At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
GSK's investigational vaccine 692342 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy HIV-negative Adolescents Living in a TB Endemic Region
In Brief
A Phase 2 clinical trial evaluating GSK's investigational vaccine 692342 and Placebo for Tuberculosis. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesSouth Africa
CollaboratorsAeras
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartDec 2009
Primary CompletionSep 2010
TodayJul 2026
First PostedAug 3, 2009
Enrollment StartDec 8, 2009
Primary CompletionSep 30, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.9 years ago
Interventions
GSK's investigational vaccine 692342biological
Intramuscular injection, 2 doses
Placebobiological
Intramuscular injection, 2 doses