Post-marketing multi-center safety surveillance of inactivated enterovirus A71 vaccine (Vero cell)
10.3760/cma.j.issn.0253-9624.2019.03.003
- VernacularTitle: 肠道病毒A71型灭活疫苗（Vero细胞）上市后多中心安全性研究
- Author:
Ji ZENG
1
;
Tian TANG
2
;
Yijun WANG
3
;
Huakun LYU
4
;
Jianhua HUANG
5
;
Xiuqun LI
6
;
Ningning JIA
1
;
Gang ZENG
1
;
Zhiping CHEN
7
Author Information
1. Clinical Research Department, Sinovac Biotech Co., Ltd, Beijing 100085, China
2. Immunoprophylaxis Department, Beijing Fengtai District Center for Disease Control and Prevention, Beijing 100071, China
3. Prevention and Control of Acute Infectious Diseases Department, Dongtai Municipal Center for Disease Control and Prevention, Yancheng 224200, China
4. Immunization Program Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China
5. Immunization Program Department, Pingguo County Center for Disease Control and Prevention, Guangxi, Baise 531499, China
6. Immunization Program Department, Pingle County Center for Disease Control and Prevention, Guilin 542499, China
7. Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China
- Publication Type:Journal Article
- Keywords:
Enterovirus;
Vaccination;
Viral vaccines;
Inactivated enterovirus 71 vaccine;
Adverse reactions
- From:
Chinese Journal of Preventive Medicine
2019;53(3):252-257
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the post-marketing safety profiles of the inactivated enterovirus type 71 (EV-A71) vaccine (Vero cell) after routine inoculation.
Methods:Eleven cities of Zhejiang Province, Fengtai district of Beijing, Qinnan district, two counties as Pingle and Pingguo of Guangxi Zhuang Autonomous Region, and Dongtai city of Jiangsu Province were selected as the field sites. A total of 45 239 subjects were enrolled in this study from children who seeked the vaccination of EV-A71 vaccine during the period from July, 2016 to June, 2018. Different sampling method were adopted in different sites. All vaccinated children were invited to participate in the study in Fengtai and Dongtai, however, systematic sampling method were adopted in other sites. Active surveillance was conducted and information about adverse reactions (ARs) occurred in 30 min, 3 d and 30 d following each dose of EV-A71 immunization was collected by field observation, phone-call or face-to-face interview. The incidence of ARs in different types, symptoms and grades were described.
Results:In total, there were 45 239 children who received 71 243 doses EV-A71 vaccine. The overall incidence of ARs was 1.079% (769 doses), with the highest incidence of 1.182% (177/14 973) in 5-11 month group and the lowest incidence of 0.849% (18/2 119) in ≥ 36 month group among different age groups. There was a higher incidence in solicited ARs, which was 1.047% (746 doses). The incidences of grade 1 and grade 2 ARs were also higher, which were 0.404% (288 doses) and 0.554% (395 doses), respectively. No grade 4 ARs occurred. The doses of the first and the second vaccination was 40 736 and 30 507, respectively, and the incidences of ARs were 1.281% (522 doses) and 0.810% (247 doses). Also, the incidences of ARs were 0.091% (37 doses) and 0.043% (13 doses) in local, and 1.168% (476 doses) and 0.760% (232 doses) in system. The symptoms of ARs after the two doses of vaccination were basically the same. Redness at the injection site was the most common local ARs after each dose vaccination, with doses of 24 and 11, while fever was the most common systemic ARs, with doses of 362 and 190. Moreover, ARs mainly occurred in 30 min to 3 d after each dose vaccination, with incidence of 1.016% (414 doses) and 0.698% (213 doses) in the first and second dose, respectively.
Conclusion:The ARs had a low incidence after vaccination in children and most were mild or moderate. EV-A71 vaccine with good safety is suitable for inoculation in a large scale.
