Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases. There has been a significant increase in EV71 epidemic activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen associated with a severe from of brainstem encephalitis associated with pulmonary oedema and high case-fatality rates. The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. According to the immunogenicity and safety results, the 320U with adjuvant with immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
10,245
inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28
0/0.5ml placebo, two doses, on day0, 28
Donghai County Center for Disease Control and Prevention
Lianyungang, Jiangsu, China
Pizhou County-Level City Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Baoying County Center for Disease Control and Prevention
Yangzhou, Jiangsu, China
Chaoyang Distinct Center for Disease Control and Prevention
Beijing, China
the incidence density of the EV71-associated diseases in the vaccine group and placebo group.
compare the incidence density of the EV71-associated diseases between the vaccine group and placebo group in Chinese children aged 6-35 months.
Time frame: begin at day 56 up to 14 months
the frequency of all the adverse events in vaccine group and placebo group.
compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.
Time frame: up to 14 months
Seropositive rate of the vaccine group
calculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
Time frame: 8 months after first vaccination
Seroconversion rate of the vaccine group
calculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
Time frame: 8 months after first vaccination
GMT of the vaccine group
calculate the geometric mean titre (GMT) of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
Time frame: 8 months after first vaccination
Seropositive rate of the vaccine group
calculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
Time frame: 14 months after first vaccination
Seroconversion rate of the vaccine group
calculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
Time frame: 14 months after first vaccination
GMT of the vaccine group
calculate the geometric mean titre (GMT) of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
Time frame: 14 months after first vaccination
Seropositive rate of the vaccine group and placebo group
compare the seropositive rate of the vaccine group and placebo group in healthy children aged 6-35 months.
Time frame: 28 days after the second vaccination
Seroconversion rate of the vaccine group and placebo group
compare the Seroconversion rate of the vaccine group and placebo group in healthy children aged 6-35 months.
Time frame: 28 days after the second vaccination
GMT of the vaccine group and placebo group
compare the geometric mean titre (GMT) of the vaccine group and placebo group in healthy children aged 6-35 months.
Time frame: 28 days after the second vaccination
GMI of the vaccine group and placebo group
compare the geometric mean fold increase (GMFI) of the vaccine group and placebo group in healthy children aged 6-35 months.
Time frame: 28 days after the second vaccination
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