drugset / Trial / NCT05116241

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

NCT05116241

Phase 2 Completed 368 enrolled ILiAD Biotechnologies
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

EvaluationDrugModalityDoseRoute
Subject BPZE1 Vaccine Intranasal
Subject Boostrix Vaccine

Indications