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Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Study description shortened, about 20 wordsv8
  2. Enrollment target: 150 to 155v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Apr 2028 to Jul 2028
    • Site details revised
    • Study title shortened, about 4 words
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Sep 2027 to Apr 2028
    • Study completion date: Dec 2027 to Dec 2028
    • Start date changed from estimate of Sep 2022 to Sep 26, 2022
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Start date: Jun 2022 to Sep 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).
Trial Details
NCT Number NCT05329961
Lead Sponsor Boston Medical Center
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Human Papilloma Virus
Enrollment 155 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov