This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Sinovac Reports Progress In EV71 Vaccine Phase III Clinical Trial And Commercialization Preparation Status





BEIJING, June 25, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, 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 China's Jiangsu 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 China. 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.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,063.93 -16.21 -0.09%
S&P 500 2,113.05 -4.64 -0.22%
NASDAQ 5,069.2950 -22.79 -0.45%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs