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
Creators: name: Wu, Qianhui
name: Qian, Mengcen
name: Welby, Sarah
name: Guignard, Adrienne
name: Rosillon, Dominique
name: Gopala, Kusuma
name: Xu, Yuan
name: Liu, Keruo
name: He, Yunkun
name: Jiang, Ning
name: Tan, Qin
name: Xie, Jiamin
name: Zhu, Taoying
name: Wang, Qizhang
name: Pan, Yingzi
name: Zeng, Ruikun
name: Yang, Jie
name: Zhao, Xiaoqian
name: Zhou, Man
name: Navarro-Torné, Adoración
name: Yu, Hongjie
name: Borys, Dorota
Publisher: name: Taylor & Francis
Year: 2023
Subjects: subject: Medicine
subject: Biotechnology
subject: Science Policy
subject: Immunology
subject: FOS: Clinical medicine
subject: Mathematical Sciences not elsewhere classified
subject: Cancer
subject: Mental Health
subject: Infectious Diseases
subject: FOS: Health sciences

description: Following the approval of <i>Cervarix</i> 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 <i>Cervarix</i> 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 <i>Cervarix</i> 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. <i>Cervarix</i> 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 <i>Cervarix</i> 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. Infection with high-risk human papillomavirus is a prerequisite for cervical cancerCervarix is a human papillomavirus-16/18 AS04-adjuvanted vaccineMulti-centre prospective cohort study to monitor safety of Cervarix immunisationSafety was monitored in 3,013 girls/women aged 9–45 years in China (8,839 doses)Cervarix was well tolerated, and no safety concerns were identified Infection with high-risk human papillomavirus is a prerequisite for cervical cancer Cervarix is a human papillomavirus-16/18 AS04-adjuvanted vaccine Multi-centre prospective cohort study to monitor safety of Cervarix immunisation Safety was monitored in 3,013 girls/women aged 9–45 years in China (8,839 doses) Cervarix was well tolerated, and no safety concerns were identified