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Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults

NCT00397943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-06-19

Study results available
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Summary

This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.

Conditions

Interventions

BIOLOGICAL

GSK's candidate Mycobacterium tuberculosis vaccine 692342

Intramuscular injection, 2 doses at 0, 1 month

BIOLOGICAL

Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system

Intramuscular injection, 2 doses at 0, 1 month

BIOLOGICAL

Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline

Intramuscular injection, 2 doses at 0, 1 month

BIOLOGICAL

Control vaccine with the adjuvant system.

Intramuscular injection, 2 doses at 0, 1 month

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-15
Primary Completion
2009-12-01
Completion
2009-12-01

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT00397943 on ClinicalTrials.gov