The FDA has approved MenHibrix (Meningococcal [Groups C and Y] and Haemophilus b Tetanus Toxoid Conjugate Vaccine; GlaxoSmithKline), the first combination vaccine indicated to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib) in children aged six weeks through 18 months.

This approval was based on data from clinical trials over a period of seven years in which 7,521 infants and toddlers received at least one dose of MenHibrix. Adverse events in clinical trials included pain and redness at the injection site, irritability, drowsiness and loss of appetite.

MenHibrix was developed to align with the recommended infant immunization schedule for Hib vaccination and to allow for vaccination against meningococcal groups C and Y without adding additional shots.

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

This article originally appeared on MPR