HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 26FEB25:12:28:1726FEB25:12:28:17 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS _1257722SASDATA 6.06 26FEB25:12:28:1726FEB25:12:28:17 Deviation Analysis Dataset HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000006400000000000000000000 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 rSEX Sex z) RACE Race {'RACESPY Race Specify ¤ETHNIC Ethnicity ËRANDFL Randomized Population Flag áSAFFL Safety Population Flag âFASBABFLFull Analysis Set bAb Population Flag ãFASNABFLFull Analysis Set nAb Population Flag äPPBABFL Per Protocol bAb Population Flag åPPNABFL Per Protocol nAb Population Flag æPPBD29FLPer Protocol bAb Day 29 Flag çPPBD57FLPer Protocol bAb Day 57 Flag èPPND29FLPer Protocol nAb Day 29 Flag éPPND57FLPer Protocol nAb Day 57 Flag êSAR1FL First Solicited Safety Population Flag ëSAR2FL Second Solicited Safety Population Flag ìSARAFL Solicited Safety Population Flag íFASNA2FLFAS nAb 2 Population Flag îPPNAB2FLPP nAb 2 Population Flag ïPN2D29FLPer Protocol nAb 2 Day 29 Flag ð PN2D57FLPer Protocol nAb 2 Day 57 Flag ñ!COMPLFL Completers Population Flag ò"DVBABFL Deviation Impact bAb Flag ó#DVNABFL Deviation Impact nAb Flag ô$DOSE1FL Vaccination 1 Flag õ%DOSE2FL Vaccination 2 Flag ö&DOSEROFLDosing Error Flag ÷'COV19BL Baseline COVID Infection ø(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 -TRT01A Actual Treatment for Period 01 .TRT01AN Actual Treatment for Period 01 (N) BEST //TR01SDT Date of First Exposure in Period 01 DATE 70TR01SDTMDatetime of First Exposure in Period 01 DATETIME ?1TR01EDT Date of Last Exposure in Period 01 DATE G2TR01EDTMDatetime of Last Exposure in Period 01 DATETIME O3TRTSDTM Datetime of First Exposure to Treatment DATETIME W4TRTEDTM Datetime of Last Exposure to Treatment DATETIME _5DOSE2DT Date of Dose 2 DATE g6DOS2DTM Datetime of Dose 2 DATETIME o7DVSEQ Sequence Number BEST w8DVCAT Category for Protocol Deviation 9DVSCAT Subcategory for Protocol Deviation ‘ :DVSTDTC Start Date/Time of Deviation ¯;DVSTDY Study Day of Start of Deviation BEST ¹ÇDVTERM2 Protocol Deviation Term 2 Ks?DVTERM3 Protocol Deviation Term 3 @DVSIG Significant Protocol Deviation …HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201mRNA-1273-P201-US204-1075US2041075US204USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MMULTIPLE (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦:DDVQHqÌmHq¦:DHqÌmDVQHqÌmAProtocol DeviationVisit Scheduling 2020-07-13B*P10: VISIT COMPLETED OUT OF WINDOW NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1075US2041075US204USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MMULTIPLE (b)(6) NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦:DDVQHqÌmHq¦:DHqÌmDVQHqÌmA Protocol DeviationVisit Scheduling 2020-07-21B2P10: VISIT COMPLETED OUT OF WINDOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1064US2041064US204USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNNNYYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®c¸DV^HqÝÑ„Hq®c¸HqÝÑ„DV^HqÝÑ„AProtocol DeviationVisit Scheduling 2020-07-14B%P10: THE PI DID NOT ENSURE ADHERENCE TO PROTOCOL PROCEDURES AS FOLLOWS: SUBJECT US2041064 VISIT 1 WAS CONDUCTED ON 08JUN2020. VISIT 4 WAS CONDUCTED ON 14JUL2020, ONE DAY OUTSIDE OF THE ALLOWABLE visit window per Table 7 of the protocol. Alison Pierce, Unblinded Coordinator, explained the site did not have the appropriate gauge needle to complete the dosing. Per Ms. Pierce the needles hadbeen ordered but had not yet arrived. Ms. Pierce requested to use a different size needle for the visit via an sPIP, but had not received a response in time to conduct the visit. Ms. Pierce explainedshe did not want to violate the protocol by using a different gauge needle than what was specified in the protocol.SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®Y,DV^HqÝ¥8Hq®Y,HqÝ¥8DV^HqÝ¥8AProtocol DeviationVisit Scheduling 2020-07-13B$P10.3 SUBJECT 2041092 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 13JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT visit was not conducted within window. The subject visit was completed on 14Jul2020. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1049US2041049US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq©˜DV^HqÝÎHq©˜HqÝÎDV^HqÝÎAProtocol DeviationVisit Scheduling 2020-07-08B#P10.3 SUBJECT 2041049 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 08JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT visit was not conducted within window. The subject visit has not yet been completed and/or scheduled per the site staff. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1055US2041055US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYNNNNNNNNYNYNNNNNYYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§zlDV5Hq§zlHq§zlHq§zl..AProtocol DeviationVisit Scheduling 2020-07-07B#P10.3 SUBJECT 2041055 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 07JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT visit was not conducted within window. The subject visit has not yet been completed and/or scheduled per the site staff. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1058US2041058US204USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNNNYYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§¢øDV5Hq§¢øHq§¢øHq§¢ø..AProtocol DeviationVisit Scheduling 2020-07-07B#P10.3 SUBJECT 2041058 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 07JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT visit was not conducted within window. The subject visit has not yet been completed and/or scheduled per the site staff. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1059US2041059US204USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNNNYYYNNNot DetectedNNNPlacebo APlacebo ADV4Hq¦m DV4Hq¦m Hq¦m Hq¦m ..AProtocol DeviationVisit Scheduling 2020-07-06B#P10.3 SUBJECT 2041059 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 06JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. HOWEVER, DUE TO THE SITE NOT HAVING NEEDLES THE SUBJECT visit was not conducted within window. The subject visit has not yet been completed and/or scheduled per the site staff. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§ÒPDVVHqÓSHq§ÒPHqÓSDVVHqÓSAICH/GCP Deviation Inv Record Keeping Source Docs2020-07-23B3CRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION. 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER to remain up to date on EDC data entry. This issue and site processes to prevent recurrence are addressed in sPIP follow up SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1007US2021007US202USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤ò$DVOHqÉ±@Hq¤ò$HqÉ±@DVOHqÉ±@AICH/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-US202-1003US2021003US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq¡+XDVPHqÊöTHq¡+XHqÊöTDVPHqÊöTAICH/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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq çØDVLHqÅ»Hq çØHqÅ»DVLHqÅ»AICH/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-US202-1011US2021011US202USAB:YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq¡#$DVLHqÅÊHq¡#$HqÅÊDVLHqÅÊAICH/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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq¤ÔØDVOHqÉ·XHq¤ÔØHqÉ·XDVOHqÉ·XAICH/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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV0Hq àXDVLHqÅ½tHq àXHqÅ½tDVLHqÅ½tAICH/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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡DV]HqÜ`ØHq¡HqÜ`ØDV]HqÜ`ØA 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡DVRHqÎøHq¡HqÎøDVRHqÎøAICH/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-US202-1020US2021020US202USABHYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq¤ëDVPHqËÌHq¤ëHqËÌDVPHqËÌAICH/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-US202-1021US2021021US202USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV0Hq î,DVLHqÅ¿Hq î,HqÅ¿DVLHqÅ¿AICH/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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV3Hq¤ö\DVVHqÓ¤Hq¤ö\HqÓ¤DVVHqÓ¤AICH/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-US202-1031US2021031US202USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¥%DVOHqÉê¬Hq¥%HqÉê¬DVOHqÉê¬AICH/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-US203-1016US2031016US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq¨ã\DVRHqÍ@Hq¨ã\HqÍ@DVRHqÍ@AProtocol DeviationStudy Procedures/Assessments 2020-06-08APP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1042US2031042US203USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq©ÄDVVHqÓ-ØHq©ÄHqÓ-ØDVVHqÓ-ØAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1043US2031043US203USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq©)èDVRHqÍíxHq©)èHqÍíxDVRHqÍíxAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1060US2031060US203USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq©lDVRHqÍèÈHq©lHqÍèÈDVRHqÍèÈAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1062US2031062US203USAB!YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq©"hDVRHqÎHq©"hHqÎDVRHqÎAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1071US2031071US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq©(DVRHqÍŠHq©(HqÍŠDVRHqÍŠAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1079US2031079US203USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq©$DVRHqÍ³XHq©$HqÍ³XDVRHqÍ³XAProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1080US2031080US203USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq¨úÌDVRHqÍê¨Hq¨úÌHqÍê¨DVRHqÍê¨AProtocol DeviationStudy Procedures/Assessments 2020-06-04AP08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). ON 04JUN2020, THE SITE COLLECTED COVID AND BIOFIRE SAMPLES, HOWEVER THE samples were not shipped from the site until 08Jun2020. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1065US2081065US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅ©ÄDVhHqê‰8HqÅ©ÄHqê‰8DVhHqê‰8AICH/GCP Deviation ICF Process/Timing 2020-08-24B<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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1066US2081066US208USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅÜdDVhHqê¡\HqÅÜdHqê¡\DVhHqê¡\AICH/GCP Deviation ICF Process/Timing 2020-08-25B=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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1081US2081081US208USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqÉ½èDVmHqñChHqÉ½èHqñChDVmHqñChAICH/GCP Deviation ICF Process/Timing 2020-08-27B<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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1085US2081085US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHqÏ&\DVzHrUHqÏ&\HrUDVzHrUAICH/GCP Deviation ICF Process/Timing 2020-08-26B7ICF 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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1099US2081099US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅ®8DVmHqñ$ðHqÅ®8Hqñ$ðDVmHqñ$ðAICH/GCP Deviation ICF Process/Timing 2020-08-26B>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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1112US2081112US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHqÏ$DVzHrf4HqÏ$Hrf4DVzHrf4AICH/GCP Deviation ICF Process/Timing 2020-08-26B7ICF 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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1120US2081120US208USABHYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqÌ¦üDVmHqñx`HqÌ¦üHqñx`DVmHqñx`AICH/GCP Deviation ICF Process/Timing 2020-08-26B9ICF 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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqË$øDVPHqË$øHqË$øHqË$ø..AICH/GCP Deviation ICF Process/Timing 2020-08-25B9ICF 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; DEVIATION resulted in an invalid consent SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1017US2071017US207USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¦~ðDVQHqÌ‘lHq¦~ðHqÌ‘lDVQHqÌ‘lAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-30BCRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOremain up to date on EDC data entry. This issue and site processes to prevent recurrence are addressed in sPIP follow up SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1026US2071026US207USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq®T@DV]HqÜkdHq®T@HqÜkdDV]HqÜkdAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-08ACRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOremain up to date on EDC data entry. This issue and site processes to prevent recurrence are addressed in sPIP follow up SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªrDDVZHqØ‘$HqªrDHqØ‘$DVZHqØ‘$AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-12A€CRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOremain up to date on EDC data entry. This issue and site processes to prevent recurrence are addressed in sPIP follow up SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1086US2071086US207USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅâôDVmHqñIDHqÅâôHqñIDDVmHqñIDAICH/GCP Deviation Inv Record Keeping Source Docs2020-07-09AàCRF ENTRY IS NOT SUPPORTED BY SOURCE DOCUMENTATION 24SEP: ROOT CAUSE ANALYSIS INDICATES THE MISSING SOURCE IS RELATED TO UNSUPERVISED SITE MANAGER REMOVING SOURCE DATA AND SUBJECT BINDERS IN ORDER TOremain up to date on EDC data entry. This issue and site processes to prevent recurrence are addressed in sPIP follow up SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1081US2031081US203USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedYNNPlacebo APlacebo ADV6Hq¨ÙüDVRHqÍ¥Hq¨ÙüHqÍ¥DVRHqÍ¥AProtocol DeviationStudy Procedures/Assessments 2020-08-03B=(P08 : STUDY PROCEDURES/ASSESSMENTS) LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. US2031081-COVID PCR SWAB SHIPPED DIRECTLY TO VIRACOR AND NOT PPD CENTRAL LAB,per protocol. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1116US2031116US203USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVOHqÉ¡ŒDVnHqò¢øHqÉ¡ŒHqò¢øDVnHqò¢øAProtocol DeviationStudy Procedures/Assessments 2020-08-28B=(P08 : STUDY PROCEDURES/ASSESSMENTS) LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. US2031116-COVID PCR SWAB SHIPPED DIRECTLY TO VIRACOR AND NOT PPD CENTRAL LAB,per protocol. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1008US2061008US206USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§ª<DVVHqÒèHq§ª<HqÒèDVVHqÒèAProtocol DeviationStudy Procedures/Assessments 2020-06-04A P08-SUBJECT US2061008-REPORTED MILD UNDERARM GLAND SWELLING OR TENDERNESS ON THE SAME ARM AS THE INJECTION SITE ON DAY 2 (6/4/2020) IN THE EDIARY. THE SITE STAFF CONTACTED THE SUBJECT WITHIN 24 HOURSof becoming aware. However the subject did not return to the clinic for an assessment by Dr. Glover as per protocol requirements. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1080US2081080US208USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVQHqÌo¬DVoHqóàÈHqÌo¬HqóàÈDVoHqóàÈAProtocol DeviationInformed Consent 2020-08-28B;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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1088US2081088US208USAB?YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqÍªpDVrHq÷ºHqÍªpHq÷ºDVrHq÷ºAProtocol DeviationInformed Consent 2020-08-31B=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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqÍôDVoHqô¸HqÍôHqô¸DVoHqô¸AProtocol DeviationInformed Consent 2020-08-28B: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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1097US2081097US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVQHqÌ=DVoHqóÞpHqÌ=HqóÞpDVoHqóÞpAProtocol DeviationInformed Consent 2020-08-28B;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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1108US2081108US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVSHqÎïüDVoHqô HqÎïüHqô DVoHqô AProtocol DeviationInformed Consent 2020-08-28B9ICF 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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1110US2081110US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHqÎòDVoHqóüèHqÎòHqóüèDVoHqóüèAProtocol DeviationInformed Consent 2020-08-28B9ICF 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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1113US2081113US208USAB<YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVXHqÕ€°DVyHr\HqÕ€°Hr\DVyHr\AProtocol DeviationInformed Consent 2020-09-08B?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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1118US2081118US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVQHqÌŽœDVoHqôHqÌŽœHqôDVoHqôAProtocol DeviationInformed Consent 2020-08-28B;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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1121US2081121US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqÒëHDVyHr<HqÒëHHr<DVyHr<AProtocol DeviationInformed Consent 2020-08-24B2ICF 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 AN invalid consent NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1018US2021018US202USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYYmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡DV]HqÜ`ØHq¡HqÜ`ØDV]HqÜ`ØAProtocol DeviationVisit Scheduling 2020-07-13B.P10: US2021018- VISIT 4 DAY 29 WAS DELAYED DUE TO COVID-19 IMPACT. SUBJECT WAS AWAITING COVID TEST RESULTS. UPON RECEIVING NEGATIVE TEST RESULTS, SUBJECT RESUMED VISIT 4 DAY 29 AND ALL ASSESSMENTS. Day 1 was to occur on 26Jun2020 and occurred on 13 Jul2020. This is withinn the 21 day window. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqÔqHDVsHqùr@HqÔqHHqùr@DVsHqùr@A@Protocol DeviationStudy Treatment Admin/Dispense2020-08-04BVACCINATION 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-US207-1092US2071092US207USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅÏ€DVeHqæ¸XHqÅÏ€Hqæ¸XDVeHqæ¸XAProtocol DeviationInclusion Criteria 2020-06-19ÁpP02: SUBJECT 2071092 SCREENING BMI WAS 31.5 BUT RANDOMIZED TO TRIAL. PER SITE, THEY ARE UNSURE IF COLLECTION OF INCORRECT HEIGHT AT SCREENING VISIT WAS DUE TO SUBJECT HIGH HEEL SHOES OR BAD collection. CRA confirmed site documented protocol deviation SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1092US2041092US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®Y,DV^HqÝ¥8Hq®Y,HqÝ¥8DV^HqÝ¥8A Protocol DeviationVisit Scheduling 2020-07-14B%P10: THE PI DID NOT ENSURE ADHERENCE TO PROTOCOL PROCEDURES AS FOLLOWS: SUBJECT 204-1092 THE SUBJECT RETURNED FOR VISIT 4 (SECOND DOSING VISIT) ON 14JUL2020 OUTSIDE THE ALLOWABLE WINDOW (>35 DAYS after the first dose). SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1108US2031108US203USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVVHqÓ)(DVrHq÷àHqÓ)(Hq÷àDVrHq÷àAProtocol DeviationStudy Procedures/Assessments 2020-08-20B.P08 : STUDY PROCEDURES/ASSESSMENTS (LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL). THE REQ ID LISTED FOR VISIT 6 PAPER REQ IN SUBJECT CHART (1EH33890307) DATED20-Aug and e-Req ID in Preclarus (1EH33893505) dated 12-Aug for Visit 6 do not match. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US203-1112US2031112US203USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅÅlDVkHqî™ØHqÅÅlHqî™ØDVkHqî™ØAProtocol DeviationStudy Procedures/Assessments 2020-09-02BE(P10 : VISIT SCHEDULING)- VISIT COMPLETED OUT OF WINDOW: V7/DAY57 VISIT FOR SUBJECT US2031112 WAS OUT OF WINDOW PER PROTOCOL (>35 DAYS FROM LAST VACCINATION). SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1101US2031101US203USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqÉÜØDVrHqø=”HqÉÜØHqø=”DVrHqø=”AProtocol DeviationVisit Scheduling 2020-07-20B(P10: VISIT SCHEDULING; VISIT PERFORMED OUT OF WINDOW)- SUBJECT US2031101- VISIT 3 DAY 15 PERFORMED OUT OF WINDOW (+/- 3 DAYS). SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1006US2061006US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§nxDVQHqÌw¤Hq§nxHqÌw¤DVQHqÌw¤AProtocol DeviationMissing Endpoint Assessments 2020-07-03B3JUL2020 THE SUBJECT MISSED DAYS 3 TO5 OF DIARY ENTRY AFTER VACCINATION #2 VISIT 4 . SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1021US2061021US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq©ìDVRHqÍà”Hq©ìHqÍà”DVRHqÍà”AProtocol DeviationVisit Scheduling 2020-07-21B021JUL2020 VISIT 6 WAS +2 DAYS OUT OF WINDOW. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1017US2071017US207USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¦~ðDVQHqÌ‘lHq¦~ðHqÌ‘lDVQHqÌ‘lA Protocol DeviationExclusion Criteria 2020-05-25Á€EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1098US2071098US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADVQHqÌ^TDVtHqúÒ„HqÌ^THqúÒ„DVtHqúÒ„AProtocol DeviationExclusion Criteria 2020-08-24B7EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1101US2071101US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNNNYYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqÊàDVrHqøLHqÊàHqøLDVrHqøLAProtocol DeviationExclusion Criteria 2020-08-24B9EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1001US2051001US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨»HDVRHqÍŸlHq¨»HHqÍŸlDVRHqÍŸlAICH/GCP Deviation ICF Process/Timing 2020-05-26ÁI02.01_INCORRECT ICF SIGNED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1002US2051002US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦DXDVRHqÍ¸Hq¦DXHqÍ¸DVRHqÍ¸AICH/GCP Deviation ICF Process/Timing 2020-05-26ÁpI02.01_INCORRECT ICF SIGNED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1003US2051003US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYYNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq¡ \DVIHqÁÝ”Hq¡ \HqÁÝ”DVIHqÁÝ”AICH/GCP Deviation ICF Process/Timing 2020-05-26Á0I02.01_INCORRECT ICF SIGNED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦lDVQHqÌNdHq¦lHqÌNdDVQHqÌNdAICH/GCP Deviation ICF Process/Timing 2020-08-18BNI02.01_RECONSENT NOT COLLECTED FOR NEW ICF VERSION 3.0 (US2041060 AT VISIT 7) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªrDDVZHqØ‘$HqªrDHqØ‘$DVZHqØ‘$A Protocol DeviationMissing Endpoint Assessments 2020-08-05B>IMMUNOGENICITY RESULTS NOT AVAILABLE (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED AND PROCESSED AS OUTLINED IN LAB MANUAL) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNPlacebo APlacebo ADV:Hq®XDV:Hq®XHq®XHq®X..AProtocol DeviationMissing Endpoint Assessments 2020-06-22AðIMMUNOGENICITY RESULTS NOT AVAILABLE (ANTIBODY-MEDIATED IMMUNOGENICITY SAMPLES NOT COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1015US2081015US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV3Hq¥DVQHqÌQpHq¥HqÌQpDVQHqÌQpAProtocol DeviationStudy Procedures/Assessments 2020-07-01BLAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§¢DDVWHqÔ<Hq§¢DHqÔ<DVWHqÔ<AProtocol DeviationStudy Procedures/Assessments 2020-07-07B#LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1025US2081025US208USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§zäDVWHqÔxPHq§zäHqÔxPDVWHqÔxPAProtocol DeviationStudy Procedures/Assessments 2020-07-07B#LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq¨Ÿ DVWHqÔ@Hq¨Ÿ HqÔ@DVWHqÔ@AProtocol DeviationStudy Procedures/Assessments 2020-07-07B"LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦S”DVWHqÔ>lHq¦S”HqÔ>lDVWHqÔ>lAProtocol DeviationStudy Procedures/Assessments 2020-07-07B$LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¥þ€DVWHqÔHDHq¥þ€HqÔHDDVWHqÔHDAProtocol DeviationStudy Procedures/Assessments 2020-07-07B$LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®8 DVXHqÕ® Hq®8 HqÕ® DVXHqÕ® AProtocol DeviationStudy Procedures/Assessments 2020-07-08BLAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1041US2081041US208USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq¨æàDVWHqÔ^Hq¨æàHqÔ^DVWHqÔ^AProtocol DeviationStudy Procedures/Assessments 2020-07-07B"LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV<Hq°†„DVXHqÕt€Hq°†„HqÕt€DVXHqÕt€AProtocol DeviationStudy Procedures/Assessments 2020-07-08BLAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨¾DVWHqÔ{˜Hq¨¾HqÔ{˜DVWHqÔ{˜AProtocol DeviationStudy Procedures/Assessments 2020-07-07B"LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1049US2081049US208USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV;Hq¯NDVXHqÕrdHq¯NHqÕrdDVXHqÕrdAProtocol DeviationStudy Procedures/Assessments 2020-07-08BLAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqªDVXHqÕ‘HqªHqÕ‘DVXHqÕ‘AProtocol DeviationStudy Procedures/Assessments 2020-07-08B"LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªFpDVXHqÕÅ˜HqªFpHqÕÅ˜DVXHqÕÅ˜AProtocol DeviationStudy Procedures/Assessments 2020-06-22BLAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªFpDVXHqÕÅ˜HqªFpHqÕÅ˜DVXHqÕÅ˜A Protocol DeviationStudy Procedures/Assessments 2020-07-08B"LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1063US2081063US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hqí DVXHqÕtHqí HqÕtDVXHqÕtAProtocol DeviationStudy Procedures/Assessments 2020-07-08BLAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªrDDVZHqØ‘$HqªrDHqØ‘$DVZHqØ‘$A0Protocol DeviationVisit Scheduling 2020-08-05B>MISSED DAY 71 DAIRY ENTRY SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1051US2061051US206USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVPHqËdDVnHqòê8HqËdHqòê8DVnHqòê8AProtocol DeviationInformed Consent 2020-06-30AP01 SUBJECT WAS NOT RECONSENTED TO V2.1_20200522 ICF AT THE NEXT SCHEDULED VISIT 30JUN2020 . SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1028US2051028US205USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MASIAN NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨öXDV6Hq¨öXHq¨öXHq¨öX..AProtocol DeviationStudy Treatment Admin/Dispense2020-07-02BP05.04_SUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1040US2011040US201USABBYEARS>=55 Years A >=55 Years A@FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq¥(DVOHqÉ¿Hq¥(HqÉ¿DVOHqÉ¿AProtocol DeviationStudy Treatment Admin/Dispense2020-07-28B:P05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1121US2011121US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqÍûˆDVnHqòÙHqÍûˆHqòÙDVnHqòÙAProtocol DeviationStudy Treatment Admin/Dispense2020-08-28B:P05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1156US2011156US201USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYYNNYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVPHqË5`DVlHqïðHqË5`HqïðDVlHqïðAProtocol DeviationStudy Treatment Admin/Dispense2020-08-26B:P05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1038US2071038US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨öXDV]HqÜ”Hq¨öXHqÜ”DV]HqÜ”AProtocol DeviationStudy Treatment Admin/Dispense2020-08-11BEP05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡$DVOHqÉ®èHq¡$HqÉ®èDVOHqÉ®èAProtocol DeviationStudy Treatment Admin/Dispense2020-07-27B<P05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1038US2081038US208USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV:HqçøDVYHqÖÃ0HqçøHqÖÃ0DVYHqÖÃ0AProtocol DeviationStudy Treatment Admin/Dispense2020-08-10B@P05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1129US2081129US208USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqÍù¨DVrHqø¤HqÍù¨Hqø¤DVrHqø¤AProtocol DeviationStudy Treatment Admin/Dispense2020-08-30B<P05: SUBJECT RECEIVED VACCINE IN DIFFERENT ARMS ON DAY 1 AND DAY 29 NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅüDVhHqêPHqÅüHqêPDVhHqêPAProtocol DeviationVisit Scheduling 2020-08-21B9P07.01 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦%hDVPHqË.XHq¦%hHqË.XDVPHqË.XA Protocol DeviationMissing Endpoint Assessments 2020-06-10AP07: SUBJECT DIARY HAS 2 OR MORE 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 YYYYYYYYYYYYYYYYYNNNYYNNot DetectedNNNPlacebo APlacebo ADV7Hqª˜DVVHqÓœHqª˜HqÓœDVVHqÓœA Protocol DeviationMissing Endpoint Assessments 2020-06-10A`P07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦ŒDVQHqÌN(Hq¦ŒHqÌN(DVQHqÌN(AProtocol DeviationMissing Endpoint Assessments 2020-07-07B$P07: SUBJECT DIARY HAS 2 OR MORE 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 YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®DVYHqÖßHq®HqÖßDVYHqÖßAProtocol DeviationMissing Endpoint Assessments 2020-07-07BP07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1070US2071070US207USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV:Hq®4DVWHqÔ.|Hq®4HqÔ.|DVWHqÔ.|AProtocol DeviationMissing Endpoint Assessments 2020-06-15A€P07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1077US2041077US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§©LDVQHqÌe\Hq§©LHqÌe\DVQHqÌe\AProtocol DeviationMissing Endpoint Assessments 2020-07-01BP07: SUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV5Hq§¬XDVQHqÌ_€Hq§¬XHqÌ_€DVQHqÌ_€AProtocol DeviationMissing Endpoint Assessments 2020-07-01BP07: SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1056US2041056US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¦OÔDVPHqË4Hq¦OÔHqË4DVPHqË4AProtocol DeviationMissing Endpoint Assessments 2020-06-30BP07: SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1135US2021135US202USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV7HqªhDVWHqÔJ`HqªhHqÔJ`DVWHqÔJ`AProtocol DeviationMissing Endpoint Assessments 2020-06-06A P07: SUBJECT US2021135 DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING. EDIARY NOT COMPLETED AT D1 AFTER VACCINATION(6.5.2020), D2 (6.6.2020) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1113US2041113US204USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqË ˆDVlHqð*ÜHqË ˆHqð*ÜDVlHqð*ÜAProtocol DeviationMissing Endpoint Assessments 2020-07-05A`P07_DOSE DIARY 1- SUBJECT MISSED DAY 6-DAY 7 EDIARY ENTRY. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1113US2041113US204USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqË ˆDVlHqð*ÜHqË ˆHqð*ÜDVlHqð*ÜA Protocol DeviationMissing Endpoint Assessments 2020-08-12B,P07_DOSE DIARY 2- SUBJECT MISSED DAY4-DAY 7 EDIARY ENTRY. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1003US2051003US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYYNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq¡ \DVIHqÁÝ”Hq¡ \HqÁÝ”DVIHqÁÝ”A Protocol DeviationMissing Endpoint Assessments 2020-06-11AàP07_SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1008US2051008US205USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡DVPHqË`Hq¡HqË`DVPHqË`AProtocol DeviationMissing Endpoint Assessments 2020-06-11AàP07_SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1019US2041019US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¦]äDVPHqË8äHq¦]äHqË8äDVPHqË8äAProtocol DeviationMissing Endpoint Assessments 2020-07-14B+P07_SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1043US2051043US205USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§œ¤DVQHqÌ£ðHq§œ¤HqÌ£ðDVQHqÌ£ðAProtocol DeviationMissing Endpoint Assessments 2020-06-11AP07_SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1009US2061009US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§à$DVWHqÔz¨Hq§à$HqÔz¨DVWHqÔz¨AProtocol DeviationVisit Scheduling 2020-08-04B?P07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1010US2061010US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§jDVXHqÕ‡|Hq§jHqÕ‡|DVXHqÕ‡|AProtocol DeviationVisit Scheduling 2020-08-04B?P07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1011US2061011US206USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§©ÄDVVHqÓ0lHq§©ÄHqÓ0lDVVHqÓ0lAProtocol DeviationVisit Scheduling 2020-08-10BEP07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1019US2061019US206USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§â|DVQHqÌ”<Hq§â|HqÌ”<DVQHqÌ”<AProtocol DeviationVisit Scheduling 2020-07-29B9P07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1024US2061024US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYYNot DetectedNNNmRNA-1273 100 ugA0Placebo ADV5Hq§Ë„DVRHqÍÿÀHq§Ë„HqÍÿÀDVRHqÍÿÀAProtocol DeviationVisit Scheduling 2020-08-04B?P07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1026US2061026US206USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hqª#HDVWHqÔR”Hqª#HHqÔR”DVWHqÔR”AProtocol DeviationVisit Scheduling 2020-08-04B=P07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1032US2061032US206USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV7HqªdDVWHqÔ’ÌHqªdHqÔ’ÌDVWHqÔ’ÌAProtocol DeviationVisit Scheduling 2020-08-05B>P07 D71 EDIARY ENTRY NOT COMPLETE, SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq©1,DVZHqØsœHq©1,HqØsœDVZHqØsœAProtocol DeviationVisit Scheduling 2020-08-04B>P07 D71 EDIARY NOT DONE. , SUBJECT NON COMPLIANT WITH SAFETY DIARY ENTRIES. SITE FAILED TO FOLLOW UP VIA TELEPHONE, NO DOCUMENTATION TO NOTE AT LEAST 2 ATTEMPTS MADE TO CONTACT SUBJECT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1041US2011041US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦%hDVPHqË.XHq¦%hHqË.XDVPHqË.XAProtocol DeviationMissing Endpoint Assessments 2020-07-07B$P07 SUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYNYNYYYYYYNY NNYYNNot DetectedNNNPlacebo APlacebo ADV:Hq®ÜDVVHqÓC¤Hq®ÜHqÓC¤DVVHqÓC¤AProtocol DeviationMissing Endpoint Assessments 2020-07-13B$P07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1055US2011055US201USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦}ÄDVPHqË[XHq¦}ÄHqË[XDVPHqË[XAProtocol DeviationMissing Endpoint Assessments 2020-07-07B$P07 SUBJECT DIARY HAS 2 OR MORE 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 YYYYYYYYYYYYYYYYYNNNYYNNot DetectedNNNPlacebo APlacebo ADV7Hqª˜DVVHqÓœHqª˜HqÓœDVVHqÓœAProtocol DeviationMissing Endpoint Assessments 2020-06-12A€P07 SUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§ÂØDVQHqÌPHq§ÂØHqÌPDVQHqÌPAProtocol DeviationMissing Endpoint Assessments 2020-07-08B$P07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1088US2011088US201USAB/YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq¨¬üDVWHqÔ9øHq¨¬üHqÔ9øDVWHqÔ9øAProtocol DeviationMissing Endpoint Assessments 2020-07-14B)P07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1103US2011103US201USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq®? DVWHqÔ•`Hq®? HqÔ•`DVWHqÔ•`AProtocol DeviationMissing Endpoint Assessments 2020-07-07BP07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1124US2011124US201USAB<YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅ÷”DVhHqê¡ HqÅ÷”Hqê¡ DVhHqê¡ AProtocol DeviationMissing Endpoint Assessments 2020-07-31B$P07 SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1090US2041090US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV:Hq®RØDVZHqØq€Hq®RØHqØq€DVZHqØq€AProtocol DeviationStudy Procedures/Assessments 2020-07-14B%P08.99 NASOPHARYNGEAL SWAB COLLECTIONS AT DAY 29 LEAKED VIAL. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US201-1011US2011011US201USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV0Hq¡$ŒDVLHqÅÅlHq¡$ŒHqÅÅlDVLHqÅÅlAProtocol DeviationStudy Procedures/Assessments 2020-05-29AP08: LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1069US2081069US208USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÆˆDVhHqêäÜHqÆˆHqêäÜDVhHqêäÜAProtocol DeviationStudy Procedures/Assessments 2020-07-24BP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1012US2051012US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦[ŒDVQHqÌr¸Hq¦[ŒHqÌr¸DVQHqÌr¸AProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1022US2051022US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV5Hq§eTDVWHqÔ;œHq§eTHqÔ;œDVWHqÔ;œAProtocol DeviationStudy Procedures/Assessments 2020-06-03AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1026US2051026US205USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦"˜DVPHqË¬Hq¦"˜HqË¬DVPHqË¬AProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1032US2051032US205USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦*DVPHqÊû|Hq¦*HqÊû|DVPHqÊû|AProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1042US2051042US205USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦4àDVQHqÌ…xHq¦4àHqÌ…xDVQHqÌ…xAProtocol DeviationStudy Procedures/Assessments 2020-06-02AP08_POST-DOSE VITAL SIGNS TIME IS PRIOR TO OR LESS THAN 60 MINUTES AFTER THE DOSE TIME. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1026US2041026US204USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦tDVPHqË>üHq¦tHqË>üDVPHqË>üAProtocol DeviationStudy Procedures/Assessments 2020-06-30BP08_PROCEDURE NOT PERFORMED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1090US2041090US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV:Hq®RØDVZHqØq€Hq®RØHqØq€DVZHqØq€A Protocol DeviationStudy Procedures/Assessments 2020-07-20B+P08_PROCEDURE NOT PERFORMED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1091US2041091US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV<Hq°ÄdDVZHqØmüHq°ÄdHqØmüDVZHqØmüAProtocol DeviationStudy Procedures/Assessments 2020-07-20B)P08_PROCEDURE NOT PERFORMED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1132US2041132US204USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅ®8DVkHqî·`HqÅ®8Hqî·`DVkHqî·`AProtocol DeviationStudy Procedures/Assessments 2020-08-13B1P08_PROCEDURE NOT PERFORMED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1026US2051026US205USAB1YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦"˜DVPHqË¬Hq¦"˜HqË¬DVPHqË¬A Protocol DeviationStudy Procedures/Assessments 2020-06-25BP08_PROCEDURE PERFORMED OUT OF WINDOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1032US2051032US205USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦*DVPHqÊû|Hq¦*HqÊû|DVPHqÊû|A Protocol DeviationStudy Procedures/Assessments 2020-06-25BP08_PROCEDURE PERFORMED OUT OF WINDOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1059US2011059US201USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦äDVPHqËØHq¦äHqËØDVPHqËØAProtocol DeviationStudy Procedures/Assessments 2020-06-30BP08 LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1128US2011128US201USAB=YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHqËDDVmHqñR,HqËDHqñR,DVmHqñR,AProtocol DeviationStudy Procedures/Assessments 2020-06-30AP08 LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1162US2011162US201USAB>YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYNNNNNNNNYYYNNNN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqÓI€DVrHqø:HqÓI€Hqø:DVrHqø:AProtocol DeviationStudy Procedures/Assessments 2020-07-01ÁPP08 LAB SAMPLES NOT SHIPPED, COLLECTED AND/OR PROCESSED PER PROTOCOL, CFC OR LAB MANUAL. (EXPIRED TUBES, AMBIENT SHIPMENT, INCORRECT LAB KIT USED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1071US2051071US205USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqÉâxDVkHqîÜ,HqÉâxHqîÜ,DVkHqîÜ,AProtocol DeviationConcomitant Medication 2020-08-24B9P09_ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1084US2051084US205USAB=YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqÌt DVmHqñ‰ôHqÌt Hqñ‰ôDVmHqñ‰ôAProtocol DeviationConcomitant Medication 2020-08-10B)P09_ADMINISTRATION OF FORBIDDEN VACCINE OR MEDICATION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1016US2041016US204USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦uTDV^HqÝ¨øHq¦uTHqÝ¨øDV^HqÝ¨øAProtocol DeviationVisit Scheduling 2020-07-06B#P10.3 SUBJECT 2041016 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 06JUL2020 WHICH INCLUDES THE +7 DAYS ALLOWED PER THE PROTOCOL. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1198US2021198US202USAB?YEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYPlacebo APlacebo ADVOHqÉÀ@DVsHqù0ÜHqÉÀ@Hqù0ÜDVsHqù0ÜAProtocol DeviationVisit Scheduling 2020-08-18B3P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 03AUG2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1131US2041131US204USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqÉòàDVyHr´HqÉòàHr´DVyHr´AProtocol DeviationVisit Scheduling 2020-08-10B+P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 03AUG2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1013US2071013US207USABIYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNYYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦YèDVYHq×)`Hq¦YèHq×)`DVYHq×)`AProtocol DeviationVisit Scheduling 2020-07-09B&P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 07JUL2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1038US2071038US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨öXDV]HqÜ”Hq¨öXHqÜ”DV]HqÜ”A Protocol DeviationVisit Scheduling 2020-07-13B(P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 09JUL2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1117US2081117US208USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqÓ"\DVzHr°øHqÓ"\Hr°øDVzHr°øAProtocol DeviationVisit Scheduling 2020-08-11B%P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 10AUG2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1119US2081119US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYPlacebo APlacebo ADVVHqÒÑDVzHrD°HqÒÑHrD°DVzHrD°AProtocol DeviationVisit Scheduling 2020-08-11B%P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 10AUG2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqªoìDV]HqÜqôHqªoìHqÜqôDV]HqÜqôAProtocol DeviationVisit Scheduling 2020-07-13B'P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 10JUL2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1207US2021207US202USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYPlacebo APlacebo ADVLHqÆDVuHqûÞhHqÆHqûÞhDVuHqûÞhAProtocol DeviationVisit Scheduling 2020-08-06B*P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 31JUL2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1114US2041114US204USAB>YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYPlacebo APlacebo ADVLHqÆDVrHq÷ñ¤HqÆHq÷ñ¤DVrHq÷ñ¤AProtocol DeviationVisit Scheduling 2020-08-03B'P10.3 VISIT 4 (VACCINE 2) SHOULD HAVE OCCURRED NO LATER THAN 31JUL2020 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1067US2011067US201USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV5Hq§ž„DVWHqÔ4Hq§ž„HqÔ4DVWHqÔ4AProtocol DeviationVisit Scheduling 2020-06-10A€P10: VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1182US2021182US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq®DVWHqÔ=¸Hq®HqÔ=¸DVWHqÔ=¸AProtocol DeviationVisit Scheduling 2020-07-31B6P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqÌ¨ DVmHqñ™0HqÌ¨ Hqñ™0DVmHqñ™0A0Protocol DeviationVisit Scheduling 2020-09-08BFP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1215US2021215US202USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqÉØ DVrHqø*\HqÉØ Hqø*\DVrHqø*\AProtocol DeviationVisit Scheduling 2020-09-08BHP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US203-1107US2031107US203USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqÉ $DVkHqîÃHqÉ $HqîÃDVkHqîÃAProtocol DeviationVisit Scheduling 2020-09-02BBP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1008US2041008US204USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¥ÄDVQHqÌ©THq¥ÄHqÌ©TDVQHqÌ©TAProtocol DeviationVisit Scheduling 2020-08-11BHP10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1011US2051011US205USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§˜0DVWHqÔE°Hq§˜0HqÔE°DVWHqÔE°A Protocol DeviationVisit Scheduling 2020-07-30B:P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1017US2051017US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqªA„DVWHqÔ<HqªA„HqÔ<DVWHqÔ<AProtocol DeviationVisit Scheduling 2020-07-29B7P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1022US2051022US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV5Hq§eTDVWHqÔ;œHq§eTHqÔ;œDVWHqÔ;œA Protocol DeviationVisit Scheduling 2020-07-29B9P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1024US2051024US205USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNNNYYYYYNN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦&XDVWHqÔMlHq¦&XHqÔMlDVWHqÔMlAProtocol DeviationVisit Scheduling 2020-07-28B9P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1025US2051025US205USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hqª0,DVYHqÖçHHqª0,HqÖçHDVYHqÖçHAProtocol DeviationVisit Scheduling 2020-07-30B8P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1027US2051027US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®0(DVWHqÔS„Hq®0(HqÔS„DVWHqÔS„AProtocol DeviationVisit Scheduling 2020-07-31B6P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1029US2051029US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨ÍDVYHq×ÌHq¨ÍHq×ÌDVYHq×ÌAProtocol DeviationVisit Scheduling 2020-07-30B9P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq© €DVWHqÔBàHq© €HqÔBàDVWHqÔBàA Protocol DeviationVisit Scheduling 2020-07-28B7P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1035US2051035US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq¨¾DVXHqÕÉHq¨¾HqÕÉDVXHqÕÉA Protocol DeviationVisit Scheduling 2020-07-30B9P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1044US2051044US205USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV7HqªHDVVHqÓäHqªHHqÓäDVVHqÓäA Protocol DeviationVisit Scheduling 2020-07-28B6P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1059US2051059US205USAB9YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqÅþœDVkHqîÍ,HqÅþœHqîÍ,DVkHqîÍ,AProtocol DeviationVisit Scheduling 2020-08-18B6P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1164US2021164US202USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:HqøœDVXHqÕHHqøœHqÕHDVXHqÕHAProtocol DeviationVisit Scheduling 2020-08-07B=P10: (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) VISIT 6 COMPLETED 19 DAYS AFTER VISIT 4 SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNN YYYNNNot DetectedYNNPlacebo APlacebo ADV7Hqª[ˆDV7Hqª[ˆHqª[ˆHqª[ˆ..AProtocol DeviationStudy Procedures/Assessments 2020-07-06B P10: US2021094- VISIT 4 DAY 29 PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SUBJECT WAS AWAITING COVID TEST RESULTS. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNN YYYNNNot DetectedYNNPlacebo APlacebo ADV7Hqª[ˆDV7Hqª[ˆHqª[ˆHqª[ˆ..A Protocol DeviationStudy Procedures/Assessments 2020-07-15B)P10: US2021094- VISIT 5 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNN YYYNNNot DetectedYNNPlacebo APlacebo ADV7Hqª[ˆDV7Hqª[ˆHqª[ˆHqª[ˆ..A0Protocol DeviationStudy Procedures/Assessments 2020-07-17B+P10: US2021094- VISIT 6 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1094US2021094US202USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYNNNNNNNNYNYNNNN YYYNNNot DetectedYNNPlacebo APlacebo ADV7Hqª[ˆDV7Hqª[ˆHqª[ˆHqª[ˆ..A@Protocol DeviationStudy Procedures/Assessments 2020-08-06B?P10: US2021094- VISIT 7 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNYYYYYNN NNYYNNot DetectedYNNPlacebo APlacebo ADV:Hq®[DVWHqÔ˜lHq®[HqÔ˜lDVWHqÔ˜lAProtocol DeviationStudy Procedures/Assessments 2020-07-15B&P10: US2021137- VISIT 5 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNYYYYYNN NNYYNNot DetectedYNNPlacebo APlacebo ADV:Hq®[DVWHqÔ˜lHq®[HqÔ˜lDVWHqÔ˜lA0Protocol DeviationStudy Procedures/Assessments 2020-08-18BHP10: US2021137- VISIT 7 PROCEDURES AND ASSESSMENTS WERE COMPLETED OUT OF WINDOW DUE TO COVID-19 IMPACT. CONVALESCENT VISIT OCCURRED ON 11AUG2020. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1137US2021137US202USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYNNNNYYYYYNN NNYYNNot DetectedYNNPlacebo APlacebo ADV:Hq®[DVWHqÔ˜lHq®[HqÔ˜lDVWHqÔ˜lA Protocol DeviationStudy Procedures/Assessments 2020-07-21B,P10: US2021137 VISIT 6 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1144US2021144US202USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV7Hqª"XDVVHqÒ÷xHqª"XHqÒ÷xDVVHqÒ÷xAProtocol DeviationStudy Procedures/Assessments 2020-08-10BCP10: US2021144- VISIT 7 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1162US2021162US202USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNPlacebo APlacebo ADV:Hq®(äDV:Hq®(äHq®(äHq®(ä..AProtocol DeviationStudy Procedures/Assessments 2020-06-16AP10: US2021162 MISSED VISIT 2 DUE TO A FALSE POSITIVE COVID-19 LAB RESULT ON DAY 1 FROM VIRACOR LAB. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US202-1162US2021162US202USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNPlacebo APlacebo ADV:Hq®(äDV:Hq®(äHq®(äHq®(ä..A Protocol DeviationStudy Procedures/Assessments 2020-06-23BP10: US2021162 MISSED VISIT 3 DUE TO A FALSE POSITIVE COVID-19 LAB RESULT ON DAY 1 FROM CENTRAL LAB. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1162US2021162US202USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNPlacebo APlacebo ADV:Hq®(äDV:Hq®(äHq®(äHq®(ä..A0Protocol DeviationStudy Procedures/Assessments 2020-07-13B$P10: US2021162 MISSED VISIT 4 DAY 29 VACCINATION 2 DUE TO A FALSE POSITIVE COVID-19 LAB RESULT ON DAY 1 FROM VIRACOR LAB. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqÌ¨ DVmHqñ™0HqÌ¨ Hqñ™0DVmHqñ™0A Protocol DeviationStudy Procedures/Assessments 2020-08-19B2P10: US2021208 VISIT 6 WERE COMPLETED OVER THE PHONE AND PROCEDURES AND ASSESSMENTS WERE MISSED DUE TO COVID-19 IMPACT. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1011US2041011US204USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV3Hq¤÷ÄDVQHqÌF0Hq¤÷ÄHqÌF0DVQHqÌF0AProtocol DeviationVisit Scheduling 2020-06-15AðP10: VISIT COMPLETED OUT OF WINDOW NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1011US2041011US204USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV3Hq¤÷ÄDVQHqÌF0Hq¤÷ÄHqÌF0DVQHqÌF0A Protocol DeviationVisit Scheduling 2020-08-17BNP10: VISIT COMPLETED OUT OF WINDOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1014US2041014US204USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV0Hq¡!€DVLHqÅ»ÐHq¡!€HqÅ»ÐDVLHqÅ»ÐAProtocol DeviationVisit Scheduling 2020-07-08B)P10: VISIT COMPLETED OUT OF WINDOW NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1046US2041046US204USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨í¬DVRHqÍ¡LHq¨í¬HqÍ¡LDVRHqÍ¡LAProtocol DeviationVisit Scheduling 2020-06-15AÀP10: VISIT COMPLETED OUT OF WINDOW NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1055US2041055US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFAMERICAN INDIAN OR ALASKA NATIVE HISPANIC OR LATINO YYNNNNNNNNYNYNNNNNYYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§zlDV5Hq§zlHq§zlHq§zl..A Protocol DeviationVisit Scheduling 2020-06-25BP10: VISIT COMPLETED OUT OF WINDOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1112US2041112US204USAB=YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅéHDVlHqðD,HqÅéHHqðD,DVlHqðD,AProtocol DeviationVisit Scheduling 2020-08-18B6P10: VISIT COMPLETED OUT OF WINDOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1063US2061063US206USAB8YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVPHqËhDVlHqðGtHqËhHqðGtDVlHqðGtAProtocol DeviationVisit Scheduling 2020-08-11B+P10_V6D43 WAS NOT DONE;(IMMUNOGENECITY SAMPLES WERE NOT COLLECTED). SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqËÐDVoHqóâlHqËÐHqóâlDVoHqóâlA Protocol DeviationVisit Scheduling 2020-08-25B9P10_V6D43 WAS NOT DONE;(IMMUNOGENECITY SAMPLES WERE NOT COLLECTED). SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1006US2061006US206USAB#YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§nxDVQHqÌw¤Hq§nxHqÌw¤DVQHqÌw¤A Protocol DeviationVisit Scheduling 2020-07-22B2P10_V6D43 WAS OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1045US2061045US206USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqÊdDVkHqîù´HqÊdHqîù´DVkHqîù´AProtocol DeviationVisit Scheduling 2020-08-20B5P10_V7 DAY 57 WAS OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1107US2041107US204USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÆlDVkHqî®HqÆlHqî®DVkHqî®AProtocol DeviationVisit Scheduling 2020-07-09AàP10_V28 OCCURRED >3 DAYS OUT OF WINDOW. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US204-1094US2041094US204USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqÅï`DVhHqêã8HqÅï`Hqêã8DVhHqêã8AProtocol DeviationVisit Scheduling 2020-08-11B/P10_VISIT COMPLETED OUT OF WINDOW. (V6D43 OUT OF WINDOW.) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1019US2041019US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¦]äDVPHqË8äHq¦]äHqË8äDVPHqË8äA Protocol DeviationVisit Scheduling 2020-07-28B9P10_VISIT COMPLETED OUT OF WINDOW. (V7D57 OUT OF WINDOW) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1060US2041060US204USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦lDVQHqÌNdHq¦lHqÌNdDVQHqÌNdA Protocol DeviationVisit Scheduling 2020-08-18BNP10_VISIT COMPLETED OUT OF WINDOW. (V7D57 OUT OF WINDOW) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1061US2041061US204USAB4YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦p¤DVVHqÓ(Hq¦p¤HqÓ(DVVHqÓ(AProtocol DeviationVisit Scheduling 2020-08-13BIP10_VISIT COMPLETED OUT OF WINDOW. (V7D57 OUT OF WINDOW) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1072US2051072US205USABEYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedYNNPlacebo APlacebo ADVVHqÓEüDVrHq÷ÕHqÓEüHq÷ÕDVrHq÷ÕAProtocol DeviationVisit Scheduling 2020-09-09BBP10_VISIT NOT PERFORMED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US204-1064US2041064US204USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNNNYYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®c¸DV^HqÝÑ„Hq®c¸HqÝÑ„DV^HqÝÑ„A Protocol DeviationVisit Scheduling 2020-07-14B%P10_VISIT NOT PERFORMED. (US2041064, VISIT 3 NOT PERFORMED) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1068US2061068US206USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqËÐDVoHqóâlHqËÐHqóâlDVoHqóâlAProtocol DeviationVisit Scheduling 2020-08-11B+P10 11AUG2020 V5 WAS +2 DAYS OUT OF WINDOW. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US206-1035US2061035US206USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅâ¸DVdHqåepHqÅâ¸HqåepDVdHqåepAProtocol DeviationStudy Treatment Compliance 2020-07-20BP10 23JUL2020(b)(6):SUBJECT US2061035 WAS VACCINATED WITH V4D29 (20JUL20) VACCINATION 24 DAYS AFTER THE FIRST TREATMENT (26JUN20) INSTEAD OF AT LEAST 28 DAYS BETWEEN VACCINATIONS. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1019US2061019US206USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§â|DVQHqÌ”<Hq§â|HqÌ”<DVQHqÌ”<A Protocol DeviationVisit Scheduling 2020-07-21B1P10 V6 20JUL2020 IS +3 DAYS OUT OF WINDOW. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1001US2061001US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq©1,DVZHqØsœHq©1,HqØsœDVZHqØsœA Protocol DeviationVisit Scheduling 2020-07-10B%P10 VISIT 4 DATE IS > 35 DAYS AFTER DAY1 VISIT 1 VACCINATION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1011US2051011US205USAB.YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§˜0DVWHqÔE°Hq§˜0HqÔE°DVWHqÔE°AProtocol DeviationVisit Scheduling 2020-07-17B-P10 VISIT 6 COMPLETED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1033US2051033US205USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq© €DVWHqÔBàHq© €HqÔBàDVWHqÔBàAProtocol DeviationVisit Scheduling 2020-07-17B,P10 VISIT 6 COMPLETED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1035US2051035US205USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq¨¾DVXHqÕÉHq¨¾HqÕÉDVXHqÕÉAProtocol DeviationVisit Scheduling 2020-07-17B,P10 VISIT 6 COMPLETED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1044US2051044US205USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNPlacebo APlacebo ADV7HqªHDVVHqÓäHqªHHqÓäDVVHqÓäAProtocol DeviationVisit Scheduling 2020-07-16B*P10 VISIT 6 COMPLETED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US205-1111US2051111US205USABFYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVVHqÓAˆDVsHqùnDHqÓAˆHqùnDDVsHqùnDAProtocol DeviationVisit Scheduling 2020-08-24B2P10 VISIT 6 COMPLETED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US201-1122US2011122US201USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅüDVhHqêPHqÅüHqêPDVhHqêPA Protocol DeviationVisit Scheduling 2020-08-21B9P10 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 YYYYYYYYYYYYYYYYYNNNYYNNot DetectedNNNPlacebo APlacebo ADV7Hqª˜DVVHqÓœHqª˜HqÓœDVVHqÓœA0Protocol DeviationVisit Scheduling 2020-06-12A€P10 VISIT NOT PERFORMED (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1030US2071030US207USAB%YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV5Hq§ÒPDVVHqÓSHq§ÒPHqÓSDVVHqÓSA Protocol DeviationVisit Scheduling 2020-08-11BFP10 VISIT PERFORMED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1067US2071067US207USAB"YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7Hqª/xDVXHqÕ÷ÀHqª/xHqÕ÷ÀDVXHqÕ÷ÀAProtocol DeviationVisit Scheduling 2020-08-13BFP10 VISIT PERFORMED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1103US2071103US207USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNNNYYYYYYN NYYYNNot DetectedNNNPlacebo APlacebo ADVRHqÍù¨DVuHqûÌ HqÍù¨HqûÌ DVuHqûÌ AProtocol DeviationVisit Scheduling 2020-09-11BHP10 VISIT PERFORMED OOW SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US202-1208US2021208US202USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYNYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqÌ¨ DVmHqñ™0HqÌ¨ Hqñ™0DVmHqñ™0AProtocol DeviationVisit Scheduling 2020-08-05B$P.10: US2021208 V2 D8 OCCURRED 2 DAYS OUT OF WINDOW. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1094US2071094US207USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVVHqÒæ DVsHqùQèHqÒæ HqùQèDVsHqùQèAProtocol DeviationStudy Procedures/Assessments 2020-08-04BPROCEDURE NOT PERFORMED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1094US2071094US207USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVVHqÒæ DVsHqùQèHqÒæ HqùQèDVsHqùQèA Protocol DeviationStudy Procedures/Assessments 2020-08-04BPROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1015US2081015US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV3Hq¥DVQHqÌQpHq¥HqÌQpDVQHqÌQpA Protocol DeviationStudy Procedures/Assessments 2020-06-01APROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1023US2081023US208USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§¢DDVWHqÔ<Hq§¢DHqÔ<DVWHqÔ<A Protocol DeviationStudy Procedures/Assessments 2020-07-08B$PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¥þ€DVWHqÔHDHq¥þ€HqÔHDDVWHqÔHDA Protocol DeviationStudy Procedures/Assessments 2020-05-29Á@PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1033US2081033US208USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¥þ€DVWHqÔHDHq¥þ€HqÔHDDVWHqÔHDA0Protocol DeviationStudy Procedures/Assessments 2020-06-02APROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNPlacebo APlacebo ADV:Hq®XDV:Hq®XHq®XHq®X..A Protocol DeviationStudy Procedures/Assessments 2020-07-14B%PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1064US2081064US208USAB0YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq®DVYHqÖá0Hq®HqÖá0DVYHqÖá0AProtocol DeviationStudy Procedures/Assessments 2020-07-10B!PROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1076US2081076US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVQHqÌV DVtHqú¸HqÌV Hqú¸DVtHqú¸AProtocol DeviationStudy Procedures/Assessments 2020-07-01APROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1116US2081116US208USABKYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqÉú`DVmHqñ^˜HqÉú`Hqñ^˜DVmHqñ^˜AProtocol DeviationStudy Procedures/Assessments 2020-07-07APROCEDURE NOT PERFORMED (EXCLUDING IMMUNOGENICITY BLOOD DRAWS AND VACCINATIONS) (NASOPHARYNGEAL SWAB COLLECTIONS AT D1, D29, D57, UNS, MAAE) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1039US2071039US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqªoìDV]HqÜqôHqªoìHqÜqôDV]HqÜqôA Protocol DeviationStudy Procedures/Assessments 2020-06-05APROCEDURE NOT PERFORMED (NASOPHARYNGEAL SWAB COLLECTIONS AT D1) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤áDVPHqË:Hq¤áHqË:DVPHqË:AProtocol DeviationStudy Procedures/Assessments 2020-07-27B9PROCEDURE NOT PERFORMED PHYSICAL EXAM SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1016US2071016US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§¥ŒDVXHqÕ¹hHq§¥ŒHqÕ¹hDVXHqÕ¹hAProtocol DeviationStudy Procedures/Assessments 2020-08-03B>PROCEDURE NOT PERFORMED PHYSICAL EXAM NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1066US2071066US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV;Hq¯¯ÔDVXHqÕÌ Hq¯¯ÔHqÕÌ DVXHqÕÌ AProtocol DeviationStudy Procedures/Assessments 2020-08-03B8PROCEDURE NOT PERFORMED PHYSICAL EXAM NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤áDVPHqË:Hq¤áHqË:DVPHqË:A Protocol DeviationStudy Procedures/Assessments 2020-07-21B3PROCEDURE NOT PERFORMED VITAL SIGNS SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤áDVPHqË:Hq¤áHqË:DVPHqË:A0Protocol DeviationStudy Procedures/Assessments 2020-07-27B9PROCEDURE NOT PERFORMED VITAL SIGNS SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1016US2071016US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§¥ŒDVXHqÕ¹hHq§¥ŒHqÕ¹hDVXHqÕ¹hA Protocol DeviationStudy Procedures/Assessments 2020-08-03B>PROCEDURE NOT PERFORMED VITAL SIGNS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1066US2071066US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV;Hq¯¯ÔDVXHqÕÌ Hq¯¯ÔHqÕÌ DVXHqÕÌ A Protocol DeviationStudy Procedures/Assessments 2020-08-03B8PROCEDURE NOT PERFORMED VITAL SIGNS NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1005US2081005US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV3Hq¤ÐdDVQHqÌ|Hq¤ÐdHqÌ|DVQHqÌ|AProtocol DeviationStudy Procedures/Assessments 2020-06-01APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq¤Ì,DVRHqÍ×pHq¤Ì,HqÍ×pDVRHqÍ×pAProtocol DeviationStudy Procedures/Assessments 2020-06-15AðPROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¥@DVPHqË$Hq¥@HqË$DVPHqË$AProtocol DeviationStudy Procedures/Assessments 2020-06-15AðPROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1017US2081017US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV4Hq¦ÈDVVHqÓ=PHq¦ÈHqÓ=PDVVHqÓ=PAProtocol DeviationStudy Procedures/Assessments 2020-05-28ÁPPROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1017US2081017US208USAB>YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV4Hq¦ÈDVVHqÓ=PHq¦ÈHqÓ=PDVVHqÓ=PA Protocol DeviationStudy Procedures/Assessments 2020-06-02APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1019US2081019US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦&XDVPHqË LHq¦&XHqË LDVPHqË LAProtocol DeviationStudy Procedures/Assessments 2020-06-02APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦S”DVWHqÔ>lHq¦S”HqÔ>lDVWHqÔ>lA Protocol DeviationStudy Procedures/Assessments 2020-06-02APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1041US2081041US208USAB)YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq¨æàDVWHqÔ^Hq¨æàHqÔ^DVWHqÔ^A Protocol DeviationStudy Procedures/Assessments 2020-06-04APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦S”DVWHqÔ>lHq¦S”HqÔ>lDVWHqÔ>lA0Protocol DeviationStudy Procedures/Assessments 2020-06-02APROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) (SAFETY FOLLOW UP CALLS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1051US2081051US208USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqªDVXHqÕ‘HqªHqÕ‘DVXHqÕ‘A Protocol DeviationStudy Procedures/Assessments 2020-07-08B"PROCEDURE PERFORMED OUT OF WINDOW (OTHER THAN VACCINATION OR BLOOD SAMPLE VISITS) (SAFETY FOLLOW UP CALLS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1004US2071004US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq¨µ¨DVXHqÕ†ÈHq¨µ¨HqÕ†ÈDVXHqÕ†ÈAProtocol DeviationInformed Consent 2020-08-06B@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 YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV5Hq§§äDVWHqÔsÜHq§§äHqÔsÜDVWHqÔsÜAProtocol DeviationInformed Consent 2020-08-05B@RECONSENT NOT COLLECTED FOR NEW ICF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1049US2071049US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq¨Á$DVXHqÕ‰˜Hq¨Á$HqÕ‰˜DVXHqÕ‰˜AProtocol DeviationInformed Consent 2020-08-06B@RECONSENT NOT COLLECTED FOR NEW ICF SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqÅÅ¨DVeHqæ¯èHqÅÅ¨Hqæ¯èDVeHqæ¯èAICH/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-US207-1098US2071098US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADVQHqÌ^TDVtHqúÒ„HqÌ^THqúÒ„DVtHqúÒ„A 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-US207-1084US2071084US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅÂ`DVkHqîLHqÅÂ`HqîLDVkHqîLAICH/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-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqÔqHDVsHqùr@HqÔqHHqùr@DVsHqùr@AICH/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-US207-1037US2071037US207USABGYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§|DVWHqÔv¬Hq§|HqÔv¬DVWHqÔv¬AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02ÁSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - IP ACCOUNTABILITY LOG WAS MISSING ENTRY OF "DATE USED" NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªrDDVZHqØ‘$HqªrDHqØ‘$DVZHqØ‘$A@ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AàSOURCE 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-US207-1032US2071032US207USABYEARS>=18 and <55 YearsA>=23 and <=25 YearsA MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®~èDVZHqØ"HHq®~èHqØ"HDVZHqØ"HAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18A°SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1074US2071074US207USAB(YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®? DVYHq×Hq®? Hq×DVYHq×AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18A°SOURCE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®eÔDVWHqÔ‘ Hq®eÔHqÔ‘ DVWHqÔ‘ AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18A°SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 50UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS NOT COMPLETED IN ITS ENTIRETY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1038US2071038US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨öXDV]HqÜ”Hq¨öXHqÜ”DV]HqÜ”A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AðSOURCE 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 LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨öXDV]HqÜ”Hq¨öXHqÜ”DV]HqÜ”A@ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AðSOURCE 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 LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqªoìDV]HqÜqôHqªoìHqÜqôDV]HqÜqôA0ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AàSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1068US2071068US207USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq®_DDVXHqÕÈhHq®_DHqÕÈhDVXHqÕÈhAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18A°SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE 100UG DOSE PREPARATION AND ADMINISTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦ŒDVQHqÌN(Hq¦ŒHqÌN(DVQHqÌN(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-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV4Hq¦HDVRHqÍ•ÐHq¦HHqÍ•ÐDVRHqÍ•ÐAICH/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-US207-1088US2071088US207USABFYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅøüDVkHqîºäHqÅøüHqîºäDVkHqîºäAICH/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-US207-1069US2071069US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq®DV]HqÜ1Hq®HqÜ1DV]HqÜ1AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18A°SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1073US2071073US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV:Hq®!dDVWHqÔGTHq®!dHqÔGTDVWHqÔGTAICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18A°SOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS NOT FILLED OUT COMPLETELY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1086US2071086US207USABDYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅâôDVmHqñIDHqÅâôHqñIDDVmHqñIDA ICH/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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅÏ€DVeHqæ¸XHqÅÏ€Hqæ¸XDVeHqæ¸XA ICH/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-US207-1002US2071002US207USAB'YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤áDVPHqË:Hq¤áHqË:DVPHqË: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-US207-1003US2071003US207USAB*YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq¤Ø\DVPHqË9 Hq¤Ø\HqË9 DVPHqË9 AICH/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-US207-1006US2071006US207USABGYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦ŒDVQHqÌN(Hq¦ŒHqÌN(DVQHqÌN(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-US207-1007US2071007US207USAB:YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV4Hq¦0lDVWHqÔHøHq¦0lHqÔHøDVWHqÔHøAICH/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 LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNYYmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦YèDVYHq×)`Hq¦YèHq×)`DVYHq×)`A 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-US207-1041US2071041US207USAB@YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV4Hq¦HDVRHqÍ•ÐHq¦HHqÍ•ÐDVRHqÍ•ÐA 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-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªrDDVZHqØ‘$HqªrDHqØ‘$DVZHqØ‘$APICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18AàSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE INJECTION TIME FOR UNBLINDED SUBJECT WAS NOTED TO BE MISSING ON THE DOSE PREPARATION AND ADMINSITRATION WORKSHEET. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1005US2071005US207USAB8YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNPlacebo APlacebo ADV4Hq¦DVVHqÓ0¨Hq¦HqÓ0¨DVVHqÓ0¨AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-18BSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE PLACEBO DOSE PREPARATION AND ADMINSTRATION WORKSHEET WAS COMPLETED INCORRECTLY. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡$DVOHqÉ®èHq¡$HqÉ®èDVOHqÉ®èA ICH/GCP Deviation Inv Record Keeping Source Docs2020-05-29ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11312 (50 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1009US2081009US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV3Hq¤Ì,DVRHqÍ×pHq¤Ì,HqÍ×pDVRHqÍ×pA ICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11313 (50 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1001US2071001US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡+ÐDVPHqË7¸Hq¡+ÐHqË7¸DVPHqË7¸AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-02APSOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIAL 11328 (50 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤ëDVOHqÉí@Hq¤ëHqÉí@DVOHqÉí@AICH/GCP Deviation Inv Record Keeping Source Docs2020-06-01ASOURCE DOCUMENTATION DOSE NOT MEET ALCOA - THE SYRINGE EXPIRATION TIME ON THE DOSE PREPARATION AND ADMINISTRATION WORKSHEET HAS NOT BEEN COMPLETED FOR VIALS 11314 AND 11315 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1014US2081014US208USABCYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¥@DVPHqË$Hq¥@HqË$DVPHqË$A ICH/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-US208-1002US2081002US208USABEYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq àXDVKHqÄ`´Hq àXHqÄ`´DVKHqÄ`´AICH/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-US208-1001US2081001US208USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq â°DVJHqÃ Hq â°HqÃ DVJHqÃ AICH/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-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦S”DVWHqÔ>lHq¦S”HqÔ>lDVWHqÔ>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 11323 AND 11324 (100 MCG). NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1019US2081019US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦&XDVPHqË LHq¦&XHqË LDVPHqË 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-US208-1035US2081035US208USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦BðDVQHqÌr|Hq¦BðHqÌr|DVQHqÌr|AICH/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-US207-1087US2071087US207USABQYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅÞ¼DVnHqòŸ8HqÅÞ¼HqòŸ8DVnHqòŸ8AICH/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-US207-1083US2071083US207USABWYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqÅÅ¨DVeHqæ¯èHqÅÅ¨Hqæ¯èDVeHqæ¯èA ICH/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 LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVLHqÅÅ¨DVeHqæ¯èHqÅÅ¨Hqæ¯èDVeHqæ¯èA0ICH/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-US207-1089US2071089US207USABBYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅ¹ðDVmHqñœHqÅ¹ðHqñœDVmHqñœAICH/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 LATINOYYYYYYYYYNYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqÉíôDVmHqñŠlHqÉíôHqñŠlDVmHqñŠlAICH/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 LATINOYYYYYYYYYNYYYYYYN NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅËDVkHqî·ØHqÅËHqî·ØDVkHqî·ØAICH/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-US207-1082US2071082US207USAB9YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÆPDVlHqïî HqÆPHqïî DVlHqïî AICH/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-US207-1087US2071087US207USABQYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVLHqÅÞ¼DVnHqòŸ8HqÅÞ¼HqòŸ8DVnHqòŸ8A Protocol DeviationMissing Endpoint Assessments 2020-07-06A°SUBJECT DIARY HAS 2 OR MORE CONSECUTIVE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1093US2071093US207USABCYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVOHqÉº DVmHqñEÀHqÉº HqñEÀDVmHqñEÀAProtocol DeviationMissing Endpoint Assessments 2020-06-29ASUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1003US2081003US208USAB@YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 50 ug A mRNA-1273 50 ug A DV0Hq¡$DVOHqÉ®èHq¡$HqÉ®èDVOHqÉ®èA0Protocol DeviationMissing Endpoint Assessments 2020-06-11AàSUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1016US2081016US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤ëDVOHqÉí@Hq¤ëHqÉí@DVOHqÉí@A Protocol DeviationMissing Endpoint Assessments 2020-06-11A°SUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§¢DDVWHqÔ<Hq§¢DHqÔ<DVWHqÔ<A0Protocol DeviationMissing Endpoint Assessments 2020-06-11ASUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¥þ€DVWHqÔHDHq¥þ€HqÔHDDVWHqÔHDA@Protocol DeviationMissing Endpoint Assessments 2020-07-14B+SUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV6Hq¨¸ðDVYHq×Hq¨¸ðHq×DVYHq×AProtocol DeviationMissing Endpoint Assessments 2020-07-15B*SUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨¾DVWHqÔ{˜Hq¨¾HqÔ{˜DVWHqÔ{˜A Protocol DeviationMissing Endpoint Assessments 2020-06-11A€SUBJECT DIARY HAS 2 OR MORE 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨¾DVWHqÔ{˜Hq¨¾HqÔ{˜DVWHqÔ{˜A0Protocol DeviationMissing Endpoint Assessments 2020-07-14B)SUBJECT DIARY HAS 2 OR MORE DAYS OF SOLICITED ENTRIES MISSING SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1099US2071099US207USAB>YEARS>=55 Years A >=55 Years A@MWHITE HISPANIC OR LATINO YYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqÔqHDVsHqùr@HqÔqHHqùr@DVsHqùr@A Protocol DeviationMissing Endpoint Assessments 2020-08-11B$SUBJECT DIARY NOT COMPLETED (IN ENTIRETY) FOR SAFETY DATA COLLECTION SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNPlacebo APlacebo ADV:Hq®XDV:Hq®XHq®XHq®X..A0Protocol DeviationStudy Treatment Admin/Dispense2020-07-06BSUBJECT DID NOT COMPLY WITH STUDY VACCINATION SCHEDULE (2ND VACCINATION NOT GIVEN ) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1071US2071071US207USAB-YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7Hqª7èDVWHqÔY$Hqª7èHqÔY$DVWHqÔY$AProtocol DeviationExclusion Criteria 2020-06-05ASUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1096US2071096US207USAB7YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqÍú˜DVtHqúËôHqÍú˜HqúËôDVtHqúËôAProtocol DeviationExclusion Criteria 2020-06-24Á€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 YYYYYYYYNYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVWHqÔqHDVsHqùr@HqÔqHHqùr@DVsHqùr@A0Protocol DeviationExclusion Criteria 2020-07-07ASUBJECT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV3Hq¤ëDVOHqÉí@Hq¤ëHqÉí@DVOHqÉí@A0Protocol DeviationExclusion Criteria 2020-05-27ÁPSUBJECT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV6Hq¨¾DVWHqÔ{˜Hq¨¾HqÔ{˜DVWHqÔ{˜A@Protocol DeviationExclusion Criteria 2020-06-01Á0SUBJECT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVRHqÍ@DVuHqûé0HqÍ@Hqûé0DVuHqûé0AProtocol DeviationExclusion Criteria 2020-06-23ÁSUBJECT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVSHqÎïüDVoHqô HqÎïüHqô DVoHqô A Protocol DeviationExclusion Criteria 2020-06-23Á SUBJECT DOES NOT MEET ENTRY CRITERIA (EX#18) (EXCLUSION CRITERIA MET, BUT SUBJECT RANDOMIZED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US206-1024US2061024US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYYNot DetectedNNNmRNA-1273 100 ugA0Placebo ADV5Hq§Ë„DVRHqÍÿÀHq§Ë„HqÍÿÀDVRHqÍÿÀA Protocol DeviationVisit Scheduling 2020-07-22B2V6 WAS OUT OF WINDOW + 3 DAYS OUT OF WINDOW. NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US205-1003US2051003US205USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MBLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYYNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV0Hq¡ \DVIHqÁÝ”Hq¡ \HqÁÝ”DVIHqÁÝ”A0Protocol 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-US206-1024US2061024US206USAB&YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYYNot DetectedNNNmRNA-1273 100 ugA0Placebo ADV5Hq§Ë„DVRHqÍÿÀHq§Ë„HqÍÿÀDVRHqÍÿÀA0Protocol 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-US206-1025US2061025US206USAB YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN NNYYYNot DetectedNNNPlacebo AmRNA-1273 100 ugA0DV5Hq§ÒPDVQHqÌ äHq§ÒPHqÌ äDVQHqÌ äAProtocol 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-US207-1029US2071029US207USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAMWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV7HqªrDDVZHqØ‘$HqªrDHqØ‘$DVZHqØ‘$A`Protocol DeviationStudy Treatment Admin/Dispense2020-07-10B$VACCINATION IS NOT ACCORDING TO THE PROTOCOL UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1033US2071033US207USABYEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®DVYHqÖßHq®HqÖßDVYHqÖßA Protocol DeviationStudy Treatment Admin/Dispense2020-07-09B 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 YYYYNNNNNNYYYYNNNNYYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVOHqÊàDVrHqøLHqÊàHqøLDVrHqøLA Protocol DeviationStudy Treatment Admin/Dispense2020-08-31B@VACCINATION IS NOT ACCORDING TO THE PROTOCOL UNKNOWN ROUTE OF ADMIN; UNKNOWN IF IP WAS ACCEPTABLE FOR USE SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1058US2081058US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNPlacebo APlacebo ADV:Hq®XDV:Hq®XHq®XHq®X..A@Protocol DeviationStudy Procedures/Assessments 2020-06-22AðVISIT 3/DAY 15 CONDUCTED VIA PHONE DUE TO COVID-19 IMPACT AND VITAL SIGNS/PHYSICAL EXAM, ANTIBODY-MEDIATED IMMUNOGENICITY WERE NOT COMPLETED NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US207-1096US2071096US207USAB7YEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqÍú˜DVtHqúËôHqÍú˜HqúËôDVtHqúËôA ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-05B#VISIT4 2ND VACCINE COMPLETED BY (b)(6) BUT SOURCE DOCUMENTS FOR THE VISIT WAS NOT FULLY COMPLETED. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1098US2071098US207USABAYEARS>=55 Years A >=55 Years A@FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADVQHqÌ^TDVtHqúÒ„HqÌ^THqúÒ„DVtHqúÒ„A0ICH/GCP Deviation Inv Record Keeping Source Docs2020-08-05B$VISIT4 2ND VACCINE COMPLETED BY (b)(6) BUT SOURCE DOCUMENTS FOR THE VISIT WAS NOT FULLY COMPLETED. SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1019US2081019US208USABLYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦&XDVPHqË LHq¦&XHqË LDVPHqË LA0Protocol DeviationVisit Scheduling 2020-06-08ApVISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1023US2081023US208USAB5YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV5Hq§¢DDVWHqÔ<Hq§¢DHqÔ<DVWHqÔ<A@Protocol DeviationStudy Procedures/Assessments 2020-07-08B$VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1028US2081028US208USAB3YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦S”DVWHqÔ>lHq¦S”HqÔ>lDVWHqÔ>lAPProtocol DeviationVisit Scheduling 2020-06-08ApVISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1035US2081035US208USABDYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNYNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV4Hq¦BðDVQHqÌr|Hq¦BðHqÌr|DVQHqÌr|A Protocol DeviationVisit Scheduling 2020-06-08ApVISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1051US2081051US208USAB2YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DV7HqªDVXHqÕ‘HqªHqÕ‘DVXHqÕ‘A0Protocol DeviationVisit Scheduling 2020-07-14B(VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1066US2081066US208USABBYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVLHqÅÜdDVhHqê¡\HqÅÜdHqê¡\DVhHqê¡\A Protocol DeviationVisit Scheduling 2020-08-11B/VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1092US2081092US208USABMYEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqÍôDVoHqô¸HqÍôHqô¸DVoHqô¸A Protocol DeviationVisit Scheduling 2020-08-06B$VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) NOT SIGNIFICANTmRNA-1273-P201mRNA-1273-P201-US208-1100US2081100US208USAB;YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYNYNYNNNYYYYYYN NYYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVRHqÍÝÄDVrHq÷ÙHqÍÝÄHq÷ÙDVrHq÷ÙAProtocol DeviationVisit Scheduling 2020-09-10BGVISIT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVRHqÍŒpDVuHqûíàHqÍŒpHqûíàDVuHqûíàAProtocol DeviationVisit Scheduling 2020-07-08ApVISIT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADVRHqÍ@DVuHqûé0HqÍ@Hqûé0DVuHqûé0A Protocol DeviationVisit Scheduling 2020-07-08ApVISIT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVSHqÎïüDVoHqô HqÎïüHqô DVoHqô A0Protocol DeviationVisit Scheduling 2020-07-09ApVISIT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqÍù¨DVrHqø¤HqÍù¨Hqø¤DVrHqø¤A Protocol DeviationVisit Scheduling 2020-07-08ApVISIT 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 LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 100 ugA0mRNA-1273 100 ugA0DVRHqÍù¨DVrHqø¤HqÍù¨Hqø¤DVrHqø¤A0Protocol DeviationVisit Scheduling 2020-08-24B6VISIT COMPLETED OUT OF WINDOW (EXCLUDING DOSING VISITS) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1039US2081039US208USABYEARS>=18 and <55 YearsA>=18 and <=22 YearsAFWHITE NOT HISPANIC OR LATINOYYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DV:Hq®8 DVXHqÕ® Hq®8 HqÕ® DVXHqÕ® A Protocol DeviationVisit Scheduling 2020-06-26BVISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1085US2081085US208USAB?YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHqÏ&\DVzHrUHqÏ&\HrUDVzHrUA Protocol DeviationVisit Scheduling 2020-08-11B(VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1112US2081112US208USAB7YEARS>=55 Years A >=55 Years A@FWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYYYYNNN YYYYNNot DetectedNNYmRNA-1273 50 ug A mRNA-1273 50 ug A DVSHqÏ$DVzHrf4HqÏ$Hrf4DVzHrf4A Protocol DeviationVisit Scheduling 2020-08-11B(VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US208-1123US2081123US208USABAYEARS>=55 Years A >=55 Years A@MWHITE NOT HISPANIC OR LATINOYYYYNNNNNNYNYYNNN YYYNNNot DetectedNNNmRNA-1273 50 ug A mRNA-1273 50 ug A DVPHqË$øDVPHqË$øHqË$øHqË$ø..A Protocol DeviationVisit Scheduling 2020-08-11B+VISIT COMPLETED OUT OF WINDOW (VISITS WHERE IMMUNOGENECITY SAMPLES ARE COLLECTED) SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1017US2071017US207USAB$YEARS>=18 and <55 YearsA>25 and <55 Years A0FWHITE HISPANIC OR LATINO YYYYNNNNNNYYYYNNN YYYYNNot DetectedNNNPlacebo APlacebo ADV4Hq¦~ðDVQHqÌ‘lHq¦~ðHqÌ‘lDVQHqÌ‘lA0Protocol DeviationVisit Scheduling 2020-08-18BNVISIT NOT PERFORMED SIGNIFICANT mRNA-1273-P201mRNA-1273-P201-US207-1042US2071042US207USAB+YEARS>=18 and <55 YearsA>25 and <55 Years A0MWHITE HISPANIC OR LATINO YYYYYYYYYYYYYYYYY NNYYNNot DetectedNNNPlacebo APlacebo ADV6Hq©DVYHq×Hq©Hq×DVYHq×AProtocol DeviationVisit Scheduling 2020-07-21B0VISIT NOT PERFORMED NOT SIGNIFICANT