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

NCT01424501 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-08-20

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' investigational TB vaccine GSK 692342

Intramuscular injection, 2 doses

BIOLOGICAL

Placebo

Intramuscular injection, 2 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-14
Primary Completion
2014-04-01
Completion
2014-04-10

Countries

  • Estonia
  • Taiwan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424501 on ClinicalTrials.gov