COVID vaccine for kids: large trial shows promise in children as young as 6 months

NCT ID NCT04816643

Vaccine Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large study tested the Pfizer-BioNTech COVID-19 vaccine in over 11,800 healthy children aged 6 months to 12 years. Researchers looked at side effects and immune responses after different doses. The goal was to find the right dose that is safe and triggers strong protection. The study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)
What this could lead to: If successful, this study could show that the COVID-19 vaccine is safe and effective for children as young as 6 months, helping protect them from serious illness.
What could go wrong: This trial is already completed, but results may not apply to newer virus variants. Side effects like fever or fatigue were common, and rare serious risks remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

11,837 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 15 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. 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. 2. 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. 3. 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. 4. 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. 5. Negative urine pregnancy test for female participants who are biologically capable of having children. 6. 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. 7. 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 1. 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. 2. Phase 1 only: Known infection with HIV, HCV, or HBV. 3. Receipt of medications intended to prevent COVID-19. 4. Previous or current diagnosis of MIS-C. 5. 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 6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 8. 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. 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 10. Female who is pregnant or breastfeeding. 11. Previous vaccination with any coronavirus vaccine. 12. 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. 13. 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. 14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. 15. Previous participation in other studies involving study intervention containing LNPs. 16. 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.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2 infection, COVID-19

Contacts and locations

Locations

AHN Erie Health + Wellness Pavillion: West

Erie, Pennsylvania, 16506, United States
Acevedo Clinical Research Associates

Miami, Florida, 33142, United States
Advanced Specialty Care

Commack, New York, 11725, United States
Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States
Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States
Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States
Atrium Health-STRIVE Vaccine Research Clinic

Charlotte, North Carolina, 28207, United States
Atrium Health-STRIVE Vaccine Research Clinic (study visits)

Matthews, North Carolina, 28105, United States
Bay Colony Pediatrics

Dickinson, Texas, 77539, United States
Bayview Research Group, LLC

Valley Village, California, 91607, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.

São Paulo, 04266-010, Brazil
CHRISTUS - LATAM HUB Center of excellence and innovation S.C.

Monterrey, Nuevo León, C.P. 64060, Mexico
Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States
CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

Natal, Rio Grande do Norte, 59025-050, Brazil
Cedar Health Research

Dallas, Texas, 75251, United States
Center for Clinical Trials

Paramount, California, 90723, United States
Center for Clinical Trials, LLC

Paramount, California, 90723, United States
Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion

Mérida, Yucatán, 97130, Mexico
Centrum Badan Klinicznych JCI

Krakow, 30-348, Poland
Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States
Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Mercy Hospital

Kansas City, Missouri, 64108, United States
Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States
Children's Physician's Clinic, Spring Valley

Omaha, Nebraska, 68117, United States
Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio, 45229, United States
Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University

Palo Alto, California, 94304, United States
Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States
Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States
Clinical Research Prime

Idaho Falls, Idaho, 83404, United States
Clinical Research Professionals

Chesterfield, Missouri, 63005, United States
Coastal Pediatric Research

Charleston, South Carolina, 29414, United States
Coastal Pediatric Research

Summerville, South Carolina, 29486, United States
Cyn3rgy Research

Gresham, Oregon, 97030, United States
DM Clinical Research - MDC

Houston, Texas, 77065, United States
Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States
Duke University - Main Hospital and Clinics

Durham, North Carolina, 27703, United States
EBA Centelles

Centelles, Barcelona, 08540, Spain
Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States
Emory Children's Center Illness POD

