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news.The US Food and Drug Administration (FDA) has extended the use of Sanofi Pasteur's Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine by including a two-dose schedule for infants and children 9 months through 23 months of age.
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The vaccines division of the Sanofi-aventis Group, Sanofi Pasteur said the FDA’s decision was supported by the results from one Phase II and three Phase III multicenter trials, which demonstrated prominant immune response against the serogroups included in the vaccine.
The studies evaluated Menactra vaccine using a two-dose schedule, starting as young as 9 months of age in more than 3,300 infants.
The studies also demonstrated that measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administered concomitantly with Menactra vaccine in children.
Sanofi Pasteur Scientific and Medical Affairs vice president Michael Decker said 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.
"With this approval, it is now possible to help protect persons from 9 months through 55 years of age," Decker said.