Immunogenicity and Safety Evaluation of a New Syringe Presentation of Reduced Antigen Content Diphtheria-Tetanus-Acellular Pertussis Vaccine in Healthy Adolescents: Results from a Randomized Trial (original) (raw)

Abstract

Background: GlaxoSmithKline Vaccines' reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (dTpa), indicated for booster vaccination in children, adolescents and adults, has been licensed in >70 countries worldwide. It has been available as a single dose vial or a prefilled disposable syringe without a needle. The syringe presentation was recently replaced by a prefilled syringe with tip cap and plunger stopper manufactured with different components. The present study compared the immunogenicity and safety of dTpa in the new and previous syringe presentations. Methods: Phase IV, randomized, controlled, single-blind, multicenter, parallel-group study in Mexico and Chile (NCT01362322). Healthy adolescents aged 1015 years who had previously received 5 or 6 doses of DTP-combination vaccines, were randomized (1:1) to receive a dTpa booster in the new (dTpa-new, N=335) or previous (dTpa-previous, N=336) syringe presentation. Antibodies against diphtheria (D), teta...

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