Atlanta, Georgia, 30322, United States
Emory University School of Medicine

Atlanta, Georgia, 30322, United States
FVR, Espoo Clinic

Espoo, 02230, Finland
FVR, Helsinki East Clinic

Helsinki, 00930, Finland
FVR, Helsinki South Clinic

Helsinki, 00100, Finland
FVR, Järvenpää Clinic

Jarvenpaa, Uusimaa, 04400, Finland
FVR, Kokkola Clinic

Kokkola, 67100, Finland
FVR, Oulu Clinic

Oulu, North Ostrobothnia, 90220, Finland
FVR, Pori Clinic

Pori, 28100, Finland
FVR, Seinäjoki Clinic

Seinäjoki, 60100, Finland
FVR, Tampere Clinic

Tampere, 33100, Finland
FVR, Turku Clinic

Turku, 20520, Finland
GRAVITA Diagnostyka i Leczenie nieplodnosci

Lodz, 91-347, Poland
Grupo Pediatrico Uncibay

Málaga, Málaga, 29015, Spain
HG Pediatrics

Houston, Texas, 77008, United States
Helios Clinical Research

Houston, Texas, 77008, United States
Helios Clinical Research - HOU

Houston, Texas, 77008, United States
Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain
Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC

Salvador, Estado de Bahia, 40415-006, Brazil
Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, 28660, Spain
Hospital Universitario HM Puerta del Sur

Madrid, Madrid, Comunidad de, 28938, Spain
Hospital de Antequera

Antequera, Málaga, 29200, Spain
IN-VIVO Bydgoszcz

Bydgoszcz, 85-048, Poland
Innovo Research - Austin Regional Clinic

Austin, Texas, 78726, United States
Instituto Hispalense de Pediatria

Seville, 41012, Spain
J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States
Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States
Kaiser Permanente Oakland

Oakland, California, 94611, United States
Kaiser Permanente Sacramento

Sacramento, California, 95815, United States
Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States
Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States
Kohler & Milstein Research S.A. de C.V.

Mérida, Yucatán, 97070, Mexico
Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, 71101, United States
Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States
MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Madera Family Medical Group

Madera, California, 93637, United States
Matrix Clinical Research

Los Angeles, California, 90057, United States
MeVac - Meilahti Vaccine Research Center

Helsinki, 00290, Finland
Meridian Clinical Research LLC

Binghamton, New York, 13905, United States
Meridian Clinical Research, LLC

Macon, Georgia, 31210, United States
Meridian Clinical Research, LLC

Hastings, Nebraska, 68901, United States
Michigan Center of Medical Research

Bingham Farms, Michigan, 48025, United States
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, 41-103, Poland
Novak Center for Children's Health

Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States
Osrodek Badan Klinicznych Appletreeclinics

Lodz, 90-349, Poland
Pediatric Associates

Houston, Texas, 77087, United States
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

Charlottesville, Virginia, 22902, United States
Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States
Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States
PriMed Clinical Research

Dayton, Ohio, 45429, United States
Proactive Clinical Research, LLC

Edinburg, Texas, 78539, United States
Provita 001

Warsaw, 02-647, Poland
Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States
Rodzinne Centrum Medyczne LUBMED

Luboń, 62-030, Poland
Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States
Rutgers University

New Brunswick, New Jersey, 08901, United States
SCPMG/Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States
SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
Santa Casa De Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil
Seattle Children's Hospital

Seattle, Washington, 98105, United States
Senders Pediatrics

South Euclid, Ohio, 44121, United States
Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil
Sociedad de Metabolismo y Corazón S.C.

Veracruz, C.P. 91900, Mexico
Solaris Clinical Research

Meridian, Idaho, 83646, United States
St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States
Stanford Health Care

Stanford, California, 94305, United States
Stanford Health Care Investigational Drug Service

Stanford, California, 94305, United States
Stony Brook University

Stony Brook, New York, 11794, United States
Teen Health Connection (study visits)

Charlotte, North Carolina, 28211, United States
Texas Children's Hospital - Clinical Research Center

Houston, Texas, 77030, United States
Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States
University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, 35233, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States
Van Tran Family Practice

Houston, Texas, 77008, United States
Velocity Clinical Research, Lincoln

Lincoln, Nebraska, 68510, United States
Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016, United States
Velocity Clinical Research-Providence

East Greenwich, Rhode Island, 02818, United States
Village Health Partners (Patient Seen Address)

Frisco, Texas, 75033, United States
Virginia Research Center

Midlothian, Virginia, 23114, United States
West Houston Clinical Research Services

Houston, Texas, 77055, United States
Yale Center for Clinical Investigation

New Haven, Connecticut, 06519, United States

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