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Tracking Information | |||||
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First Received Date † | February 14, 2006 | ||||
Last Updated Date | February 6, 2007 | ||||
Start Date † | July 2004 | ||||
Current Primary Outcome Measures † |
Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00291889 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Immunogenicity as assessed by humoral and CMI response. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety and Immunogenicity of GSK Biological’s Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-Negative Adults. | ||||
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 | ||||
Brief Summary | 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. |
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Detailed Description | 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). |
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Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study | ||||
Condition † | Tuberculosis | ||||
Intervention † | Biological: Mtb72F/AS02. | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 50 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Gender | Both | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Belgium | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00291889 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | February 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |