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Sanofi Pasteur Presents Phase III Data on Intradermal Microinjection of Influenza Vaccine
Date:10/25/2010

SWIFTWATER, Pa., Oct. 25 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today the results of the Phase III clinical trial of its investigational Fluzone® Intradermal (Influenza Virus Vaccine) candidate compared to Fluzone (Influenza Virus Vaccine) administered via the traditional intramuscular method (IM).  Data from the clinical trial assessing the immunogenicity and safety of the investigational intradermal vaccine were presented by Dr. Geoffrey J. Gorse at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia.  

Earlier this year, Sanofi Pasteur announced that it had filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone Intradermal vaccine.  The file has been accepted for review by the FDA and an action date is anticipated in the first half of 2011.  

"The results from this large Phase III study in adults show that administration of influenza vaccine with an intradermal microinjection system may reduce the amount of antigen required for an immune response similar to that seen with Fluzone vaccine," said Geoffrey J. Gorse, M.D., Professor of Internal Medicine, Division of Infectious Diseases and Immunology, St. Louis University.  "The reduced amount of antigen, smaller volume of vaccine administered and shorter needle associated with intradermal microinjection compared with traditional intramuscular injection are attractive attributes for health-care providers and their patients that are likely to lead to increased acceptance of influenza vaccination and increase population coverage."  

Phase III Study Design and ResultsThe immunogenicity and safety of the Fluzone Intradermal vaccine candidate was assessed in co
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