Actively Recruiting
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
Led by Shanghai Bovax Biotechnology Co., Ltd. · Updated on 2025-12-17
330
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.
CONDITIONS
Official Title
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 9-45 years
- Participants aged 18-45 who can provide legal identification; participants aged 9-17 and their guardian can provide legal identification
- Participants and/or their guardian sign an informed consent form
- Axillary temperature less than 37.3°C (>14 years old) or less than 37.5°C (≤14 years old) at enrollment
- Ability to comply with study protocol requirements
- Women of reproductive age use effective contraception within 2 weeks before enrollment, are not pregnant (negative blood pregnancy test), not lactating, and have no birth plans within 30 days after vaccination
- Agree to use effective contraception for 30 days after completing vaccination (methods include oral contraceptives, injections, implants, hormone patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps)
You will not qualify if you...
- Previous HPV vaccination or planned HPV vaccination during study
- Participation or planned participation in other clinical trials during the study; use of medication or vaccines within 3 months before enrollment
- History of positive HPV test (including types not covered by the vaccine) in participants aged 18-45
- History of cervical intraepithelial neoplasia grade 2 or higher, cervical cancer, or pelvic radiation therapy in females
- History of HPV-related external genital diseases or related cancers, or sexually transmitted diseases
- Diagnosed immunodeficiency, HIV/AIDS, severe autoimmune diseases
- History of convulsions or epilepsy (except febrile convulsions in children ≤5 years)
- History of severe allergy requiring medical intervention or severe vaccine allergy
- Severe diseases affecting vaccination eligibility (e.g., severe cardiovascular, liver, kidney disease, malignancy, serious infections)
- Untreated or uncontrolled hypertension
- Coagulation disorders
- Absence of spleen or functional spleen
- Use of immunosuppressive therapy within 1 month before first vaccination or planned during study
- Use of immunoglobulin or blood products within 3 months before first injection or planned during study
- Acute illness or exacerbation of chronic disease within 3 days before vaccination; use of fever reducers or antihistamines
- Receipt of other vaccines within 14 days before vaccination
- History or family history of mental disorders
- Plans to move or be unavailable during study visits
- Any condition that may interfere with study assessments as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China, 530028
Actively Recruiting
Research Team
D
Dabin Liang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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