This trial is designed as a single-center, randomized, double-blind study. A total of 720 infants aged 6 to 35 months are selected (with 240 subjects in each age group: 6-11 months, 12-23 months, and 24-35 months). Subjects from different age groups are randomly allocated to three batch groups in a 1:1:1 ratio, and receive two doses of the EV71 vaccine from the commercial production batch on days 0 and 30. After each vaccination dose, subjects will be observed for immediate reactions for 30 minutes and for solicited adverse events for the next 7 days, as well as for unsolicited adverse events over the 30 days following vaccination. All subjects will have blood samples collected on day 0 (pre-immunization) and day 60 for serum antibody testing. Additionally, 270 subjects will be selected, for additional blood sampling at various time points: 7 days, 14 days, and 30 days after the first dose, and 7 days and 14 days after the second dose, to assess the EV71 antibody levels at different timepoints following various doses of vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
720
EV71 vaccine of commercial production batch
Dazhu County Center for Disease Control and Prevention
Dazhu, China
The GMT of EV71 neutralizing antibodies 30 days after complete immunization with the EV71 vaccine
Time frame: 30 days after second dose
Seroconversion rates, seropositive rates, and GMT of antibodies at 7 days, 14 days, and 30 days after the first dose of the EV71 vaccine
Time frame: 7,14 and 30 days after the first dose
Seroconversion rates, seropositive rates, and GMT of antibodies at 7 days and 14 days after the second dose of the EV71 vaccine, as well as the seroconversion rate and seropositive rate at 30 days post-vaccination
Time frame: 7,14 and 30 days after the second dose
The incidence of adverse reactions within 30 days after each dose of the EV71 vaccine
Time frame: 30 days after each dose
The incidence of solicited adverse events within 0-7 days after each dose of the EV71 vaccine
Time frame: 7 days after each dose
The incidence of serious adverse events during the safety observation period
Time frame: 30 days after the second dose
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