HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 X64_SR12 19MAY21:19:09:3119MAY21:19:09:31 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS TS SASDATA 9.4 X64_SR12 19MAY21:19:09:3119MAY21:19:09:31 Trial Summary HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000001200000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation TSSEQ Sequence Number TSPARMCDTrial Summary Parameter Short Name (TSPARM Trial Summary Parameter ĆTSVAL Parameter Value H&TSVAL1 Parameter Value 1 TSVAL2 Parameter Value 2 4 TSVALNF Parameter Null Flavor 5 TSVALCD Parameter Value Code 9 TSVCDREFName of the Reference Terminology D TSVCDVERVersion of the Reference Terminology VHEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P301TSAACTSUB Actual Number of Subjects NAV mRNA-1273-P301TSAADAPT Adaptive Design N C49487 CDISC 2019-12-20mRNA-1273-P301TSAADDON Added on to Existing Treatments N C49487 CDISC 2019-12-20mRNA-1273-P301TSAAGEMAX Planned Maximum Age of Subjects PINF mRNA-1273-P301TSAAGEMIN Planned Minimum Age of Subjects P18Y ISO 8601 mRNA-1273-P301TSADCUTDESCData Cutoff Description INTERIM ANALYSIS mRNA-1273-P301TSADCUTDTC Data Cutoff Date 2021-03-26 ISO 8601 mRNA-1273-P301TSAEXTTIND Extension Trial Indicator N C49487 CDISC 2019-12-20mRNA-1273-P301TSAFCNTRY Planned Country of Investigational SitesUSA ISO 3166 mRNA-1273-P301TSAHLTSUBJIHealthy Subject Indicator Y C49488 CDISC 2019-12-20mRNA-1273-P301TSAINDIC Trial Disease/Condition Indication SARS Coronavirus 415360003 SNOMED 2020-03-09mRNA-1273-P301TSAINTMODELIntervention Model PARALLEL C82639 CDISC 2019-12-20mRNA-1273-P301TSAINTTYPE Intervention Type BIOLOGIC C307 CDISC 2019-12-20mRNA-1273-P301TSALENGTH Trial Length P26M mRNA-1273-P301TSANARMS Planned Number of Arms 3 mRNA-1273-P301TSANCOHORT Number of Groups/Cohorts 3 mRNA-1273-P301TSAOBJPRIM Trial Primary Objective To demonstrate the efficacy of mRNA-1273 to prevent COVID-19. mRNA-1273-P301TSA OBJPRIM Trial Primary Objective To evaluate the safety and reactogenicity of 2 injections of the mRNA-1273 vaccine given 28 days apart. mRNA-1273-P301TSA0OBJSEC Trial Secondary Objective To evaluate VE against a secondary definition of COVID-19. mRNA-1273-P301TSA@OBJSEC Trial Secondary Objective To evaluate VE to prevent death caused by COVID-19. mRNA-1273-P301TSAPOBJSEC Trial Secondary Objective To evaluate the efficacy of mRNA-1273 to prevent COVID-19 after the first dose of IP. mRNA-1273-P301TSA`OBJSEC Trial Secondary Objective To evaluate the efficacy of mRNA-1273 to prevent COVID-19 in all study participants, regardless of evidence of prior SARS-CoV-2 infection. mRNA-1273-P301TSApOBJSEC Trial Secondary Objective To evaluate the efficacy of mRNA-1273 to prevent asymptomatic SARS-CoV-2 infection. mRNA-1273-P301TSA OBJSEC Trial Secondary Objective To evaluate the efficacy of mRNA-1273 to prevent serologically confirmed SARS-CoV-2 infection or COVID-19 regardless of symptomatology or severity. mRNA-1273-P301TSAOBJSEC Trial Secondary Objective To evaluate the efficacy of mRNA-1273 to prevent severe COVID-19. mRNA-1273-P301TSA€OBJSEC Trial Secondary Objective To evaluate the immunogenicity of 2 doses of mRNA-1273 given 28 days apart. mRNA-1273-P301TSA@OUTMSPRIPrimary Outcome Measure Medically attended adverse events (MAAEs) or AEs leading to withdrawal through the entire study period. mRNA-1273-P301TSA`OUTMSPRIPrimary Outcome Measure Pregnancies and perinatal outcomes. mRNA-1273-P301TSAPOUTMSPRIPrimary Outcome Measure Serious adverse events (SAEs) throughout the entire study period. mRNA-1273-P301TSA OUTMSPRIPrimary Outcome Measure Solicited local and systemic adverse reactions (ARs) through 7 days after each dose of IP. mRNA-1273-P301TSA0OUTMSPRIPrimary Outcome Measure Unsolicited adverse events (AEs) through 29 days after each dose of IP. mRNA-1273-P301TSAOUTMSPRIPrimary Outcome Measure Vaccine efficacy of mRNA-1273 to prevent the first occurrence of COVID-19 starting 14 days after the second dose of investigational product (IP). mRNA-1273-P301TSA°OUTMSSECSecondary Outcome Measure Geometric mean fold rise (GMFR) of S protein-specific bAb relative to Day 1 on Day 29, Day 57, Day 209, Day 394, and Day 759. mRNA-1273-P301TSAOUTMSSECSecondary Outcome Measure Geometric mean fold rise (GMFR) of SARS-CoV-2-specific nAb relative to Day 1 on Day 29, Day 57, Day 209, Day 394, and Day 759. mRNA-1273-P301TSA OUTMSSECSecondary Outcome Measure Geometric mean titer (GMT) of S protein-specific binding antibody (bAb) on Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759. mRNA-1273-P301TSA€OUTMSSECSecondary Outcome Measure Geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibody (nAb) on Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759. mRNA-1273-P301TSA@OUTMSSECSecondary Outcome Measure Vaccine efficacy of mRNA-1273 to prevent death due to a cause directly attributed to a complication of COVID-19, starting 14 days after the second IP dose. mRNA-1273-P301TSAOUTMSSECSecondary Outcome Measure Vaccine efficacy of mRNA-1273 to prevent severe COVID19, defined as first occurrence of COVID-19 starting 14 days after the second dose of IP, (as per the primary endpoint) AND any of the predefinedsigns of severe COVID 19. mRNA-1273-P301TSAPOUTMSSECSecondary Outcome Measure Vaccine efficacy of mRNA-1273 to prevent the first occurrence of COVID-19 starting 14 days after the first dose of IP. mRNA-1273-P301TSA`OUTMSSECSecondary Outcome Measure Vaccine efficacy of mRNA-1273 to prevent the first occurrence of COVID-19 starting 14 days after the second dose of IP regardless of evidence of prior SARS-CoV-2 infection determined by serologic titer against SARS-CoV-2 nucleocapsid. mRNA-1273-P301TSA OUTMSSECSecondary Outcome Measure Vaccine efficacy of mRNA-1273 to prevent the first occurrence of either COVID-19 or SARS-CoV-2 infection starting 14 days after the second IP dose. mRNA-1273-P301TSA0OUTMSSECSecondary Outcome Measure Vaccine efficacy of mRNA-1273 to prevent the secondary case definition of COVID-19 starting 14 days after the second IP dose. mRNA-1273-P301TSApOUTMSSECSecondary Outcome Measure Vaccine efficacy to prevent the first occurrence of SARS-CoV-2 infection in the absence of symptoms defining COVID-19 starting 14 days after the second IP dose. mRNA-1273-P301TSAPCLAS Pharmacologic Class Vaccine N0000193912MED-RT 44109 mRNA-1273-P301TSAPDPSTINDPediatric Postmarket Study Indicator N C49487 CDISC 2019-12-20mRNA-1273-P301TSAPDSTIND Pediatric Study Indicator N C49487 CDISC 2019-12-20mRNA-1273-P301TSAPIPIND Pediatric Investigation Plan Indicator N C49487 CDISC 2019-12-20mRNA-1273-P301TSAPLANSUB Planned Number of Subjects 30000 mRNA-1273-P301TSARANDOM Trial is Randomized Y C49488 CDISC 2019-12-20mRNA-1273-P301TSARDIND Rare Disease Indicator N C49487 CDISC 2019-12-20mRNA-1273-P301TSAREGID Registry Identifier NCT04470427 NCT04470427CLINICALTRIALS.GOV mRNA-1273-P301TSASDTIGVERSDTM IG Version 3.2 mRNA-1273-P301TSASDTMVER SDTM Version 1.4 mRNA-1273-P301TSASENDTC Study End Date NAV ISO 8601 mRNA-1273-P301TSASEXPOP Sex of Participants BOTH C49636 CDISC 2019-12-20mRNA-1273-P301TSASPONSOR Clinical Study Sponsor ModernaTX, Inc. mRNA-1273-P301TSASSTDTC Study Start Date 2020-07-27 ISO 8601 mRNA-1273-P301TSASTOPRULEStudy Stop Rules EARLY EFFICACY OR SAFETY CONCERN mRNA-1273-P301TSASTYPE Study Type INTERVENTIONAL C98388 CDISC 2019-12-20mRNA-1273-P301TSATBLIND Trial Blinding Schema DOUBLE BLIND C15228 CDISC 2019-12-20mRNA-1273-P301TSATCNTRL Control Type PLACEBO C49648 CDISC 2019-12-20mRNA-1273-P301TSATDIGRP Diagnosis Group NAV SNOMED 2020-03-09mRNA-1273-P301TSATHERAREATherapeutic Area Infectious Disease mRNA-1273-P301TSATINDTP Trial Intent Type PREVENTION C49657 CDISC 2019-12-20mRNA-1273-P301TSATITLE Trial Title A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older mRNA-1273-P301TSATPHASE Trial Phase Classification PHASE III TRIAL C15602 CDISC 2019-12-20mRNA-1273-P301TSATRT Investigational Therapy or Treatment SARS-COV-2 B6L4N5Z4GH UNII 2020-07-31mRNA-1273-P301TSATTYPE Trial Type EFFICACY C49666 CDISC 2019-12-20mRNA-1273-P301TSA0TTYPE Trial Type IMMUNOGENICITY C120842 CDISC 2019-12-20mRNA-1273-P301TSA TTYPE Trial Type SAFETY C49667 CDISC 2019-12-20