NCT00291889

Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.

Evaluate the Safety, Reactogenicity & Immunogenicity of 2 Antigen Dose Levels of GSK Biologicals' Candidate Tuberculosis Vaccine, Mtb72F/AS02 to Healthy PPD-negative Volunteers Aged 18 to 45 Yrs

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.

Detailed description

The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers will receive the vaccine alone without an immunostimulant and 1 control group will receive the adjuvant (AS02) alone to assess the true effect of the candidate tuberculosis vaccine (Mtb72F/AS02).

Conditions

• Tuberculosis (TB)

Interventions

Type	Name	Description
BIOLOGICAL	Mtb72F/AS02.

Timeline

• Start date: 2004-07-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2006-02-15
• Last updated: 2017-05-30

Locations

1 site across 1 country: Belgium