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Phase Ib (High Dose), Single Centre, Dose-escalating, Placebo-controlled, Randomized Study of a Live Attenuated B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Volunteers
This study evaluates the safety and immunogenicity of a higher dose formulation of a new live attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce the live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose), single centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis strain BPZE1 given as a single intranasal dose to healthy adult volunteer.
Details
| Lead sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 54 |
| Start date | 2015-09 |
| Completion | 2017-12 |
Conditions
- Pertussis
- Whooping Cough
Interventions
- BPZE1
- Placebo
Primary outcomes
- The Primary Safety Endpoint is the Number and Percentage of Participants Per Dose Group and Randomized Allocation, With at Least One of the Following Adverse Events Between Day 0 and Day 28 — 28 days
Percentage is based on subjects experiencing at least one of the following events: * Cough and spasmodic cough of grade 2 or higher * Other respiratory tract AE related or possibly related to vaccination of grade 3 or higher * Any other AE related or possibly related to vaccination of grade 3 or higher
Countries
Sweden