China-based Sinovac Biotech has reported preliminary top-line data from a Phase III trial evaluating Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD) in infants aged six months to 35 months.

The preliminary results of the double-blind Phase III placebo-controlled study demonstrated an efficacy rate of 95.4%.

Approximately 10,000 healthy infants were recruited in the trial, carried out at three sites across China’s Jiangsu province.

The infants underwent a two-dose vaccination schedule (at 0 and 28 days) in the first quarter of 2012, prior to the HFMD epidemic season in China, followed by active monitoring period.

Sinovac conducted another clinical trial with 1,400 children from six-months to five years old to evaluate the consistency of three consecutive lots of EV71 vaccine.

“The preliminary results of the double-blind Phase III placebo-controlled study demonstrated an efficacy rate of 95.4%.”

The company observed consistent immune response for all three lots and a good safety profile.

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Sinovac chairman, president and CEO Dr Weidong Yin said the conclusion of the trial signifies important milestone in the company’s proprietary vaccine development.

“Hand, foot, and mouth disease continues to represent a significant unmet public health need and economic burden in China, as well as several other Asian countries,” Yin said.

“Our EV71 vaccine is poised to provide an effective solution to prevent hand, food and mouth disease caused by EV71, a much-needed resource given the current limited prevention and EV71 specific treatment methods.”

Lead principal investigator Professor Hua Wang said; “The Phase III study for Sinovac’s EV71 vaccine candidate met its primary objective. The trial results demonstrated that the vaccine is not only safe, but shows significant efficacy in subjects.”

The company now plans to submit the final clinical report to the PRC State Food and Drug Administration (SFDA) for new drug certificate, GMP certification and the production license to commence commercial production of the vaccine.