Menactra Gains Indication for Immunization of Infants
MENACTRA (meningococcal polysaccharide diphtheria toxoid conjugate vaccine) by Sanofi Pasteur
The FDA has expanded the indication for Menactra (meningococcal [Groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine; Sanofi Pasteur) to include a two-dose schedule for infants and children 9–23 months old. This approval was based on results from one Phase 2 and three Phase 3 trials on more than 3,300 infants showing that two doses of Menactra given 3 months apart elicits a robust immune response against the serogroups included in the vaccine. The studies also showed that the measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administered concomitantly with Menactra in children.
Menactra is already indicated for meningitis immunization in patients 2–55 years old.