FRIDAY, June 15, 2012 (HealthDay News) -- The combination vaccine Menhibrix has been approved by the U.S. Food and Drug Administration to prevent two deadly bacterial infections among infants and toddlers -- Neisseria meningitides serogroups C and Y and Haemophilus influenzae type b.
The approval covers youngsters aged 6 weeks through 18 months, the agency said in a news release. Neisseria meningitides causes meningococcal disease, and Haemophilus influenzae causes Hib disease. Both germs can infect the bloodstream and the lining that surrounds the brain and spinal cord, potentially leading to blindness, mental retardation or amputations.
Early symptoms of both fast-progressing diseases -- which may include fever, vomiting or neck pain and stiffness -- can make them difficult to distinguish from other childhood maladies, the FDA said.
The vaccine's safety and effectiveness were clinically evaluated among 7,500 infants and toddlers in the United States, Mexico and Australia, the agency said. Common adverse reactions included pain, injection-site redness and swelling, irritability and fever.
The GlaxoSmithKline vaccine is given as a four-dose series, starting as early as 6 weeks of age, the FDA said.