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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.
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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.
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10,077 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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