CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3,575 enrolled
Drug / intervention
GSK Biologicals' investigational TB vaccine (GSK692342) +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/NCT01755598
NCT01755598Phase 2Completed
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Efficacy of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 Against TB Disease, in Adults Living in a TB Endemic Region

GlaxoSmithKline·interventional·Posted Dec 24, 2012·Updated Dec 3, 2019

In Brief

A Phase 2 clinical trial evaluating GSK Biologicals' investigational TB vaccine (GSK692342) and Placebo for Tuberculosis and Tuberculosis Vaccines. Completed, enrolled 3,575 participants across 9 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the protective efficacy of two doses of GSK Biologicals' candidate TB vaccine against pulmonary TB, as compared to placebo. The efficacy will be evaluated in adults living in TB endemic countries and aged 18 - 50 years because pulmonary TB occurs frequently in these countries and age range. In addition, the safety and immunogenicity of the candidate tuberculosis vaccine will be evaluated in a subset of volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Tuberculosis Vaccines
CountriesKenya, South Africa, Zambia
CollaboratorsAeras

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2012
Enrollment StartAug 19, 2014
Primary CompletionNov 16, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 13.5 years ago

Interventions

GSK Biologicals' investigational TB vaccine (GSK692342)biological

2 doses administered intramuscularly in the deltoid region of the arm.

Placebobiological

2 doses administered intramuscularly in the deltoid region of the arm.