TUESDAY, Oct. 20, 2009 (HealthDay News) -- GlaxoSmithKline's seasonal flu vaccine, Fluarix, has been approved by the U.S. Food and Drug Administration for children aged 3 to 17, the agency said in a news release.
The vaccine had been approved for adults 18 and older.
Fluarix contains killed influenza A and B viruses. With the approval, Glaxo is now the fourth company licensed in the United States to produce a vaccine for children against seasonal flu. Fluarix will not protect against the H1N1 swine flu virus, the agency warned.
The vaccine's safety and effectiveness were evaluated in a clinical study of more than 3,300 children that compared Fluarix with Fluzone, an FDA-approved seasonal flu vaccine for children 6 months and older. The two vaccines were about equal in triggering production of blood antibodies that would protect children from seasonal flu, the FDA said.
Common adverse reactions to Fluarix -- including injection-site pain and redness, irritability, loss of appetite and drowsiness -- are typical of many flu shots, the agency said.
Learn more about this approval from the FDA.