The U.S. Food and Drug Administration approved Menhibrix, a
combination vaccine for infants and children ages 6 weeks
through 18 months, for prevention of invasive disease caused
by Neisseria meningitidis serogroups C and Yand Haemophilus
influenzae type b. Diseases caused by the bacteria Neisseria
meningitidis (meningococcal disease) and Haemophilus
influenzae type b (Hib disease) can be life-threatening.
These bacteria can infect the bloodstream causing sepsis,
and the lining that surrounds the brain and spinal cord
causing meningitis. In young children, Neisseria
meningitidis and Haemophilus influenzae type b are important
causes of bacterial meningitis. Without vaccination,
children younger than two years are susceptible to these
serious illnesses. Meningococcal and Hib diseases are
particularly dangerous because both diseases often progress
rapidly and can cause death or serious, long-lasting health
consequences such as blindness, mental retardation or
amputations. Early symptoms for both diseases often are
difficult to distinguish from other common childhood
illnesses. The effectiveness of Menhibrix was based on
immune responses in several hundred U.S. infants and
toddlers vaccinated with Menhibrix. For the Hib component of
the vaccine, immune responses in infants and toddlers
following vaccination with Menhibrix were comparable to
immune responses in infants and toddlers who received an
FDA-approved vaccine against invasive Hib disease. For the
meningococcal component, study results showed that the
vaccine produces antibodies in the blood at levels that are
considered to be predictive of protection against invasive
meningococcal disease caused by serogroups C and Y. The
safety of Menhibrix was evaluated in about 7,500 infants and
toddlers in the U.S., Mexico and Australia. Common adverse
reactions reported after administration of Menhibrix were
pain, redness and swelling at the injection site,
irritability and fever. Menhibrix is given as a four-dose
series at 2, 4, 6 and 12 through 15 months of age. The first
dose may be given as early as 6 weeks of age. The fourth
dose may be given as late as 18 months of age. With the
approval of Menhibrix, there is now a combination vaccine
that can be used to prevent potentially life-threatening Hib
disease and two types of meningococcal disease in children.
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