AzTrials
AzTrials

SARS-CoV-2 VirusPhase 3NCT05543616

A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

A Phase 3 study testing Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose and Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose in people with SARS-CoV-2 Virus and Severe Acute Respiratory Syndrome Coronavirus 2, run by BioNTech SE at 96 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. Read more about this study

Who is it for?
Ages 6 months to 11 yearsHealthy volunteers can take part
What is being tested?
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose and Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,338 participants
Where
96 sitesin 5 countries
Study dates
23 Sep 2022to 10 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
  • Healthy male or female participants = ≥6 months to <5 years of age, at the time of enrollment.
  • Healthy male or female participants ≥6 months to <5 years of age, at the time of randomization/enrollment.
  • Healthy male or female participants ≥5 years to <12 years of age, at the time of enrollment.
  • Healthy male or female participants ≥5 years to <12 years of age, at the time of enrollment.

Who cannot join

  • 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.
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  • 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
  • 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
  • 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
  • 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
  • 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.

Trial locations and contacts

96 sites in 5 countries.

96 sites in 5 countries

United States72 sites

  • Advanced Research Center Inc.

    Anaheim, California, 92805

  • The Iowa Clinic, P.C.

    Ankeny, Iowa, 50023

  • Emory Children's Center Illness POD

    Atlanta, Georgia, 30322

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Center for Immunization Research Inpatient Unit

    Baltimore, Maryland, 21224

  • Johns Hopkins Center for Immunization Outpatient Clinic

    Baltimore, Maryland, 21224

  • Velocity Clinical Research, Binghamton

    Binghamton, New York, 13905

  • UAB Child Health Research Unit (CHRU)

    Birmingham, Alabama, 35233

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boston Medical Center Crosstown Building

    Boston, Massachusetts, 02119

  • SUNY Downstate Health Sciences University

    Brooklyn, New York, 11203

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina, 28207

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Senders Pediatrics

    Cleveland, Ohio, 44121

  • Velocity Clinical Research, Cleveland

    Cleveland, Ohio, 44122

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • Cedar Health Research

    Dallas, Texas, 75251

  • Dayton Clinical Research

    Dayton, Ohio, 45409

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • Proactive Clinical Research, LLC

    Edinburg, Texas, 78539

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506

  • ACRC Trials

    Frisco, Texas, 75033

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Cyn3rgy Research

    Gresham, Oregon, 97030

  • Velocity Clinical Research, Hastings

    Hastings, Nebraska, 68901

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • PediaClinic

    Highlands Ranch, Colorado, 80126

  • Texas Children's Hospital

    Houston, Texas, 77030

  • DM Clinical Research- Cyfair

    Houston, Texas, 77065

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256

  • Velocity Clinical Research, Lincoln

    Lincoln, Nebraska, 68510

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Dr. Ruben Aleman and Associates

    McAllen, Texas, 78504

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142

  • Bio-Medical Research LLC

    Miami, Florida, 33144

  • Virginia Research Center

    Midlothian, Virginia, 23114

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Yale University- Yale Center for Clinical Investigation

    New Haven, Connecticut, 06519

  • AMR Clinical

    Newton, Kansas, 67114

  • Kaiser Permanente Oakland

    Oakland, California, 94611

  • Children's Hospital & Medical Center

    Omaha, Nebraska, 68114

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • SEC Clinical Research

    Pensacola, Florida, 32503

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • ACRC Trials (Administrative Site)

    Plano, Texas, 75024

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Kaiser Permanente Sacramento

    Sacramento, California, 95815

  • Seattle Children's- Building Cure

    Seattle, Washington, 98101

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana, 71101

  • Coastal Pediatric Research

    Summerville, South Carolina, 29486

  • PAS Research

    Tampa, Florida, 33613

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia, 20009

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Velocity Clinical Research, Washington DC

    Washington D.C., District of Columbia, 20016

  • The Iowa Clinic, P.C.

    West Des Moines, Iowa, 50266

  • The Iowa Clinic

    West Des Moines, Iowa, 50266

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

Other trials in United States

South Africa14 sites

  • REIMED Reiger Park

    Boksburg, Gauteng, 1459

  • TREAD Research

    Cape Town, Western Cape, 7530

  • Synergy Biomed Research Institute

    East London, Eastern Cape, 5201

  • Wits RHI

    Johannesburg, Gauteng, 2001

  • University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

    Johannesburg, Gauteng, 2013

  • Wits VIDA Nkanyezi Research Unit

    Johannesburg, Gauteng, 2093

  • Newtown Clinical Research

    Johannesburg, Gauteng, 2113

  • Perinatal HIV Research Unit (PHRU)

    Klerksdorp, North West, 2571

  • Merclinco

    Middelburg, Mpumalanga, 1055

  • Tsitsikamma Clinical Research Initiative (TCRI)

    Plettenberg Bay, Western Cape, 6600

  • Gole Biomed Research Centre

    Polokwane, Limpopo, 0699

  • Botho Ke Bontle Health Services

    Pretoria, Gauteng, 0184

  • Sandton Medical Research Centre

    Sandton, Gauteng, 2196

  • Jaymed Research

    Welkom, Free State, 9460

Other trials in South Africa

Brazil5 sites

  • Centro Médico São Francisco

    Curitiba, Paraná, 80810-050

  • Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN

    Natal, Rio Grande do Norte, CEP: 59025-050

  • Obras Sociais Irma Dulce

    Salvador, Estado de Bahia, 41680-020

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Mexico3 sites

  • Caimed Investigacion En Salud S.A. de C.V.

    Mexico City, Mexico City, 06760

  • CHRISTUS - LATAM HUB Center of excellence and innovation S.C.

    Monterrey, Nuevo León, 64060

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, Veracruz, 91900

Other trials in Mexico

Puerto Rico2 sites

  • Clinical Research Puerto Rico

    Guayama, 00784

  • University of Puerto Rico - Medical Sciences Campus

    San Juan, Puerto RICO, 00935

Other trials in Puerto Rico

About this study

Official title: A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT-ADAPTED BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY CHILDREN

The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in.

  • Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in.
  • Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
  • Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose.
  • Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
  • Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.
Being tested
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose, Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose, Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
Keywords
COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram doseBiological

    Injection in the muscle

  • Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram doseBiological

    Injection in the muscle

  • Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram doseBiological

    Injection in the muscle

  • Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram doseBiological

    Injection in the muscle

  • Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram doseBiological

    Injection in the muscle

  • Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram doseBiological

    injection in the muscle

  • Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram doseBiological

    Injection in the muscle

Study groups in NCT05543616
Study groupRoleWhat they receive
3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)ExperimentalInjection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)ExperimentalInjection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)ExperimentalInjection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week scheduleExperimentalInjection in the muscle at 0- and 8-weeks
Receives: Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week scheduleExperimentalInjection in the muscle at 0- and 8-weeks
Receives: Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)ExperimentalInjection in the muscle, 2 doses 2 months apart
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
10 microgram dose, 5 to <12 Years (Substudy D, Group 1)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
10 microgram dose, 5 to <12 Years (Substudy D, Group 2)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
10 microgram dose, 5 to <12 Years (Substudy D, Group 3)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)ExperimentalInjection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)ExperimentalInjection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose; Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)ExperimentalInjection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week scheduleExperimentalInjection in the muscle at 0-, 3-, and 11-weeks
Receives: Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single doseExperimentalInjection in the muscle, 1 dose
Receives: Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single doseExperimentalInjection in the muscle, 1 dose
Receives: Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)ExperimentalInjection in the muscle, 1 dose
Receives: Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week scheduleExperimentalInjection in the muscle at 0- and 8-weeks
Receives: Biological: Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions

    Participants ≥6 months to <2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to <5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4

  2. SSA - Ph 1 dose finding, percentage of participants reporting systemic events

    Participants ≥6 months to <2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to <5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4

  3. SSA - Ph 1 dose finding, percentage of participants reporting adverse events

    as elicited by investigational site staff

    Measured: from Dose 1 to 1 month after Dose 3 and from Dose 4 to 1 month after Dose 4

  4. SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events

    as elicited by investigational site staff

    Measured: from Dose 1 to 6 months after the last dose

  5. SSA - Ph 2/3, percentage of participants reporting local reactions

    Participants ≥6 months to <2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to <5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)

  6. SSA - Ph 2/3, percentage of participants reporting systemic events

    Participants ≥6 months to <2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to <5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)

  7. SSA - Ph 2/3, percentage of participants reporting adverse events

    as elicited by investigational site staff

    Measured: from Dose 1 to 1 month after the last dose

  8. SSA - Ph 2/3, percentage of participants reporting serious adverse events

    as elicited by investigational site staff

    Measured: from Dose 1 to 6 months after the last dose

  9. SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥6 months to <2 years of age

    As measured at the central laboratory

    Measured: At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) to 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram

  10. SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain titers in participants ≥6 months to <2 years of age

    As measured at the central laboratory

    Measured: At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) and at 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram

  11. SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥2 to <5 years of age

    As measured at the central laboratory

    Measured: At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age to 1 month after 3 doses (on a 0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age

  12. SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain in participants ≥2 to <5 years of age

    As measured at the central laboratory

    Measured: At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age and at 1 month after 3 doses (0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age

  13. Substudy B (SSB) - percentage of participants reporting local reactions

    Participants ≥6 months to <2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to <5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)

  14. SSB - percentage of participants reporting systemic events

    Participants ≥6 months to <2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to <5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)

  15. SSB - percentage of participants reporting adverse events

    as elicited by investigational site staff

    Measured: from the first study vaccination to 1 month after the first study vaccination (for Groups 1, 2, and 3), and from the second study vaccination to 1 month after the second study vaccination (for Group 1 only)

  16. SSB - percentage of participants reporting serious adverse events

    as elicited by investigational site staff

    Measured: from Dose 1 to 6 months after the last dose

  17. SSB - superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

  18. SSB - noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

  19. Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions

    Participants ≥6 months to <2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to <5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1

