1.Post-marketing evaluation of the effectiveness and safety of a varicella attenuated live vaccine in ;China
Haiping CHEN ; Xiaoqin LIU ; Hongjie SHEN ; Fubao MA ; Lizhi SONG ; Chi ZHANG ; Xinliang SHEN ; Qinyuan GUO ; Bin XU ; Linyun LUO
Chinese Journal of Microbiology and Immunology 2016;36(8):600-604
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.
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