The U.S. Food and Drug Administration (FDA) announced approval of Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b. Ther vaccine is manufactured by GlaxoSmithKline Biologicals, based in Rixensart, Belgium. Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “With today’s approval of Menhibrix, there is now a combination vaccine that can be used to prevent potentially life-threatening Hib disease and two types of meningococcal disease in children. It is the first meningococcal vaccine that can be given starting as young as six weeks of age.”

The safety of Menhibrix was evaluated in about 7,500 infants and toddlers in the U.S., Mexico and Australia. Common adverse reactions reported after administration of Menhibrix were pain, redness and swelling at the injection site, irritability and fever. Menhibrix is given as a four-dose series at 2, 4, 6 and 12 through 15 months of age. The first dose may be given as early as 6 weeks of age. The fourth dose may be given as late as 18 months of age.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308350.htm