NCT05630352

A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children

A MASTER PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BIVALENT BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY INFANTS AND CHILDREN

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 72 Days – 102 Days
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children. Sub study A of this clinical trial will test up to four different dose levels of the vaccine in infants who are under 6 months of age and have not previously received a coronavirus vaccination. This will be a 3- dose primary series of the study vaccine with each dose separated by 8 weeks.

Conditions

• 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	Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose	Injection in the muscle

Timeline

• Start date: 2025-01-06
• Primary completion: 2026-07-13
• Completion: 2026-07-13
• First posted: 2022-11-29
• Last updated: 2024-03-18

Regulatory

• FDA-regulated drug study