CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11,837 enrolled
Drug / intervention
Biological/Vaccine: BNT162b2 10mcg +4 morebiological
Likely dose
Biological/Vaccine: BNT162b2 10mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04816643
NCT04816643Phase 3Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN

BioNTech SE·interventional·Posted Mar 25, 2021·Updated May 28, 2026

In Brief

A Phase 3 clinical trial evaluating Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, and 3 other interventions for SARS-CoV-2 Infection, COVID-19. Completed, enrolled 11,837 participants across 128 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2 Infection, COVID-19
CountriesBrazil, Finland, Mexico, Poland, Spain, United States
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 25, 2021
Enrollment StartMar 24, 2021
Primary CompletionOct 4, 2023
Study CompletionDec 8, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.3 years ago

Interventions

Biological/Vaccine: BNT162b2 10mcgbiological

BNT162b2 Low/Mid-Dose (10mcg) level

BNT162b2 20mcgbiological

BNT162b2 Mid-Dose (20mcg) level

BNT162b2 30mcgbiological

BNT162b2 High-Dose (30mcg) level

Placeboother

Intramuscular injection

Biological/Vaccine: BNT162b2 3mcgbiological

BNT162b2 Low-Dose (3mcg) level