HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 X64_SR12 18JUN21:06:47:2118JUN21:06:47:21 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS TS SASDATA 9.4 X64_SR12 18JUN21:06:47:2118JUN21:06:47:21 Trial Summary HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000001200000000000000000000 STUDYID Study Identifier DOMAIN Domain Abbreviation TSSEQ Sequence Number TSGRPID Group ID TSPARMCDTrial Summary Parameter Short Name !(TSPARM Trial Summary Parameter )ÆTSVAL Parameter Value QÃTSVAL1 Parameter Value 1 TSVALNF Parameter Null Flavor Ú TSVALCD Parameter Value Code ÞTSVCDREFName of the Reference Terminology é TSVCDVERVersion of the Reference Terminology ûHEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 mRNA-1273-P201TSA ACTSUB Actual Number of Subjects 600 mRNA-1273-P201TSA ADAPT Adaptive Design N C49487 CDISC 2020-06-26mRNA-1273-P201TSA ADDON Added on to Existing Treatments N C49487 CDISC 2020-06-26mRNA-1273-P201TSA AGEMAX Planned Maximum Age of Subjects PINF mRNA-1273-P201TSA AGEMIN Planned Minimum Age of Subjects P18Y ISO 8601 mRNA-1273-P201TSADateDesc1DCUTDESCData Cutoff Description DATA EXTRACT mRNA-1273-P201TSADateDesc1DCUTDTC Data Cutoff Date 2021-06-11 ISO 8601 mRNA-1273-P201TSA EXTTIND Extension Trial Indicator N C49487 CDISC 2020-06-26mRNA-1273-P201TSA FCNTRY Planned Country of Investigational SitesUSA ISO 3166 mRNA-1273-P201TSA HLTSUBJIHealthy Subject Indicator Y C49488 CDISC 2020-06-26mRNA-1273-P201TSA INDIC Trial Disease/Condition Indication SARS Coronavirus 415360003 SNOMED 2020-03-09mRNA-1273-P201TSA INTMODELIntervention Model PARALLEL C82639 CDISC 2020-06-26mRNA-1273-P201TSA INTTYPE Intervention Type BIOLOGIC C307 CDISC 2020-06-26mRNA-1273-P201TSA LENGTH Trial Length P14M mRNA-1273-P201TSA NARMS Planned Number of Arms 3 mRNA-1273-P201TSA NCOHORT Number of Groups/Cohorts 2 mRNA-1273-P201TSA OBJPRIM Trial Primary Objective To evaluate the safety and reactogenicity of 2 dose levels of mRNA-1273 vaccine, each administered in 2 doses 28 days apart. mRNA-1273-P201TSA OBJPRIM Trial Primary Objective To evaluate the immunogenicity of 2 dose levels of mRNA-1273 vaccine, each administered in 2 doses 28 days apart, as assessed by the level of specific binding antibody (bAb) mRNA-1273-P201TSA OBJSEC Trial Secondary Objective To evaluate the immunogenicity of 2 dose levels of mRNA-1273 vaccine, each administered in 2 doses 28 days apart, as assessed by the titer of neutralizing antibody (nAb) mRNA-1273-P201TSA OUTMSPRIPrimary Outcome Measure Solicited local and systemic ARs through 7 days after each injection mRNA-1273-P201TSA OUTMSPRIPrimary Outcome Measure Unsolicited AEs through 28 days after each injection mRNA-1273-P201TSA0 OUTMSPRIPrimary Outcome Measure MAAEs through the entire study period mRNA-1273-P201TSA@ OUTMSPRIPrimary Outcome Measure SAEs throughout the entire study period mRNA-1273-P201TSAP OUTMSPRIPrimary Outcome Measure Part A: Safety laboratory abnormalities at Day 29 and Day 57 (Cohort 2 only) mRNA-1273-P201TSA` OUTMSPRIPrimary Outcome Measure Vital sign measurements and physical examination findings mRNA-1273-P201TSAp OUTMSPRIPrimary Outcome Measure Part A: Level of SARS-CoV-2-specific binding antibody (bAb) measured by ELISA on Day 1, Day 29 (M1), Day 43, Day 57 (M2), Day 209 (M7), and Day 394 (M13) mRNA-1273-P201TSA€ OUTMSPRIPrimary Outcome Measure Part B: For participants receiving 100 ug of mRNA-1273 as 2 doses 28 days apart: Level of SARS CoV-2-specific bAb measured by ELISA on OL-Day 1, OL-Day 8, OL-Day 15, OL Day 29 (OL-Month 1), OL-Day 57 (OL-Month 2), and OL-Day 209 (OL Month 7) mRNA-1273-P201TSA OUTMSPRIPrimary Outcome Measure Part B: For participants receiving 50 ug of mRNA-1273 as a single booster: Level of SARS CoV 2-specific bAb measured by ELISA on OL-Day 1, OL-Day 8, OL-Day 15, OL-Day 29 (OL-Month 1), OL-Day 57 (OL-Month 2), and OL-Day 181 (OL-Month 6) mRNA-1273-P201TSA OUTMSPRIPrimary Outcome Measure Part C: For participants receiving 2 dose levels (20 and 50 ug) of mRNA-1273.351 or one dose level (50 ug total) of mRNA-1273/mRNA-1273.351 mixture as a single booster: titer of serum neutralizing antibody against SARS-CoV2 as measured by pseudovirus (and/or live virus) using the B.1.351 and D614G variant sequences of SARS-CoV-2 protein (and/or variant strains) on OL-Day 1, OL-Day 8, mRNA-1273-P201TSA° OUTMSPRIPrimary Outcome Measure Part C: For participants receiving 2 dose levels (20 and 50 ug) of mRNA-1273.351 or one dose level (50 ug total) of mRNA-1273/mRNA-1273.351 mixture as a single booster: seroconversion on OL-Day 8, OL-Day 15, and OL-Day 29 (OL-Month 1), OL Day 57 (OL Month 2), and OL-Day 181 (OL-Month 6) and the proportion of participants with a >=2-, >=3-, or >=4-fold rise in antibody titer from open label mRNA-1273-P201TSA OUTMSSECSecondary Outcome Measure Part A: Titer of SARS-CoV-2-specific neutralizing antibody (nAb) on Day 1, Day 29 (M1), Day 43, Day 57 (M2), Day 209 (M7), and Day 394 (M13) mRNA-1273-P201TSA OUTMSSECSecondary Outcome Measure Part A: Seroconversion on Day 29 (M1), Day 43, Day 57 (M2), Day 209 (M7), and Day 394 (M13) as measured by an increase of SARS-CoV-2-specific nAb titer either from below the limit of detection (LOD)or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers mRNA-1273-P201TSA0 OUTMSSECSecondary Outcome Measure Part B: For participants receiving 100 ug of mRNA-1273 as 2 doses 28 days apart: Titer of SARS-CoV-2-specific nAb on OL- Day 1, OL-Day 8, OL- Day 15, OL- Day 29 (OL-Month 1), OL Day 57 (OL-Month 2), and OL- Day 209 (OL-Month 7) mRNA-1273-P201TSA@ OUTMSSECSecondary Outcome Measure Part B: For participants receiving 50 ug of mRNA-1273 as a single booster: Titer of SARS CoV-2-specific nAb on OL-Day 1, OL-Day 8, OL-Day 15, OL-Day 29 (OL-Month 1), OL-Day 57 (OL-Month 2), and OL-Day 181 (OL-Month 6) mRNA-1273-P201TSAP OUTMSSECSecondary Outcome Measure Part B: For participants receiving 100 ug of mRNA-1273 as 2 doses 28 days apart: Seroconversion on OL-Day 8, OL-Day 15, OL-Day 29 (OL-Month 1), OL Day 57 (OL-Month 2), and OL-Day 209 (OL-Month 7) mRNA-1273-P201TSA` OUTMSSECSecondary Outcome Measure Part B: For participants receiving 50 ug of mRNA-1273 as a single booster: Seroconversion on OL-Day 8, OL-Day 15, OL-Day 29 (OL-Month 1), OL-Day 57 (OL-Month 2), and OL-Day 181 (OL-Month 6), and the proportion of participants with a >=2-, >=3-, or >=4-fold rise in antibody titer from open-label baseline mRNA-1273-P201TSAp OUTMSSECSecondary Outcome Measure Part C: For participants receiving 2 dose levels (20 and 50 ug) of mRNA-1273.351 or one dose level (50 ug total) of mRNA-1273/mRNA-1273.351 mixture as a single booster: level of SARS CoV 2-specific serum binding antibody against the B.1.351 and D614G variant sequences of SARS-CoV-2 protein on OL-Day 1, OL-Day 8, OL-Day 15, OL-Day 29 (OL Month 1), OL-Day 57 (OL Month 2), and OL-Day 181 mRNA-1273-P201TSA PCLAS Pharmacologic Class Vaccine N0000193912MED-RT 2020-10-05mRNA-1273-P201TSA PDPSTINDPediatric Postmarket Study Indicator N C49487 CDISC 2020-06-26mRNA-1273-P201TSA PDSTIND Pediatric Study Indicator N C49487 CDISC 2020-06-26mRNA-1273-P201TSA PIPIND Pediatric Investigation Plan Indicator N C49487 CDISC 2020-06-26mRNA-1273-P201TSA PLANSUB Planned Number of Subjects 600 mRNA-1273-P201TSA RANDOM Trial is Randomized Y C49488 CDISC 2020-06-26mRNA-1273-P201TSA RDIND Rare Disease Indicator N C49487 CDISC 2020-06-26mRNA-1273-P201TSA REGID Registry Identifier NCT04405076 NCT04405076CLINICALTRIALS.GOV mRNA-1273-P201TSA SDTIGVERSDTM IG Version 3.2 mRNA-1273-P201TSA SDTMVER SDTM Version 1.4 mRNA-1273-P201TSA SENDTC Study End Date 2021-09-30 ISO 8601 mRNA-1273-P201TSA SEXPOP Sex of Participants BOTH C49636 CDISC 2020-06-26mRNA-1273-P201TSA SPONSOR Clinical Study Sponsor ModernaTX, Inc. mRNA-1273-P201TSA SSTDTC Study Start Date 2020-05-18 ISO 8601 mRNA-1273-P201TSA STOPRULEStudy Stop Rules NONE mRNA-1273-P201TSA STYPE Study Type INTERVENTIONAL C98388 CDISC 2020-06-26mRNA-1273-P201TSA TBLIND Trial Blinding Schema DOUBLE BLIND C15228 CDISC 2020-06-26mRNA-1273-P201TSA TCNTRL Control Type PLACEBO C49648 CDISC 2020-06-26mRNA-1273-P201TSA TDIGRP Diagnosis Group NAV mRNA-1273-P201TSA THERAREATherapeutic Area Infectious Disease mRNA-1273-P201TSA TINDTP Trial Intent Type PREVENTION C49657 CDISC 2020-06-26mRNA-1273-P201TSA TITLE Trial Title A Phase 2a, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older mRNA-1273-P201TSA TPHASE Trial Phase Classification PHASE II TRIAL C15601 CDISC 2020-06-26mRNA-1273-P201TSA TRT Investigational Therapy or Treatment SARS-COV-2 B6L4N5Z4GH UNII 2020-07-31mRNA-1273-P201TSA TTYPE Trial Type IMMUNOGENICITY C120842 CDISC 2020-06-26mRNA-1273-P201TSA TTYPE Trial Type SAFETY C49667 CDISC 2020-06-26