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On April 22, 2011, the FDA approved the use of the meningococcal vaccine Menactra in children as young as 9 months. This vaccine was previously approved only for individuals aged 2 years to 55 years.
Menactra contains Neisseria meningitidis serogroup A, C, Y, and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. It is administered by intramuscular injection at a dose of 0.5 mL. Children aged 9 months through 23 months receive two doses, 3 months apart; other age groups receive a single dose.
The approval of Menactra in infants is based on four clinical studies involving 3721 children who received the vaccine at 9 and 12 months of age. Within 1 month after the second vaccination, >90% of the children …