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An open, randomized phase I/II study to demonstrate the non inferiority in term of cellular mediated immune response between GlaxoSmithKline Biologicals influenza candidate vaccines containing various...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-002360-28

An open, randomized phase I/II study to demonstrate the non inferiority in term of cellular mediated immune response between GlaxoSmithKline Biologicals influenza candidate vaccines containing various adjuvants administered in elderly population (aged 65 years and older) and Fluarix™ (known as alpha-Rix™ in Belgium) administered in adults (18-40 years)

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Extrait

To demonstrate the non inferiority 21 days post-vaccination between the influenza adjuvanted vaccines administrated in elderly subjects (aged 65 years and older) and Fluarix™ administered in adults (aged 18-40 years) in terms of frequency of antigen-specific CD4 T-lymphocytes producing at least two different cytokines (CD40L, IL-2, TNF-alpha, IFN-gamma).

Critère d'inclusion

  • Immunisation against influenza disease in adults aged 18-40 years and elderly population aged over 65 years (>65 years)

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