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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 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 11,837 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04816643
The ClinicalTrials.gov registry entry for NCT04816643 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 11,837 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04816643 reports 0 study locations.
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.
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