Post-marketing evaluation of the effectiveness and safety of a varicella attenuated live vaccine in ;China

VernacularTitle:水痘减毒活疫苗流行病学保护效果及安全性研究
Author: Haiping CHEN ; Xiaoqin LIU ; Hongjie SHEN ; Fubao MA ; Lizhi SONG ; Chi ZHANG ; Xinliang SHEN ; Qinyuan GUO ; Bin XU ; Linyun LUO
Publication Type:Journal Article
Keywords: Varicella attenuated live vaccine; Multicenter study; Vaccine efficacy; Vaccine safety
From: Chinese Journal of Microbiology and Immunology 2016;36(8):600-604
CountryChina
Language:Chinese
Abstract: Objective To evaluate the effectiveness and safety of varicella attenuated live vaccine ( VarV) produced by A Co. Ltd. Methods We selected 3 provinces in China and enrolled 15 002 children aged 3-<11 in this random, multicenter study. Participants were randomly divided into two groups: the ex-perimental group and the control group. Every varicella case was collected and recorded to calculate the vac-cine efficacy. Vaccine safety was assessed by means of spontaneous report and regular follow-up visits. Re-sults During the observation period, the incidence of varicella was 0. 147% in the experimental group and 1. 155% in the control group (P<0. 001). The vaccine efficacy was 87. 27%. The adverse reaction rate af-ter vaccination was lower than the rates reported in other literatures. Conclusion The VarV produced by A Co. , Ltd. in China was effective and safe in preventing varicella.