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Due to on-site coordination issues and lack of cooperation from the research site staff, the study was withdrawn.
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| Name | Class |
|---|---|
| Center for Disease Control and Prevention of Yinzhou District, Ningbo City, China | UNKNOWN |
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | The subject who is receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine at the enrollment. |
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| Non-exposed group | The subject who does not have any HPV vaccination history at the enrollment or during the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Survey and Cervical Cancer Screening | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of high-risk HPV infection 12 other hr-HPV positive besides of type 16/18 | 12 other hr-HPV positive besides of type 16/18 infection is defined as at least one positive for HPV 31/33/35/39/45/51/52/56/58/59/66/68 or multiple types DNA PCR assay at enrollment (Month 0) or follow-up (Month 36) or any additional screenings during the study period. | up to 36 month |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36401179 | Derived | 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. |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002577 | Uterine Cervical Diseases |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Number of Participants with Any cervical lesions or diseases | Any cervical lesions or diseases is defined as atypical squamous cells of undefined significance (ASC-US), atypical glandular cells (AGC), atypical squamous cells, cannot exclude for highly squamous intraepithelial lesions (ASC-H), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), Cervical Intraepithelial Neoplasia (CIN) 1, CIN2, CIN3, squamous cell carcinoma (SCC), adenocarcinoma in situ (AIS) and adenocarcinoma (ADC). Any hr-HPV type infection is defined as at least one positive for HPV 16/18/31/33/35/39/45/51/52/56/58/59/66/68 or multiple types DNA PCR assay in the aforesaid cervical sample. | up to 36 month |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |