RecruitingPhase 3NCT05027776

Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Enrollment

1,348 participants

Start Date

Sep 15, 2021

Study Type

INTERVENTIONAL

Conditions

Vaginal Cancer CIN1 CIN2 CIN3 Genital Wart HPV Infections Cervical Cancer Stage IIa

Summary

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

Eligibility

Sex: FEMALEMin Age: 9 YearsMax Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and immune response (how well it protects against HPV) of the quadrivalent HPV vaccine in healthy Chinese females aged 9 to 26 years. HPV vaccination helps protect against several strains of the virus that can cause cervical cancer and genital warts. **You may be eligible if...** - You are a healthy Chinese female aged 9 to 26 years - You have a negative pregnancy test and are not breastfeeding - You are using adequate contraception or are not sexually active - You do not have a fever on the day of enrollment - You or your guardian (if you are a minor) agree to participate and sign consent **You may NOT be eligible if...** - You have already received an HPV vaccine - You are pregnant or planning to become pregnant within 7 months - You have a condition that weakens your immune system or are taking immunosuppressant medications - You have a current fever or acute illness 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

BIOLOGICAL2-doses Group among 9-14 years

Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.

BIOLOGICAL3-doses Group among 9-19 years

Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

BIOLOGICAL3-doses Group among 20-26 years

Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

Locations(1)

Center for Disease Control and Prevention

Mianyang, Sichuan, China

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NCT05027776

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