The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.
The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,400
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
placebo, two doses, 28 days interval
Jurong
Zhenjiang, Jiangsu, China
The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination
Time frame: 28 days after first 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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