FDA approves Kinrix - combination vaccine for diphtheria, tetanus, pertussis and polio diseases in one shot

Jun 24 2008

GlaxoSmithKline has announced 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."

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.

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-Barre 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.

http://www.Kinrix.com and http://www.gsk.com