  20. SSC - Ph 1 dose finding, percentage of participants reporting systemic events

    Participants ≥6 months to <2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to <5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1

  21. SSC - Ph 1 dose finding, percentage of participants reporting adverse events

    as elicited by investigational site staff

    Measured: 1 month after Dose 1

  22. SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events

    as elicited by investigational site staff

    Measured: 6 months after Dose 1

  23. SSC - Ph 1 dose finding - geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  24. SSC - Ph 1 dose finding - geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  25. SSC - Ph 1 dose finding - percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  26. Substudy D (SSD) - percentage of participants reporting local reactions

    pain at the injection site, redness, and swelling as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1

  27. SSD - percentage of participants reporting systemic events

    fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1

  28. SSD - percentage of participants reporting adverse events

    as elicited by investigational site staff

    Measured: 1 month after Dose 1

  29. SSD - percentage of participants reporting serious adverse events

    as elicited by investigational site staff

    Measured: 6 months after Dose 1

  30. SSD - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age

    As measured at the central laboratory

    Measured: at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 10 μg and a fourth dose of bivalent BNT162b2 to those at 1 month after Dose 3 for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 μg

  31. SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age

    As measured at the central laboratory

    Measured: at 1 month after bivalent BNT162b2 as a fourth dose for participants who received 3 prior doses of BNT162b2 10 µg and at 1 month after a third dose of BNT162b2 10 µg for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 µg

  32. Substudy E (SSE) - percentage of participants reporting local reactions

    pain at the injection site, redness, and swelling as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1

  33. SSE - percentage of participants reporting systemic events

    fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

    Measured: for up to 7 days following Dose 1

  34. SSE - percentage of participants reporting adverse events

    as elicited by investigational site staff

    Measured: from Dose 1 to 1 month after Dose 1

  35. SSE - percentage of participants reporting serious adverse events

    as elicited by investigational site staff

    Measured: from Dose 1 to 6 months after Dose 1

  36. SSE - Ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers

    As measured at the central laboratory

    Measured: At 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 10 microgram in participants ≥5 to 12 years of age to 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 30 microgram in participants ≥12 years of age from study C4591054 Substudy A

  37. SSE - difference in percentage of participants with seroresponse to Omicron XBB.1.5

    As measured at the central laboratory

    Measured: At 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 10 microgram in participants ≥5 to 12 years of age and 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 30 microgram in participants ≥12 years of age from study C4591054 Substudy A

Secondary outcomes (17)

  1. SSA - Ph 1 dose finding, geometric mean titers elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 2, 1 month after Dose 3, and 1 month after Dose 4

  2. SSA - Ph 1 dose finding, geometric mean fold rise elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

  3. SSA - Ph 1 dose finding, percentage of participants with seroresponse elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant-adapted vaccine type in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

  4. SSA - Ph 2/3, geometric mean titers elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine-naive participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

  5. SSA - Ph 2/3, geometric mean fold rise elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine naive participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

  6. SSA - Ph 2/3, percentages of participants with seroresponse elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine-naive participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

  7. SSB - geometric mean titers elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age

    As measured at the central laboratory

    Measured: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1

  8. SSB - geometric mean fold rise elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age

    As measured at the central laboratory

    Measured: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1

  9. SSB - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age

    As measured at the central laboratory

    Measured: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1

  10. SSB - noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 reference strain-neutralizing titers in participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

  11. SSB - noninferiority with respect to seroresponse rate to the reference strain in participants ≥6 months to <5 years of age

    As measured at the central laboratory

    Measured: at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

  12. SSD - geometric mean titers elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  13. SSD - geometric mean fold rise elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  14. SSD - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  15. SSE - geometric mean titers elicited by BNT162b2 (Omicron XBB.1.5) given as a single 10 microgram dose in participants ≥5 to <12 years of age and as a single 30 microgram dose in Study C4591054 Substudy A participants ≥12 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  16. SSE - geometric mean fold rise elicited by BNT162b2 (Omicron XBB.1.5) given as a single 10 microgram dose in participants ≥5 to <12 years of age and as a single 30 microgram dose in Study C4591054 Substudy A participants ≥12 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

  17. SSE - percentage of participants with seroresponse elicited by BNT162b2 (Omicron XBB.1.5) given as a single 10 microgram dose in participants ≥5 to <12 years of age and as a single 30 mcg dose in Study C4591054 Substudy A participants ≥12 years of age

    As measured at the central laboratory

    Measured: At baseline (before Dose 1) and 1 month after Dose 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start23 Sep 2022
  3. Primary completion10 Jul 2026
  4. Study completion10 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543616
Sponsor's protocol ID
C4591048
Other IDs
2024-000001-33, 2023-503736-40-00, 2023
Status last verified
Aug 2026
First submitted
14 Sep 2022
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose and Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose in people with SARS-CoV-2 Virus and Severe Acute Respiratory Syndrome Coronavirus 2, run by BioNTech SE at 96 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, South Africa, Brazil, Mexico, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions (time frame: for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05543616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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