FDA approves new combination meningitis C/Y-Hib vaccine

The FDA has approved a combination vaccine for use in infants and children ages 6 weeks through 18 months, according to an FDA press release.

The combination vaccine (meningitis C/Y-Hib; Menhibrix, GlaxoSmithKline Biologicals) is indicated for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib) and 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, according to the FDA.

“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 6 weeks of age,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research.

Effectiveness of the meningitis C/Y-Hib combination vaccine was based on immune responses in several hundred vaccinated US infants and toddlers. For the Hib component of the vaccine, immune responses in infants and toddlers following vaccination were comparable to immune responses in infants and toddlers who received an FDA-approved Hib vaccine.

For the meningococcal component, the FDA said that study findings showed the vaccine produced antibodies in the blood at levels that are considered to be predictive of protection against invasive meningococcal disease caused by serogroups C and Y.

The safety of meningitis C/Y-Hib combination vaccine was evaluated in about 7,500 infants and toddlers in the United States, Mexico and Australia. Common adverse reactions reported after administration of the vaccine were pain, redness and swelling at the injection site, irritability and fever, according to the FDA.