CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 487 enrolled
Drug / intervention
AERAS-402 1.5 x 10^10 vp +3 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/NCT01198366
NCT01198366Phase 2Completed
CompareCT.gov

A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis

Aeras·interventional·Posted Sep 10, 2010·Updated May 8, 2017

In Brief

A Phase 2 clinical trial evaluating AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, and 2 other interventions for Tuberculosis. Completed, enrolled 487 participants across 7 sites in 3 countries.

Detailed Summary

AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesKenya, Mozambique, South Africa
CollaboratorsEuropean and Developing Countries Clinical Trials Partnership (EDCTP)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.8 years ago

Interventions

AERAS-402 1.5 x 10^10 vpbiological

AERAS-402 3.0 x 10^10 vpbiological

AERAS-402 1.0 x 10^11 vpbiological

Placebobiological