deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03891758

Confirmatory Study of BK1310 in Healthy Infants

Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

Sponsor: Tanabe Pharma Corporation

Updated 13 times since 2019 Last updated: Dec 15, 2025 Started: Apr 1, 2019 Primary completion: Sep 18, 2019 Completion: Aug 10, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03891758, this PHASE3 trial focuses on Bacterial Meningitis and Diphtheria and remains completed. Sponsored by Tanabe Pharma Corporation, it has been updated 13 times since 2019, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jul 2019 · 2 months · monthly snapshot~Jul 2019 – ~Dec 2019 · 5 months · monthly snapshot~Dec 2019 – ~Jun 2020 · 6 months · monthly snapshot~Jun 2020 – ~Dec 2020 · 6 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – ~Jan 2026 · 4 months · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – present · 6 months · monthly snapshot

Change History

13 versions recorded
  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Jan 2026 — Feb 2026 [monthly]

    Completed PHASE3

  3. Sep 2025 — Jan 2026 [monthly]

    Completed PHASE3

  4. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE3

  5. Sep 2024 — Feb 2025 [monthly]

    Completed PHASE3

Show 8 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  2. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  3. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Jun 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2019 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  6. Jul 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  7. May 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  8. Apr 2019 — May 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tanabe Pharma Corporation
  • The Research Foundation for Microbial Diseases of Osaka University
Data source: Tanabe Pharma Corporation

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

Study Locations