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Estudio de vacunación, fase III, observador ciego, aleatorizado (3:3:2), control activo, multinacional, multicéntrico para evaluar la respuesta inmune celular y humoral de la vacuna FLU NG de GSK Biol...

Update Il y a 4 ans
Reference: EUCTR2008-004711-35

Estudio de vacunación, fase III, observador ciego, aleatorizado (3:3:2), control activo, multinacional, multicéntrico para evaluar la respuesta inmune celular y humoral de la vacuna FLU NG de GSK Biologicals [GSK2186877A] comparada con Fluarix™ en adultos de 65 años y mayores, y comparada con Fluarix™ en adultos jóvenes de 18 a 40 años. A phase III, observer-blind, randomized (3:3:2), active-controlled, multi-country, multi-center study to evaluate the cell mediated and humoral immune responses to GSK Biologicals’ FLU NG vaccine [GSK2186877A] compared to Fluarix™ in adults 65 years of age and older, and compared to Fluarix™ in younger adults (18-40 years)

Woman and Man

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Extract

•To demonstrate, in subjects aged 65 years and older, that the frequency of influenza-specific CD4 T-cells per 10^6 CD4+ T-cells identified after in vitro stimulation with pooled vaccine strains as producing at least two different markers (CD40L, IL-2, TNF-alpha, IFN-gamma) induced by the FLU NG vaccine is superior to the one induced by Fluarix at Day 21 after vaccination.

Inclusion criteria

  • Inmunización frente a la gripe estacional de varones y mujeres de 65 años y mayores o de 18 a 40 años Immunization against seasonal influenza in men and woman aged 65 years and older or 18 to 40 years

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