« Return to News | Clinical Intelligence

Sinovac begins phase III trial in hand, foot and mouth disease

Friday, January 13, 2012 12:14 PM

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.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.