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
机构：[1]Key Laboratory of Public Health Safety, Ministry of Education, Fudan University, Shanghai, China.[2]Key Laboratory of Health Technology Assessment, Ministry of Health, Fudan University, Shanghai, China.[3]GSK, Wavre, Belgium.[4]GSK, Bangalore, India.[5]GSK, Wuhan, China.[6]GSK, Shanghai, China.[7]Shunde District Center for Disease Control and Prevention, Guangdong, China.[8]Wuhou District Center for Disease Control and Prevention, Sichuan, China.[9]Pudong New Area Center for Disease Control and Prevention, Shanghai, China.[10]Wujin District Center for Disease Control and Prevention, Jiangsu, China.[11]Longgang District Center for Disease Control and Prevention, Guangdong, China.[12]Luohu District Center for Disease Control and Prevention, Guangdong, China.[13]Taocheng District Center for Disease Control and Prevention, Hebei, China.[14]Xicheng District Center for Disease Control and Prevention, Beijing, China.[15]Shanghai Institute of Infectious Disease and Biosecurity, Fudan University, Shanghai, China.[16]Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.[17]Present Address: DESiRE-Consulting, Belgium.[18]Present Address: UCB, Belgium.
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.
基金：
GlaxoSmithKline Biologicals SA funded this study (GSK study identifier: 207350 or NCT03438006) and was involved in all stages of study conduct, including analysis of the data.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类|4 区医学
小类|3 区生物工程与应用微生物4 区免疫学
最新[2023]版：
大类|4 区医学
小类|3 区生物工程与应用微生物4 区免疫学
第一作者：
第一作者机构：[1]Key Laboratory of Public Health Safety, Ministry of Education, Fudan University, Shanghai, China.
通讯作者：
通讯机构：[1]Key Laboratory of Public Health Safety, Ministry of Education, Fudan University, Shanghai, China.[15]Shanghai Institute of Infectious Disease and Biosecurity, Fudan University, Shanghai, China.[16]Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.
推荐引用方式(GB/T 7714)：
Wu Qianhui,Qian Mengcen,Welby Sarah,et al.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[J].Human Vaccines & Immunotherapeutics.2023,19(3):2283912.doi:10.1080/21645515.2023.2283912.
APA：
Wu Qianhui,Qian Mengcen,Welby Sarah,Guignard Adrienne,Rosillon Dominique...&Borys Dorota.(2023).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,19,(3)
MLA：
Wu Qianhui,et al."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 19..3(2023):2283912
