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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02001233
Study type Observational
Source Sinovac Biotech Co., Ltd
Contact
Status Completed
Phase
Start date March 2013
Completion date October 2014

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