FDA Approves Menactra for Infants from 9 Months
- By BSTQ Staff
Menactra, a vaccine for the prevention of invasive meningococcal disease for children ages 9 months and older has been approved by the U.S. Food and Drug Administration. The vaccine had previously been approved for patients ages 2 through 55. The approval for the younger age comes after one Phase II and three Phase III modified single-blind, controlled, multicenter clinical trialsinvolving more than 3,700 patients that included safety data for children as young as 9 months. Among babies ages 9 to 12 months, the most commonly reported adverse events included irritability and tenderness at the injection site. And, the likelihood of fever was similar to that found among other pediatric vaccines.