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news.Sinovac Biotech has released results from a single center, randomized, double blinded, and placebo controlled Phase I trial of its vaccine against human enterovirus 71 (EV71), which causes Hand, Foot, and Mouth Disease (HFMD).
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The study assessed around 168 healthy subjects to investigate the safety and preliminary immunogenicity in the different age groups.
The preliminary immunogenicity results demonstrated that the vaccine has the potential to accelerate good immune responses in adult, children and infant groups.
The company is set to start the Phase II study within one or two months for investigating EV71 vaccine candidates.
The company has obtained the approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its EV71 vaccine on 23 December 2010.