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

Completed · Phase 3

Conditions studied: SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19

In brief

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.

Key facts

Study ID

NCT05543616

Run by

BioNTech SE

People needed

4338

Starts

2022-09-23

Expected to finish

2026-07-10

Last updated by the study team

2026-08-06

Who can join

Age: 1 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Advanced Research Center Inc. — Anaheim, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Kaiser Permanente Oakland — Oakland, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Peninsula Research Associates — Rolling Hills Estates, California, United States
• Kaiser Permanente Sacramento — Sacramento, California, United States
• PediaClinic — Highlands Ranch, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Yale University- Yale Center for Clinical Investigation — New Haven, Connecticut, United States
• Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Velocity Clinical Research, Washington DC — Washington D.C., District of Columbia, United States
• Indago Research & Health Center, Inc — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
• Acevedo Clinical Research Associates — Miami, Florida, United States
• Bio-Medical Research LLC — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• SEC Clinical Research — Pensacola, Florida, United States
• PAS Research — Tampa, Florida, United States
• Emory Children's Center Illness POD — Atlanta, Georgia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
• UAB Child Health Research Unit (CHRU) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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