Actively Recruiting
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
Led by Shanghai Bovax Biotechnology Co., Ltd. · Updated on 2024-04-17
1348
Participants Needed
1
Research Sites
262 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 Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years
CONDITIONS
Official Title
Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Chinese females aged 9 to 26 years with legal identification
- Voluntary agreement to enroll with informed consent (including guardian consent for minors)
- Negative urine pregnancy test on enrollment day for those of childbearing age
- Not breastfeeding and no birth plan within 7 months
- Use of effective contraception or judged by investigator as having no pregnancy possibility
- No fever on enrollment day (temperature limits depend on age)
- Ability to understand study procedures and commit to regular follow-ups
You will not qualify if you...
- Previous or planned receipt of marketed HPV vaccines or participation in HPV vaccine clinical trials
- Enrollment or planned enrollment in other drug or vaccine clinical trials
- History of positive HPV test, cervical cancer, abnormal cervical biopsy, or pelvic radiotherapy
- History of HPV-related diseases or sexually transmitted diseases
- Known allergy to vaccine components or history of severe allergic diseases
- Primary or acquired immunodeficiency diseases
- History of epilepsy or convulsions (except febrile convulsions under age 5)
- Existing infectious diseases like TB, viral hepatitis, HIV, liver or kidney conditions, cardiovascular diseases, or malignancy
- Untreated or uncontrolled hypertension as defined by age-specific blood pressure thresholds
- Contraindications such as thrombocytopenia or coagulopathy
- Asplenia or functional asplenia
- Recent or planned immunosuppressive treatments or immune globulin/blood product receipt within specified timeframes
- Acute illness or recent use of antipyretic, analgesic, or anti-allergic drugs before vaccination
- Recent receipt of other vaccines within specified timeframes
- Existing or family history of mental illness
- Any condition interfering with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center for Disease Control and Prevention
Mianyang, Sichuan, China
Actively Recruiting
Research Team
T
Ting Huang
CONTACT
J
Ji Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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