Sinovac, a provider of biopharmaceutical products in China, has commenced a phase III clinical trial for its proprietary inactivated EV71 vaccine against hand, foot and mouth disease (HFMD).
The first shot to 10,000 healthy volunteers (ranging from 6 to 35 months old) is anticipated to be completed within one month. The trial, designed as a randomization, double-blind, placebo-controlled study, calls for two shots at 0 and 28 days. The vaccine will be a formulation of 400U with aluminum adjuvant, which was selected from the phase II clinical trial completed in November 2011.
"Commencing the phase III EV71 vaccine trial is a significant milestone,” said Dr. Weidon Tin, CEO and president of Sinovac. “The advancement of the clinical program demonstrates our integrated clinical team's ability, as seen with our positive results from the phase I and II clinical trials. The EV71 vaccine addresses a significant unmet medical need with over 5.14 million HFMD infection cases documented in China since 2007 with over 1900 fatal cases."
Sinovac anticipates the trial to be completed in the first half of 2013.