Sanofi Gains Menactra Indication for Infants

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, 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 (PCV7) can be administered along with Menactra vaccine in children.

“The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups,” said Michael Decker, M.D., MPH, vice president, scientific and medical affairs at Sanofi Pasteur. “With this approval, it is now possible to help protect persons from 9 months through 55 years of age.”