drugset / Trial / NCT05116241
Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.
Timeline
- Start
- 2021-11-11
- Primary completion
- 2024-05-15
- Completion
- 2024-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BPZE1 | Vaccine | — | Intranasal |
| Subject | Boostrix | Vaccine | — | — |