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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00707967 |
This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis (TB) |
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342 Biological: Control vaccine with the adjuvant system. Biological: Control vaccine with physiological saline |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-Positive Adults. |
Estimated Enrollment: | 40 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group B: Placebo Comparator
Subjects receiving the adjuvant
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Biological: Control vaccine with the adjuvant system.
Intramuscular injection, 2 doses at 0, 1 month
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Group C: Placebo Comparator
Subjects receiving physiological saline
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Biological: Control vaccine with physiological saline
Intramuscular injection, 2 doses at 0, 1 month
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Group A: Experimental
Subjects receiving the candidate vaccine
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Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 2 doses at 0, 1 month
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must be HIV-positive and must have:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111517 |
Study First Received: | June 27, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00707967 |
Health Authority: | Switzerland: Swissmedic |
Tuberculosis vaccine |
Bacterial Infections Gram-Positive Bacterial Infections HIV Seropositivity HIV Infections |
Acquired Immunodeficiency Syndrome Mycobacterium Infections Tuberculosis |
Actinomycetales Infections |