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Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

NCT00621322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-08-24

Study results available
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Summary

This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' AS01B adjuvant

Intramuscular injection, 2 doses

BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1

Intramuscular injection, 2 doses

BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2

Intramuscular injection, 2 doses

BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3

Intramuscular injection, 2 doses

BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1

Intramuscular injection, 2 doses

BIOLOGICAL

GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2

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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-03
Primary Completion
2009-04-03
Completion
2009-04-03

Countries

  • Philippines

Study Locations

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Entities

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 NCT00621322 on ClinicalTrials.gov