New COVID-19 vaccine trial aims to protect kids from latest variants

NCT ID NCT05543616

Vaccine Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This large study is testing updated mRNA vaccines designed to protect against newer Omicron variants of COVID-19 in healthy children aged 6 months to 12 years. Over 4,000 participants will receive one or more doses depending on their age and vaccination history. Researchers are monitoring safety, side effects, and immune responses to find the best dose and schedule.

What this could mean

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

Active substance: Updated COVID-19 mRNA vaccine (BNT162b2 adapted for Omicron variants)
What this could lead to: If successful, this could provide safe and effective COVID-19 protection for children, including those not yet vaccinated.
What could go wrong: This is an ongoing trial; results are not yet final. Side effects like injection site pain or fever are possible, and the vaccine may not work as well against future variants.

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

4,338 people

The number who actually took part.

Started

Sep 2022

Finished

Jul 2026

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 11 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.

Substudy A Inclusion Criteria: * Phase 1: Healthy male or female participants ≥6 months to \<4 years 3 months of age, at the time of randomization. * Phase 2/3: Healthy male or female participants ≥6 months to \<5 years of age at the time of randomization/enrollment. Exclusion Criteria: * Previous or current diagnosis of multisystem inflammatory syndrome in children (MIS-C). * 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, or individuals who receive treatment with immunosuppressive therapy. * 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. * Any history of myocarditis or pericarditis. * Previous vaccination with any COVID-19 vaccine. * Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), 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. Substudy B Inclusion Criteria: \- Healthy male or female participants = ≥6 months to \<5 years of age, at the time of enrollment. Exclusion Criteria: * Previous or current diagnosis of MIS-C. * 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, or individuals who receive treatment with immunosuppressive therapy. * Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. * Prior receipt of any COVID 19 vaccine other than BNT162b2. * Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), 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. Substudy C Inclusion Criteria: \- Healthy male or female participants ≥6 months to \<5 years of age, at the time of randomization/enrollment. Exclusion Criteria: * Previous or current diagnosis of MIS-C. * 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, or individuals who receive treatment with immunosuppressive therapy. * Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. * Prior receipt of any COVID 19 vaccine other than BNT162b2. * Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), 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. Substudy D Inclusion Criteria: \- Healthy male or female participants ≥5 years to \<12 years of age, at the time of enrollment. Exclusion Criteria: * Previous or current diagnosis of MIS-C. * 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, or individuals who receive treatment with immunosuppressive therapy. * Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. * Female who is pregnant or breastfeeding. * Prior receipt of any COVID 19 vaccine other than BNT162b2. * Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), 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. Substudy E Inclusion Criteria: \- Healthy male or female participants ≥5 years to \<12 years of age, at the time of enrollment. Exclusion Criteria: * Previous or current diagnosis of MIS-C. * 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, or individuals who receive treatment with immunosuppressive therapy. * Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. * Any history of myocarditis or pericarditis. * Female who is pregnant or breastfeeding. * Previous vaccination with any COVID 19 vaccine. * Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), 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.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 prevention target

As listed by the trial registrant

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

COVID-19 SARS-CoV-2 virus Severe acute respiratory syndrome coronavirus 2

Contacts and locations

Locations

ACRC Trials

Frisco, Texas, 75033, United States
ACRC Trials (Administrative Site)

Plano, Texas, 75024, United States
AMR Clinical

Newton, Kansas, 67114, United States
Acevedo Clinical Research Associates

Miami, Florida, 33142, United States
Advanced Research Center Inc.

Anaheim, California, 92805, United States
Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States
Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States
Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28207, United States
Bio-Medical Research LLC

Miami, Florida, 33144, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
Boston Medical Center Crosstown Building

Boston, Massachusetts, 02119, United States
Botho Ke Bontle Health Services

Pretoria, Gauteng, 0184, South Africa
CEPIC - Centro Paulista de Investigação Clínica

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

Monterrey, Nuevo León, 64060, Mexico
Caimed Investigacion En Salud S.A. de C.V.

