BEIJING, June 28, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq:SVA - News), a leading provider of biopharmaceutical products in China, announced today the commencement of the Phase II clinical trial for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD). The safety observation results from the EV71 vaccine Phase I trial completed in May 2011 showing good safety and tolerance profiles for all three age groups (adult, children and infant groups) and the preliminary immunogenicity study results showed the vaccine can induce good immune responses.
The purpose of the Phase II clinical trial is to determine the dosage level through evaluating the immunogenicity and safety with different level of dosages of Sinovac's EV71 vaccine candidate, and to provide the reference data for Phase III clinical trial. The phase II clinical trial is designed as a single center, randomization, double blinded, and placebo controlled study. In phase II, there will be 540 healthy volunteers from 3 to 35 months old, separated in three age groups. Dosing with the first shot was started on schedule. It is anticipated to take 6 months to complete the phase II clinical trial.