drugset / Trial / NCT05630352
A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |