Sinovac Biotech Ltd.begins the phase III clinical trial for its proprietary inactivated EV71 vaccine against hand, foot and mouth disease (HFMD). The Phase II trial, completed in November 2011, confirmed favorable safety and tolerance profiles, and good immunogenicity. According to the results of phase II clinical trial, the formulation of 400U with aluminum adjuvant was selected to be used in phase III clinical trial to evaluate the efficacy of Sinovac’s EV71 vaccine in protecting against HFMD. The Phase III clinical trial is expected to enroll up to 10,000 healthy volunteers with ages 6-35 months, and was designed as a randomization, double blinded, placebo controlled study. The vaccination schedule calls for two shots at 0 and 28 days. Sinovac anticipates the trial to be completed in the first half of 2013.
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