deltatrials
Completed PHASE3 INTERVENTIONAL 5-arm NCT04508309

Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls

Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries

Sponsor: Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA

Conditions Cervical Cancer
Interventions Cecolin® Gardasil®
Updated 12 times since 2020 Last updated: Dec 11, 2024 Started: Mar 15, 2021 Primary completion: Dec 14, 2023 Completion: Dec 14, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04508309, this PHASE3 trial focuses on Cervical Cancer and remains completed. Sponsored by Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA, it has been updated 12 times since 2021, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotNot Yet Recruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotNot Yet Recruiting~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshotNot Yet Recruiting~Apr 2021 – ~Nov 2021 · 7 months · monthly snapshotRecruiting~Nov 2021 – ~Mar 2022 · 4 months · monthly snapshotRecruiting~Mar 2022 – ~May 2022 · 2 months · monthly snapshotActive Not Recruiting~May 2022 – ~Dec 2023 · 19 months · monthly snapshotActive Not Recruiting~Dec 2023 – ~Feb 2024 · 2 months · monthly snapshotActive Not Recruiting~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshotCompleted~Feb 2025 – present · 18 months · monthly snapshotCompleted

Change History

12 versions recorded

  1. Feb 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Feb 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Dec 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

▶ Show 7 earlier versions

  1. May 2022 — Dec 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Mar 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  3. Nov 2021 — Mar 2022 [monthly]

    Recruiting PHASE3

  4. Apr 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  5. Mar 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE3

  6. Jan 2021 — Mar 2021 [monthly]

    Not Yet Recruiting PHASE3

  7. Sep 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Malaria Research Centre, Agogo Presbyterian Hospital, Ghana
  • PATH
  • The Emmes Company, LLC
  • Xiamen Innovax Biotech Co., Ltd
Data source: PATH

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

Study Locations