Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020
Following the approval of Cervarix for the immunization of girls and women in China against high-risk human papillomavirus types 16 and 18, a non-interventional post-authorization safety study was performed. A multi-center prospective cohort study assessed safety following Cervarix vaccination of Ch...
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Taylor & Francis Group
2023-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2023.2283912 |
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| author | Qianhui Wu Mengcen Qian Sarah Welby Adrienne Guignard Dominique Rosillon Kusuma Gopala Yuan Xu Keruo Liu Yunkun He Ning Jiang Qin Tan Jiamin Xie Taoying Zhu Qizhang Wang Yingzi Pan Ruikun Zeng Jie Yang Xiaoqian Zhao Man Zhou Adoración Navarro-Torné Hongjie Yu Dorota Borys |
| author_facet | Qianhui Wu Mengcen Qian Sarah Welby Adrienne Guignard Dominique Rosillon Kusuma Gopala Yuan Xu Keruo Liu Yunkun He Ning Jiang Qin Tan Jiamin Xie Taoying Zhu Qizhang Wang Yingzi Pan Ruikun Zeng Jie Yang Xiaoqian Zhao Man Zhou Adoración Navarro-Torné Hongjie Yu Dorota Borys |
| author_sort | Qianhui Wu |
| collection | DOAJ |
| description | Following the approval of Cervarix for the immunization of girls and women in China against high-risk human papillomavirus types 16 and 18, a non-interventional post-authorization safety study was performed. A multi-center prospective cohort study assessed safety following Cervarix vaccination of Chinese girls and women aged 9–45 years between 31 May 2018 and 3 December 2020. Adverse events following immunization (AEFIs), potential immune-mediated diseases (pIMDs), and pregnancy-related outcomes were collected up to 12 months from the third immunization or 24 months from the first immunization, whichever came first. Among 3,013 women who received 8,839 Cervarix doses, 167 (5.5%) reported ≥ 1 any AEFI, and 22 (0.7%) reported 40 serious AEFIs. During the 30 days after each dose, 147 women (4.9%) reported 211 medically attended AEFIs, including 3 serious AEFIs reported by 1 woman (0.03%). One woman reported a pIMD. Cervarix was inadvertently administered to 65 women (2.2%) within 60 days before conception or during pregnancy. Of these women, 34 (52.3%) gave birth to live infant(s) with no apparent congenital anomalies, and 1 (1.5%) woman gave birth to a live infant with a congenital anomaly. No serious AEFIs or pIMDs were considered to be related to the vaccination. In Chinese women aged 9–45 years, immunization with the Cervarix three-dose schedule was well tolerated. Overall, no safety concerns were identified, although rare adverse events may have been missed due to the study sample size.Clinical trial registration: NCT03438006. |
| format | Article |
| id | doaj-art-013c2edcdc94474787ebcf0c03e3a739 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-013c2edcdc94474787ebcf0c03e3a7392025-08-20T03:26:39ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2023-12-0119310.1080/21645515.2023.2283912Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020Qianhui Wu0Mengcen Qian1Sarah Welby2Adrienne Guignard3Dominique Rosillon4Kusuma Gopala5Yuan Xu6Keruo Liu7Yunkun He8Ning Jiang9Qin Tan10Jiamin Xie11Taoying Zhu12Qizhang Wang13Yingzi Pan14Ruikun Zeng15Jie Yang16Xiaoqian Zhao17Man Zhou18Adoración Navarro-Torné19Hongjie Yu20Dorota Borys21Key Laboratory of Public Health Safety, Ministry of Education, Fudan University, Shanghai, ChinaKey Laboratory of Public Health Safety, Ministry of Education, Fudan University, Shanghai, ChinaGSK, Wavre, BelgiumGSK, Wavre, BelgiumGSK, Wavre, BelgiumGSK, Bangalore, IndiaGSK, Wuhan, ChinaGSK, Shanghai, ChinaGSK, Shanghai, ChinaGSK, Shanghai, ChinaShunde District Center for Disease Control and Prevention, Guangdong, ChinaShunde District Center for Disease Control and Prevention, Guangdong, ChinaWuhou District Center for Disease Control and Prevention, Sichuan, ChinaPudong New Area Center for Disease Control and Prevention, Shanghai, ChinaWujin District Center for Disease Control and Prevention, Jiangsu, ChinaLonggang District Center for Disease Control and Prevention, Guangdong, ChinaLuohu District Center for Disease Control and Prevention, Guangdong, ChinaTaocheng District Center for Disease Control and Prevention, Hebei, ChinaXicheng District Center for Disease Control and Prevention, Beijing, ChinaGSK, Wavre, BelgiumKey Laboratory of Public Health Safety, Ministry of Education, Fudan University, Shanghai, ChinaGSK, Wavre, BelgiumFollowing the approval of Cervarix for the immunization of girls and women in China against high-risk human papillomavirus types 16 and 18, a non-interventional post-authorization safety study was performed. A multi-center prospective cohort study assessed safety following Cervarix vaccination of Chinese girls and women aged 9–45 years between 31 May 2018 and 3 December 2020. Adverse events following immunization (AEFIs), potential immune-mediated diseases (pIMDs), and pregnancy-related outcomes were collected up to 12 months from the third immunization or 24 months from the first immunization, whichever came first. Among 3,013 women who received 8,839 Cervarix doses, 167 (5.5%) reported ≥ 1 any AEFI, and 22 (0.7%) reported 40 serious AEFIs. During the 30 days after each dose, 147 women (4.9%) reported 211 medically attended AEFIs, including 3 serious AEFIs reported by 1 woman (0.03%). One woman reported a pIMD. Cervarix was inadvertently administered to 65 women (2.2%) within 60 days before conception or during pregnancy. Of these women, 34 (52.3%) gave birth to live infant(s) with no apparent congenital anomalies, and 1 (1.5%) woman gave birth to a live infant with a congenital anomaly. No serious AEFIs or pIMDs were considered to be related to the vaccination. In Chinese women aged 9–45 years, immunization with the Cervarix three-dose schedule was well tolerated. Overall, no safety concerns were identified, although rare adverse events may have been missed due to the study sample size.Clinical trial registration: NCT03438006.https://www.tandfonline.com/doi/10.1080/21645515.2023.2283912ChinaHPV-16/18 AS04-adjuvanted vaccinehuman papillomaviruspost-marketingpregnancysafety |
| spellingShingle | Qianhui Wu Mengcen Qian Sarah Welby Adrienne Guignard Dominique Rosillon Kusuma Gopala Yuan Xu Keruo Liu Yunkun He Ning Jiang Qin Tan Jiamin Xie Taoying Zhu Qizhang Wang Yingzi Pan Ruikun Zeng Jie Yang Xiaoqian Zhao Man Zhou Adoración Navarro-Torné Hongjie Yu Dorota Borys Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020 Human Vaccines & Immunotherapeutics China HPV-16/18 AS04-adjuvanted vaccine human papillomavirus post-marketing pregnancy safety |
| title | Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020 |
| title_full | Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020 |
| title_fullStr | Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020 |
| title_full_unstemmed | Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020 |
| title_short | Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018–2020 |
| title_sort | prospective multi center post marketing surveillance cohort study to monitor the safety of the human papillomavirus 16 18 as04 adjuvanted vaccine in chinese girls and women aged 9 to 45 years 2018 2020 |
| topic | China HPV-16/18 AS04-adjuvanted vaccine human papillomavirus post-marketing pregnancy safety |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2023.2283912 |
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