The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.
The phase II study of inactivated vaccine (vero cell) against EV71 has completed on Dec 2011 in China. The data from the phase I and II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. In order to evaluate the efficacy of the vaccine against Hand, Foot and Mouth disease caused by EV71, and to further explore the safety profile of this vaccine in expending infant population, a phase III clinical trial is planed to conduct.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
10,077
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
0/0.5ml placebo, two doses, 28 days interval
Ganyu
Lianyungang, Jiangsu, China
Taixing
Taizhou, Jiangsu, China
Sheyang CDC
Yancheng, Jiangsu, China
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Time frame: From 28 days after the second vaccination to one year
The GMT of anti-EV71 antibodies in serum after second vaccination
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination
Time frame: 28 days after first vaccination
The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination
to evaluate the immune persistence of anti-EV71 antibodies in serum
Time frame: 7 and 13 months after second vaccination
Frequency of systemic and local adverse reactions after the first vaccination
Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine
Time frame: 28 days after the first vaccination
Frequency of systemic and local adverse reactions after the second vaccination
Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine
Time frame: 28 days after the second vaccination
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