August 26, 2010
FDA accepts sBLA for Menactra for immunization of infants and toddlersSanofi Pasteur announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) for the use of Menactra (Meningococcal [Groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135. The filing is based on results of one Phase 1 and three Phase 3, open-label, controlled, multicenter trials, in which >3600 infants and toddlers received Menactra using a 2 dose schedule at 9 months and 12 months of age. Data showed that a dose of Menactra vaccine at 9 and 12 months of age elicits a robust immune response against the serogroups included in the vaccine.
Menactra is currently approved for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in patients 2–55 years of age.
For more information call (800) VACCINE or visit www.menactra.com.