Impact of HPV Vaccination on HPV Infection and Cervical Related Disease Burden in Real-World Settings (HPV-RWS)

NCT ID: NCT05341284

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2022-08-01

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 Regional Health Information Platform (YRHIP), in order to bridge the gap in relevant evidence in China.

Conditions

HPV Infection; Cervical Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed group

The subject who is receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine at the enrollment.

Questionnaire Survey and Cervical Cancer Screening

Intervention Type: OTHER

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.

Non-exposed group

The subject who does not have any HPV vaccination history at the enrollment or during the study period.

Questionnaire Survey and Cervical Cancer Screening

Intervention Type: OTHER

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.

Interventions

Questionnaire Survey and Cervical Cancer Screening

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Disease Control and Prevention of Yinzhou District, Ningbo City, China

UNKNOWN

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 36401179 (View on PubMed)

Other Identifiers

HPV-RWS

Identifier Type: -

Identifier Source: org_study_id