Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

May 26, 2026 updated by: BioNTech SE

A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN

This is a Phase 1/2/3 study in healthy children.

Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.

Study Overview

Status

Completed

Conditions

SARS-CoV-2 Infection, COVID-19

Intervention / Treatment

Detailed Description

Phase 1 Dose-Finding

Is the open-label dose-finding portion of the study that will evaluate safety, tolerability, and immunogenicity of BNT162b2 administered on a 2-dose (separated by approximately 21 days) schedule in up to 3 age groups (participants ≥5 to <12 years, ≥2 to <5 years, and ≥6 months to <2 years of age).

Dose finding is being initiated in this study in participants ≥5 to <12 years of age based on the acceptable blinded safety assessment of the 30-µg dose in 12- to 15-year-olds in the C4591001 study.

The purpose of Phase 1 is to identify preferred dose level(s) of BNT162b2 from up to 3 different dose levels in each age group.

Dependent upon safety and/or immunogenicity data generated during the course of this study, it is possible that dose levels may not be started, may be terminated early, and/or may be added with dose levels below the lowest stated dose.

Update as part of protocol amendment 6: All participants will receive a third dose of BNT162b2. For participants ≥6 months to <5 years, the third dose will occur at least 8 weeks after the second dose. In participants ≥5 to <12 years, the third dose will occur at least 6 months after the second dose. The interval between the second and third doses will be based on the participant's age at the time of enrollment. The dose level of the third dose of BNT162b2 will be based on age at the time of vaccination: participants <5 years of age at the time of the third dose will receive the 3-µg dose level, participants ≥5 to <12 years of age at the time of the third dose will receive the 10-µg dose level, and participants ≥12 years of age at the time of the third dose will receive the 30-µg dose level.

Participants will have blood drawn prior to both Dose 1 and Dose 2 and 7 days after Dose 2 to assess immunogenicity to determine the selected BNT162b2 dose level for Phase 2/3. Participants will also have blood drawn prior to Dose 3 and 1, 6, and 12 months after Dose 3.

Phase 2/3 Selected-Dose

Is the portion of the study that will evaluate the safety, tolerability, and immunogenicity in each age group at the selected dose level from the Phase 1 dose-finding portion of the study. Efficacy will be evaluated within or across age groups in which immunobridging is successful, depending on accrual of a sufficient number of cases in those age groups.

Participants will have blood drawn at baseline prior to Dose 1 and 6 months after Dose 2. Immunobridging to participants 16 to 25 years of age in the C4591001 study will be based on immunogenicity data collected at (1) baseline and 1 month after Dose 2 and (2) baseline and 1 month after Dose 3. The persistence of the immune response will be based on immunogenicity data collected in participants at (1) baseline and 1 and 6 months after Dose 2 and (2) baseline and 1, 6, 12, and 18 months after Dose 3. In addition, efficacy against confirmed COVID-19 and against asymptomatic infection will also be assessed in participants ≥5 to <12 years of age.

At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age. Additional samples will be obtained prior to Dose 3 and 1 month after Dose 3 (original BNT162b2 group only). These samples will be used on an exploratory basis to investigate the postvaccination cell-mediated immune response at these time points.

At the 6-month follow-up visit, all participants will be unblinded. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 as part of the study. Participants who originally received placebo and become eligible for receipt of BNT162b2 or another COVID-19 vaccine according to local or national recommendations prior to the 6 month follow-up visit (Visit 5 or 405) (detailed separately and available in the electronic study reference portal) will have the opportunity to receive BNT162b2 (10 µg or 3 µg) based on age at the time of vaccination.

Update as part of protocol amendment 6: All participants will receive a third dose of BNT162b2. For participants ≥6 months to <5 years, the third dose will occur at least 8 weeks after the second dose. In participants ≥5 to <12 years, the third dose will occur at least 6 months after the second dose. The interval between the second and third doses will be based on the participant's age at the time of enrollment. The dose level of the second and third doses of BNT162b2 will be based on age at the time of vaccination: participants <5 years of age at the time of the second/third dose will receive the 3-µg dose level, participants ≥5 to <12 years of age at the time of the second/third dose will receive the 10-µg dose level, and participants ≥12 years of age at the time of the second/third dose will receive the 30-µg dose level.

Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing

If testing of troponin I levels in individuals who did not receive BNT162b2 indicates that troponin I level could be a reliable indicator of potential subclinical myocarditis, obtaining serum samples for potential troponin I testing during the period of increased risk of clinical myocarditis may help characterize the absence/presence and frequency of subclinical myocarditis. To assess, an additional group of participants will be included: ≥5 to <12 years: randomized 2:1 to receive BNT162b2 10 µg or placebo, and ≥12 to <16 years of age: open-label receipt of BNT162b2 30 µg.

Update as part of protocol amendment 7: All participants will receive a third dose of BNT162b2. For all participants (≥5 to <12 and ≥12 to <16 years of age), the third dose will occur at least 5 months after Dose 2.

The dose level of the second and third doses of BNT162b2 will be based on age at the time of vaccination: participants ≥5 to <12 years of age at the time of the second/third dose will receive the 10-µg dose level, and participants ≥12 years of age at the time of the second/third dose will receive the 30-µg dose level.

Update as part of protocol amendment 8: The Lower-Dose Evaluation portion of the protocol has been removed.

Participation in the study will cease 6 months after the third dose of BNT162b2.

Study Type

Interventional

Enrollment (Actual)

11837

Phase

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

Brazil
- - São Paulo, Brazil, 04266-010
    - CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 40415-006
    - Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30150-221
    - Santa Casa De Misericórdia de Belo Horizonte
- Paraná
  - Curitiba, Paraná, Brazil, 80810-050
    - Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Francisco
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brazil, 59025-050
    - CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
Finland
- - Espoo, Finland, 02230
    - FVR, Espoo Clinic
  - Helsinki, Finland, 00100
    - FVR, Helsinki South Clinic
  - Helsinki, Finland, 00290
    - MeVac - Meilahti Vaccine Research Center
  - Helsinki, Finland, 00930
    - FVR, Helsinki East Clinic
  - Kokkola, Finland, 67100
    - FVR, Kokkola Clinic
  - Pori, Finland, 28100
    - FVR, Pori Clinic
  - Seinäjoki, Finland, 60100
    - FVR, Seinäjoki Clinic
  - Tampere, Finland, 33100
    - FVR, Tampere Clinic
  - Turku, Finland, 20520
    - FVR, Turku Clinic
- North Ostrobothnia
  - Oulu, North Ostrobothnia, Finland, 90220
    - FVR, Oulu Clinic
- Uusimaa
  - Jarvenpaa, Uusimaa, Finland, 04400
    - FVR, Järvenpää Clinic
Mexico
- - Veracruz, Mexico, C.P. 91900
    - Sociedad de Metabolismo y Corazón S.C.
- Nuevo León
  - Monterrey, Nuevo León, Mexico, C.P. 64060
    - CHRISTUS - LATAM HUB Center of excellence and innovation S.C.
- Yucatán
  - Mérida, Yucatán, Mexico, 97070
    - Kohler & Milstein Research S.A. de C.V.
  - Mérida, Yucatán, Mexico, 97130
    - Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
Poland
- - Bydgoszcz, Poland, 85-048
    - IN-VIVO Bydgoszcz
  - Krakow, Poland, 30-348
    - Centrum Badan Klinicznych JCI
  - Lodz, Poland, 90-349
    - Osrodek Badan Klinicznych Appletreeclinics
  - Lodz, Poland, 91-347
    - GRAVITA Diagnostyka i Leczenie nieplodnosci
  - Luboń, Poland, 62-030
    - Rodzinne Centrum Medyczne LUBMED
  - Siemianowice Śląskie, Poland, 41-103
    - Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
  - Warsaw, Poland, 02-647
    - Provita 001
- Kuyavian-Pomeranian Voivodeship
  - Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
    - MICS Centrum Medyczne Torun
Spain
- - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Seville, Spain, 41012
    - Instituto Hispalense de Pediatria
- A Coruña
  - Santiago de Compostela, A Coruña, Spain, 15706
    - Hospital Clinico Universitario Santiago de Compostela
- Barcelona
  - Centelles, Barcelona, Spain, 08540
