CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
GSK Biologicals' investigational TB vaccine GSK 692342biological
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/NCT01669096
NCT01669096Phase 2Completed
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Evaluation of the Kinetics of mRNA Expression After Two Doses of GSK Biologicals' Candidate Tuberculosis (Tuberculosis) Vaccine GSK 692342 in Healthy Adults

GlaxoSmithKline·interventional·Posted Aug 20, 2012·Updated Mar 22, 2019

In Brief

A Phase 2 clinical trial evaluating GSK Biologicals' investigational TB vaccine GSK 692342 for Tuberculosis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule. In, addition, blood samples collected at different time points after vaccination will be analysed to see when exactly genes are activated by the vaccine using an assay called mRNA expression profiling. The different methods for mRNA expression profiling using whole blood samples versus Peripheral Blood Mononuclear cell(s) (PBMCs), will also be compared.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesBelgium
CollaboratorsAeras

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 20, 2012
Enrollment StartAug 21, 2012
Primary CompletionDec 6, 2012
Study CompletionMay 24, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.9 years ago

Interventions

GSK Biologicals' investigational TB vaccine GSK 692342biological

2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm