RecruitingPhase 3NCT04422366

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

A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the 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


Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Enrollment

8,000 participants

Start Date

Apr 28, 2020

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 20 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of a 9-valent HPV vaccine (which protects against 9 strains of the human papillomavirus, a leading cause of cervical cancer) in Chinese women. You may be eligible if: - You are a Chinese woman between 20 and 45 years old - You are sexually active and have a valid ID - You have either never been screened for cervical cancer, or your past screening results were normal - You have not had sex, vaginal flushing, or used vaginal products for the required time before your gynecology visit - You have a negative pregnancy test and are not breastfeeding - You are using reliable contraception and do not plan to become pregnant during the study period - Your temperature is below 37.3°C at the time of enrollment You may NOT be eligible if: - You have received an HPV vaccine before or participated in an HPV vaccine trial - You have a previous history of abnormal cervical cells, cervical cancer, or genital lesions (such as genital warts, vulvar cancer, or vaginal cancer) - You have had a hysterectomy or pelvic radiation therapy - You have a history of seizures, severe allergic reactions, or significant immune system problems (such as HIV, lupus, leukemia, or other autoimmune diseases) - You have severe liver, kidney, heart, or other serious conditions - You have received a blood product or immune-suppressing medicine recently - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

BIOLOGICALGARDASIL®

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule


Locations(1)

Liuzhou center for disease control and prevention

Liuzhou, Guangxi, China

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NCT04422366


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