drugset / Trial / NCT03651544
The Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac
Phase 1
Completed
36 enrolled
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Non-randomizedSequentialOpen-labelPrevention
Summary
The present clinical phase I study designed to examine the safety, reactogenicity and immunogenicity of the medicinal product - Vaccine vector against influenza A - in healthy volunteers after a single dose in the three groups with dose escalation.
Timeline
- Start
- 2018-10-15
- Primary completion
- 2018-12-24
- Completion
- 2019-03-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GamFluVac | Vaccine | 0.5 ml | — |
| Subject | GamFluVac | Vaccine | 2.5e+10 unknown | — |
| Subject | GamFluVac | Vaccine | 1e+11 unknown | — |
| Subject | GamFluVac | Vaccine | 2.5e+11 unknown | — |