Trials / Completed
CompletedNCT00730795
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults
A Phase I Open Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine, Mtb72F With AS02A Adjuvant, When Administered Intramuscularly to Healthy PPD-Negative Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK's candidate Mycobacterium tuberculosis vaccine 692342 | Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high) |
Timeline
- Start date
- 2004-01-01
- Primary completion
- 2004-12-01
- First posted
- 2008-08-08
- Last updated
- 2008-08-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00730795. Inclusion in this directory is not an endorsement.