FDA Extends Sanofi Pasteur Menactra Use
The approval was based on results from a Phase II trial and three Phase III trials in more than 3,300 infants that received Menactra vaccine using a two-dose schedule.
Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, announced last week that it received approval from the FDA for the expanded use of meningococcal conjugate vaccine Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), in infants and children 9 to 23 months of age.
The approval was based on results from a Phase II trial and three Phase III trials in more than 3,300 infants that received Menactra vaccine using a two-dose schedule. Results showed that two doses of Menactra vaccine given three months apart elicits an immune response against the serogroups included in the vaccine.
The studies also showed that measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (
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