On Jun. 24, 2008, GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) had approved KINRIX™ [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.

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®) and three doses of IPV (IPOL®). All children in the study also received the second dose of U.S. licensed measles, mumps and rubella (MMR) vaccine (M-M-RII®) at the same time.

KINRIX is approved for children 4 to 6 years of age whose previous Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccinations have been with PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] and/or INFANRIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed].