Quadrivalent meningococcal polysacchardie diptheria toxoid conjugate vaccine (Menactra): Treatment to prevent invasive meningococcal disease caused by Neisseria meningitis serogroups A, C, Y, and W-135

July 1, 2011

New indication: Menactra Quadrivalent meningococcal polysacchardie diptheria toxoid conjugate vaccine was approved by FDA as treatment to prevent meningococcal disease in infants and toddlers as young as 9 months of age.

Meningococcal disease is a rare (1,000 to 2,600 Americans affected annually) but deadly disease caused by the bacterium Neisseria meningitides. Meningococcal disease often progresses rapidly and can result in the death (in about 10% of patients) in as fast as a single day. Survivors often suffer permanent disability including hearing loss, neurological damage, and limb amputation. In 2005, the Menactra vaccine became the first quadrivalent meningococcal (groups A, C, Y, and W-135) conjugate vaccine available in the United States for people ages 11 to 55 years. It was subsequently approved in 2007 for use in children aged 2 to 10 years. On April 22, 2011, Menactra was granted FDA approval for use in infants and toddlers as young as 9 months of age. This is the first FDA approval of a meningococcal vaccine for this age group. The safety and effectiveness of Menactra have not been established in children younger than aged 9 months.

Efficacy. The efficacy of Menactra in infants and toddlers was assessed in one phase 2 and three phase 3 single-blind, controlled, US multicenter trials enrolling more than 3,300 subjects. Menactra was administered using a 2-dose schedule, starting in children as young as aged 9 months. These studies demonstrated that Menactra resulted in a significant immune response against the meningococcal serogroups included in the vaccine. In 1 of these studies, the proportion of infants and toddlers achieving a human serum bactericidal assay (SBA-H) titer of at least 1:8 (the primary determinant of efficacy in this study) was 95.6%, 100%, 96.4%, and 86.4% for the A, C, Y, and W-135 serogroups, respectively at 30 days after the second dose of Menactra.

Safety. The most common adverse events in infants and toddlers aged 9 and 12 months (occurring in ≥10% of study participants) were injection-site tenderness, erythema and swelling, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever. Guillain-Barré syndrome (GBS) has been reported following Menactra administration.