Objective To investigate preventive effect and safety of inactivated Enterovirus 71 vaccine （EV71 vaccine） in the prevention of hand-foot-mouth disease （HFMD）.

Methods A total of 786 school-age children in Damatou Town, Guangrao County were recruited as research subjects from January to December 2018. According to whether receiving EV71 vaccine or not, they were divided into study group （n = 367 cases, vaccinated） and control group （n = 419 cases, not vaccinated）. Their adverse reactions after receiving EV71 vaccine were analyzed, and the incidence of EV71 type HFMD and severe HFMD within 2 years were compared between 2 groups.

Results The incidence of adverse reactions within 30 days after receiving EV71 vaccine in the study group was 3.54%（26/734）； There was no statistical significance in systemic and local adverse reactions after EV71 vaccination among children of different genders and ages （all P > 0.05）. After 2 years follow-up, the incidence of EV71 HFMD in the study group was 0.27%, which was lower than that in the control group （2.15%） （P < 0.05）. There was no significant difference in the incidence of severe HFMD between 2 groups （P > 0.05）.

Conclusion EV71 vaccination has low incidence of adverse reactions and mild symptoms with high safety. It can effectively reduce the incidence of EV71 HFMD.