FDA Approves Sanofi Pasteur’s Meningococcal Vaccine for Children Aged 9–23 Months

FDA has cleared Sanofi Pasteur’s quadrivalent meningococcal conjugate vaccine, Menactra® (Meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine), for use in infants aged 9–23 months. Approval in the U.S. is the first for a meningococcal vaccine for this age group, Sanofi Pasteur points out.

Menactra was first approved by FDA in 2005 for use in children and adults aged 11–55 years. In 2007 the license was expanded to cover use of the vaccine in children aged 2–10 years.

The latest clearance of Menactra in infants was based on data from one Phase II and three Phase III multicenter trials including over 3,300 infants. The results showed that two doses of Menactra given three months apart elicited a robust immune response against the relevant serogroups. Data from the studies also confirmed that Menactra could be administered concurrently with the measles-mumps-rubella-varicella vaccine and pneumococcal conjugate vaccine PCV7.