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Recruiting Phase 3 NCT04422366

Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

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Plain-language summary for patients

Trial Parameters

Condition Cervical Cancer
Sponsor Shanghai Bovax Biotechnology Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 8,000
Sex FEMALE
Min Age 20 Years
Max Age 45 Years
Start Date 2020-04-28
Completion 2027-09-15
Interventions
9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)GARDASIL®

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Brief Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .

Eligibility Criteria

Inclusion Criteria: (If the "\*" option is not met during screening, the visit can be rescheduled) * Chinese women aged 20-45 who can provide legal identification and have a sexual life history; * The subject fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent; * Subjects are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in follow-up according to the study requirements; * Subjects have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal; * \*0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to refrain from sexual intercourse (including anal, vaginal, or genital/genital contact of the same or opposite sex) for 48 hours prior to any visit that inc

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