Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

March 3, 2026 updated by: BioNTech SE

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 INDIVIDUALS

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.

The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part.

The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate:

As a 2-dose (separated by 21 days) schedule;
At various different dose levels in Phase 1;
As a booster;
In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).

The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.

Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.

In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity.

The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.

To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.

To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46969

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - CABA, Argentina, 1426
    - Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Brazil
- - São Paulo, Brazil, 04266-010
    - CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca)
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, CEP: 40415-006
    - Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce
Germany
- - Berlin, Germany, 13353
    - CRS Clinical Research Services Berlin GmbH
  - Essen, Germany, 45355
    - Medizentrum Essen Borbeck
  - Frankfurt am Main, Germany, 60596
    - IKF Pneumologie GmbH & Co KG
  - Hamburg, Germany, 20359
    - Universitätsklinikum Hamburg-Eppendorf
  - Mannheim, Germany, 68167
    - CRS Clinical Research Services Mannheim GmbH
  - Stuhr, Germany, 28816
    - Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher
South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2113
    - Newtown Clinical Research Centre
  - Pretoria, Gauteng, South Africa, 0183
    - Jongaie Research
- Limpopo
  - Thabazimbi, Limpopo, South Africa, 0380
    - Limpopo Clinical Research Initiative
- Western Cape
  - Cape Town, Western Cape, South Africa, 7530
    - Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06230
    - Hacettepe Üniversitesi Tip Fakültesi
  - Istanbul, Turkey (Türkiye), 34093
    - Istanbul Universitesi Istanbul Tip Fakultesi
  - Istanbul, Turkey (Türkiye), 34214
    - Medipol Mega Universite Hastanesi
  - Istanbul, Turkey (Türkiye), 34020
    - Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
  - Istanbul, Turkey (Türkiye), 34098
    - Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi
  - Istanbul, Turkey (Türkiye), 34303
    - Acibadem Atakent Hastanesi
  - Kocaeli, Turkey (Türkiye), 41380
    - Kocaeli Universitesi Tip Fakultesi
  - Sakarya, Turkey (Türkiye), 54100
    - Sakarya Universitesi Egitim ve Arastirma Hastanesi
United States
- Alabama
  - Athens, Alabama, United States, 35611
    - North Alabama Research Center, LLC
  - Birmingham, Alabama, United States, 35216
    - Birmingham Clinical Research Unit
  - Huntsville, Alabama, United States, 35801
    - Medical Affiliated Research Center
  - Huntsville, Alabama, United States, 35802
    - Optimal Research, LLC
  - Mobile, Alabama, United States, 36608
    - Alliance For multispecialty Research, LLC
- Arizona
  - Chinle, Arizona, United States, 86503
    - Chinle Comprehensive Health Care Facility
  - Chinle, Arizona, United States, 86503
    - Johns Hopkins Center for American Indian Health
  - Phoenix, Arizona, United States, 85018
    - Hope Research Institute
  - Phoenix, Arizona, United States, 85018
    - The Pain Center of Arizona
  - Phoenix, Arizona, United States, 85023
    - Hope Research Institute
  - Tempe, Arizona, United States, 85281
    - Alliance For multispecialty Research, LLC
  - Whiteriver, Arizona, United States, 85941
    - Johns Hopkins Center for American Indian Health
  - Whiteriver, Arizona, United States, 85941
    - Whiteriver Indian Hospital
  - Whiteriver, Arizona, United States, 85941
    - Whiteriver Indian Hospital - Garrett Building
- California
  - Anaheim, California, United States, 92801
    - Anaheim Clinical Trials, LLC
  - Garden Grove, California, United States, 92845
    - Collaborative Neuroscience Research, LLC. - Investigator Site File Location
  - Long Beach, California, United States, 90806
    - Collaborative Neuroscience Research, LLC
  - Long Beach, California, United States, 90806
    - Long Beach Clinical Trials Services Inc.
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90057
    - National Research Institute
  - North Hollywood, California, United States, 91606
    - Velocity Clinical Research, North Hollywood
  - Redding, California, United States, 96001
    - Paradigm Clinical Research Center
  - Sacramento, California, United States, 95815
    - Kaiser Permanente Sacramento
  - Sacramento, California, United States, 95817
    - University of California Davis Health
  - Sacramento, California, United States, 95817
    - Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC)
  - San Diego, California, United States, 92123
    - California Research Foundation
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Santa Clara
  - Valley Village, California, United States, 91607
    - Bayview Research Group
  - Walnut Creek, California, United States, 94598
    - Diablo Clinical Research, Inc.
- Colorado
  - Aurora, Colorado, United States, 80012
    - Lynn Institute of Denver
