# A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

> **NCT04816643** · PHASE2,PHASE3 · COMPLETED · sponsor: **BioNTech SE** · enrollment: 11837 (actual)

## Conditions studied

- SARS-CoV-2 Infection, COVID-19

## Interventions

- **BIOLOGICAL:** Biological/Vaccine: BNT162b2 10mcg
- **BIOLOGICAL:** BNT162b2 20mcg
- **BIOLOGICAL:** BNT162b2 30mcg
- **OTHER:** Placebo
- **BIOLOGICAL:** Biological/Vaccine: BNT162b2 3mcg

## Key facts

- **NCT ID:** NCT04816643
- **Lead sponsor:** BioNTech SE
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-03-24
- **Primary completion:** 2023-10-04
- **Final completion:** 2023-12-08
- **Target enrollment:** 11837 (ACTUAL)
- **Last updated:** 2023-12-19

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04816643

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04816643, "A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT04816643. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*