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NCT04816643 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
A Phase 3 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 3
- Development phase
- 11,837
- Enrollment target
NCT04816643: Completed Phase 3 study, sponsored by BioNTech SE.
NCT04816643 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 11,837 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1435% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04816643, a Phase 3 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11,837 participants
- Enrollment target
Study 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.
Primary Outcome
Local reactions were collected in electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after Dose 1. Redness and swelling were measured and recorded in measuring device unit (mdu) where, 1 mdu = 0.5 centimeter (cm) and were graded as mild (\>=0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm), severe (\>7.0 cm) and Grade 4 (necrosis \[redness and swelling\] or exfoliative dermatitis \[redness\]). Pain at injection site was graded as mild (did not interfere with activity)
Interventions
- OTHER Placebo
- BIOLOGICAL Biological/Vaccine: BNT162b2 10mcg
- BIOLOGICAL BNT162b2 20mcg
- BIOLOGICAL BNT162b2 30mcg
- BIOLOGICAL Biological/Vaccine: BNT162b2 3mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,837 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2023-12-08 |
| Phase | Phase 3 |
What the finished NCT04816643 record still lists
NCT04816643 is an interventional study that assigns participants to a tested intervention. Its 11,837 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1435% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04816643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04816643 about?
NCT04816643 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children". 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 e...
What is the current status of trial NCT04816643?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11,837 participants. The study started on 2021-03-24. Estimated completion is 2023-12-08.
What interventions are being tested in trial NCT04816643?
The interventions under investigation include: Placebo (OTHER), Biological/Vaccine: BNT162b2 10mcg (BIOLOGICAL), BNT162b2 20mcg (BIOLOGICAL), BNT162b2 30mcg (BIOLOGICAL), Biological/Vaccine: BNT162b2 3mcg (BIOLOGICAL).
Who is sponsoring clinical trial NCT04816643?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04816643's enrollment target sits among peer trials
11,837 20th of 2000 higher than 1,981 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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