This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,000
500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Fengcai Zhu
Nanjing, China
Consistency of different batches for geometric mean titre(GMT) after vaccination
Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination
Time frame: 56 days after vaccination
Incidence and severity of adverse reactions/adverse events after each dose
Incidence and severity of adverse reactions/adverse events within 1 month after each dose
Time frame: 1 month after each dose
Incidence of sever adverse events after vaccination
Incidence of sever adverse events within 13 months after vaccination
Time frame: 13 months after vaccination
GMTof EV-A71 neutralizing antibody on day 56 after vaccination
GMTof EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time frame: 56 days after vaccination
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time frame: 56 days after vaccination
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time frame: 56 days after vaccination
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time frame: 56 days after vaccination
GMTof EV-A71 neutralizing antibody on month 13 after vaccination
GMTof EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Time frame: 13 months after vaccination
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Time frame: 13 months after vaccination
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