Clinical Trial

Lot-to-Lot Consistency Clinical Trial of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)

Recruiting Phase 4
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Summary
To support international market access and comply with World Health Organization Prequalification requirements, this lot-to-lot consistency trial is planned for initiation. The goal of this clinical trial is to evaluate lot-to-lot immunogenicity and safety of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli) in 18-30 years-old females in China. The main question it aims to answer is: · Is immunogenicity consistent across three commercially produced batches of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia coli)? Researchers will compare the immune responses at 1 month post full vaccination to see if the lot-to-lot consistency of immunogenicity can be achieved. Participants will: * Visit the clinic site on Month 0, 1, 2, 6 and 7. * Take 3 doses of investigational vaccine on Month 0, 1 and 6. * Provide approximately 5.0 mL venous blood samples on Month 0 and Month 7. * Keep a diary of their adverse events (AEs) within 30 days after each vaccination. * Report serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancies occurring during the trial.
Trial Details
NCT Number NCT07668271
Lead Sponsor Xiamen Innovax Biotech Co., Ltd
Conditions Infection by Human Papilloma Virus
Enrollment 720 participants
Start Date 2026-05-26
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-25