The US Food and Drug Administration (FDA) has approved GlaxoSmithKline plc's vaccine MenHibrix [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine].

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

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. MenHibrix was developed to align with the Centres for Disease Control and Prevention’s recommended infant immunization schedule for Hib vaccination and to allow for vaccination against meningococcal groups C & Y without adding additional shots. GSK will provide additional details on when MenHibrix will be available in the near future.

“All of us at GSK Vaccines look at today’s approval as a good day for infants, toddlers and healthcare providers,” said Leonard Friedland, MD, vice president, Head, Clinical and Medical Affairs, North America Vaccine Development, GSK Vaccines. “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 basis for FDA approval of MenHibrix included data GSK submitted 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.  Adverse events in clinical trials included pain and redness at the injection site, irritability, drowsiness and loss of appetite.

Meningococcal disease is a rare but serious bacterial infection caused by the bacterium N meningitidis. The highest incidence of meningococcal disease, across all serogroups, occurs in infants and toddlers less than two years of age one. Meningococcal disease is unpredictable, can be difficult to diagnose and can rapidly worsen within 24 to 48 hours after the onset of symptoms.

While serogroup distribution may vary from year to year, 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.

Haemophilus influenzae type b, which most commonly presents as meningitis. Hib was the leading cause of bacterial meningitis in the United States among children younger than five years of age before the introduction of effective Hib vaccines. The disease has been virtually eliminated through routine infant vaccination. In the United States, most cases of Hib disease occur in under-immunized children and infants who are too young to have completed the primary immunization series.

A severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b-, meningococcal-, or tetanus toxoid-containing vaccine or any component of MenHibrix is a contraindication.

If Guillain-Barré (GBS) syndrome occurred within 6 weeks of  receipt of a prior vaccine containing tetanus toxoid, the decision to give and tetanus toxoid-containing vaccine, including MenHibrix, should be based on careful consideration of the potential benefits and possible risks.

Syncope (fainting) can occur in association with administration of injectable vaccines, including MenHibrix. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including MenHibrix, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination.

Rates of local injection site pain, redness, and welling ranged from 15% to 46% depending on reaction and specific dose in schedule. Commonly reported systemic events included irritability (62% to 71%), drowsiness (49% to 63%), loss of appetite (30% to 34%), and fever (11% to 26%) (specific rate depended on the event and dose in the schedule).

Vaccination with MenHibrix may not result in protection in all vaccine recipients.