ST LOUIS (MD Consult) - On June 14, 2012, the US Food and Drug Administration (FDA) and GlaxoSmithKline announced the approval of the vaccine Menhibrix for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b in infants and children aged 6 weeks to 18 months. In young children, Neisseria meningitidis and Haemophilus influenzae type b (Hib) are important causes of bacterial meningitis.
The basis for the FDA approval of Menhibrix included data from clinical trials conducted in the United States, Mexico, Australia, Belgium, and Germany over 7 years in which 7521 infants and toddlers received at least 1 dose of Menhibrix. The effectiveness of Menhibrix was determined on the basis of immune-response measurements in several hundred US infants and toddlers vaccinated with Menhibrix. For the Hib component of the vaccine, immune responses in infants and toddlers after vaccination with Menhibrix were comparable to immune responses in infants and toddlers who received an FDA-approved vaccine against invasive Hib disease. For the meningococcal component, study results showed that the vaccine produces antibodies in the blood at levels that are considered to be predictive of protection against invasive meningococcal disease caused by serogroups C and Y.
According to GlaxoSmithKline, serogroup distribution of Neisseria meningitidis may vary from year to year, but serogroups B, C, and Y cause most cases of meningococcal disease in the United States. The most common vaccine-preventable serogroups are C and Y. No vaccine is currently available in the United States to protect against serogroup B.
Adverse events in clinical trials included pain and redness at the injection site, irritability, drowsiness, and loss of appetite.
Menhibrix is given as a 4-dose series to infants and children aged 2, 4, 6, and 12 through 15 months. The first dose may be given as early as the age of 6 weeks. The fourth dose may be given as late as the age of 18 months.