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

10/18/05

FDA grants expanded indication to protect younger children against hepatitis A

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® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and Hib conjugate vaccine (PRP-T). The administration of two doses of Havrix (720 EL.U/0.5 mL on a 0, 6-month schedule) starting at 11-13 months of age or 15-18 months of age was safe and immunogenic compared to two doses administered to children at approximately two years of age. One hundred percent of children demonstrated a positive immune response against hepatitis A. The study also showed the immune response of both Havrix and Hib conjugate vaccine (PRP-T) was comparable when given together or separately. Havrix was shown to be well tolerated. Solicited local and general side effects with the use of Havrix alone were comparable across all age groups.

About Hepatitis A
Hepatitis A is a serious liver disease caused by the hepatitis A virus. This virus is found in the stool of persons with hepatitis A and is spread by close personal contact and by eating food or drinking water contaminated with the hepatitis A virus. Hepatitis A can be easily passed by those infected with the disease to others within the same household.

About one in five people with the disease has to be hospitalized and up to 100 people with the disease may die each year in the U.S. Symptoms of the disease can be debilitating and include fever, fatigue, loss of appetite, nausea, abdominal discomfort, jaundice and dark urine.

According to the Centers for Disease Control and Prevention, hepatitis A incidence rates in children have been among the highest reported because they often come in close contact with other children.

Later this month, the Advisory Committee on Immunization Practices (ACIP) will convene to determine if hepatitis A vaccination requirements should be expanded to all children 12 months of age or older – helping reduce the burden of one of the most commonly reported vaccine-preventable diseases in the country.

"Expanding childhood vaccination is a strategy that could reduce the burden of hepatitis A in our country," said Barbara Howe, Vice President of Clinical and Medical Affairs at GlaxoSmithKline.

GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, N.C., is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For full prescribing information related to Havrix, go to www.havrix.com.

Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2004.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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