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A phase II, observer-blind, randomized study to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with GSK Biologicals’ A/California/7/2009 (H1N1)v-like vaccine containing th...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-013931-39

A phase II, observer-blind, randomized study to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with GSK Biologicals’ A/California/7/2009 (H1N1)v-like vaccine containing the AS03 adjuvant when co-administered with GSK Biologicals’ seasonal 2009-2010 influenza vaccine Fluarix™ either at the time of first or second vaccination in elderly subjects aged 61 years and older

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Extrait

•To assess whether vaccination with two doses of the H1N1 candidate vaccine results in an HI immune response to the vaccine-homologous virus that meets or exceeds the EMEA (CHMP) guidance targets for pandemic influenza vaccines (seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean fold rise (GMFR)) at 21 days after the second dose of H1N1 vaccine when co-administered with Fluarix either at the time of first or second vaccination in elderly subjects aged 61 years and older. •To assess whether vaccination with one dose of Fluarix results in an HI immune response that meets or exceeds for each vaccine strain of the seasonal vaccine at least one of the EMEA (CHMP) guidance targets for seasonal influenza vaccines (SCR, and/or SPR and/or GMFR) at 21 days after vaccination when co-administered with either the first or second dose of the H1N1 candidate vaccine in elderly subjects aged 61 years and older.

Critère d'inclusion

  • Immunization against A/California/7/2009 (H1N1)v-like influenza and seasonal influenza (2009-2010) in male and female subjects aged 61 years and older

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