Status:
WITHDRAWN
Impact of HPV Vaccination on HPV Infection and Cervical Related Disease Burden in Real-World Settings (HPV-RWS)
Lead Sponsor:
Peking University
Collaborating Sponsors:
Center for Disease Control and Prevention of Yinzhou District, Ningbo City, China
GlaxoSmithKline
Conditions:
HPV Infection
Cervical Disease
Eligibility:
FEMALE
9-45 years
Brief Summary
Take AS04 adjuvanted HPV16/18 vaccine as an example to evaluate the impact of HPV vaccination on HPV infection and related disease burden in the real world based on prospective cohort and Yinzhou Regi...
Eligibility Criteria
Inclusion
- Permanent female resident in the Yinzhou District (i.e. at least residing in the Yinzhou District for a 3-year period and at least 6months in every 12-month period).
- Between 9 and 45 years old at time of the enrollment.
- Receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine (exposed group). Or without any HPV vaccination history (non-exposed group).
- Subjects and their parents / legal guardians agreed to comply with the requirements mentioned in the protocol (e.g., physically and mentally healthy, be able to complete the baseline and follow-up survey and would comply with the visits, etc.).
- Written informed consent will be obtained from the subject. For subjects who are below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject according to EC requirement as well as local law. Subjects must understand the protocol and be voluntarily willing to join this study with written informed consent form.
Exclusion
- Pregnancy at the enrollment.
- Females with historical cervical diseases (i.e., CIN1, CIN2, CIN3, and cervical cancer) before the recruitment.
- After hysterectomy.
- Females with malignant tumor history or other severe diseases (e.g., liver failure, heart failure, etc.) whose life expectancy is less than 12 months.
- Females who (1) have historical HPV vaccination, or (2) are in non-exposed groups but have clear intention for HPV vaccination in next 3 years.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05341284
Start Date
August 1 2022
End Date
August 1 2022
Last Update
August 14 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.