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FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers
Date:8/26/2010

SWIFTWATER, Pa., Aug. 26 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.

Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States to help protect against meningococcal disease, a rare but serious disease that can take the life of a child within 24 hours.  Menactra vaccine is currently indicated for active immunization of individuals two through 55 years of age and is designed to help offer protection against four serogroups of Neisseria meningitidis (A, C, Y, and W-135), the bacterium that causes meningococcal infection.

The filing is based on results of one Phase II and three Phase III, open-label, controlled, multicenter trials, in which more than 3600 infants and toddlers from the United States received Menactra vaccine using a 2 dose schedule at 9 months and 12 months of age.  At 12 months Menactra vaccine was given concomitantly with either measles-mumps-rubella-varicella vaccine (MMRV), pneumococcal conjugate vaccine (PCV7), or Hepatitis A vaccine (HepA).  Results from the clinical studies show that a dose of Menactra vaccine at 9 and 12 months of age elicits a robust immune response against the serogroups included in the vaccine.  Responses to the concomitantly administered vaccines were equally robust.  Vaccine related reactions were similar to those described for other infant vaccines including swelling and tenderness at the site of vac
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