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Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease

Tuberculosis Clinical Trial

Official title:
Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 When Administered to Adults With TB Disease

Clinical Trial Summary

This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative adults who have received treatment for TB disease (denoted TB-treated cohort) or are currently receiving treatment for TB disease (denoted TB-treatment cohort). For comparative purposes, subjects who have never had TB disease (denoted TB-naïve cohort) will also be enrolled.

Clinical Trial Description

A Protocol Amendment 1, May 2012, was made following the decision to add a second country in the study (i.e. Estonia). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01424501
Study type Interventional
Source GlaxoSmithKline
Contact
Status Terminated
Phase Phase 2
Start date November 14, 2011
Completion date April 10, 2014
View Details
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