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Sponsors and Collaborators: |
GlaxoSmithKline Corixa Corporation |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00730795 |
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.
Condition | Intervention | Phase |
Tuberculosis (TB) |
Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342 |
Phase I |
MedlinePlus related topics: | Tuberculosis |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 12 |
Study Start Date: | January 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Group A: Experimental
Subjects receiving the low-dose antigen candidate TB vaccine
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Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)
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Group B: Experimental
Subjects receiving the high-dose antigen candidate TB vaccine
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Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |||||
GSK Clinical Trials Call Center | |||||
Tacoma, Washington, United States, 9843 |
GlaxoSmithKline |
Corixa Corporation |
Study Director: | Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 692342/001, CCTB001-01 |
First Received: | August 7, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00730795 |
Health Authority: | United States: Food and Drug Administration |
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