Sponsor study identifier
observational
0
0 countries
N/A
Study Start
August 1, 2022
Actual (reported)Primary Completion
August 1, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)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 Regional Health Information Platform (YRHIP), in order to bridge the gap in relevant evidence in China.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 29, 2022
Actual (reported)April 22, 2022
Actual (reported)August 1, 2022
Actual (reported)August 1, 2022
Actual (reported)August 1, 2022
Actual (reported)Number of Participants with Cervical infection with HPV-16 and/or HPV-18 (by PCR)
HPV-16 and/or HPV-18 infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at enrollment (Month 0) or follow-up (Month 36) or any additional screenings during the study period.
up to 36 month
The occurrence of high-risk HPV infection 12 other hr-HPV positive besides of type 16/18
up to 36 month
Number of Participants with Any cervical lesions or diseases
up to 36 month
The subject who is receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine at the enrollment.
The subject who does not have any HPV vaccination history at the enrollment or during the study period.
A brief questionnaire will be administered to all participants at enrollment and at the pre-scheduled follow-up visit at Month 36. For the subject who are eligible for the screening (i.e. (1)≥ 18 years old; (2) had sexual debut prior to enrollment, (3) no contradiction to the screening, (4) voluntary to the screening) will be referred to the study site hospitals by offering the subjects a cervical cancer screening voucher, and the type-specific HPV test will be performed as primary screening approach at Month 0 and 36.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study will enroll the permanent female residents between 9 to 45 years old in the Yinzhou District, with AS04 adjuvanted HPV 16/18 vaccination history or without any HPV vaccination history.
Liu Z, Li P, Zeng X, Yao X, Sun Y, Lin H, Shen P, Sun F, Zhan S. Impact of HPV vaccination on HPV infection and cervical related disease burden in real-world settings (HPV-RWS): protocol of a prospective cohort. BMC Public Health. 2022 Nov 18;22(1):2117. doi: 10.1186/s12889-022-14474-1.
0 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2022
First Posted
April 22, 2022
Study Start
August 1, 2022
Actual (reported)Phase I Clinical Trial of a Candidate HPV Vaccine
Contact the study team to confirm eligibility.
Primary Completion
August 1, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)Last Updated
August 14, 2025
Record last verified: 2022-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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