    - EBA Centelles
  - Esplugues de Llobregat, Barcelona, Spain, 08950
    - Hospital Sant Joan de Deu
  - Sant Cugat del Vallès, Barcelona, Spain, 08195
    - Hospital Universitari General de Catalunya
- Madrid
  - Boadilla del Monte, Madrid, Spain, 28660
    - Hospital Universitario HM Monteprincipe
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Spain, 28938
    - Hospital Universitario HM Puerta del Sur
- Málaga
  - Antequera, Málaga, Spain, 29200
    - Hospital de Antequera
  - Málaga, Málaga, Spain, 29015
    - Grupo Pediatrico Uncibay
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham - School of Medicine
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Phoenix Children's Hospital
- California
  - Los Angeles, California, United States, 90057
    - Matrix Clinical Research
  - Los Angeles, California, United States, 90027
    - SCPMG/Kaiser Permanente Los Angeles Medical Center
  - Madera, California, United States, 93637
    - Madera Family Medical Group
  - Oakland, California, United States, 94611
    - Kaiser Permanente Oakland
  - Palo Alto, California, United States, 94304
    - Lucile Packard Children's Hospital Stanford
  - Palo Alto, California, United States, 94304
    - Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
  - Paramount, California, United States, 90723
    - Center for Clinical Trials, LLC
  - Paramount, California, United States, 90723
    - Center for Clinical Trials
  - Rolling Hills Estates, California, United States, 90274
    - Peninsula Research Associates
  - Sacramento, California, United States, 95815
    - Kaiser Permanente Sacramento
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Santa Clara
  - Stanford, California, United States, 94305
    - Stanford Health Care
  - Stanford, California, United States, 94305
    - Stanford Health Care Investigational Drug Service
  - Valley Village, California, United States, 91607
    - Bayview Research Group, LLC
- Colorado
  - Aurora, Colorado, United States, 80045
    - Children's Hospital Colorado
- Connecticut
  - New Haven, Connecticut, United States, 06519
    - Yale Center for Clinical Investigation
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Children's National Medical Center
  - Washington D.C., District of Columbia, United States, 20016
    - Velocity Clinical Research, Washington DC
  - Washington D.C., District of Columbia, United States, 20009
    - Emerson Clinical Research Institute
- Florida
  - 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
- Georgia
  - Atlanta, Georgia, United States, 30331
    - Atlanta Center for Medical Research
  - Atlanta, Georgia, United States, 30322
    - Emory University School of Medicine
  - Atlanta, Georgia, United States, 30322
    - Emory Children's Center Illness POD
  - Macon, Georgia, United States, 31210
    - Meridian Clinical Research, LLC
  - Union City, Georgia, United States, 30291
    - Rophe Adult and Pediatric Medicine/SKYCRNG
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Clinical Research Prime
  - Meridian, Idaho, United States, 83646
    - Solaris Clinical Research
- 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
  - Louisville, Kentucky, United States, 40202
    - Novak Center for Children's Health
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
  - Shreveport, Louisiana, United States, 71101
    - Louisiana State University Health Sciences Shreveport
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Johns Hopkins Bayview Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
- Michigan
  - Bingham Farms, Michigan, United States, 48025
    - Michigan Center of Medical Research
- Mississippi
  - Ridgeland, Mississippi, United States, 39157
    - SKY Integrative Medical Center/SKYCRNG
- Missouri
  - Chesterfield, Missouri, United States, 63005
    - Clinical Research Professionals
  - Kansas City, Missouri, United States, 64108
    - Children's Mercy Hospital
- Nebraska
  - Hastings, Nebraska, United States, 68901
    - Meridian Clinical Research, LLC
  - Lincoln, Nebraska, United States, 68510
    - Velocity Clinical Research, Lincoln
  - Omaha, Nebraska, United States, 68114
    - Children's Hospital & Medical Center
  - Omaha, Nebraska, United States, 68117
    - Children's Physician's Clinic, Spring Valley
- New Jersey
  - New Brunswick, New Jersey, United States, 08901
    - Cancer Institute of New Jersey
  - New Brunswick, New Jersey, United States, 08901
    - Rutgers University
- New York
  - Binghamton, New York, United States, 13905
    - Meridian Clinical Research LLC
  - Commack, New York, United States, 11725
    - Advanced Specialty Care
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center
  - Rochester, New York, United States, 14609
    - Rochester Clinical Research, Inc.
  - Stony Brook, New York, United States, 11794
    - Stony Brook University
  - Syracuse, New York, United States, 13210
    - SUNY Upstate Medical University
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Atrium Health-STRIVE Vaccine Research Clinic
  - Charlotte, North Carolina, United States, 28211
    - Teen Health Connection (study visits)
  - Durham, North Carolina, United States, 27703
    - Duke University - Main Hospital and Clinics
  - Matthews, North Carolina, United States, 28105
    - Atrium Health-STRIVE Vaccine Research Clinic (study visits)
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Cincinnati Children's Hospital Medical Center Vaccine Research Center
  - Columbus, Ohio, United States, 43213
    - Centricity Research Columbus Ohio Multispecialty
  - Dayton, Ohio, United States, 45429
    - PriMed Clinical Research
  - South Euclid, Ohio, United States, 44121
    - Senders Pediatrics
- Oregon
  - Gresham, Oregon, United States, 97030
    - Cyn3rgy Research
- Pennsylvania
  - Erie, Pennsylvania, United States, 16506
    - AHN Erie Health + Wellness Pavillion: West
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Velocity Clinical Research-Providence
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Coastal Pediatric Research
  - Greenville, South Carolina, United States, 29607
    - Tribe Clinical Research, LLC
  - Summerville, South Carolina, United States, 29486
    - Coastal Pediatric Research
- Tennessee
  - Memphis, Tennessee, United States, 38105
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, United States, 37203
    - Clinical Research Associates Inc
- Texas
  - Austin, Texas, United States, 78726
    - Innovo Research - Austin Regional Clinic
  - Corpus Christi, Texas, United States, 78411
    - Driscoll Children's Hospital
  - Dallas, Texas, United States, 75251
    - Cedar Health Research
  - Dickinson, Texas, United States, 77539
    - Bay Colony Pediatrics
  - Edinburg, Texas, United States, 78539
    - Proactive Clinical Research, LLC
  - Frisco, Texas, United States, 75033
    - Village Health Partners (Patient Seen Address)
  - Houston, Texas, United States, 77055
    - West Houston Clinical Research Services
  - Houston, Texas, United States, 77008
    - HG Pediatrics
  - Houston, Texas, United States, 77008
    - Van Tran Family Practice
  - Houston, Texas, United States, 77030
    - Texas Children's Hospital - Clinical Research Center
  - Houston, Texas, United States, 77087
    - Pediatric Associates
  - Houston, Texas, United States, 77008
    - Helios Clinical Research - HOU
  - Houston, Texas, United States, 77008
    - Helios Clinical Research
  - Houston, Texas, United States, 77065
    - DM Clinical Research - MDC
- 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
  - Charlottesville, Virginia, United States, 22902
    - Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
  - Midlothian, Virginia, United States, 23114
    - Virginia Research Center
- Washington
  - Seattle, Washington, United States, 98105
    - Seattle Children's 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

