CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
GSK Biologicals' AS01B adjuvant +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00621322
NCT00621322Phase 2Completed

Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines (692342) When Administered to Healthy Adults Aged 18 to 45 Years.

GlaxoSmithKline·interventional·Posted Feb 22, 2008·Updated Aug 24, 2018

In Brief

A Phase 2 clinical trial evaluating GSK Biologicals' AS01B adjuvant, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1, and 4 other interventions for Tuberculosis. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesPhilippines
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2008
Enrollment StartApr 3, 2008
Primary CompletionApr 3, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.4 years ago

Interventions

GSK Biologicals' AS01B adjuvantbiological

Intramuscular injection, 2 doses

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

Intramuscular injection, 2 doses

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

Intramuscular injection, 2 doses

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

Intramuscular injection, 2 doses

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

Intramuscular injection, 2 doses

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

Intramuscular injection, 2 doses