Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa (MTBVACN3)
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
Sponsor: Biofabri, S.L
Listed as NCT04975178, this PHASE3 trial focuses on Tuberculosis and remains actively recruiting participants. Sponsored by Biofabri, S.L, it has been updated 7 times since 2022, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
7 versions recorded-
Mar 2025 — Present [monthly]
Recruiting PHASE3
-
Sep 2024 — Mar 2025 [monthly]
Recruiting PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
-
Nov 2023 — Jul 2024 [monthly]
Recruiting PHASE3
-
Nov 2022 — Nov 2023 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
▶ Show 2 earlier versions
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Sep 2022 — Nov 2022 [monthly]
Not Yet Recruiting PHASE3
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Sep 2021 — Sep 2022 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Biofabri, S.L
- Biomedical Research Center EPLS
- Institut Pasteur de Madagascar
- TuBerculosis Vaccine Initiative
- Universidad de Zaragoza
- University of Cape Town
- University of KwaZulu
- University of Stellenbosch
- Wits Health Consortium (Pty) Ltd
For direct contact, visit the study record on ClinicalTrials.gov .