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FDA approves GSK MenHibrix vaccine

The FDA has approved GlaxoSmithKline's (GSK) MenHibrix, meningococcal groups C and Y and Haemophilus b Tetanus toxoid conjugate vaccine.

The vaccine, which is approved for use in children aged six weeks through 18 months, is indicated to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b.

GSK Vaccines, North America vaccine development, clinical and medical affairs head, vice president Leonard Friedland said, "MenHibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers."

The vaccination schedule for MenHibrix is a four-dose series given at two, four, six, and 12 through 15 months of age.

The first dose can be given as early as six weeks of age and the last as late as 18 months of age.

The FDA approval was based on data from clinical trials conducted over seven years in which 7,521 infants and toddlers received at least one dose of MenHibrix.

Adverse events such as pain, drowsiness, loss of appetite, irritability and redness at the injection site were reported.