Application for expanded use of Menactra in infants, toddlers

September 1, 2010

The FDA has accepted for review a supplemental biologics license application for the use of Menactra for active immunization of infants and toddlers for the prevention of invasive meningococcal disease.

The FDA has accepted for review a supplemental biologics license application for the use of Menactra for active immunization of infants and toddlers for the prevention of invasive meningococcal disease.

Menactra is designed to help offer protection against 4 serogroups of N meningitidis, the bacterium that causes meningococcal infection. Meningococcal disease can be difficult to recognize because symptions are similar to those of more common viral illnesses. However, the disease can progress quickly and can cause death within 24 hours.

Results from clinical studies show that a dose of the vaccine at 9 and 12 months of age elicits a robust immune response against the 4 serogroups. Reactions were similar to those for other infant vaccines, including swelling and tenderness at the site of vaccination and irritability. Most of these side effects were mild and of short duration.