RecruitingPhase 3NCT04895020

Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus(Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial


Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Enrollment

1,200 participants

Start Date

May 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years


Eligibility

Sex: FEMALEMin Age: 9 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether the 9-valent HPV (human papillomavirus) vaccine provides the same level of immune protection in younger Chinese females (ages 9–19) compared to older women (ages 20–45). If results show similar immunity, the vaccine could be approved for use in younger age groups in China. **You may be eligible if...** - You are a healthy Chinese female between 9 and 45 years old (for the first stage) or 9–19 years old (for the second stage) - You are willing to participate and, if a minor, your legal guardian also consents - You have a negative pregnancy test on the day of enrollment (if of childbearing age) - You are using effective contraception or are not sexually active - You have received all 3 doses of the trial vaccine (for the second stage) **You may NOT be eligible if...** - You have previously received an HPV vaccine or plan to receive one during the study - You have a history of HPV infection, cervical cancer, abnormal pap smears, or hysterectomy - You have had pelvic radiation - You are pregnant, breastfeeding, or planning a pregnancy within 7 months - You have a fever on the day of enrollment 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 HPV vaccine

9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule


Locations(1)

Huakun Lv

Hangzhou, China

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NCT04895020


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