- Connecticut
  - Milford, Connecticut, United States, 06460
    - Clinical Research Consulting, LLC
  - New Haven, Connecticut, United States, 06510
    - Yale University
  - New Haven, Connecticut, United States, 06519
    - Yale Center for Clinical Investigations (CSRU)
- Florida
  - Coral Gables, Florida, United States, 33134
    - Alliance for Multispecialty Research
  - DeLand, Florida, United States, 32720
    - DeLand Clinical Research Unit
  - Fleming Island, Florida, United States, 32003
    - Fleming Island Center for Clinical Research
  - Hialeah, Florida, United States, 33012
    - Indago Research & Health Center, Inc
  - Hollywood, Florida, United States, 33024
    - Research Centers of America
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research
  - Jacksonville, Florida, United States, 32256
    - Clinical Neuroscience Solutions, Inc.
  - Miami, Florida, United States, 33142
    - Acevedo Clinical Research Associates
  - Orlando, Florida, United States, 32801
    - Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
- Georgia
  - Atlanta, Georgia, United States, 30331
    - Atlanta Center for Medical Research
  - Columbus, Georgia, United States, 31904
    - IACT Health
  - Savannah, Georgia, United States, 31406
    - Meridian Clinical Research
  - Savannah, Georgia, United States, 31406
    - Velocity Clinical Research, Washington DC
  - Stockbridge, Georgia, United States, 30281
    - Clinical Research Atlanta
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - East-West Medical Research Institute
- Idaho
  - Meridian, Idaho, United States, 83646
    - Solaris Clinical Research
- Illinois
  - Peoria, Illinois, United States, 61614
    - Optimal Research
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals & Clinics
  - Iowa City, Iowa, United States, 42242
    - University of Iowa Hospitals & Clinics Investigational Drug Servces
  - Sioux City, Iowa, United States, 51106
    - Velocity Clinical Research, Norfolk
- Kansas
  - Newton, Kansas, United States, 67114
    - Alliance For multispecialty Research, LLC
  - Wichita, Kansas, United States, 67207
    - Alliance For multispecialty Research, LLC
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Kentucky Pediatric/ Adult Research
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Benchmark Research
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
  - Shreveport, Louisiana, United States, 71103
    - LSUHSC-Shreveport
  - Shreveport, Louisiana, United States, 71101
    - LSU Health Sciences Center at Shreveport Clinical Trials Office
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Pharmaron CPC, Inc.
  - Baltimore, Maryland, United States, 21224
    - Johns Hopkins Bayview Medical Center
  - Baltimore, Maryland, United States, 21201
    - University of Maryland Medical Center Investigational Drug Service Pharmacy
  - Baltimore, Maryland, United States, 21201
    - University of Maryland, Baltimore, Health Sciences Research Facility III
  - Baltimore, Maryland, United States, 21201
    - University of Maryland, Center for Vaccine Development and Global Health
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Worcester, Massachusetts, United States, 01655
    - UMass Memorial Medical Center - University Campus
- Michigan
  - Farmington Hills, Michigan, United States, 48334
    - Michigan Center for Medical Research
- Mississippi
  - Gulfport, Mississippi, United States, 39503
    - MedPharmics, LLC
- Missouri
  - Chesterfield, Missouri, United States, 63005
    - Clinical Research Professionals
  - St Louis, Missouri, United States, 63141
    - Sundance Clinical Research, LLC
- Montana
  - Bozeman, Montana, United States, 59715
    - Bozeman Health Deaconess Hospital
  - Bozeman, Montana, United States, 59715
    - Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research
- Nebraska
  - Fremont, Nebraska, United States, 68025
    - Methodist Physicians Clinic / CCT Research
  - Norfolk, Nebraska, United States, 68701
    - Velocity Clinical Research, Norfolk
  - Omaha, Nebraska, United States, 68114
    - Quality Clinical Research, Inc.
  - Omaha, Nebraska, United States, 68134
    - Meridian Clinical Research, LLC
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Wake Research-Clinical Research Center of Nevada, LLC
- New Jersey
  - Raritan, New Jersey, United States, 08869
    - Amici Clinical Research
  - Somers Point, New Jersey, United States, 08244
    - South Jersey Infectious Disease
- New Mexico
  - Gallup, New Mexico, United States, 87301
    - Gallup Indian Medical Center
  - Gallup, New Mexico, United States, 87301
    - Johns Hopkins Center for American Indian Health
  - Shiprock, New Mexico, United States, 87420
    - Johns Hopkins Center for American Indian Health
  - Shiprock, New Mexico, United States, 87420
    - Northern Navajo Medical Center
- New York
  - Binghamton, New York, United States, 13901
    - Meridian Clinical Research, LLC
  - Binghamton, New York, United States, 13905
    - Meridian Clinical Research LLC
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinaï
  - New York, New York, United States, 10016
    - NYU Langone Health
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinai - Investigational Drug Service
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center
  - Rochester, New York, United States, 14609
    - Rochester Clinical Research, Inc.
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center- Kari Steinmetz
  - Syracuse, New York, United States, 13215
    - SUNY Upstate Medical University Global Health Research Unit
  - Vestal, New York, United States, 13850
    - Meridian Clinical Research LLC
- North Carolina
  - Cary, North Carolina, United States, 27518
    - PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
  - Charlotte, North Carolina, United States, 28209
    - PMG Research of Charlotte LLC
  - Durham, North Carolina, United States, 27703
    - Duke University - Main Hospital and Clinics
  - Greensboro, North Carolina, United States, 27408
    - PharmQuest
  - Hickory, North Carolina, United States, 28601
    - PMG Research of Hickory, LLC
  - Raleigh, North Carolina, United States, 27612
    - M3 Wake Research, Inc.
  - Raleigh, North Carolina, United States, 27609
    - PMG Research of Raleigh, LLC
  - Salisbury, North Carolina, United States, 28144
    - PMG Research of Salisbury, LLC
  - Wilmington, North Carolina, United States, 28401
    - PMG Research of Wilmington, LLC
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston-Salem, LLC
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Lillestol Research LLC
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Cincinnati Children's Hospital Medical Center
  - Cincinnati, Ohio, United States, 45219
    - Meridian Clinical Research, LLC
  - Cincinnati, Ohio, United States, 45246
    - Meridian Clinical Research LLC
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center
  - Cleveland, Ohio, United States, 44122
    - Velocity Clinical Research, Inc.
  - Cleveland, Ohio, United States, 44106
    - Va Northeast Ohio Healthcare System
  - Columbus, Ohio, United States, 43213
    - Aventiv Research Inc.
  - Dayton, Ohio, United States, 45406
    - Dayton Clinical Research
  - Dayton, Ohio, United States, 45409
    - Dayton Clinical Research
  - Dayton, Ohio, United States, 45429
    - PriMED Clinical Research
  - South Euclid, Ohio, United States, 44121
    - Senders Pediatrics
- Oklahoma
  - Norman, Oklahoma, United States, 73072
    - Lynn Institute of Norman
- Oregon
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Northwest-Center for Health Research
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18102
    - Lehigh Valley Health Network/Network Office of Research and Innovation
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Velocity Clinical Research, Providence
- South Carolina
  - Little River, South Carolina, United States, 29566
    - Main Street Physician's Care
  - Loris, South Carolina, United States, 29569
    - Main Street Physician's Care
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Holston Medical Group-Clinical Research
  - Kingsport, Tennessee, United States, 37660
    - Holston Medical Group
  - Knoxville, Tennessee, United States, 37920
    - Alliance For multispecialty Research, LLC
  - Knoxville, Tennessee, United States, 37909
    - Alliance For multispecialty Research, LLC
  - Memphis, Tennessee, United States, 38119
    - Clinical Neuroscience Solutions, Inc.
  - Nashville, Tennessee, United States, 37203
    - Clinical Research Associates, Inc.
  - Tullahoma, Tennessee, United States, 37388
    - Trinity Clinical Research
- Texas
  - Austin, Texas, United States, 78745
    - Tekton Research, Inc.
  - Austin, Texas, United States, 78705
    - Benchmark Research
  - Austin, Texas, United States, 78726
    - Innovo Research - Austin Regional Clinic
  - Dallas, Texas, United States, 75246
    - North Texas Infectious Diseases Consultants, P.A.
  - Fort Worth, Texas, United States, 76104
    - Ventavia Research Group, LLC
  - Fort Worth, Texas, United States, 76135
    - Benchmark Research
  - Fort Worth, Texas, United States, 76135
    - Texas Health Resources
  - Galveston, Texas, United States, 77555
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77081
    - Texas Center for Drug Development, Inc.
  - Houston, Texas, United States, 77008
    - Hany H. Ahmed, MD
  - Houston, Texas, United States, 77008
    - Ventavia Research Group, LLC
  - Keller, Texas, United States, 76248
    - Ventavia Research Group, LLC
  - Mesquite, Texas, United States, 75149
    - SMS Clinical Research, LLC
  - Pearland, Texas, United States, 77584
    - LinQ Research, LLC
  - San Angelo, Texas, United States, 76904
    - Benchmark Research.
  - San Antonio, Texas, United States, 78229
    - Diagnostics Research Group
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas, Inc.
  - Tomball, Texas, United States, 77375
    - Martin Diagnostic Clinic
- Utah
  - Salt Lake City, Utah, United States, 84109
    - J. Lewis Research, Inc. / Foothill Family Clinic
  - Salt Lake City, Utah, United States, 84121
    - J. Lewis Research, Inc. / Foothill Family Clinic South
- Virginia
  - Annandale, Virginia, United States, 22003
    - Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
  - Annandale, Virginia, United States, 22003
    - Infectious Diseases Physicians, LLC
  - Midlothian, Virginia, United States, 23114
    - Virginia Research Center LLC
- Washington
  - Seattle, Washington, United States, 98101
    - Benaroya Research Institute at Virginia Mason
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

• Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization.

Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment.

Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization.

Note that participants <18 years of age cannot be enrolled in the EU.

Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19.
Boostability and protection-against-VOCs existing participant subset only: Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window.
Capable of giving personal signed informed consent

Exclusion Criteria:

Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Receipt of medications intended to prevent COVID 19.
Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19
Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
- Hypertension
- Diabetes mellitus
- Chronic pulmonary disease
- Asthma
- Current vaping or smoking
- History of chronic smoking within the prior year
- BMI >30 kg/m2
- Anticipating the need for immunosuppressive treatment within the next 6 months
Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Previous vaccination with any coronavirus vaccine.
Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids.
Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation.
Previous participation in other studies involving study intervention containing lipid nanoparticles.
Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.
Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention.
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo, 18-55 years of age	Other: Placebo Intramuscular injection
Placebo Comparator: Placebo, 65-85 years of age	Other: Placebo Intramuscular injection
Experimental: 10 µg dose, 18-55 years of age (2 doses)	Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection
Experimental: 20 µg dose, 18-55 years of age (2 doses)	Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection
Experimental: 30 µg dose, 18-55 years of age (2 doses)	Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection
Experimental: 10 µg dose, 65-85 years of age (2 doses)	Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection
Experimental: 20 µg dose, 65-85 years of age (2 doses)	Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection
Experimental: 30 µg dose, 65-85 years of age (2 doses)	Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection
Experimental: 30 µg dose, ≥12 years of age (2 doses)	Biological: BNT162b2 Intramuscular injection
Placebo Comparator: Placebo, ≥12 years of age	Other: Placebo Intramuscular injection
Experimental: 100 µg dose, 18-55 years of age (2 doses)	Biological: BNT162b1 Intramuscular injection
Other: Vaccination of Placebo recipients with BNT162b2 - Stage 1 Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study.	Biological: BNT162b2 Intramuscular injection
Other: Vaccination of placebo recipients with BNT162b2 - Stage 2 Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.	Biological: BNT162b2 Intramuscular injection
Experimental: Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg	Biological: BNT162b2 Intramuscular injection
Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg	Biological: BNT162b2 Intramuscular injection
Experimental: Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg	Biological: BNT162b2SA Intramuscular injection
Experimental: Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg	Biological: BNT162b2SA Intramuscular injection
Experimental: Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg	Biological: BNT162b2SA Intramuscular injection
Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg	Biological: BNT162b2 Intramuscular injection
Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg	Biological: BNT162b2 Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1 Time Frame: Within 7 days after Dose 1	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).	Within 7 days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 1 Time Frame: Within 7 days after Dose 2	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).	Within 7 days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 1 Time Frame: Within 7 days after Dose 1	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 hours[h]), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).	Within 7 days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 1 Time Frame: Within 7 days after Dose 2	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).	Within 7 days after Dose 2
Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1 Time Frame: From Dose 1 to 1 Month After Dose 2	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For BNT162b1 100 mcg, participants received one dose of 100 mcg, followed by one dose of 10 mcg.	From Dose 1 to 1 Month After Dose 2
Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1 Time Frame: From Dose 1 to 6 Months After Dose 2	An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. For BNT162b1 100 mcg, participants received one dose of 100 mcg, followed by one dose of 10 mcg.	From Dose 1 to 6 Months After Dose 2
Percentage of Participants With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1 Time Frame: 1 Day After Dose 1	Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x lower limit of normal (LLN), Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x upper limit of normal (ULN), Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.	1 Day After Dose 1
Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1 Time Frame: 7 Days After Dose 1	Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x LLN, Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x ULN, Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.	7 Days After Dose 1
Percentage of Participants With Abnormalities in Hematology Parameters Before Dose 2: Phase 1 Time Frame: Before Dose 2	Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x LLN, Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x ULN, Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.	Before Dose 2
Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1 Time Frame: 7 Days After Dose 2	Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : <0.8x LLN, Hematocrit : <0.8x LLN, Erythrocytes : <0.8x LLN, Ery. Mean Corpuscular Volume: <0.9x LLN, Ery. Mean Corpuscular Hemoglobin : <0.9x LLN Ery. Mean Corpuscular HGB Concentration : <0.9x LLN, Platelets : <0.5x LLN, Leukocytes : <0.6x LLN, Lymphocytes : <0.8x LLN, Neutrophils : <0.8x LLN, Basophils: >1.2x ULN, Eosinophils >1.2x ULN, Monocytes >1.2x ULN. Only parameters with abnormal values were reported in this outcome measure.	7 Days After Dose 2
Percentage of Participants With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1 Time Frame: 1 Day After Dose 1	Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.	1 Day After Dose 1
Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1 Time Frame: 7 Days After Dose 1	Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.	7 Days After Dose 1
Percentage of Participants With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1 Time Frame: Before Dose 2	Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.	Before Dose 2
Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1 Time Frame: 7 Days After Dose 2	Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: >1.5x ULN, AST: >3.0x ULN, ALT: >3.0x ULN, ALP: >3.0x ULN, urea nitrogen: >1.3x ULN, creatinine: >1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin.	7 Days After Dose 2
Percentage of Participants With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1 Time Frame: 1 Day After Dose 1	Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.	1 Day After Dose 1
Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1 Time Frame: 7 Days After Dose 1	Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.	7 Days After Dose 1
Percentage of Participants With Grade Shift in Hematology Parameters Before Dose 2: Phase 1 Time Frame: Before Dose 2	Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.	Before Dose 2
Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 2: Phase 1 Time Frame: 7 Days After Dose 2	Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: <8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: <8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: <1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: <250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: >5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: <25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: >31; G4: requires dialysis. Only parameters where grade shift was observed were reported.	7 Days After Dose 2
Percentage of Participants With Grade Shift in Chemistry Parameters 1 Day After Dose 1: Phase 1 Time Frame: 1 Day After Dose 1	Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(milligram per deciliter [mg/dL]): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.	1 Day After Dose 1
Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 1: Phase 1 Time Frame: 7 Days After Dose 1	Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.	7 Days After Dose 1
Percentage of Participants With Grade Shift in Chemistry Parameters Before Dose 2: Phase 1 Time Frame: Before Dose 2	Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.	Before Dose 2
Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 2: Phase 1 Time Frame: 7 Days After Dose 2	Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: >31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: > 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: >10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: >10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: >1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: >3.0 x ULN. Only parameters where grade shift was observed were reported.	7 Days After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2/3 Time Frame: Within 7 Days after Dose 1	Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).	Within 7 Days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2/3 Time Frame: Within 7 Days after Dose 2	Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).	Within 7 Days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2/3 Time Frame: Within 7 Days after Dose 1	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).	Within 7 Days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2/3 Time Frame: Within 7 Days after Dose 2	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).	Within 7 Days after Dose 2
Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3 Time Frame: From Dose 1 to 1 Month After Dose 2	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded from this analysis.	From Dose 1 to 1 Month After Dose 2
Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 2/3 Time Frame: From Dose 1 to 6 Months After Dose 2	An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded from this analysis.	From Dose 1 to 6 Months After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2 Time Frame: Within 7 Days after Dose 1	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).	Within 7 Days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2 Time Frame: Within 7 Days after Dose 2	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain).	Within 7 Days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2 Time Frame: Within 7 Days after Dose 1	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).	Within 7 Days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2 Time Frame: Within 7 Days After Dose 2	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization).	Within 7 Days After Dose 2
Percentage of Participants Reporting Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 Time Frame: From Dose 1 to 7 Days After Dose 2	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	From Dose 1 to 7 Days After Dose 2
Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 Time Frame: From Dose 1 to 7 Days After Dose 2	A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events.	From Dose 1 to 7 Days After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose Time Frame: Within 7 Days After Booster Dose	Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.	Within 7 Days After Booster Dose
Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose Time Frame: Within 7 Days After Booster Dose	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.	Within 7 Days After Booster Dose
Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose Time Frame: From First Booster Dose to 1 Month After Booster Dose	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.	From First Booster Dose to 1 Month After Booster Dose
Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 6 Months After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose Time Frame: From First Booster Dose to 6 Months After Booster Dose	A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.	From First Booster Dose to 6 Months After Booster Dose
Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA Time Frame: Within 7 Days After Booster Dose 1	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded from this analysis.	Within 7 Days After Booster Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA Time Frame: Within 7 Days after Booster Dose 2	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded from this analysis.	Within 7 Days after Booster Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA Time Frame: Within 7 Days After Booster Dose 1	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants excluded.	Within 7 Days After Booster Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA Time Frame: Within 7 Days After Booster Dose 2	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants excluded.	Within 7 Days After Booster Dose 2
Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA Time Frame: From First Booster Dose to 1 Month After Second Booster Dose	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.	From First Booster Dose to 1 Month After Second Booster Dose
Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 5 Months After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA Time Frame: From First Booster Dose to 5 Months After Second Booster Dose	An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.	From First Booster Dose to 5 Months After Second Booster Dose
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA Time Frame: Within 7 Days After Dose 1	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.	Within 7 Days After Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA Time Frame: Within 7 Days After Dose 2	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.	Within 7 Days After Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA Time Frame: Within 7 Days After Dose 1	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.	Within 7 Days After Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA Time Frame: Within 7 Days After Dose 2	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.	Within 7 Days After Dose 2
Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA Time Frame: From Dose 1 Through 1 Month After Dose 2	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.	From Dose 1 Through 1 Month After Dose 2
Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA Time Frame: From Dose 1 to 6 Months After Dose 2	A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.	From Dose 1 to 6 Months After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Time Frame: Within 7 days After Booster Dose	Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (> 2.0 to 5.0 cm), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded.	Within 7 days After Booster Dose
Percentage of Participants With Systemic Events Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Time Frame: Within 7 days After Booster Dose	Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature >=38.0 deg C categorized as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded.	Within 7 days After Booster Dose
Percentage of Participants Reporting Adverse Events From Booster Dose to 1 Month After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Time Frame: From Booster Dose to 1 Months After Booster Dose	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded.	From Booster Dose to 1 Months After Booster Dose
Percentage of Participants Reporting Serious Adverse Events From Booster Dose to 6 Months After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Time Frame: From Booster Dose to 6 Months after Booster Dose	A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded.	From Booster Dose to 6 Months after Booster Dose
COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3 Time Frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.247, Placebo - 6.003)	Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, without serological or virological evidence of prior SARS-CoV-2 infection were reported in this outcome measure. HIV positive participants were excluded from this analysis.	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.247, Placebo - 6.003)
COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) Time Frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.214, Placebo - 2.222)	Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, without serological or virological evidence of prior SARS-CoV-2 infection (analysis for EUA) were reported in this outcome measure.	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.214, Placebo - 2.222)
COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3 Time Frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.509, Placebo - 6.274)	Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, with or without serological or virological evidence of prior SARS-CoV-2 infection were reported in this outcome measure.	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.509, Placebo - 6.274)
COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) Time Frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.332, Placebo - 2.345)	Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, with or without serological or virological evidence (analysis for EUA) of prior SARS-CoV-2 infection were reported in this outcome measure. HIV positive participants were excluded from this analysis.	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.332, Placebo - 2.345)
GMR Based on Geometric Mean Titer (N1a) - Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection (N1a) up to 1 Month After Dose 2: Phase 3 Time Frame: 1 Month After Dose 2	GMR based on geometric mean titer, comparison of 1 month after dose 2 between vaccine groups: BNT162b2-naive participants without evidence of infection up to 1 month after dose 2 were reported in this outcome measure. HIV positive participants excluded from this analysis.	1 Month After Dose 2
Percentage Difference of Participants Achieving Seroresponse Comparison (N1b) of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 Time Frame: 1 Month After Dose 2	Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the lower limit of quantification (LLOQ), a post vaccination assay result >=4 × LLOQ was considered a seroresponse. HIV positive participants excluded.	1 Month After Dose 2
GMR of Neutralizing Titers (E1a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	GMR based on geometric mean titer, comparison of 1 month after booster dose to 1 month after dose 2 for BNT162b2-experienced participants were reported in this outcome measure. HIV positive participants excluded from this analysis.	1 Month After Booster Dose to 1 Month After Dose 2
Percentage Difference of Participants Achieving Seroresponse (E1b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	Percentage difference of participants achieving seroresponse - comparison of 1 month after booster dose to 1 month after Dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 × LLOQ was considered a seroresponse. HIV positive participants excluded.	1 Month After Booster Dose to 1 Month After Dose 2
GMR of Neutralizing Titers (E2a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	GMR of neutralizing titers (E2a) for comparison of 1 month after booster dose to 1 month after dose 2: BNT162b2-experienced participants in Phase 3 were reported in this outcome measure. HIV positive participants were excluded from this analysis.	1 Month After Booster Dose to 1 Month After Dose 2
Percentage Difference of Participants Achieving Seroresponse (E2b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	Percentage difference of participants achieving seroresponse - comparison of 1 month after booster dose to 1 month after Dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 × LLOQ was considered a seroresponse. HIV positive participants excluded.	1 Month After Booster Dose to 1 Month After Dose 2

