deltatrials
Completed PHASE2 INTERVENTIONAL 4-arm NCT03536117

Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates (MTBVAC-03)

Phase 2a Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates Living in a High-Burden Tuberculosis-Endemic Region

Sponsor: Biofabri, S.L

Conditions Tuberculosis
Interventions BCG MTBVAC
Updated 11 times since 2018 Last updated: Apr 23, 2025 Started: Feb 12, 2019 Primary completion: May 17, 2022 Completion: May 17, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03536117, this PHASE2 trial focuses on Tuberculosis and remains completed. Sponsored by Biofabri, S.L, it has been updated 11 times since 2019, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotNot Yet Recruiting~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshotNot Yet Recruiting~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshotNot Yet Recruiting~Mar 2019 – ~Jan 2021 · 22 months · monthly snapshotRecruiting~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshotRecruiting~Jun 2021 – ~Sep 2022 · 15 months · monthly snapshotActive Not Recruiting~Sep 2022 – ~Jul 2023 · 10 months · monthly snapshotCompleted~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~May 2025 · 8 months · monthly snapshotCompleted~May 2025 – present · 14 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. May 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — May 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jul 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Sep 2022 — Jul 2023 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

Show 6 earlier versions
  1. Jun 2021 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  2. Jan 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  3. Mar 2019 — Jan 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  4. Feb 2019 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE2

  5. Jan 2019 — Feb 2019 [monthly]

    Not Yet Recruiting PHASE2

  6. Jun 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Biofabri, S.L
  • South African Tuberculosis Vaccine Initiative
  • TuBerculosis Vaccine Initiative
  • Universidad de Zaragoza
Data source: Biofabri, S.L

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations