NCT05543616

A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT-ADAPTED BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY CHILDREN

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,292 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. * Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. * Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. * Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.

Conditions

• SARS-CoV-2 Virus
• Severe Acute Respiratory Syndrome Coronavirus 2
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose	Injection in the muscle
BIOLOGICAL	Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose	Injection in the muscle
BIOLOGICAL	Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose	Injection in the muscle
BIOLOGICAL	Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose	Injection in the muscle
BIOLOGICAL	Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose	Injection in the muscle
BIOLOGICAL	Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose	injection in the muscle
BIOLOGICAL	Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose	Injection in the muscle

Timeline

• Start date: 2022-09-23
• Primary completion: 2026-07-23
• Completion: 2026-07-23
• First posted: 2022-09-16
• Last updated: 2026-04-13

Locations

96 sites across 5 countries: United States, Brazil, Mexico, Puerto Rico, South Africa

Regulatory

• FDA-regulated drug study