On Apr. 22, 2005, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age. This was the first U.S. approval of a meningococcal vaccine for this age group.

Meningococcal disease is a rare but deadly disease caused by the bacterium Neisseria meningitidis.  The disease can progress quickly and take the life of a child within 24 hours. Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States for active immunization against meningococcal disease caused by the serogroups contained in the vaccine (A, C, Y and W-135).  More than 36 million doses of Menactra vaccine have been distributed in the United States since its licensure in 2005.

The FDA approval of Menactra vaccine for infants was based on results of one Phase II and three Phase III modified single-blind, controlled, multicenter trials in which more than 3,300 infants from the United States received Menactra vaccine using a two-dose schedule, starting as young as 9 months of age. Results from these studies showed that 2 doses of Menactra vaccine given 3 months apart elicit a robust 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 concomitantly with Menactra vaccine in children. Vaccine related reactions included swelling, tenderness at injection site, and irritability.

Menactra (Meningococcal  [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only U.S. licensed conjugate vaccine for persons age 9 months through 55 years of age for active immunization against invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y and W-135.

Sanofi Pasteur is a vaccine industry leader with a strong heritage of meningococcal vaccine development.  Meningococcal vaccines designed to help protect against serogroups A and C were introduced in the mid-1970s.  In 1981, Menomune® – A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined) became the first meningococcal vaccine available to help protect against meningococcal disease caused by four of the five most common serogroups (A, C, Y and W-135).  In 2005, Menactra vaccine became the first quadrivalent meningococcal conjugate vaccine available in the United States for people ages 11 through 55 years of age.  Menactra vaccine was approved for use in children ages 2 through 10 years of age in 2007; and approved for use in infants as young as 9 months of age in 2011.