Trials / Completed
CompletedNCT02501421
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Research Institute for Biological Safety Problems · Other Government
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | tuberculosis vaccine | Live recombinant influenza vectored tuberculosis vaccine |
| BIOLOGICAL | Placebo | Buffer |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-04-01
- Completion
- 2015-02-01
- First posted
- 2015-07-17
- Last updated
- 2020-08-28
Source: ClinicalTrials.gov record NCT02501421. Inclusion in this directory is not an endorsement.