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...

Full description

Saved in:

Bibliographic Details
Published in:	Human vaccines & immunotherapeutics Vol. 19; no. 3; p. 2283912
Main Authors:	Wu, Qianhui, Qian, Mengcen, Welby, Sarah, Guignard, Adrienne, Rosillon, Dominique, Gopala, Kusuma, Xu, Yuan, Liu, Keruo, He, Yunkun, Jiang, Ning, Tan, Qin, Xie, Jiamin, Zhu, Taoying, Wang, Qizhang, Pan, Yingzi, Zeng, Ruikun, Yang, Jie, Zhao, Xiaoqian, Zhou, Man, Navarro-Torné, Adoración, Yu, Hongjie, Borys, Dorota
Format:	Journal Article
Language:	English
Published:	United States Taylor & Francis 15-12-2023 Taylor & Francis Group
Subjects:	Adjuvants, Immunologic Adolescent Adult Child China East Asian People Female HPV-16/18 AS04-adjuvanted vaccine human papillomavirus Human papillomavirus 16 Human Papillomavirus Viruses Humans Middle Aged Papillomavirus Infections - prevention & control Papillomavirus Vaccines - adverse effects post-marketing Pregnancy Product Surveillance, Postmarketing Prospective Studies safety Uterine Cervical Neoplasms - prevention & control Young Adult HPV-16/18 AS04-adjuvanted vaccine China safety human papillomavirus pregnancy post-marketing
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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. 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
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Present Address: DESiRE-Consulting, Belgium. Present Address: UCB, Belgium.
ISSN:	2164-5515 2164-554X
DOI:	10.1080/21645515.2023.2283912