Safety of an inactivated enterovirus 71 vaccine administered concurrently with other vaccines among infants aged 6-11 months: An observational study using active surveillance.

Vaccine co-administration can efficiently increase vaccination uptake and timely immunization. This study aimed to evaluate the safety of the enterovirus 71 (EV71) vaccine administered alone or concurrently with other vaccines in infants 6-11 months. A total of 3,769 EV71 vaccine doses were administered to children in the active surveillance area, of which 1,909 were administered concurrently with other vaccines and 1,860 doses were administered alone. Active surveillance was conducted to observe adverse events (AEs) within 0-7 and ≥8 days after vaccination and to determine the incidence of reported AEs. The overall AE incidence was 2.12% (95% CI: 1.66%-2.58%), with 1.56% (95% CI:1.00%-2.12%) for the EV71 vaccine alone and 2.67% (95% CI: 1.95%-3.40%) for simultaneous administration of the EV71 vaccine and other vaccines ( = 5.612, p = .018). The solicited local AE incidence was 1.00% (95% CI: 0.55%-1.44%) in the EV71 vaccine co-administration group and 0.59% (95% CI: 0.24%-0.94%) in the EV71 vaccine alone group ( = 1.946, p = .018). The solicited systemic AE incidence was 1.68% (95% CI: 1.10%-2.25%) and 0.86% (95% CI: 0.44%-1.28%) in the EV71 vaccine co-administered and EV71 vaccine alone groups, respectively ( = 4.990, p = .025). No serious vaccine-related AEs were reported. Fever was the most common AE; no difference was observed in the incidence rate of fever between the two groups ( = 3.467, p = .063). Overall, AE incidence following EV71 vaccination alone or concurrently with other vaccines was acceptable; concurrent vaccination did not increase AE risk or severity.