FDA approves combination Haemophilus influenzae type b, meningococcal disease vaccine

The US Food and Drug Administration (FDA) has approved a combination vaccine for preventing invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C and Y (meningococcal disease) in children aged 6 weeks to 18 months.

The vaccination schedule is a 4-dose series given at 2, 4, 6, and 12 through 15 months. The first dose may be given as early as 6 weeks.

The effectiveness of meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine was based on immune responses in several hundred US infants and toddlers who received the vaccine. Vaccine safety was evaluated in 7,500 infants in the United States, Mexico, and Australia.

For the meningococcal component, the vaccine produced antibodies in the blood at levels considered to be predictive of protection against invasive meningococcal disease caused by serogroups C and Y.

Common adverse reactions reported after administration were pain, redness and swelling at the injection site, irritability, and fever.