Randomised, Double-Blind, Controlled Phase 3 Trial to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Healthy HIV Unexposed (HU) and HIV Exposed Uninfected (HEU) Newborns in Tuberculosis-Endemic Regions of Sub-Saharan Africa

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 12 Oct 2023

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At a glance

Drugs MTBVAC (Primary) ; BCG vaccine
Indications Tuberculosis
Focus Therapeutic Use
Acronyms MTBVACN3
Sponsors Biofabri

Most Recent Events

06 Oct 2023 Planned number of patients changed from 6960 to 7120.
29 Sep 2023 Planned primary completion date changed from 1 Jun 2027 to 1 Jun 2028.
10 Oct 2022 Status changed from not yet recruiting to recruiting.

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