BUT IP DETERMINED ACCEPTABLE FOR USE AND NO IMPACT TO SUBJECT SAFETY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq$DVOHqɮHq$HqɮDVOHqɮA@Protocol DeviationVisit Scheduling 2020-11-29BP10: SITE FAILS TO FOLLOW UP VIA TELEPHONE (AT LEAST 2 ATTEMPTS MUST BE DOCUMENTED) WITH SUBJECT WHO WHO ARE NON COMPLIANT WITH SAFETY DIARY ENTRIES (FOR DIARY ENTRIES DAY 71 AND BEYOND) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1005US2081005US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3HqdDVQHq̐|HqdHq̐|DVQHq̐|AProtocol DeviationStudy Procedures/Assessments 2020-06-01AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq,DVRHqpHq,HqpDVRHqpAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq,DVRHqpHq,HqpDVRHqpA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11313 (50 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq,DVRHqpHq,HqpDVRHqpA Protocol DeviationStudy Procedures/Assessments 2020-06-15AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq@DVPHq$Hq@Hq$DVPHq$AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq@DVPHq$Hq@Hq$DVPHq$A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11316 AND 11322 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq@DVPHq$Hq@Hq$DVPHq$A Protocol DeviationStudy Procedures/Assessments 2020-06-15AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1015US2081015US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3HqDVQHqQpHqHqQpDVQHqQpA Protocol DeviationStudy Procedures/Assessments 2020-06-01AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1015US2081015US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV3HqDVQHqQpHqHqQpDVQHqQpAProtocol DeviationStudy Procedures/Assessments 2020-07-01BP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHq@HqHq@DVOHq@AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHq@HqHq@DVOHq@APICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11314 AND 11315 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHq@HqHq@DVOHq@A Protocol DeviationExclusion Criteria 2020-05-27PP03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHq@HqHq@DVOHq@A0Protocol DeviationMissing Endpoint Assessments 2020-06-11AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3HqDVOHq@HqHq@DVOHq@A@Protocol DeviationVisit Scheduling 2020-08-28BYP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1017US2081017US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV4HqDVVHq=PHqHq=PDVVHq=PAProtocol DeviationStudy Procedures/Assessments 2020-05-28PP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1017US2081017US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNPlacebo APlacebo ADV4HqDVVHq=PHqHq=PDVVHq=PA Protocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1019US2081019US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq&XDVPHq LHq&XHq LDVPHq LAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1019US2081019US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq&XDVPHq LHq&XHq LDVPHq LA@ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11329 AND 11330 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1019US2081019US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq&XDVPHq LHq&XHq LDVPHq LA Protocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1019US2081019US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq&XDVPHq LHq&XHq LDVPHq LA0Protocol DeviationVisit Scheduling 2020-06-08ApP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1023US2081023US208USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDDVWHq<HqDHq<DVWHq<AProtocol DeviationMissing Endpoint Assessments 2020-06-11AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1023US2081023US208USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDDVWHq<HqDHq<DVWHq<A Protocol DeviationStudy Procedures/Assessments 2020-07-07B#P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1023US2081023US208USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDDVWHq<HqDHq<DVWHq<A0Protocol DeviationStudy Procedures/Assessments 2020-07-08B$P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1023US2081023US208USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqDDVWHq<HqDHq<DVWHq<A@Protocol DeviationVisit Scheduling 2020-07-08B$P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqzDVWHqxPHqzHqxPDVWHqxPAICH/GCP Deviation Inv Safety Reporting (CRF) 2021-01-25BI11: UNREPORTED AE IN CRF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5HqzDVWHqxPHqzHqxPDVWHqxPA Protocol DeviationStudy Procedures/Assessments 2020-07-07B#P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1026US2081026US208USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV6HqDVWHq@HqHq@DVWHq@AProtocol DeviationStudy Procedures/Assessments 2020-07-07B"P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqSDVWHq>lHqSHq>lDVWHq>lAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqSDVWHq>lHqSHq>lDVWHq>lAPICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11323 AND 11324 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqSDVWHq>lHqSHq>lDVWHq>lA0Protocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqSDVWHq>lHqSHq>lDVWHq>lA Protocol DeviationStudy Procedures/Assessments 2020-07-07B$P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqSDVWHq>lHqSHq>lDVWHq>lA@Protocol DeviationVisit Scheduling 2020-06-08ApP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHDAICH/GCP Deviation Inv Safety Reporting (CRF) 2021-01-05BI11: UNREPORTED AE IN CRF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHDA Protocol DeviationMissing Endpoint Assessments 