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A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Mar 31, 2025 to Apr 11, 2025
    • Site contacts updated at 4 of 4 sites
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in Chinese males aged 18-45 years.
Trial Details
NCT Number NCT06866574
Lead Sponsor Xiamen University
Collaborators: Xiamen Innovax Biotech Co., Ltd
Conditions
(from sponsor)		 Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Penile/Perianal/Perineal Cancer, Anal Cancer, Genital Warts
Related terms Anus Neoplasms, Condylomata Acuminata
Enrollment 9,300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov