drugset / Trial / NCT04036526
A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
Phase 1/2
Unknown
50 enrolled
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
RandomizedParallel-groupSingle-blindPrevention
Summary
The study should be leaded as a randomized double-blind placebo-controlled comparative research of potency and safety of a GamLPV, a live intranasal Bordetella pertussis vaccine, using two dosing schedules and methods of application in healthy human volunteers. The study contains three periods: screening, inpatient hospitalization and follow-up.
Timeline
- Start
- 2019-06-04
- Primary completion
- 2020-05-29
- Completion
- 2020-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GamLPV | Vaccine | — | Intranasal |