CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 240 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.

Search/NCT01262976
NCT01262976Phase 2Completed
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Safety and Immunogenicity of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to HIV-positive Adults Living in a Tuberculosis Endemic Region

GlaxoSmithKline·interventional·Posted Dec 20, 2010·Updated Sep 17, 2018

In Brief

A Phase 2 clinical trial evaluating GSK's investigational vaccine 692342 and Physiological saline for Tuberculosis. Completed, enrolled 240 participants across 1 site.

Detailed Summary

The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis endemic region. Subjects will be followed-up for 3 years. Subjects will be enrolled in 3 cohorts: * HIV-positive adults on highly active antiretroviral therapy * HIV-positive adults not on highly active antiretroviral therapy * HIV-negative adults Each cohort will have 2 groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesIndia
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2010
Enrollment StartJan 17, 2011
Primary CompletionJul 17, 2012
Study CompletionJun 4, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.5 years ago

Interventions

GSK's investigational vaccine 692342biological

Intramuscular, 2 doses

Physiological salinebiological

Intramuscular, 2 doses