Active — Not RecruitingPhase 3

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

United States, Brazil, Mexico4,292 participantsStarted 2022-09-23

Plain-language 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. 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.

Who can participate

Age range

6 Months – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 enrollme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

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

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

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

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

Timeframe: 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)

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

Timeframe: 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)

Trial details

NCT IDNCT05543616

SponsorBioNTech SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-23

View on ClinicalTrials.gov More SARS-CoV-2 Virus trials

Plain-language summary

Who can participate

Age range

6 Months – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

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

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

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

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

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

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

Timeframe: 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)

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

Timeframe: 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)