KING OF PRUSSIA, Pa., June 5 /PRNewswire/ -- Enrollment will begin for a pivotal influenza vaccine clinical trial sponsored by the National Institutes of Health (NIH), CSL Biotherapies announced today. The study will assess the safety and immunogenicity of single-dose and multi-dose formulations of influenza vaccine and has been designed to meet U.S. Food & Drug Administration (FDA) requirements.
CSL Biotherapies will supply the vaccine, which is already approved and widely supplied in 16 countries throughout the world. CSL Biotherapies' parent company, CSL Limited, has partnered with the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH, on the trial.
Nine sites across the United States will enroll approximately 1,350 healthy adults in a Phase III, randomized, double-blind, placebo-controlled study. Overall, 26 clinical studies have already been conducted in other countries with this vaccine, which has been manufactured by CSL Limited in Melbourne, Australia, since 1968.
"We are excited about the opportunity to work with the NIH and our aim is to supply a new, reliable source of influenza vaccine to patients and healthcare professionals in the United States," said Colin Armit, President, CSL Biotherapies. "The start of the trial represents achievement of our first milestone in registering the product in time to supply for the 2007 influenza vaccination season. We will continue to build on the reputation and commitment to early delivery that our parent company, CSL Limited, in Melbourne, Australia, has established for over nearly 40 years."
About CSL Biotherapies
CSL Biotherapies is headquartered in King of Prussia, PA. Its parent company, CSL Limited, in Melbourne, Australia, operates one of the world's largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its headquarters with its sister company, ZLB Behring, is commercializing CSL Limited's influenza vaccine products across the U.S. and Europe. At CSL Biotherapies, delivering vaccines is our mission, protecting lives our passion. The CSL Group, which also includes CSL Research & Development, CSL Bioplasma, CSL Pharmaceuticals, and ZLB Behring, has more than 7,000 employees globally and operates in 26 countries around the world. For more information, visit us at http://www.cslbiotherapies.com.
CSL BiotherapiesCONTACT: Sheila A. Burke, +1-610-878-4209, United States,info@cslbiotherapies.com, www.cslbiotherapies.com, or Dr. Rachel David, CSLLimited, Australia and New Zealand, +61-401-775-779,rachel.david@csl.com.au, http://www.csl.com.au
