At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2b Placebo-Controlled Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess Immunological Response and Safety of a Single Dose BPZE1 With/Without Coadministration of Tdap (Boostrix™)
In Brief
A Phase 2 clinical trial evaluating BPZE1 pertussis vaccine and placebo, BPZE1 pertussis vaccine and Boostrix, and 1 other intervention for Bordetella Pertussis, Whooping Cough. Completed, enrolled 368 participants across 16 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Live attenuated pertussis vaccine and placebo
Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine
Tetanus, diphtheria, and aP vaccine and placebo