Trials / Completed
CompletedNCT03017378
Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine
A Randomized, Open Clinical Trial Phase 1 Vaccine TB/FLU-01L by Intranasal and Sublingual Application for Specific Immunotherapy Pulmonary Tuberculosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (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, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TB/FLU-01L | TB / FLU-01L (intranasal application) |
| BIOLOGICAL | TB/FLU-01L | TB/FLU-01L (sublingual application) |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-04-01
- Completion
- 2015-02-01
- First posted
- 2017-01-11
- Last updated
- 2017-01-11
Locations
1 site across 1 country: Kazakhstan
Source: ClinicalTrials.gov record NCT03017378. Inclusion in this directory is not an endorsement.