Actively Recruiting
Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
Led by Shanghai Bovax Biotechnology Co., Ltd. · Updated on 2024-06-07
8000
Participants Needed
1
Research Sites
489 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .
CONDITIONS
Official Title
Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese women aged 20 to 45 years who can provide legal identification and have a sexual history
- Fully understand the study procedures, risks, and benefits, and voluntarily sign informed consent
- Able to read, understand, and fill in diary and contact forms and participate in follow-up as required
- Have not been screened for cervical cancer or have normal cervical cancer screening results
- Agree to avoid sexual activity for 48 hours and vaginal flushing, cleansing, or medication for 72 hours before gynecological visits
- Negative urine pregnancy test at enrollment, not breastfeeding, and agree to use effective contraception for 7 months after enrollment
- Body temperature below 37.3°C (underarm)
You will not qualify if you...
- Previously vaccinated with any HPV vaccine or participated in HPV vaccine trials
- History of HPV infection or abnormal cervical cytology including certain squamous or glandular abnormalities
- History of anal or genital diseases such as vulvar, vaginal, or anal intraepithelial neoplasia or cancer
- Received total hysterectomy or pelvic radiotherapy
- Cervical insufficiency or abnormal cervical structure
- History of sexually transmitted infections or visible genital warts
- History of seizures, convulsions, or family history of mental illness
- Participation in other gynecology-related clinical trials within past 6 months or use of investigational products within 3 months
- History of severe allergies or adverse reactions to vaccines or vaccine components
- Received immunoglobulin or blood product within 3 months or plans to within 7 months
- Immune impairments or autoimmune diseases
- Immunosuppressant therapy within 1 month before first dose or planned during study
- Absence or dysfunction of spleen
- Severe liver, kidney, cardiovascular diseases, diabetes, or malignancies with complications
- Coagulation disorders contraindicating intramuscular injection
- Recent vaccination with inactivated or recombinant vaccines within 14 days or live vaccines within 28 days
- Acute illness or chronic illness flare requiring medication within 3 days prior to vaccination
- Pregnancy at vaccination or within 6 weeks post-pregnancy
- Fever or menstrual period at vaccination
- Severe vaginitis or cervicitis with visible purulent secretion
- High blood pressure before first vaccination
- Suspected genital warts or precancerous/cancerous genital lesions
- Unable to comply with study procedures or plans to relocate permanently
- Investigator judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Liuzhou center for disease control and prevention
Liuzhou, Guangxi, China
Actively Recruiting
Research Team
Y
Yi Mo, Master
CONTACT
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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