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Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

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

Record History

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  1. Secondary endpoints revised (16)v8
  2. Study title revisedv7
  3. 3 versions Re-verified since Feb 10, 2022, no change to tracked fieldsv4-v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 9000 to confirmed 9327
    • Site details revised at 2 of 2 sites
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women aged 18-45 years old.
Trial Details
NCT Number NCT04537156
Lead Sponsor Xiamen University
Collaborators: Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Conditions
(from sponsor)		 Cervical Intraepithelial Neoplasia, Cervical Cancer, Condylomata Acuminata
Related terms Condylomata Acuminata, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
Enrollment 9,327 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov