A new combination vaccine protects infants and children against both meningococcal and Haemophilus influenzae type b infections.
The Food and Drug Administration on June 14 approved GlaxoSmithKline Biologicals’ Menhibrix, a combination vaccine for infants and children aged 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. It is the first meningococcal vaccine that can be given starting as young as 6 weeks of age, Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The effectiveness of Menhibrix was based on immune responses in several hundred U.S. infants and toddlers who received the vaccine. For the Hib component of the vaccine, immune responses in infants and toddlers following vaccination with Menhibrix were found to be comparable to immune responses in infants and toddlers who received another FDA-approved vaccine against invasive Hib disease. For the meningococcal component, data showed that the vaccine induced the production of antibodies at levels considered to be predictive of protection against invasive meningococcal disease caused by serogroups C and Y, the FDA said.
Safety data for Menhibrix were obtained from about 7,500 infants and toddlers in the United States, 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, and the fourth dose may be given as late as 18 months of age.
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention is scheduled to address the subject of meningococcal vaccines at its meeting on June 20.