HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 9.4 Linux 31MAR21:12:06:0931MAR21:12:06:09 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS TS SASDATA 9.4 Linux 31MAR21:12:06:0931MAR21:12:06:09 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 #ĄTSVAL Parameter Value KbTSVAL1 Parameter Value 1   TSVALNF Parameter Null Flavor m TSVALCD Parameter Value Code o TSVCDREFName of the Reference Terminology z TSVCDVERVersion of the Reference Terminology ŒHEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001TSA ACTSUB Actual Number of Subjects 14918 C4591001TSA ADAPT Adaptive Design N C49487 CDISC 2020-05-08C4591001TSA ADDON Added on to Existing Treatments N C49487 CDISC 2020-05-08C4591001TSA AGEMAX Planned Maximum Age of Subjects P85Y ISO 8601 C4591001TSA AGEMIN Planned Minimum Age of Subjects P18Y ISO 8601 C4591001TSA COMPTRT Comparative Treatment Name NA ISO 21090 C4591001TSA DCUTDESCData Cutoff Description DATABASE LOCK C4591001TSA DCUTDTC Data Cutoff Date NI ISO 21090 C4591001TSA EXTTIND Extension Trial Indicator N C49487 CDISC 2020-05-08C4591001TSA FCNTRY Planned Country of Investigational SitesUSA USA ISO 3166 C4591001TSA HLTSUBJIHealthy Subject Indicator Y C49488 CDISC 2020-05-08C4591001TSA INDIC Trial Disease/Condition Indication 2019 novel coronavirus vaccination (procedure) 840534001 SNOMED 2020-03-01C4591001TSA INTMODELIntervention Model PARALLEL C82639 CDISC 2020-05-08C4591001TSA INTTYPE Intervention Type BIOLOGIC C307 CDISC 2020-05-08C4591001TSA LENGTH Trial Length P26M ISO 8601 C4591001TSA NARMS Planned Number of Arms 9 C4591001TSA NCOHORT Number of Groups/Cohorts 3 C4591001TSAPhase 2/3OBJEXP Trial Exploratory Objective To evaluate the immune response over time to prophylactic BNT162b2 and persistence of immune response in participants with and without serological or virological evidence of SARS-CoV-2 infection before vaccination C4591001TSA Phase 2/3OBJEXP Trial Exploratory Objective To evaluate the immune response (non-S) to SARS-CoV-2 in participants with and without confirmed COVID-19 during the study C4591001TSA0Phase 2/3OBJEXP Trial Exploratory Objective To describe the serological responses to the BNT vaccine candidate in cases of: Confirmed COVID-19, Confirmed severe COVID-19, SARS-CoV-2 infection without confirmed COVID-19 C4591001TSAPhase 1 OBJPRIM Trial Primary Objective To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses C4591001TSA Phase 2/3OBJPRIM Trial Primary Objective To evaluate the efficacy of prophylactic BNT162b2 against confirmed COVID-19 in participants without evidence of infection before vaccination C4591001TSA0Phase 2/3OBJPRIM Trial Primary Objective To evaluate the efficacy of prophylactic BNT162b2 against confirmed COVID-19 in participants with and without evidence of infection before vaccination C4591001TSA@Phase 2/3OBJPRIM Trial Primary Objective To define the safety profile of prophylactic BNT162b2 in the first 360 participants randomized (Phase 2) C4591001TSAPPhase 2/3OBJPRIM Trial Primary Objective To define the safety profile of prophylactic BNT162b2 in all participants randomized in Phase 2/3 C4591001TSAPhase 1 OBJSEC Trial Secondary Objective To describe the immune responses elicited by prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses C4591001TSA Phase 2/3OBJSEC Trial Secondary Objective To evaluate the efficacy of prophylactic BNT162b2 against confirmed severe COVID-19 in participants without evidence of infection before vaccination C4591001TSA0Phase 2/3OBJSEC Trial Secondary Objective To evaluate the efficacy of prophylactic BNT162b2 against confirmed severe COVID-19 in participants with and without evidence of infection before vaccination C4591001TSA@Phase 2/3OBJSEC Trial Secondary Objective To describe the efficacy of prophylactic BNT162b2 against confirmed COVID-19 (according to the CDC-defined symptoms) in participants without evidence of infection before vaccination C4591001TSAPPhase 2/3OBJSEC Trial Secondary Objective To describe the efficacy of prophylactic BNT162b2 against confirmed COVID-19 (according to the CDC-defined symptoms) in participants with and without evidence of infection