Pressroom

Source: FDA News Release

06/14/2012

Menhibrix, a combination vaccine that protects against invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib), has received U.S. Food and Drug Administration approval. These diseases can be life-threatening, infecting the bloodstream and causing sepsis, or infecting the lining around the brain and spinal cord and causing meningitis. Researchers tested the safety and effectiveness of Menhibrix in about 7,500 infants and toddlers. For the vaccine’s Hib component, the children’s immune responses after vaccination were comparable to immune responses in those who received a previously approved vaccine against invasive Hib disease. For Menhibrix’s meningococcal component, results showed that the vaccine produces antibodies at levels considered predictive of protection against invasive meningococcal disease caused by serogroups C and Y. Menhibrix is given in four doses at two, four, six, and 12 to 15 months of age. The first dose can be given as early as six weeks of age, and the fourth dose can be given as late as 18 months of age. Menhibrix is manufactured by GlaxoSmithKline Biologicals.