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioNTech SE

Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2020

Primary Completion (Actual)

February 10, 2023

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C4591001
2020-002641-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Pfizer

Active, not recruiting

A Study to Learn About How Well Yearly Updates to the COVID-19 Vaccine Work to Protect People From COVID-19 and How Much Money People Spend on Healthcare for COVID-19

COVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 Infection

United States
Shanghai Public Health Clinical Center

Not yet recruiting

Safety and Immunogenicity Evaluation of the Recombinant Flagellin Protein Adjuvant

COVID - 19

China
Duke University
National Institute on Minority Health and Health Disparities (NIMHD)

Completed

You and Me Healthy: Test to Treat (YMTT)

COVID - 19

United States
Eggensberger OHG
Bavarian Health and Food Safety Authority (LGL)

Recruiting

Effects of Kneipp Hydrotherapy in Post-COVID-19 Patients (HydroCoVitalB)

Post COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)

Germany
Pfizer

Recruiting

A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir

Respiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 Infection

Belgium
ModeX Therapeutics, An OPKO Health Company

Recruiting

A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.

COVID -19 | COVID-19 (Prevention)

United States
Lawson Research Institute of St. Joseph's
Canadian Institutes of Health Research (CIHR); Western University, Canada

Recruiting

Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial (PREFACER)

Fatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID Condition

Canada
University of Roma La Sapienza
Queen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention Srl

Completed

Sulfureous Water Therapy in Viral Respiratory Diseases (STWandRVD)

Post Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 Syndrome

Italy
Yang I. Pachankis

Active, not recruiting

COVID-19 Vaccination Detoxification in LDL-C

COVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated Stroke

China
Indonesia University

Recruiting

Effect of Telerehabilitation Practice in Long COVID-19 Patients

Post-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19

Indonesia

Clinical Trials on BNT162b1

BioNTech SE
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Completed

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects

SARS-CoV-2

China
BioNTech SE

Completed

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults

RNA Virus Infections | Virus Diseases | Vaccine Adverse Reaction | Infection Viral | Infections, Respiratory | Protection Against COVID-19 and Infections With SARS CoV 2