6 months to 18 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and <16 years of age.
Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment 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.
Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
Negative urine pregnancy test for female participants who are biologically capable of having children.
Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).

Exclusion Criteria

Phase 1 only: Past 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: Known infection with HIV, HCV, or HBV.
Receipt of medications intended to prevent COVID-19.
Previous or current diagnosis of MIS-C.
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. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Female who is 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. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 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 and/or during study participation.
Previous participation in other studies involving study intervention containing LNPs.
Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech 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: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low/Mid-Dose, ≥5 to <12 Years Low/Mid-Dose (10mcg), 2 doses 21 days apart	Biological: Biological/Vaccine: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) level
Experimental: Mid-Dose, ≥5 to <12 Years Mid-Dose, (20mcg), 2 doses 21 days apart	Biological: BNT162b2 20mcg BNT162b2 Mid-Dose (20mcg) level
Experimental: High-Dose, ≥5 to <12 Years High-Dose (30mcg), 2 doses 21 days apart	Biological: BNT162b2 30mcg BNT162b2 High-Dose (30mcg) level
Experimental: Low/Mid-Dose, ≥2 to < 5 Years Low/Mid-Dose (10mcg), 2 doses 21 days apart	Biological: Biological/Vaccine: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) level
Experimental: Mid-Dose, ≥2 to <5 Years Mid-Dose, (20mcg), 2 doses 21 days apart	Biological: BNT162b2 20mcg BNT162b2 Mid-Dose (20mcg) level
Experimental: High-Dose, ≥2 to <5 Years High-Dose, (30mcg), 2 doses 21 days apart	Biological: BNT162b2 30mcg BNT162b2 High-Dose (30mcg) level
Experimental: Low/Mid-Dose, ≥6 Months to <2 Years Low/Mid-Dose, (10mcg), 2 doses 21 days apart	Biological: Biological/Vaccine: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) level
Experimental: Mid-Dose, ≥6 Months to <2 Years Mid-Dose, (20mcg), 2 doses 21 days apart	Biological: BNT162b2 20mcg BNT162b2 Mid-Dose (20mcg) level
Experimental: High-Dose, ≥6 Months to <2 Years High-Dose, (30mcg), 2 doses 21 days apart	Biological: BNT162b2 30mcg BNT162b2 High-Dose (30mcg) level
Placebo Comparator: Placebo, ≥6 Months to <2 Years	Other: Placebo Intramuscular injection
Placebo Comparator: Placebo, ≥2 to <5 Years	Other: Placebo Intramuscular injection
Placebo Comparator: Placebo, ≥5 to <12 Years	Other: Placebo Intramuscular injection
Experimental: Low-Dose, ≥6 Months to <2 Years Low-Dose (3mcg), 2 doses 21 doses apart	Biological: Biological/Vaccine: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) level
Experimental: Low-Dose, ≥2 to <5 Years Low-Dose (3mcg), 2 doses 21 days apart	Biological: Biological/Vaccine: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) level
Experimental: High-Dose, 12 to <16 Years (Troponin I Testing) High-Dose (30mcg), 3 doses	Biological: BNT162b2 30mcg BNT162b2 High-Dose (30mcg) level
Experimental: Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing) Low/Mid-Dose (10mcg), 3 doses	Biological: Biological/Vaccine: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) level
Experimental: Placebo, ≥5 to <12 Years (Troponin I Testing)	Other: Placebo Intramuscular injection
Experimental: Low-Dose, ≥6 Months to <2 Years (3-dose regimen) Low-Dose (3mcg), 3 doses	Biological: Biological/Vaccine: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) level
Experimental: Low-Dose, ≥2 to <5 Years (3-dose regimen) Low-Dose (3mcg), 3 doses	Biological: Biological/Vaccine: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) level
Placebo Comparator: Placebo, ≥6 Months to <2 Years (3-dose regimen)	Other: Placebo Intramuscular injection
Placebo Comparator: Placebo, ≥2 to <5 Years (3-dose regimen)	Other: Placebo Intramuscular injection

What is the study measuring?

Primary Outcome Measures

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)

March 24, 2021

Primary Completion (Actual)

October 4, 2023

Study Completion (Actual)

December 8, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C4591007
2020-005442-42 (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

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Clinical Trials on SARS-CoV-2 Infection, 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
The Institute of Molecular and Translational Medicine...
University Hospital Olomouc; Palacky University

Completed

Study SARS-CoV-2-CZ-PREVAL-II - Arm of the Olomouc Region

SARS-CoV-2 | SARS-CoV-2 (COVID-19) Infection

Czechia
University of Melbourne
Australian and New Zealand Intensive Care Research Centre; The Peter Doherty... and other collaborators

Active, not recruiting

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial (ASCOT)

SARS-CoV-2 Infection (COVID-19)

Australia
St. Olavs Hospital
The Research Council of Norway; Helse Nord-Trøndelag HF; Alesund Hospital; Namsos... and other collaborators

Completed

The Corona Study of Middle Norway (CUT COVID-19)

SARS-CoV-2 Acute Respiratory Disease | SARS-CoV-2 Sepsis | SARS CoV 2 Infection

Norway
University of Valladolid

Completed

Impact of the Elevation Training Mask in CrossFit® Post-SARS-CoV-2 Infection. (ETMEXCOVID)

SARS-CoV-2 Infection (Symptomatic) | COVID-19 Pulmonary Complications | SARS-CoV-2 Positive Patients | COVID19- Infection with SARS-CoV-2 Virus

Spain
Interna Therapeutics Ltd.

