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Title: FDA Approves New Combination Vaccine for Children
URL: http://www.pslgroup.com/dg/224392.htm
Doctor's Guide
June 25, 2008

NEW YORK -- June 25, 2008 -- The US Food and Drug Administration (FDA) has approved Kinrix(TM) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], a combination vaccine to offer protection against diphtheria, tetanus, pertussis, and polio diseases in 1 shot.

"Children aged 4 to 6 years can receive 5 or more vaccinations in a single visit, which can be stressful for parents and vaccinators," said William P. Hitchcock, MD, University of California, San Diego School of Medicine, San Diego, California.

"By reducing the number of shots given in 1 visit, combination vaccines like Kinrix may make it easier for kids to meet school vaccination requirements and CDC [Centers for Disease Control and Prevention] recommendations."

Clinical studies of Kinrix have demonstrated that this new combination vaccine offers similar protection to the separately administered diphtheria and tetanus toxoids, acellular pertussis (DTaP), and inactivated poliovirus (IPV) vaccines, with a comparable safety profile.

Kinrix is approved for children aged 4 to 6 years whose previous diphtheria, tetanus toxoids, and DTaP vaccinations have been with Pediarix(R) [Diphtheria, Tetanus Toxoids, Acellular Pertussis, Hepatitis B (Recombinant), and Inactivated Poliovirus Vaccine] and/or Infanrix(R) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed].

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.

SOURCE: GlaxoSmithKline

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