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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)
Sponsor: Xiamen Innovax Biotech Co., Ltd
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.
Official title: A Single-center, Randomized, Double-blind, Phase IV Lot-to-lot Consistency Clinical Trial in 18-30 Years-old Females in China to Evaluate Immunogenicity and Safety of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)
Key Details
Gender
FEMALE
Age Range
18 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
720
Start Date
2026-05-26
Completion Date
2027-02-28
Last Updated
2026-06-25
Healthy Volunteers
Yes
Conditions
Interventions
9-valent HPV vaccine (Cecolin 9)
Recombinant human papillomavirus 9-valent (types 6/11/16/18/31/33/45/52/58) vaccine (Escherichia Coli) (Xiamen Innovax Biotech Co., Ltd., Xiamen, China)
Locations (1)
Zhangping Center for Disease Control and Prevention
Zhangping, Fujian, China