Active, not recruiting

Safety, Tolerability, and Systemic Exposure of Apo-Si- K170A-C76 in Healthy Volunteers (BID)

SARS-CoV-2 (COVID-19) Infection

Israel
Boston University
National Institute of Allergy and Infectious Diseases (NIAID); Kamuzu University... and other collaborators

Recruiting

COVID-19 Transmission and Morbidity in Malawi (COVID-TMM)

SARS CoV 2 Infection | SARS CoV 2 Vaccination

United States, Malawi
The Board of Medicine
Apollo Neuroscience, Inc.

Recruiting

Effect of Apollo Wearable on Long COVID-19 Symptoms.

Post-acute Sequelae of SARS-COV-2 Infection

United States
Ono Pharmaceutical Co. Ltd

Completed

A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)

SARS-CoV-2 Infection (COVID-19)

Japan
Rohto Pharmaceutical Co., Ltd.

Completed

A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)

SARS-CoV-2 Infection( COVID-19 )

Japan

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
West Penn Allegheny Health System

Completed

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Asthma | Allergic Rhinitis

United States

Outcome Measure	Measure Description	Time Frame
Phase 1: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=6 Months to <2 Years of Age: Participants Without Evidence of Infection Time Frame: Phase 1: 7 days post Dose 2	GMT of SARS-CoV-2 neutralizing titer after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs(based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.	Phase 1: 7 days post Dose 2
Phase 1: GMT of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=2 to <5 Years of Age: Participants Without Evidence of Infection Time Frame: Phase 1: 7 days post Dose 2	GMT of SARS-CoV-2 neutralizing titers after the study vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs(based on Student's t distribution).Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.	Phase 1: 7 days post Dose 2
Phase 1: GMT of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=5 to <12 Years of Age: Participants Without Evidence of Infection Time Frame: Phase 1: 7 days post Dose 2	GMT of SARS-CoV-2 neutralizing titer after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs(based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.	Phase 1: 7 days post Dose 2
Phase 2/3: Geometric Mean Titer - Neutralizing Titer (NT50) : 5 to <12 Years of Age: Before Dose 1 and 1 Month After Dose 2:Participants Without Evidence of Infection Time Frame: Phase 2/3: Before Dose 1 and 1 Month after Dose 2	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.	Phase 2/3: Before Dose 1 and 1 Month after Dose 2
Phase 2/3: Geometric Mean Titer - NT50: 5 to <12 Years of Age: Pre-Dose 3 and 1 Month After Dose 3:Participants Without Evidence of Infection Time Frame: Phase 2/3: From Dose 3 set: Pre-Dose 3 and 1 Month after Dose 3	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 *LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population (EIP) included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.	Phase 2/3: From Dose 3 set: Pre-Dose 3 and 1 Month after Dose 3
Phase 2/3: Geometric Mean Titer - NT50:2 to <5 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Time Frame: Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 *LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19.	Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3
Phase 2/3: Geometric Mean Titer- NT50:6 Months to <2 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Time Frame: Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19.	Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3
Phase 2/3: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Dose 1 to 1 Month After Dose 2: >=5 to 12 Years of Age: Participants Without Evidence of Infection Time Frame: Phase 2/3: From Dose 1 to 1 Month after Dose 2	GMFR of SARS-CoV-2 neutralizing titers from dose 1 to 1 month after dose 2 were reported in this outcome measure. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Assay results below the LLOQ were set to 0.5* LLOQ in the analysis.	Phase 2/3: From Dose 1 to 1 Month after Dose 2
Phase 2/3:GMFR of SARS-CoV-2 Neutralizing Titers From Dose 3 to 1 Month After Dose 3: >=5 to 12 Years of Age: Participants Without Evidence of Infection Time Frame: Phase 2/3: From Dose 3 to 1 Month after Dose 3	GMFR of SARS-CoV-2 neutralizing titers from before Dose 3 to 1 month after Dose were reported in this outcome measure. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomized participants who received the study interventions to which they were randomized, had a valid and determined immunogenicity result within 28-42 days after Dose 3, and had no other important protocol deviations as determined by the clinicians.	Phase 2/3: From Dose 3 to 1 Month after Dose 3
Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Pre-Dose 3 and 1 Month After Dose 3: >=2 to 5 Years of Age: Participants Without Evidence of Infection Time Frame: Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs(based on the Student t distribution). Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 infection.Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.	Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3
Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Pre-Dose 3 and 1 Month After Dose 3: >=6 Months to 2 Years of Age: Participants Without Evidence of Infection Time Frame: Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection prior to the 1-month post-Dose 2.	Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 2 to Prior to Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=5 to <12 Years of Age Time Frame: Phase 2/3: From 7 days after Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.591; Placebo - 0.292)	COVID-19 incidence from 7 days after dose 2 to prior to dose 3 without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by clinician on or before 7 days after Dose 2.	Phase 2/3: From 7 days after Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.591; Placebo - 0.292)
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 2 to Prior to Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=5 to <12 Years of Age Time Frame: Phase 2/3: From 7 Days After Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.653; Placebo - 0.326)	COVID-19 incidence from 7 days after dose 2 to prior to dose 3 with or without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviation as determined by clinician on or before 7 days after Dose 2.	Phase 2/3: From 7 Days After Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.653; Placebo - 0.326)
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=6 Months to <5 Years of Age Time Frame: Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.124; Placebo - 0.054)	COVID-19 incidence from 7 days after dose 3 without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 3 received within the predefined window (within 19-42 days after Dose 2) and have no other important protocol deviations as determined by clinician on or before 7 days after Dose 3.	Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.124; Placebo - 0.054)
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=6 Months to <5 Years of Age Time Frame: Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.149; Placebo - 0.067)	COVID-19 incidence from 7 days after dose 3 without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 3 received within the predefined window (within 19-42 days after Dose 2) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 3.	Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.149; Placebo - 0.067)