before vaccination C4591001TSAPhase 2/3OUTMSEXPExploratory Outcome Measure GMT, GMFR, and percentage of participants with titers greater than defined threshold(s), at baseline and 1, 6, 12, and 24 months after completion of vaccination for SARS-CoV-2 anti-S1 binding antibody levels and/or anti-RBD binding antibody levels C4591001TSA Phase 2/3OUTMSEXPExploratory Outcome Measure GMT, GMFR, and percentage of participants with titers greater than defined threshold(s), at baseline and 1, 6, 12, and 24 months after completion of vaccination for SARS-CoV-2 serum neutralizing titers C4591001TSA0Phase 2/3OUTMSEXPExploratory Outcome Measure GMTs/GMCs, GMFRs of SARS-CoV-2 serum neutralizing titers, SARS-CoV-2 anti-S1 binding antibody and anti-RBD binding antibody C4591001TSAPhase 1 OUTMSPRIPrimary Outcome Measure Percentage of participants reporting local reactions (pain at the injection site, redness, and swelling) for up to 7 days following each dose C4591001TSA Phase 1 OUTMSPRIPrimary Outcome Measure Percentage of participants reporting systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for up to 7 days following each dose C4591001TSA0Phase 1 OUTMSPRIPrimary Outcome Measure Percentage of participants reporting adverse events from dose 1 to 1 month after the last dose C4591001TSA@Phase 1 OUTMSPRIPrimary Outcome Measure Percentage of participants reporting serious AEs (SAEs) from dose 1 to 6 months after the last dose C4591001TSAPPhase 1 OUTMSPRIPrimary Outcome Measure Percentage of participants with abnormal hematology and chemistry laboratory values 1 and 7 days after dose 1, and 7 days after dose 2 C4591001TSA`Phase 1 OUTMSPRIPrimary Outcome Measure Percentage of participants with grading shifts in hematology and chemistry laboratory assessments between baseline and 1 and 7 days after dose 1, and before dose 2 and 7 days after dose 2 C4591001TSApPhase 2/3OUTMSPRIPrimary Outcome Measure COVID-19 incidence per 1000 person-years of follow-up based on central laboratory or locally confirmed NAAT in participants with no serological or virological evidence (up to 7 days after receipt of the last dose) of past SARS-CoV-2 infection C4591001TSA€Phase 2/3OUTMSPRIPrimary Outcome Measure COVID-19 incidence per 1000 person-years of follow-up based on central laboratory or locally confirmed NAAT C4591001TSAPhase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting local reactions (pain at the injection site, redness, and swelling) for up to 7 days following each dose in the first 360 participants randomized (Phase 2) C4591001TSA Phase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for up to 7 days following each dose in the first 360 participants randomized (Phase 2) C4591001TSA°Phase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting adverse events from dose 1 to 1 month after the last dose in the first 360 participants randomized (Phase 2) C4591001TSAĄPhase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting serious AEs (SAEs) from dose 1 to 6 months after the last dose in the first 360 participants randomized (Phase 2) C4591001TSAŠPhase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting adverse events from dose 1 to 1 month after the last dose in all participants randomized in Phase 2/3 C4591001TSAąPhase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting serious AEs (SAEs) from dose 1 to 6 months after the last dose in all participants randomized in Phase 2/3 C4591001TSAšPhase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting local reactions (pain at the injection site, redness, and swelling) for up to 7 days following each dose in a subset of at least 6000 participants C4591001TSBPhase 2/3OUTMSPRIPrimary Outcome Measure Percentage of participants reporting systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for up to 7 days following each dose in a subset of at least 6000 participants C4591001TSAPhase 1 OUTMSSECSecondary Outcome Measure Geometric mean titers (GMTs) for SARS-CoV-2 serum neutralizing titers at each time point C4591001TSA Phase 1 OUTMSSECSecondary Outcome Measure Geometric mean fold rise (GMFR) in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point after vaccination C4591001TSA0Phase 1 OUTMSSECSecondary Outcome Measure Proportion of participants achieving >=4-fold rise from before vaccination to each subsequent time point after vaccination in SARS-CoV-2 serum neutralizing titers C4591001TSA@Phase 1 OUTMSSECSecondary Outcome Measure Geometric mean concentrations (GMCs) for SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels at each time point C4591001TSAPPhase 1 OUTMSSECSecondary Outcome Measure GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from prior to first dose of study intervention to each subsequent time point C4591001TSA`Phase 1 OUTMSSECSecondary Outcome Measure Proportion of participants achieving >=4-fold rise from before vaccination to each subsequent time point after vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels C4591001TSApPhase 1 OUTMSSECSecondary Outcome Measure Geometric mean ratio (GMR), estimated by the ratio of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS-CoV-2 binding antibody levels at each time point C4591001TSA€Phase 2/3OUTMSSECSecondary Outcome Measure Confirmed severe COVID-19 incidence per 1000 person-years of follow-up in participants with no serological or virological evidence of past SARS-CoV-2 infection C4591001TSAPhase 2/3OUTMSSECSecondary Outcome Measure Confirmed severe COVID-19 incidence per 1000 person-years of follow-up C4591001TSA Phase 2/3OUTMSSECSecondary Outcome Measure COVID-19 incidence per 1000 person-years of follow-up based on central laboratory or locally confirmed NAAT in participants with no serological or virological evidence (up to 7 days after receipt of the last dose) of past SARS-CoV-2 infection C4591001TSA°Phase 2/3OUTMSSECSecondary Outcome Measure COVID-19 incidence per 1000 person-years of follow-up based on central laboratory or locally confirmed NAAT C4591001TSA PCLAS Pharmacologic Class Vaccines, Nucleic Acid C0600412 NCI C4591001TSA PDPSTINDPediatric Postmarket Study Indicator N C49487 CDISC 2020-05-08C4591001TSA PDSTIND Pediatric Study Indicator N C49487 CDISC 2020-05-08C4591001TSA PIPIND Pediatric Investigation Plan Indicator N C49487 CDISC 2020-05-08C4591001TSA PLANSUB Planned Number of Subjects 29481 C4591001TSA RANDOM Trial is Randomized Y C49488 CDISC 2020-05-08C4591001TSAPhase 1 RANDQT Randomization Quotient 0.8 C4591001TSA Phase 2/3RANDQT Randomization Quotient 0.5 C4591001TSA RDIND Rare Disease Indicator N C49487 CDISC 2020-05-08C4591001TSA REGID Registry Identifier NCT04368728 NCT04368728ClinicalTrials.GOV C4591001TSA ROUTE Route of Administration INTRAMUSCULAR C28161 CDISC 2020-05-08C4591001TSA SDTIGVERSDTM IG Version 3.2 C4591001TSA SDTMVER SDTM Version 1.4 C4591001TSA SENDTC Study End Date 2023-01-23 ISO 8601 C4591001TSA SEXPOP Sex of Participants BOTH C49636 CDISC 2020-05-08C4591001TSA SPONSOR Clinical Study Sponsor PFIZER INC. 00-132-6495DUNS C4591001TSA SPONSOR Clinical Study Sponsor BioNTech SE 34-082-2384DUNS C4591001TSA SSTDTC Study Start Date 2020-04-29 ISO 8601 C4591001TSA STOPRULEStudy Stop Rules The sponsor designee reserves the right to close the study site or terminate the study at any time for any reason at the sole discretion of the sponsor. C4591001TSA STRATFCTStratification Factor Age C4591001TSA STYPE Study Type INTERVENTIONAL C98388 CDISC 2020-05-08C4591001TSA TBLIND Trial Blinding Schema OBSERVER BLIND C4591001TSA TCNTRL Control Type PLACEBO C49648 CDISC 2020-05-08C4591001TSA TDIGRP Diagnosis Group NA ISO 21090 C4591001TSA THERAREATherapeutic Area Vaccines C4591001TSA TINDTP Trial Intent Type PREVENTION C49657 CDISC 2020-05-08C4591001TSA TITLE Trial Title A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS C4591001TSA TPHASE Trial Phase Classification PHASE I/II/III TRIAL C4591001TSA TRT Investigational Therapy or Treatment BNT162b1 UNII 2020-01-12C4591001TSA TRT Investigational Therapy or Treatment BNT162b2 UNII 2020-01-12C4591001TSA TTYPE Trial Type SAFETY C49667 CDISC 2020-05-08C4591001TSA TTYPE Trial Type TOLERABILITY C98791 CDISC 2020-05-08C4591001TSA0 TTYPE Trial Type IMMUNOGENICITY C120842 CDISC 2020-05-08C4591001TSA@ TTYPE Trial Type EFFICACY C49666 CDISC 2020-05-08