Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00397943 |
This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis (TB) |
Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342 Biological: Control vaccine with the adjuvant system. |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety, Reactogenicity & Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Administered Intramuscularly According to a Schedule of 0, 1 Month, to Healthy Adults Aged 18 to 50 Years. |
Estimated Enrollment: | 110 |
Study Start Date: | November 2006 |
Study Completion Date: | March 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group C: Active Comparator |
Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system
Intramuscular injection, 2 doses at 0, 1 month
|
Group E: Placebo Comparator |
Biological: Control vaccine with the adjuvant system.
Intramuscular injection, 2 doses at 0, 1 month
|
Groupe D: Active Comparator |
Biological: Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline
Intramuscular injection, 2 doses at 0, 1 month
|
Group A: Experimental |
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 2 doses at 0, 1 month
|
Group B: Experimental |
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 2 doses at 0, 1 month
|
The study is designed to have a vaccination phase (includes screening, 2 doses of vaccine 1 month apart and follow-up until 1 month post dose 2), which will be performed in an observer blinded manner. This will be followed by 3 years of follow-up which will continue in an open manner.
No new subjects will be recruited at the follow-up phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 106227, 108738 (EXT Y3), 106228 (EXT Y1), 108736 (EXT Y2) |
Study First Received: | November 9, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00397943 |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Tuberculosis |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis Healthy |
Actinomycetales Infections |