Actively Recruiting
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
8
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Vaccine and Serum Institute, China
Lead Sponsor
C
Chengdu Institute of Biological Products Co.,Ltd.
Collaborating Sponsor
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 vaccine's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive 3 doses of vaccine or placebo by intramuscular injection in the upper arm deltoid muscle according to the 0, 2, and 6 months immunization schedule.
3 visits (in-person) for vaccinations at months 0, 2, and 6
Duration - Up to 72 months after the full vaccination
Participants are monitored for safety, immune response, and incidence of related conditions after completing the vaccination schedule.
Multiple follow-up visits at 7 (1 month after first dose), 12, 24, 36, 48, 60, and 72 months after vaccination
Trial Site Locations
Total: 8 locations
1
Hechi Yizhou District Center for Disease Control and Prevention
Hechi, Guangxi, China, 546300
Not Yet Recruiting
2
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi, China, 542899
Not Yet Recruiting
3
Lianyuan Center for Disease Control and Prevention
Lianyuan, Hunan, China, 417100
Actively Recruiting
4
Qiyang Center for Disease Control and Prevention
Wuxi, Hunan, China, 426100
Actively Recruiting
5
Yongji Center for Disease Control and Prevention
Yongji, Shanxi, China, 044500
Not Yet Recruiting
6
Yuanqu Center for Disease Control and Prevention
Yuncheng, Shanxi, China, 043700
Not Yet Recruiting
7
Mianyang Youxian District Center for Disease Control and Prevention
Mianyang, Sichuan, China, 621000
Not Yet Recruiting
8
Neijiang Shizhong District Center for Disease Control and Prevention
Neijiang, Sichuan, China, 641000
Not Yet Recruiting
Research Team
Z
Zhaojun Mo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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