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Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from The University of Texas Medical Branch, Galveston

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Aug 2027
    • Study completion pushed from Aug 2027 to Aug 2028
    • Eligibility criteria expanded, about 16 words
    • Publications: details revised at 1 of 1 entry
  2. 4 versions Re-verified since Oct 4, 2023, no change to tracked fieldsv3-v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2023 to Jan 18, 2023
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.
Trial Details
NCT Number NCT05672927
Lead Sponsor The University of Texas Medical Branch, Galveston
Collaborators: Cancer Prevention Research Institute of Texas
Conditions
(from sponsor)		 Immunization, HPV Infection, Human Papillomavirus
Related terms Papillomavirus Infections
Enrollment 618 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov