New Combination Vaccine For Children Approved By US FDA

Main Category: Immune System / Vaccines
Also Included In: Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 26 Jun 2008 - 7:00 PDT


GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has 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.

"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®) 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 contains the same DTaP and IPV components used in INFANRIX and PEDIARIX®, 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 year-olds can receive protection against four serious diseases with one less shot."

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About KINRIX and Combination Vaccines

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].

Health experts recommend combination vaccines to reduce the number of shots children receive in a single doctor visit. In fact, combination vaccines, such as DTP [diphtheria, tetanus and pertussis], have been available and effectively used for almost 60 years. KINRIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], manufactured by GlaxoSmithKline, is the latest combination vaccine.

Important Safety Information

In clinical studies, common adverse events were injection-site reactions (pain, redness, swelling, or increase in arm circumference), drowsiness, fever, and loss of appetite. Previous hypersensitivity to any component of KINRIX, including neomycin and polymyxin B, is a contraindication. Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. The decision to give KINRIX should be based on potential benefits and risks, if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events have occurred in temporal relation to receipt of a pertussis-containing vaccine. The needleless, prefilled syringes contain dry natural latex rubber and may cause allergic reactions. For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination. Vaccination with KINRIX may not protect all individuals who received the vaccine. More information on KINRIX is available at http://www.kinrix.com/.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, 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. GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world - an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.

KINRIX, INFANRIX, and PEDIARIX are all trademarks of the GlaxoSmithKline group of companies.

IPOL is a registered trademark of Sanofi Pasteur, the vaccines business of sanofi-aventis Group. M-M-RII is a registered trademark of Merck & Co., Inc.

Source: Jennifer Armstrong
Cohn & Wolfe

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