Mexico City, Mexico City, 06760, Mexico
Cedar Health Research

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

Paramount, California, 90723, United States
Center for Immunization Research Inpatient Unit

Baltimore, Maryland, 21224, United States
Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States
Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN

Natal, Rio Grande do Norte, CEP: 59025-050, Brazil
Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States
Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

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

Nashville, Tennessee, 37203, United States
Clinical Research Puerto Rico

Guayama, 00784, Puerto Rico
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- Cyfair

Houston, Texas, 77065, United States
Dayton Clinical Research

Dayton, Ohio, 45409, United States
Dr. Ruben Aleman and Associates

McAllen, Texas, 78504, United States
Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States
Duke Vaccine and Trials Unit

Durham, North Carolina, 27703, United States
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
Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil
Gole Biomed Research Centre

Polokwane, Limpopo, 0699, South Africa
Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States
Jaymed Research

Welkom, Free State, 9460, South Africa
Johns Hopkins Center for Immunization Outpatient Clinic

Baltimore, Maryland, 21224, United States
Kaiser Permanente

Los Angeles, California, 90027, United States
Kaiser Permanente Oakland

Oakland, California, 94611, United States
Kaiser Permanente Sacramento

Sacramento, California, 95815, United States
Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, 71101, United States
Merclinco

Middelburg, Mpumalanga, 1055, South Africa
Newtown Clinical Research

Johannesburg, Gauteng, 2113, South Africa
Obras Sociais Irma Dulce

Salvador, Estado de Bahia, 41680-020, Brazil
PAS Research

Tampa, Florida, 33613, United States
PediaClinic

Highlands Ranch, Colorado, 80126, United States
Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States
Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States
Perinatal HIV Research Unit (PHRU)

Klerksdorp, North West, 2571, South Africa
Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States
Proactive Clinical Research, LLC

Edinburg, Texas, 78539, United States
REIMED Reiger Park

Boksburg, Gauteng, 1459, South Africa
Rochester Clinical Research, LLC

Rochester, New York, 14609, United States
Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States
Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States
SEC Clinical Research

Pensacola, Florida, 32503, United States
SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States
SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States
Sandton Medical Research Centre

Sandton, Gauteng, 2196, South Africa
Seattle Children's Hospital

Seattle, Washington, 98105, United States
Seattle Children's- Building Cure

Seattle, Washington, 98101, United States
Senders Pediatrics

Cleveland, Ohio, 44121, United States
Sociedad de Metabolismo y Corazon S.C.

Veracruz, Veracruz, 91900, Mexico
St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States
Stanford University Medical Center

Palo Alto, California, 94304, United States
Synergy Biomed Research Institute

East London, Eastern Cape, 5201, South Africa
TREAD Research

Cape Town, Western Cape, 7530, South Africa
Texas Children's Hospital

Houston, Texas, 77030, United States
The Iowa Clinic

West Des Moines, Iowa, 50266, United States
The Iowa Clinic, P.C.

Ankeny, Iowa, 50023, United States
The Iowa Clinic, P.C.

West Des Moines, Iowa, 50266, United States
Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States
Tsitsikamma Clinical Research Initiative (TCRI)

Plettenberg Bay, Western Cape, 6600, South Africa
UAB Child Health Research Unit (CHRU)

Birmingham, Alabama, 35233, United States
University of Puerto Rico - Medical Sciences Campus

San Juan, Puerto RICO, 00935, Puerto Rico
University of Rochester Medical Center

Rochester, New York, 14642, United States
University of Texas Medical Branch

Galveston, Texas, 77555, United States
University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

Johannesburg, Gauteng, 2013, South Africa
Velocity Clinical Research, Binghamton

Binghamton, New York, 13905, United States
Velocity Clinical Research, Cleveland

Cleveland, Ohio, 44122, United States
Velocity Clinical Research, Hastings

Hastings, Nebraska, 68901, United States
Velocity Clinical Research, Lincoln

Lincoln, Nebraska, 68510, United States
Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016, United States
Virginia Research Center

Midlothian, Virginia, 23114, United States
Wits RHI

Johannesburg, Gauteng, 2001, South Africa
Wits VIDA Nkanyezi Research Unit

Johannesburg, Gauteng, 2093, South Africa
Yale University School of Medicine

New Haven, Connecticut, 06510, United States
Yale University- Yale Center for Clinical Investigation

New Haven, Connecticut, 06519, United States

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