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Vaccine. 2019 Feb 4;37(6):889-897. doi: 10.1016/j.vaccine.2018.12.030. Epub 2019 Jan 9.

Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up.

Author information

1
Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Beijing, 100021, China. Electronic address: chenwen@cicams.ac.cn.
2
Department of Obstetrics and Gynecology, Peking University People's Hospital, 11 Xizhimen South Street, Beijing 100044, China.
3
Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, 1 Xueshi Road, Hangzhou 310006, China. Electronic address: xiex@zju.edu.cn.
4
Department of Gynecologic Oncology, Cancer Center, Sun Yat-sen University, 651 Dongfeng Road East, Guangzhou 510060, China. Electronic address: liujh@sysucc.org.cn.
5
Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Beijing, 100021, China. Electronic address: wangshaoming@cicams.ac.cn.
6
MSD R&D (China), 21 Rongda Road, Wangjing R&D Base, Zhongguancun Electronic Zone West Zone, Chaoyang District, Beijing 100012, China. Electronic address: Xue.yan.liao@merck.com.
7
MSD R&D (China), 21 Rongda Road, Wangjing R&D Base, Zhongguancun Electronic Zone West Zone, Chaoyang District, Beijing 100012, China. Electronic address: qiong.shou@merck.com.
8
MSD R&D (China), 21 Rongda Road, Wangjing R&D Base, Zhongguancun Electronic Zone West Zone, Chaoyang District, Beijing 100012, China. Electronic address: Ming.huan.zheng@merck.com.
9
Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: alfred_saah@merck.com.
10
Department of Obstetrics and Gynecology, Peking University People's Hospital, 11 Xizhimen South Street, Beijing 100044, China. Electronic address: weilhpku@163.com.
11
Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, Beijing, 100021, China. Electronic address: qiaoy@cicams.ac.cn.

Abstract

BACKGROUND:

A quadrivalent human papillomavirus (qHPV) vaccine (HPV6/11/16/18) has demonstrated efficacy and acceptable safety in international studies. However, these studies did not include participants from mainland China, which has a substantial burden of HPV-related disease. This is the first safety report with a follow-up period of up to 90 months from a randomized, double-blind, placebo-controlled trial of qHPV vaccine in Chinese women 20-45 years of age.

METHODS:

Participants were randomized 1:1 to receive three doses of qHPV vaccine or placebo (Day1, Month 2, and Month 6). Efficacy outcomes are reported elsewhere. Injection-site and systemic adverse events (AEs) were collected using vaccination report cards (VRCs) for 15 days following each vaccination. Serious AEs (SAEs), pregnancy outcomes, new medical conditions, and fetal/infant SAEs were collected during the entire study.

RESULTS:

Of 3006 participants randomized, AEs were reported by 926 (61.8%) qHPV vaccine recipients and 856 (57.1%) placebo recipients over the entire study. Four participants (two in each group) discontinued the study vaccination due to AEs that were considered vaccination-related. Within 15 days following any vaccination, injection-site AEs prompted for on the VRC were more frequent among qHPV vaccine recipients (37.6% vs 27.8%), and systemic AEs prompted for on the VRC were similar in frequency between qHPV vaccine and placebo groups (46.8% vs 45.1%). Thirty-eight and 43 participants reported SAEs in qHPV vaccine and placebo groups, respectively. No SAE was considered qHPV vaccine-related. Pregnancy outcomes, fetal/infant SAEs, and new medical conditions were generally similar in frequency between the qHPV vaccine and placebo groups, and within normal ranges.

CONCLUSION:

The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20-45 years of age, consistent with findings from global trials and safety surveillance studies.

TRIAL REGISTRATION:

clinicaltrials.gov; NCT00834106.

KEYWORDS:

Quadrivalent human papillomavirus vaccine; Randomised controlled trial; Safety

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