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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 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11837

Last updated 2023-12-19

No results posted yet for this 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.

Conditions

  • SARS-CoV-2 Infection, COVID-19

Interventions

BIOLOGICAL

Biological/Vaccine: BNT162b2 10mcg

BNT162b2 Low/Mid-Dose (10mcg) level

BIOLOGICAL

BNT162b2 20mcg

BNT162b2 Mid-Dose (20mcg) level

BIOLOGICAL

BNT162b2 30mcg

BNT162b2 High-Dose (30mcg) level

OTHER

Placebo

Intramuscular injection

BIOLOGICAL

Biological/Vaccine: BNT162b2 3mcg

BNT162b2 Low-Dose (3mcg) level

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2023-10-04
Completion
2023-12-08
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Finland
  • Mexico
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816643 on ClinicalTrials.gov