Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00291889 |
Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis |
Biological: Mtb72F/AS02. |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Evaluate the Safety, Reactogenicity & Immunogenicity of 2 Antigen Dose Levels of GSK Biologicals’ Candidate Tuberculosis Vaccine, Mtb72F/AS02 to Healthy PPD-Negative Volunteers Aged 18 to 45 Yrs |
Estimated Enrollment: | 50 |
Study Start Date: | July 2004 |
The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers will receive the vaccine alone without an immunostimulant and 1 control group will receive the adjuvant (AS02) alone to assess the true effect of the candidate tuberculosis vaccine (Mtb72F/AS02).
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Study ID Numbers: | 102039 |
Study First Received: | February 14, 2006 |
Last Updated: | February 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00291889 History of Changes |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis Healthy |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis Actinomycetales Infections |