Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults (MTBVAC-Ph1b)
A Randomized, Double-blind, Dose-escalation Clinical Trial of the Safety, Reactogenicity and Immunogenicity of MTBVAC Compared to BCG Vaccine SSI, in Newborns Living in a Tuberculosis Endemic Region With a Safety Arm in Adults
Sponsor: Biofabri, S.L
This PHASE1/PHASE2 trial investigates Tuberculosis and is currently completed. Biofabri, S.L leads this study, which shows 6 recorded versions since 2015 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
Status: Active Not Recruiting → Completed
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Jul 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE1_PHASE2
▶ Show 1 earlier version
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Jan 2017 — Jul 2017 [monthly]
Active Not Recruiting PHASE1_PHASE2
First recorded
Sep 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Biofabri, S.L
- South African Tuberculosis Vaccine Initiative
- Triclinium Clinical Trial Project Management (Pty) Ltd.
- TuBerculosis Vaccine Initiative
- Universidad de Zaragoza
For direct contact, visit the study record on ClinicalTrials.gov .