2020-07-14B+P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHDA@Protocol DeviationStudy Procedures/Assessments 2020-05-29@P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHDAPProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected YNNPlacebo APlacebo ADV4HqDVWHqHDHqHqHDDVWHqHDA0Protocol DeviationStudy Procedures/Assessments 2020-07-07B$P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1035US2081035US208USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqBDVQHqr|HqBHqr|DVQHqr|AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02AI10: SOURCE DOCUMENTATION DOSE NOT MEET ALCOA NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1035US2081035US208USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqBDVQHqr|HqBHqr|DVQHqr|A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11332 AND 11331 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1035US2081035US208USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4HqBDVQHqr|HqBHqr|DVQHqr|A Protocol DeviationVisit Scheduling 2020-06-08ApP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1036US2081036US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVYHqHqHqDVYHqAICH/GCP Deviation Inv Safety Reporting (CRF) 2020-11-20BI11: UNREPORTED AE IN CRF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1036US2081036US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVYHqHqHqDVYHqA ICH/GCP Deviation Inv Safety Reporting (CRF) 2020-12-15BI11: UNREPORTED AE IN CRF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1036US2081036US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVYHqHqHqDVYHqA0Protocol DeviationMissing Endpoint Assessments 2020-07-15B*P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1036US2081036US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVYHqHqHqDVYHqA@Protocol DeviationVisit Scheduling 2020-11-05BP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1038US2081038US208USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV:HqDVYHq0HqHq0DVYHq0AProtocol DeviationStudy Treatment Admin/Dispense2020-08-10B@P05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER CONTRA-INDICATION, ETC.) BUT IP DETERMINED ACCEPTABLE FOR USE AND NO IMPACT TO SUBJECT SAFETY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1039US2081039US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq8 DVXHqծHq8 HqծDVXHqծAICH/GCP Deviation ICF Process/Timing 2020-09-04BYI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1039US2081039US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq8 DVXHqծHq8 HqծDVXHqծA Protocol DeviationStudy Procedures/Assessments 2020-07-08BP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1039US2081039US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq8 DVXHqծHq8 HqծDVXHqծA0Protocol DeviationVisit Scheduling 2020-06-26BP10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1041US2081041US208USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVWHq^HqHq^DVWHq^A Protocol DeviationStudy Procedures/Assessments 2020-06-04AP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1041US2081041US208USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6HqDVWHq^HqHq^DVWHq^AProtocol DeviationStudy Procedures/Assessments 2020-07-07B"P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1042US2081042US208USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV<HqDVXHqtHqHqtDVXHqtAProtocol DeviationStudy Procedures/Assessments 2020-07-08BP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{AProtocol DeviationExclusion Criteria 2020-06-010P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{A Protocol DeviationMissing Endpoint Assessments 2020-06-11AP07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{A0Protocol DeviationMissing Endpoint Assessments 2020-07-14B)P07: SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{A@Protocol DeviationStudy Procedures/Assessments 2020-07-07B"P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1045US2081045US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6HqDVWHq{HqHq{DVWHq{APProtocol DeviationStudy Procedures/Assessments 2021-01-07BP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1046US2081046US208USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected YNNPlacebo APlacebo ADV:HqSDVYHqňHqSHqňDVYHqňAICH/GCP Deviation ICF Process/Timing 2020-09-30BsI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADV;HqNDVXHqrdHqNHqrdDVXHqrdAProtocol DeviationStudy Procedures/Assessments 2020-07-08BP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1051US2081051US208USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq DVXHqՑHq HqՑDVXHqՑAProtocol DeviationStudy Procedures/Assessments 2020-07-08B"P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1051US2081051US208USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq DVXHqՑHq HqՑDVXHqՑA Protocol DeviationStudy Procedures/Assessments 2020-07-08B"P08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1051US2081051US208USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hq DVXHqՑHq HqՑDVXHqՑA0Protocol DeviationVisit Scheduling 2020-07-14B(P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1052US2081052US208USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hq*DVYHq4Hq*Hq4DVYHq4AICH/GCP Deviation ICF Process/Timing 2020-10-27BI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1054US2081054US208USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqFpDVXHqŘHqFpHqŘDVXHqŘAProtocol DeviationStudy Procedures/Assessments 2020-06-22BP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1054US2081054US208USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqFpDVXHqŘHqFpHqŘDVXHqŘA Protocol DeviationStudy Procedures/Assessments 2020-07-08B"P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:HqXDV:HqXHqXHqX..A Protocol DeviationMissing Endpoint Assessments 2020-06-22AP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:HqXDV:HqXHqXHqX..A0Protocol DeviationStudy Procedures/Assessments 2020-07-14B%P08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:HqXDV:HqXHqXHqX..AProtocol DeviationStudy Treatment Admin/Dispense2020-07-06BP05.04: SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN ) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNPlacebo APlacebo ADV:HqXDV:HqXHqXHqX..A@Protocol DeviationVisit Scheduling 2020-06-22AP10: MISSED VISIT (DUE TO COVID-19) EVEN IF TELEPHONE VISIT CONDUCTED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1063US2081063US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq DVXHqՏtHq HqՏtDVXHqՏtAICH/GCP Deviation Inv Safety Reporting (CRF) 2020-10-12BI11: UNREPORTED AE IN CRF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1063US2081063US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq DVXHqՏtHq HqՏtDVXHqՏtA Protocol DeviationStudy Procedures/Assessments 2020-07-08BP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1064US2081064US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqDVYHq0HqHq0DVYHq0AProtocol DeviationStudy Procedures/Assessments 2020-08-25BOP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1065US2081065US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqũDVhHq8HqũHq8DVhHq8AICH/GCP Deviation ICF Process/Timing 2020-08-24B<I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1066US2081066US208USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqdDVhHq\HqdHq\DVhHq\AICH/GCP Deviation ICF Process/Timing 2020-08-25B=I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1066US2081066US208USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVLHqdDVhHq\HqdHq\DVhHq\A Protocol DeviationVisit Scheduling 2020-08-11B/P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1069US2081069US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqDVhHqHqHqDVhHqAProtocol DeviationStudy Procedures/Assessments 2020-07-24BP08: PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS), (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1070US2081070US208USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNNYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqXDVhHqHqXHqDVhHqAProtocol DeviationStudy Procedures/Assessments 2020-06-12P08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL (APPLIES TO SAFETY LABS FOR COHORT 2 AT D29, D57), (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1076US2081076US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqV DVtHqHqV HqDVtHqAICH/GCP Deviation ICF Process/Timing 2021-01-27BI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1076US2081076US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqV DVtHqHqV HqDVtHqA Protocol DeviationStudy Procedures/Assessments 2020-07-01AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1077US2081077US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVPHqBDVrHqXHqBHqXDVrHqXAProtocol DeviationVisit Scheduling 2020-10-21BrP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1080US2081080US208USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHqoDVoHqHqoHqDVoHqAProtocol DeviationInformed Consent 2020-08-28B;P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1081US2081081US208USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɽDVmHqChHqɽHqChDVmHqChAICH/GCP Deviation ICF Process/Timing 2020-08-27B<I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1081US2081081US208USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqɽDVmHqChHqɽHqChDVmHqChA ICH/GCP Deviation ICF Process/Timing 2021-01-27BI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1085US2081085US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHq&\DVzHrUHq&\HrUDVzHrUAICH/GCP Deviation ICF Process/Timing 2020-08-26B7I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1085US2081085US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHq&\DVzHrUHq&\HrUDVzHrUA Protocol DeviationVisit Scheduling 2020-08-11B(P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1088US2081088US208USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqͪpDVrHqHqͪpHqDVrHqAProtocol DeviationInformed Consent 2020-08-31B=P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqͭDVoHqHqͭHqDVoHqAProtocol DeviationInformed Consent 2020-08-28B:P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqͭDVoHqHqͭHqDVoHqA Protocol DeviationVisit Scheduling 2020-08-06B$P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1097US2081097US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq= DVoHqpHq= HqpDVoHqpAProtocol DeviationInformed Consent 2020-08-28B;P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1097US2081097US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVQHq= DVoHqpHq= HqpDVoHqpA Protocol DeviationVisit Scheduling 2020-09-24BVP10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1099US2081099US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYNNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqŮ8DVmHq$HqŮ8Hq$DVmHq$AICH/GCP Deviation ICF Process/Timing 2020-08-26B>I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNYNNNYYYYYYNYNYYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqDVrHqHqHqDVrHqAProtocol DeviationVisit Scheduling 2020-09-10BGP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1103US2081103US208USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq͌pDVuHqHq͌pHqDVuHqAProtocol DeviationVisit Scheduling 2020-07-08ApP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1104US2081104US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq͏@DVuHq0Hq͏@Hq0DVuHq0AProtocol DeviationExclusion Criteria 2020-06-23P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1104US2081104US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNPlacebo APlacebo ADVRHq͏@DVuHq0Hq͏@Hq0DVuHq0A Protocol DeviationVisit Scheduling 2020-07-08ApP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1108US2081108US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVSHqDVoHq HqHq DVoHq A Protocol DeviationExclusion Criteria 2020-06-23P03.01: SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18), (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1108US2081108US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVSHqDVoHq HqHq DVoHq AProtocol DeviationInformed Consent 2020-08-28B9P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1108US2081108US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVSHqDVoHq HqHq DVoHq A0Protocol DeviationVisit Scheduling 2020-07-09ApP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1110US2081110US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHqDVoHqHqHqDVoHqAProtocol DeviationInformed Consent 2020-08-28B9P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1112US2081112US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHq$DVzHrf4Hq$Hrf4DVzHrf4AICH/GCP Deviation ICF Process/Timing 2020-08-26B7I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1112US2081112US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHq$DVzHrf4Hq$Hrf4DVzHrf4A ICH/GCP Deviation ICF Process/Timing 2021-01-27BI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1112US2081112US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHq$DVzHrf4Hq$Hrf4DVzHrf4A0Protocol DeviationVisit Scheduling 2020-08-11B(P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1113US2081113US208USAB<YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNPlacebo APlacebo ADVXHqՀDVyHr\HqՀHr\DVyHr\AProtocol DeviationInformed Consent 2020-09-08B?P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1116US2081116US208USABKYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHq`DVmHq^Hq`Hq^DVmHq^AProtocol DeviationStudy Procedures/Assessments 2020-07-07AP08: PROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE), (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1117US2081117US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHq"\DVzHrHq"\HrDVzHrAProtocol DeviationVisit Scheduling 2020-08-11B%P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1118US2081118US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVQHq̎DVoHqHq̎HqDVoHqAProtocol DeviationInformed Consent 2020-08-28B;P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1119US2081119US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVVHqDVzHrDHqHrDDVzHrDA Protocol DeviationVisit Scheduling 2020-08-11B%P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1119US2081119US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYYYYNNNNYYYYNNot Detected NNYPlacebo APlacebo ADVVHqDVzHrDHqHrDDVzHrDAProtocol DeviationVisit Scheduling 2021-01-29BP07.01: IMMUNOGENICITY RESULTS NOT AVAILABLE, (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1120US2081120US208USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHq̦DVmHqx`Hq̦Hqx`DVmHqx`AICH/GCP Deviation ICF Process/Timing 2020-08-26B9I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYNYYYYYYYNNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqHDVyHr<HqHHr<DVyHr<AProtocol DeviationInformed Consent 2020-08-24B2P01: ICF INCORRRECTLY SIGNED OR DATED BY SUBJECT, LAR AND/OR INVESTIGATOR; ICF RECONSENT NOT COLLECTED AT THE NEXT SCHEDULED VISIT, RECONSENT OBTAINED AT A LATER VISIT; DEVIATION DID NOT RESULT IN ANINVALID CONSENT NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$DVPHq$Hq$Hq$..AICH/GCP Deviation ICF Process/Timing 2020-08-25B9I02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNNNYNYYNNNNYYYNNNot Detected NNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHq$DVPHq$Hq$Hq$..A Protocol DeviationVisit Scheduling 2020-08-11B+P10: VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENICITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHqAICH/GCP Deviation ICF Process/Timing 2021-01-28BI02.01: ICF NOT SIGNED OR INCORRECT ICF SIGNED OR ICF NOT SIGNED AND DATED BY SUBJECT, LAR AND INVESTIGATOR OR SIGNED AFTER COMMENCING STUDY PROCEDURES; RECONSENT NOT COLLECTED FOR NEW ICF; DEVIATIONRESULTED IN AN INVALID CONSENT SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHqA Protocol DeviationStudy Treatment Admin/Dispense2020-08-31B=P05: VACCINATION IS NOT ACCORDING TO THE PROTOCOL, IP GIVEN THAT WAS NOT APPROPRIATE FOR USE (IMPACTED BY UNREPORTED TEMPERATURE DEVIATION, ETC., INCORRECT LOCATION OF ADMINISTRATION, OR OTHER CONTRA-INDICATION, ETC.) BUT IP DETERMINED ACCEPTABLE FOR USE AND NO IMPACT TO SUBJECT SAFETY NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHqA0Protocol DeviationVisit Scheduling 2020-07-08ApP10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYNYYYYYYYYNNYYNNot Detected NNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqDVrHqHqHqDVrHqA@Protocol DeviationVisit Scheduling 2020-08-24B6P10: VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANT