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FDA Approves KINRIX(TM) - New Combination Vaccine for Children
Date:6/24/2008

- New option could mean fewer shots for 4 to 6 year-olds in the U.S. -

PHILADELPHIA, June 24 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved KINRIX(TM) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.

"Children 4 to 6 years-old can receive five or more vaccinations in a single visit, which can be stressful for parents and vaccinators," said William P. Hitchcock, MD, Assistant Clinical Professor of Pediatrics, University of California, San Diego School of Medicine. "By reducing the number of shots given in one visit, combination vaccines like KINRIX may make it easier for kids to meet school vaccination requirements and CDC recommendations."

Clinical studies of KINRIX have demonstrated that this new combination vaccine offers similar protection to the separately administered Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and Inactivated Poliovirus (IPV) vaccines, with a comparable safety profile. These results were confirmed in the pivotal Phase III trial of KINRIX, which was a randomized, controlled study conducted in the U.S. in which 3,156 children 4 to 6 years of age were vaccinated with KINRIX. All children studied had previously received four doses of DTaP (INFANRIX(R)) and three doses of IPV (IPOL(R)). All children in the study also received the second dose of U.S.-licensed measles, mumps and rubella (MMR) vaccine (M-M-RII(R)) at the same time.

"KINRIX contains the same DTaP and IPV components used in INFANRIX and PEDIARIX(R), two vaccines which have been used by doctors in the U.S. for many years," said Wayde M. Weston, Ph.D., Director, U.S. Clinical Research and Development/Medical Affairs, GlaxoSmithKline. "With the introduction of KINRIX, eligible 4 to 6
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SOURCE GlaxoSmithKline
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