June 25, 2012
/PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in
, today provided an update on its Phase III clinical trial progress and commercialization preparation for its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).
EV71 Clinical Trial
The double-blinded, randomized, placebo controlled Phase III trial is being conducted at three sites across
province. This study is designed to demonstrate the efficacy of the EV71 vaccine in the prevention of the diseases caused by EV71 in infants 6 to 35 months old. About 10,000 healthy infants completed the vaccination schedule in the first quarter of 2012, prior to the epidemic season for HFMD in
. The disease surveillance period began 28 days after completion of the two-dose regimen.
A three arm active surveillance system, comprised of village health clinics, township hospitals, and local county Centers for Disease Control and Prevention (CDC), has been established at each clinical site and is in charge of epidemic surveillance, case diagnosis, epidemiological survey, and sample collection.
When a case is identified by village or township doctors, throat swabs and anal swabs are collected from the patient. Physicians from the CDC then make visits to examine the child, record information and collect additional specimens for further tests. All samples are immediately sent to the laboratories for virus identification. A part of blinded samples are sent to the national CDC laboratory for confirming the previous testing results. According to the trial protocol, the Data and Safety Monitoring Board (DSMB) will review the clinical and laboratory results and confirm the diagnosis of EV71-associated disease before unblinding.
A number of patients with HFMD symptoms have been identified EV71 positive. All professionals in the surveillance system are actively monitoring the epidemic situation to try to achieve the clinical target in advance.