Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine -- better known as MenHibrix -- was approved for use in children aged 6 weeks through 18 months.
The vaccination schedule for MenHibrix is a four-dose series given at 2, 4, 6 and 12 through 15 months of age -- with the first dose given as early as 6 weeks and the last as late as 18 months, GlaxoSmithKline officials said.
Dr. Leonard Friedland of GlaxoSmithKline Vaccines said MenHibrix was developed to align with the Centers for Disease Control and Prevention's recommended infant immunization schedule for Hib vaccination and to allow for vaccination against meningococcal groups C and Y without adding additional shots.
"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," Friedland said in a statement.
The basis for FDA approval included data submitted by GlaxoSmithKline from clinical trials conducted in the United States, Mexico, Australia, Belgium and Germany over seven years in which 7,521 infants and toddlers received at least one dose of MenHibrix. Of these participants, 3,349 were located in the United States, Friedland said.
Adverse events in the clinical trials included pain and redness at the injection site, irritability, drowsiness and loss of appetite, Friedland added.