drugset / Trial / NCT02501421
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
Phase 1
Completed
44 enrolled
Research Institute for Biological Safety Problems
Ministry of Health, Kazakhstan · collabResearch Institute of Influenza, Russia · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo 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-04L | Vaccine | — | — |