At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 301 enrolled
Drug / intervention
GSK's investigational vaccine 692342 +4 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 Infants
In Brief
A Phase 2 clinical trial evaluating GSK's investigational vaccine 692342, Tritanrix™ HB+Hib, and 3 other interventions for Tuberculosis. Completed, enrolled 301 participants across 1 site.
Detailed Summary
This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesThe Gambia
CollaboratorsAeras
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartJul 2010
Primary CompletionApr 2011
Study CompletionMar 2012
TodayJul 2026
First PostedApr 2, 2010
Enrollment StartJul 7, 2010
Primary CompletionApr 30, 2011
Study CompletionMar 16, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.3 years ago
Interventions
GSK's investigational vaccine 692342biological
Intramuscular, 1 or 2 doses
Tritanrix™ HB+Hibbiological
Intramuscular, 3 doses
Prevnar™biological
Intramuscular, 3 doses
Polio Sabin™biological
Oral, 3 doses
Menjugate™biological
Intramuscular, 3 doses