Actively Recruiting
A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) 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
312 weeks
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
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
CONDITIONS
Official 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 37.36C on enrollment day
- Able to understand the clinical trial and voluntarily sign informed consent
- Able to read, understand, and complete study forms and follow-up visits
- No previous HPV vaccination and no plan to receive HPV vaccine during the study period (about 6 years)
- Negative urine pregnancy test on day before vaccination
- Using effective contraception from first day of last menstrual cycle to enrollment and no pregnancy planned within 7 months after enrollment
- No sexual activity or vaginal drug use within 48 hours before gynecological sample collection visits
You will not qualify if you...
- Abnormal blood pressure (systolic 64 140 mmHg or diastolic 64 90 mmHg) before vaccination
- Received immune globulin or blood products within 3 months before vaccination or planned within 7 months after enrollment
- Received any vaccine within 14 days before vaccination or live vaccine within 28 days
- Acute febrile illness (temperature 6538.56C) or use of certain drugs 3 days before vaccination
- History of severe allergies requiring medical intervention
- Immunocompromised or diagnosed with immunodeficiency, HIV, lymphoma, leukemia, autoimmune diseases
- Use of immunosuppressive therapy 1 month before or planned within 7 months after enrollment
- Previous splenectomy or impaired spleen function
- Severe liver, kidney, cardiovascular diseases, complicated diabetes, or malignant tumors
- History of epilepsy, convulsions, mental illness or family history of mental illness
- Thrombocytopenia or coagulation disorders contraindicating intramuscular injection
- Participation in other clinical studies within 3 months before vaccination or during study
- Pregnant, breastfeeding, or within 6 weeks postpartum at first dose
- Menstruating at vaccination visit
- Acute lower genital tract infection at gynecological exam
- History of abnormal cervical cancer screening or lesions
- Past or current anal or genital diseases like neoplasia or cancer
- Previous hysterectomy, pelvic radiation, or severe cervical/vaginal dysplasia
- Meet exclusion criteria 5, 6, 7, 8, 9, or 12 at 2nd or 3rd dose or other reasons per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here