The purpose of this follow-up study is to evaluate the two-year 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 III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence. This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.
Study Type
OBSERVATIONAL
Enrollment
10,077
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Ganyu
Lianyungang, Jiangsu, China
Taixing
Taizhou, Jiangsu, China
Sheyang
Yancheng, Jiangsu, China
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Time frame: Within the second year after the second vaccination
The GMT of anti-EV71 antibodies in serum two years after second vaccination
to evaluate the immune persistence of anti-EV71 antibodies in serum
Time frame: 26 months after second vaccination
Frequency of serious adverse events (SAEs) with the second year after the second vaccination
Frequency of serious adverse events in healthy infants during the oney-year follow-up period
Time frame: within the second year after the second vaccination
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