CompletedPhase 3

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

United States, Brazil, Finland11,837 participantsStarted 2021-03-24

Plain-language summary

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.

Who can participate

Age range

6 Months – 15 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.

Inclusion criteria

. 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.
. 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.
. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
. 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.
. Negative urine pregnancy test for female participants who are biologically capable of having children.

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

Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age

Timeframe: Phase 1: From Day 1 to Day 7 after Dose 1

Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 2

Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 3

Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 1

Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 2

Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 3

Trial details

NCT IDNCT04816643

SponsorBioNTech SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-04

Results submitted2024-10-02

View on ClinicalTrials.gov More SARS-CoV-2 Infection, COVID-19 trials

Plain-language summary

Who can participate

Age range

6 Months – 15 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.

Inclusion criteria

. 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.
. 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.
. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
. 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.
. Negative urine pregnancy test for female participants who are biologically capable of having children.

What they're measuring

Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age

Timeframe: Phase 1: From Day 1 to Day 7 after Dose 1

Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 2

Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 3

Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 1

Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 2

Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of Age

Timeframe: Phase 1: Day 1 to Day 7 after Dose 3

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria