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news.Sinovac Biotech has started Phase II trial of EV71 vaccine as a treatment for hand, foot and mouth disease (HFMD).
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The double blinded, placebo-controlled, single center and randomized trial aims to establish the dosage level of the vaccine while assessing the immugenicity and safety of EV71.
The company expects to involve around 540 healthy volunteers in the Phase II trial.
The data from Phase I trial demonstrated that the vaccine was safe and tolerated in all three age groups (adult, children and infant groups).
The preliminary immunogenicity study results demonstrated that the vaccine can induce good immune responses.
Sinovac chairman, president and CEO Weidong Yin said they are on track to complete the Phase II clinical trial within the next six months and expected to commence the Phase III clinical trial before the HFMD outbreak season anticipated in the spring of 2012 to assess the efficacy of the vaccine candidate within the expanded population.
"At the same time, our R&D team is advancing other vaccine candidates ongoing as planned," Yin said.