Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China
This protocol was developed to conduct population-wide surveillance of the bivalent HPV-16/18-AS04-adjuvanted human papillomavirus (HPV) vaccine in terms of uptake and safety outcomes including potential immune-mediated diseases (pIMDs) and pregnancy-related outcomes in China. The study will use ele...
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| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2378535 |
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| author | Junting Yang Sarah Welby Zhike Liu Siwei Deng Guangxu Liu Ruogu Meng Yu Yang Yixin Sun Yunkun He Ning Jiang Zhenhua Wu Keruo Liu Dominique Rosillon Catherine Cohet Siyan Zhan |
| author_facet | Junting Yang Sarah Welby Zhike Liu Siwei Deng Guangxu Liu Ruogu Meng Yu Yang Yixin Sun Yunkun He Ning Jiang Zhenhua Wu Keruo Liu Dominique Rosillon Catherine Cohet Siyan Zhan |
| author_sort | Junting Yang |
| collection | DOAJ |
| description | This protocol was developed to conduct population-wide surveillance of the bivalent HPV-16/18-AS04-adjuvanted human papillomavirus (HPV) vaccine in terms of uptake and safety outcomes including potential immune-mediated diseases (pIMDs) and pregnancy-related outcomes in China. The study will use electronic health records from 2010 to 2020 from the Yinzhou Regional Health Information Platform and include a population-based cohort of female permanent residents aged 9–45 years. Baseline and follow-up periods will be defined according to the 2017 introduction of HPV-16/18-AS04 in China. Patients with pIMDs and pregnancy-related outcomes will be identified using primary diagnostic codes from outpatient and inpatient electronic health records. A time trend analysis will be performed to describe the incidence of pIMDs and pregnancy-related outcomes during baseline and follow-up periods by age and overall, per calendar year. Depending on the number of safety outcomes and the size of the study population, incidence in vaccinated and unvaccinated cohorts will be compared using a Poisson regression model for pIMDs and a logistic regression model for pregnancy-related outcomes, adjusting for age and calendar year. Methods and findings from this study will provide valuable experience for designing future real-world studies and complement observations made during clinical trials and post-marketing studies.Study registration: http://www.chinadrugtrials.org.cn/index.html: CTR20210523. |
| format | Article |
| id | doaj-art-e0ecfa3e9b9e4e9f9c8ea9e240f6dd5c |
| institution | OA Journals |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-e0ecfa3e9b9e4e9f9c8ea9e240f6dd5c2025-08-20T02:12:24ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2378535Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, ChinaJunting Yang0Sarah Welby1Zhike Liu2Siwei Deng3Guangxu Liu4Ruogu Meng5Yu Yang6Yixin Sun7Yunkun He8Ning Jiang9Zhenhua Wu10Keruo Liu11Dominique Rosillon12Catherine Cohet13Siyan Zhan14Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaGSK, Wavre, BelgiumDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaNational Institute of Health Data Science, Peking University, Beijing, ChinaNational Institute of Health Data Science, Peking University, Beijing, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaGSK, Shanghai, ChinaGSK, Shanghai, ChinaGSK, Shanghai, ChinaGSK, Shanghai, ChinaGSK, Wavre, BelgiumGSK, Wavre, BelgiumDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaThis protocol was developed to conduct population-wide surveillance of the bivalent HPV-16/18-AS04-adjuvanted human papillomavirus (HPV) vaccine in terms of uptake and safety outcomes including potential immune-mediated diseases (pIMDs) and pregnancy-related outcomes in China. The study will use electronic health records from 2010 to 2020 from the Yinzhou Regional Health Information Platform and include a population-based cohort of female permanent residents aged 9–45 years. Baseline and follow-up periods will be defined according to the 2017 introduction of HPV-16/18-AS04 in China. Patients with pIMDs and pregnancy-related outcomes will be identified using primary diagnostic codes from outpatient and inpatient electronic health records. A time trend analysis will be performed to describe the incidence of pIMDs and pregnancy-related outcomes during baseline and follow-up periods by age and overall, per calendar year. Depending on the number of safety outcomes and the size of the study population, incidence in vaccinated and unvaccinated cohorts will be compared using a Poisson regression model for pIMDs and a logistic regression model for pregnancy-related outcomes, adjusting for age and calendar year. Methods and findings from this study will provide valuable experience for designing future real-world studies and complement observations made during clinical trials and post-marketing studies.Study registration: http://www.chinadrugtrials.org.cn/index.html: CTR20210523.https://www.tandfonline.com/doi/10.1080/21645515.2024.2378535HPV-16/18-AS04human papillomavirus vaccinesafetypotential immune-mediated diseasespregnancy outcomes |
| spellingShingle | Junting Yang Sarah Welby Zhike Liu Siwei Deng Guangxu Liu Ruogu Meng Yu Yang Yixin Sun Yunkun He Ning Jiang Zhenhua Wu Keruo Liu Dominique Rosillon Catherine Cohet Siyan Zhan Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China Human Vaccines & Immunotherapeutics HPV-16/18-AS04 human papillomavirus vaccine safety potential immune-mediated diseases pregnancy outcomes |
| title | Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China |
| title_full | Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China |
| title_fullStr | Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China |
| title_full_unstemmed | Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China |
| title_short | Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China |
| title_sort | monitoring the safety of the adjuvanted human papillomavirus vaccine hpv 16 18 as04 protocol for a cohort study using electronic health records in yinzhou china |
| topic | HPV-16/18-AS04 human papillomavirus vaccine safety potential immune-mediated diseases pregnancy outcomes |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2378535 |
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