Singapore, Aug 27, 2010: Sanofi Pasteur, the vaccines division of French drug maker Sanofi-Aventis, announced that the US FDA has accepted its application to extend the age group that can receive Menactra, a vaccine that can prevent meningococcal disease.

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 months 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 vaccination, as well as irritability.  Most of these side effects were mild and of short duration.