drugset / Trial / NCT03017378
Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine
Phase 1
Completed
36 enrolled
Research Institute for Biological Safety Problems
Ministry of Health, Kazakhstan · collabResearch Institute of Influenza, Russia · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.
Timeline
- Start
- 2013-10
- Primary completion
- 2014-04
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | TB/FLU-01L | Vaccine | — | Other |
| Comparator | TB/FLU-01L | Vaccine | — | Other |