Outcome Measure	Measure Description	Time Frame
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Time Frame: Phase 1: From Day 1 to Day 7 after Dose 1	Local reactions were collected in electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after Dose 1. Redness and swelling were measured and recorded in measuring device unit (mdu) where, 1 mdu = 0.5 centimeter (cm) and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 Emergency room (ER) visit or hospitalization). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% confidence interval was based on Clopper and Pearson method.	Phase 1: From Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Fever: oral temperature >= 38.0 degree Celsius (deg C); categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 3	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 3	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization for severe tenderness at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 1	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted). Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 2	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 2.Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake),severe (refusal to feed).Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted).Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of Age Time Frame: Phase 1: Day 1 to Day 7 after Dose 3	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 3. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity).Irritability: mild (easily consolable), moderate (requiring increased attention), severe(Inconsolable; crying cannot be comforted).Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants Reporting Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of Age Time Frame: Phase 1: From Dose 1 to 1 Month after Dose 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 1 to 1 Month after Dose 2
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of Age Time Frame: Phase 1: From Dose 3 to 1 Month after Dose 3	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 1 Month after Dose 3
Phase 1: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 2: >=5 to <12 Years of Age Time Frame: Phase 1: From Dose 1 to 6 Months after Dose 2	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 1 to 6 Months after Dose 2
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of Age Time Frame: Phase 1: From Dose 3 to 6 Months after Dose 3	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 6 Months after Dose 3
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of Age Time Frame: Phase 1: From Dose 1 to 1 Month after Dose 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 1 to 1 Month after Dose 2
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=2 to <5 Years of Age Time Frame: Phase 1: From Dose 3 to 1 Month after Dose 3	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 3 to 1 Month after Dose 3
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of Age Time Frame: Phase 1: From Dose 1 to 6 Months after Dose 2	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 1 to 6 Months after Dose 2
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=2 to <5 Years of Age Time Frame: Phase 1: From Dose 3 to 6 Months after Dose 3	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 6 Months after Dose 3
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=6 Months to <2 Years of Age Time Frame: Phase 1: From Dose 1 to 1 Month after Dose 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 1 to 1 Month after Dose 2
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=6 Months to <2 Years of Age Time Frame: Phase 1: From Dose 3 to 1 Month after Dose 3	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method.Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 3 to 1 Month after Dose 3
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=6 Months to <2 Years of Age Time Frame: Phase 1: From Dose 1 to 6 Months after Dose 2	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic.Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 1 to 6 Months after Dose 2
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of Age Time Frame: Phase 1: From Dose 3 to 6 Months after Dose 3	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 6 Months after Dose 3
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=5 to <12 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm),moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 3
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 3
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of Age Time Frame: Phase 2/3: From Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN

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