drugset / Trial / NCT05630352

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

NCT05630352

Phase 1 Withdrawn BioNTech SE Pfizer · collab
Non-randomizedSequentialOpen-labelPrevention

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.

Timeline

Start
2025-01-06
Primary completion
2026-07-13
Completion
2026-07-13

Drugs

EvaluationDrugModalityDoseRoute
Subject BNT162b2 Messenger RNA (mRNA) 1 ug Intramuscular
Subject BNT162b2 Messenger RNA (mRNA) 3 ug Intramuscular
Subject BNT162b2 Messenger RNA (mRNA) 6 ug Intramuscular
Subject BNT162b2 Messenger RNA (mRNA) 10 ug Intramuscular

Indications