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An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Jun 2026 to Oct 2026
    • Primary completion date changed from estimate of Apr 2026 to Apr 15, 2026
    v24
  2. Primary completion date: Jan 2026 to Apr 2026
    • Study completion date: Jan 2026 to Jun 2026
    v23
  3. Primary and study completion dates: Sep 2025 to Jan 2026v22
  4. Primary and study completion dates: Aug 2025 to Sep 2025v21
  5. Re-verified, no change to tracked fieldsv20
Show 18 earlier versionsHide 18 earlier versions
  1. Primary completion date: Dec 2024 to Aug 2025v19 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 360 to confirmed 352
    • Study completion date: Dec 2025 to Aug 2025
    • Site details revised
  2. Primary completion date: Oct 2024 to Dec 2024
    • Study completion date: Sep 2025 to Dec 2025
    v18
  3. Primary completion date: Sep 2024 to Oct 2024v17
  4. Primary completion date: Mar 2024 to Sep 2024
    • Study completion date: Mar 2025 to Sep 2025
    v16
  5. Study completion date: Mar 2024 to Mar 2025v15
  6. Primary and study completion dates: Sep 2023 to Mar 2024v14
  7. Primary and study completion dates: Dec 2022 to Sep 2023v13
  8. Primary and study completion dates: Feb 2022 to Dec 2022v12
  9. Primary completion date: Dec 2021 to Feb 2022
    • Study completion date: Apr 2022 to Feb 2022
    v11
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2020 to Dec 1, 2020
    • Collaborators expanded, about 5 words
    v10
  11. Start date: Nov 2020 to Dec 2020v9
  12. Start date: Oct 2020 to Nov 2020v8
  13. Start date: Aug 2020 to Oct 2020
    • Primary completion date: Oct 2021 to Dec 2021
    v7
  14. Study description revised
    • Publications: 7 to 11
    • Eligibility criteria expanded, about 2 words
    v6
  15. Start date: Jun 2020 to Aug 2020v5
  16. Start date: Apr 2020 to Jun 2020v4
  17. Primary completion date: Sep 2021 to Oct 2021
    • Study completion date: Mar 2022 to Apr 2022
    • Start date: Mar 2020 to Apr 2020
    • Study description shortened, about 45 words
    v3
  18. Start date: Feb 2020 to Mar 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.
Trial Details
NCT Number NCT04206813
Lead Sponsor Boston Medical Center
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 HPV Infection
Related terms Papillomavirus Infections
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov