drugset / Trial / NCT03137927
A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
Phase 1
Completed
36 enrolled
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
RandomizedParallel-groupSingle-blindPrevention
Summary
The study contains three periods: screening, inpatient hospitalization and follow-up. And should be leaded as a randomized placebo-controlled study with in chain order enrolled volunteers and dose escalating.
Timeline
- Start
- 2017-06-13
- Primary completion
- 2017-12-19
- Completion
- 2017-12-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GamLPV | Vaccine | 2.5e+08 cells | Intranasal |
| Subject | GamLPV | Vaccine | 1e+09 cells | Intranasal |
| Subject | GamLPV | Vaccine | 4e+09 cells | Intranasal |