What is the 11-valent recombinant human papillomavirus vaccine studying for HPV infection?

This trial is studying how well the 11-valent HPV vaccine protects Chinese women from HPV infections and related cervical diseases. Researchers want to understand the vaccine's safety, immune response, and ability to prevent cervical lesions. The National Vaccine and Serum Institute in China is leading this study.

Who may be eligible for this HPV infection clinical trial?

Women aged 18 to 45 years with a history of sexual activity may be eligible. Participants should not have received an HPV vaccine before and must agree to use effective contraception during the study period. The trial only includes females who are not pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this HPV infection clinical trial?

Study-related care, including the vaccine or placebo and all trial visits, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years - 45Years

FEMALE

Healthy Volunteers

ID05262010

A Multicenter Randomized, Double-Blind, Placebo-Controlled Phase III Trial of an 11-valent Recombinant Human Papillomavirus Vaccine in Chinese Women Aged 9-45 Years

Led by National Vaccine and Serum Institute, China · Updated on 2026-01-16

13500

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus HPV vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccines ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia CIN and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

CONDITIONS

Brief Title

A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

Who Can Participate

Age: 18Years - 45Years

FEMALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Chinese women aged 18 to 45 years with a history of sexual activity
Axillary body temperature below 37.3°C on enrollment day
Ability to understand the trial and provide informed consent
Ability to read, understand, and complete study forms and attend follow-ups
No previous HPV vaccination and no plan to receive HPV vaccine during the study
Negative urine pregnancy test before vaccination
Use of effective contraception from the first day of last menstrual cycle and no plans to become pregnant for 7 months after enrollment
No vaginal drugs or preparations and no sexual activity 48 hours before gynecological sample collection

You will not qualify if you...

Abnormal blood pressure (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) before vaccination
Received immune globulin or blood products within 3 months before or planned within 7 months after enrollment
Received any vaccine within 14 days or live vaccine within 28 days before vaccination
Acute fever (≥ 38.5°C) or use of fever-reducing or allergy medications within 3 days before vaccination
History of severe allergic reactions requiring medical intervention
Immunodeficiency, HIV, lymphoma, leukemia, autoimmune diseases, or inflammatory sexually transmitted diseases
Planned or recent immunosuppressive therapy within 7 months after enrollment
Previous splenectomy or impaired spleen function
Severe liver, kidney, cardiovascular diseases, complicated diabetes, or cancer
History of epilepsy, convulsions, mental illness, or family history of mental illness
Blood clotting disorders contraindicating intramuscular injection
Participation in other clinical trials within 3 months before or during this study
Pregnancy, breastfeeding, or within 6 weeks postpartum at first vaccination
Menstruation at time of vaccination
Acute lower genital tract infection
History of abnormal cervical cancer screening or lesions
Past or current anal or genital diseases including cancers or warts
Previous hysterectomy, pelvic radiation, or severe cervical/vaginal dysplasia
Other factors affecting compliance or likely to affect study completion as judged by investigator
Meeting certain exclusion criteria at second or third dose may stop vaccination

Research Team

Zhaojun Mo

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