Actively Recruiting
Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years
Led by Shanghai Bovax Biotechnology Co., Ltd. · Updated on 2024-04-17
1200
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
S
Shanghai Bovax Biotechnology Co., Ltd.
Lead Sponsor
C
Chongqing Bovax Biopharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years
CONDITIONS
Official Title
Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Chinese females aged 9 to 45 years
- Provide legal identification
- Voluntarily agree to participate and sign informed consent (if minor, consent from legal guardian is required)
- Able to understand study procedures and commit to regular follow-ups
- Negative urine pregnancy test on enrollment day if of childbearing age
- Not breastfeeding and no birth plan within 7 months
- Use effective contraception or have no possibility of pregnancy as judged by investigator
- No fever on enrollment day (temperature limits differ by age)
- Received all 3 doses of the vaccine (for second stage participants aged 9 to 19 years)
You will not qualify if you...
- Received or plans to receive marketed HPV vaccine during study or enrolled in HPV vaccine trials
- History of HPV infection, cervical cancer, abnormal cervical biopsy, hysterectomy, pelvic radiotherapy, or HPV-related genital diseases
- History of sexually transmitted diseases such as syphilis, gonorrhea, genital herpes, and others
- Known allergy to vaccine components or history of severe allergic reactions
- Primary or acquired immunodeficiency or recent immunosuppressive treatment
- Chronic diseases or congenital malformations that may interfere with study
- Enrolled or planning to enroll in other clinical trials
- Infectious diseases such as TB, viral hepatitis, or HIV
- History of seizures, epilepsy, encephalopathy, mental illness, or family history
- Contraindications like thrombocytopenia or coagulopathy
- Asplenic or functionally asplenic status
- Acute illness or use of certain medications shortly before vaccination
- Recent receipt of other vaccines or blood products
- Fever symptoms on vaccination day
- Untreated or uncontrolled hypertension
- Plans to relocate or leave local area during study
- Any condition judged by investigator to interfere with study participation or evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huakun Lv
Hangzhou, China
Actively Recruiting
Research Team
H
Huakun Lv
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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