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FDA Grants Licensure To Expand Indication For Sanofi Pasteur's Menactra

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group (SNY,SNYNF.PK), announced that the U.S. Food and Drug Administration, or FDA, has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra, to include a two-dose schedule for infants and children 9 months through 23 months of age.

The FDA approval of Menactra vaccine for infants was based on results of one Phase II and three Phase III modified single-blind, controlled, multicenter trials in which more than 3,300 infants from the United States received Menactra vaccine using a two-dose schedule, starting as young as 9 months of age.

Results from the above studies showed that 2 doses of Menactra vaccine given 3 months apart elicit a robust immune response against the serogroups included in the vaccine.

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