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Sinovac vaccine for hand, foot and mouth disease meets study goal

March 14, 2013 7:05 am by | 0 Comments

vaccine

(Reuters) - China-based Sinovac Biotech Ltd said a late-stage trial of its experimental vaccine for hand, foot and mouth disease met the main study goal of preventing the infection in infants between the ages of 6 months and 35 months.

Sinovac shares were up 25 percent in premarket trading.

The trial results showed an immune response to the infection in 95.4 percent of vaccinated subjects. The trial tested two doses of the vaccine in 10,000 healthy infants in China.

Sinovac said the vaccine showed only a 2.2 percent incidence of adverse events, which were considered not to be related to the vaccine.

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The difference in the rates of serious adverse events in infants who received the vaccine and those who received a placebo was not statistically significant, the company said.

Sinovac will finalize the clinical report as a part of its documents to be filed with the State Food and Drug Administration (SFDA) of the People's Republic of China.

Sinovac's facility to manufacture the vaccine has been completed and is ready for inspection by the SFDA, the company said in a statement.

Hand, foot and mouth disease, which is caused by enterovirus 71, usually affects infants and children and is spread through direct contact with the mucus, saliva, or faeces of an infected person.

Shares of the company closed at $3.19 on the Nasdaq on Wednesday.

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