Phase III U.S. Pivotal Study Results on CSL Biotherapies' Afluria(R) Published in Vaccine
9/3/2008 9:22:12 AM
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Phase III pivotal study findings in the journal Vaccine showed that two formulations of CSL Biotherapies’ influenza virus vaccine Afluria® elicited an immune response (also known as immunogenicity) in healthy adults aged 18 - <65 years. The results, from a study performed at nine centers affiliated with the National Institutes of Health (NIH), met the U.S. Food and Drug Administration’s (FDA) requirements for influenza vaccine immunogenicity. These data formed the basis of CSL Biotherapies’ US biologics licensing application for Afluria that was approved through priority review by the FDA in September 2007.
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