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A phase III, randomised, single-blind study to evaluate the immunogenicity and safety of sequential administration of a licensed seasonal trivalent vaccine and the pandemic H1N1 influenza candidate va...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-014448-13

A phase III, randomised, single-blind study to evaluate the immunogenicity and safety of sequential administration of a licensed seasonal trivalent vaccine and the pandemic H1N1 influenza candidate vaccine administered in adults 61 years or above

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Extrait

To assess whether vaccination with two doses of the H1N1 candidate vaccine results in an HI immune response that meets or exceeds the EMEA (CHMP) guidance targets for pandemic influenza vaccines (seroconversion rate (SCR), seroprotection rate (SPR), and seroconversion factor (SCF)) at 21 days after the second dose of H1N1 vaccine when Fluarix™ has been administered or not at least 21 days before in subjects aged 61 years and older.

Critère d'inclusion

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

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