GlaxoSmithKline's Havrix now approved for use in children aged 12 months and older

Philadelphia, PA October 18, 2005 GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) approved the expanded use of Havrix(R) (hepatitis A vaccine, inactivated) for the prevention of hepatitis A in children aged 12 months and older. Havrix was previously approved by the FDA for use in children ages two through 18 years. This expanded indication will allow healthcare practitioners to vaccinate younger children against hepatitis A with Havrix and may help to further reduce the incidence of hepatitis A in the United States, particularly among young children who often transmit the disease.

"The expanded indication of Havrix marks an important milestone in the fight against hepatitis A in the United States," said William P. Hitchcock, M.D., of the American Board of Pediatrics, La Jolla, California. "Immunizing children under age two helps protect a very vulnerable population that often does not show symptoms of the disease but frequently spreads it to other children and family members."

Havrix for the Prevention of Hepatitis A in Children Aged 12 Months and Older
The FDA approved the expanded use of Havrix in children to 12 months and older on the basis of a pivotal trial which studied the administration of Havrix in children in the United States and Australia. The prospective, open, comparative, multi-center clinical trial involved over 1,000 healthy children and showed Havrix given to children down to the age of 11 months to be comparable to Havrix given to children approximately two years of age with regard to safety and immunogenicity. The study also showed that Havrix can be given concomitantly with OMNIHIBTM [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)], also called Hib conjugate vaccine (PRP-T).

Each subject was enrolled in one of five groups according to their age and previous vaccination history and vaccinated with either Havrix alone or Havrix with Infanrix (D


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