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A Randomized, double-blind, placebo-controlled, multi-country and multi-center, phase IV study to demonstrate the efficacy of influenza vaccine Fluarix administrated intramuscularly in adults.
Wertzová, Veronika ; Šmejkalová, Jindra (advisor) ; Havlík, Jiří (referee) ; Havlíčková, Martina (referee)
Influenza is the most common human infectious disease. Contrary to common upper tract respiratory infections influenza is a serious disease causing worldwide every year thousands of death. Influenza is always considered to be a trivial infection, not only by ordinary persons but even by specialists. Vaccination is the most effective possibility of prevention recently. However there are still doubts concerning influenza vaccine efficacy, clinical trials evaluating vaccine efficacy are not enough consistent. This work tries to evaluate the efficacy of GlaxoSmithKline Bilogicals' influenza vaccine Fluarix administrated intramuscularly in one dose scheme in healthy adults aged 18-64. 7652 subjects were enrolled in Finland and the Czech Republic during 2006/2007 influenza season to this clinical trial. The reactogenity, safety and immunogenicity of the vaccine are also presented in this work. According to obtained results the author demonstrates high vaccine efficacy, excellent immunogenicity, low reactogenity and high vaccine safety. The author tries to destroy a presumption concerning low efficacy and high adverse events frequency following influenza vaccination.
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