Germany

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers: Phase 1 Time Frame: 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2	GMTs of severe acute respiratory syndrome coronavirus 2 neutralizing titers were reported in this outcome measure. SARS-CoV-2 neutralization assay - NT50 and SARS-CoV-2 neutralization assay - NT90 were evaluated and reported in this outcome measure.	7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2
Geometric Mean Concentrations (GMCs) of Severe Acute Respiratory Syndrome Coronavirus 2: S1-binding and RBD-binding IgG Level Assay: Phase 1 Time Frame: 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2	GMCs of severe acute respiratory syndrome coronavirus S1-binding and RBD-binding IgG level were reported in this outcome measure.	7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers: Phase 1 Time Frame: 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2	GMFR of SARS-CoV-2 neutralizing titers were reported in this outcome measure. HIV positive participants excluded.	7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 S1-binding and RBD-binding IgG Level Assay: Phase 1 Time Frame: 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2	GMFR of SARS-CoV-2 S1-binding and RBD-binding IgG level assay in Phase 1 were reported in this outcome measure. HIV positive participants were excluded from this analysis.	7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2
Percentage of Participants Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: Neutralizing Titers: Phase 1 Time Frame: 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2	Percentage of participants achieving a >= 4-fold rise from before vaccination to after vaccination: neutralizing titers in Phase 1 were reported in this outcome measure. HIV positive participants were excluded from this analysis.	7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2
Percentage of Participants Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: S1-binding and RBD-binding IgG Level Assay: Phase 1 Time Frame: From before vaccination to after vaccination	Percentage of participants achieving a >= 4-fold rise from before vaccination to after vaccination: S1-binding and RBD-binding IgG level assay in Phase 1 were reported in this outcome measure. HIV positive participants were excluded from this analysis.	From before vaccination to after vaccination
GMR Based on Reference Strain NT - Comparison of Participants 12 to 15 Years of Age to Participants 16 to 25 Years of Age- Participants Without Evidence of Infection up to 1 Month After Dose 2 - Dose 2 Evaluable Immunogenicity Population: Phase2/3 Time Frame: 1 Month After Dose 2	GMR based on reference strain NT, comparison of participants 12 to 15 years of age to participants 16 to 25 years of age of participants without evidence of infection up to 1 month after dose 2 in Phase2/3 were reported in this outcome measure. HIV positive participants were excluded from this analysis.	1 Month After Dose 2
Incidence of Asymptomatic SARS-CoV-2 Infection Per 1000 Person Years Follow-up Without Serological or Virological Evidence (Up to Start of Asymptomatic Surveillance Period) of Past Infection: Phase 3 Time Frame: From start of asymptomatic surveillance (Surveillance time [1000 person-years]: BNT162b2 - 0.383; Placebo - 0.200	Incidence of asymptomatic SARS-CoV-2 infection per 1000 person years follow-up without serological or virological evidence (up to start of asymptomatic surveillance period) of past infection were reported in this outcome measure.	From start of asymptomatic surveillance (Surveillance time [1000 person-years]: BNT162b2 - 0.383; Placebo - 0.200
Incidence of Asymptomatic SARS-CoV-2 Infection Per 1000 Person Years Follow-up Without Serological or Virological Evidence of Past Infection Based on N-binding Antibody Seroconversion: Phase 3 Time Frame: From Dose 2 to the end of the surveillance period ([1000 person-years]: BNT162b2 - 13.840, Placebo - 6.481)	Incidence of asymptomatic SARS-CoV-2 infection per 1000 person years follow-up without serological or virological evidence of past infection based on N-binding antibody seroconversion were reported in this outcome measure.	From Dose 2 to the end of the surveillance period ([1000 person-years]: BNT162b2 - 13.840, Placebo - 6.481)
COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection 7 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 Time Frame: From 7 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.330, Placebo - 2.343)	COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this outcome measure.	From 7 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.330, Placebo - 2.343)
COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection 14 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 Time Frame: From 14 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.983, Placebo - 1.993)	COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this outcome measure.	From 14 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.983, Placebo - 1.993)
COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 Time Frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.213; Placebo - 2.220)	COVID-19 incidence per 1000 person years follow-up without the evidence of infection (analysis for EUA) were reported in this outcome measure.	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.213; Placebo - 2.220)
COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 Time Frame: From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.886; Placebo - 1.891)	COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this outcome measure.	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.886; Placebo - 1.891)
Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 7 Days After Dose 2: Phase 3 Time Frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.522; Placebo - 6.404)	Severe COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this outcome measure.	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.522; Placebo - 6.404)
Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 Time Frame: From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.985; Placebo - 2.007)	Severe COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection (analysis for EUA) were reported in this outcome measure.	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.985; Placebo - 2.007)
Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2: Phase 3 Time Frame: From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.257; Placebo - 6.120)	Severe COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this outcome measure.	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.257; Placebo - 6.120)
Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 Time Frame: From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.888; Placebo - 1.901)	Severe COVID-19 incidence per 1000 person years follow-up without the evidence of infection (analysis for EUA) were reported in this outcome measure.	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.888; Placebo - 1.901)
COVID-19 Incidence Per 1000 Person-Years of With or Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 Time Frame: From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.984; Placebo - 1.995)	COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection (analysis for EUA) were reported in this outcome measure.	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.984; Placebo - 1.995)
COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 Time Frame: From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.887; Placebo - 1.893)	COVID-19 incidence per 1000 person years follow-up without the evidence of infection (analysis for EUA) were reported in this outcome measure.	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.887; Placebo - 1.893)
Percentage Difference of Participants Achieving Seroresponse (Reference Strain) 1 Month After Second Dose in BNT162b2-Naive Participants: Phase 3 Time Frame: 1 Month After Dose 2	Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the lower limit of quantification (LLOQ), a post vaccination assay result >=4 × LLOQ was considered a seroresponse. HIV positive participants were excluded from this analysis.	1 Month After Dose 2
GMR Based on Geometric Mean Titer (Reference Strain) 1 Month After Second Dose in BNT162b2-Naive Participants: Phase 3 Time Frame: 1 Month After Dose 2	GMR based on GMT (Reference Strain) 1 month after second dose of BNT162b2SA and 1 month after the second dose of BNT162b2 in BNT162b2-naive participant were reported in this outcome measure.	1 Month After Dose 2
GMR Based on Geometric Mean Titer of SA NT 1 Month After Second Dose of BNT162b2SA to 1 Month After the Second Dose (N2a) of BNT162b2 Naive Participants: Phase 3 Time Frame: 1 month after the second dose	GMR based on geometric mean titer of SA NT 1 Month after second dose of BNT162b2SA to 1 Month after the second dose (N2a) of BNT162b2 naive participants of Phase 3 were reported in this outcome measure.	1 month after the second dose
Percentage Difference of Participants Achieving Seroresponse (N2b) Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 Time Frame: 1 Month After Dose 2	Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 × LLOQ was considered a seroresponse.	1 Month After Dose 2
GMR of Neutralizing Titers (E3a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	GMR of neutralizing titers (E3a) - comparison of 1 month after booster dose to 1 month after dose 2: BNT162b2-experienced participants of Phase 3 were reported in this outcome measure.	1 Month After Booster Dose to 1 Month After Dose 2
Percentage Difference of Participants Achieving Seroresponse (E3b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	Percentage difference of participants achieving seroresponse (E3b) - comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure.	1 Month After Booster Dose to 1 Month After Dose 2
GMR of Neutralizing Titers (E4a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	GMR of neutralizing titers (E4a) - comparison of 1 month after booster dose to 1 month after dose 2: BNT162b2-experienced participants of Phase 3 were reported in this outcome measure.	1 Month After Booster Dose to 1 Month After Dose 2
Percentage Difference of Participants Achieving Seroresponse (E4b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 Time Frame: 1 Month After Booster Dose to 1 Month After Dose 2	Percentage difference of participants achieving seroresponse (E4b) - comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure.	1 Month After Booster Dose to 1 Month After Dose 2
Percentage Difference of Participants Achieving Seroresponse for SA Variant NT Comparison of 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Participants Assigned to Receive 2 Booster Doses of BNT162b2SA: Phase 3 Time Frame: 1 Month after Second Booster Dose to 1 Month After Dose 2 of BNT162b2	Percentage difference of participants achieving seroresponse for SA variant NT comparison of 1 Month after second booster dose to 1 Month after Dose 2 of BNT162b2 in participants assigned to receive 2 booster doses of BNT162b2SA of Phase 3 were reported in this outcome measure.	1 Month after Second Booster Dose to 1 Month After Dose 2 of BNT162b2
GMR of SA Variant NT 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Participants Assigned to Receive 2 Booster Doses of BNT1612b2SA: Phase 3 Time Frame: 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2	GMR of SA variant NT 1 month after second booster dose to 1 month after dose 2 of BNT162b2 in participants assigned to receive 2 booster doses of BNT1612b2SA were reported in this outcome measure.	1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2
Percentage Difference of Participants Achieving Seroresponse for SA Variant NT: BNT162b2-Experienced Participants Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomized to Receive 1 Booster Dose: Phase 3 Time Frame: 1 Month After Booster Dose	Percentage difference of participants achieving seroresponse for SA variant NT: BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure.	1 Month After Booster Dose
GMR of SA Variant NT: BNT162b2-Experienced Participants Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomized to Receive 1 Booster Dose: Phase 3 Time Frame: 1 Month After Booster Dose	GMR of SA Variant NT: BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure.	1 Month After Booster Dose

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

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 INDIVIDUALS

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on COVID-19

Clinical Trials on BNT162b1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations