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A randomized, observer-blind, active-controlled phase III study to demonstrate the superior efficacy of GSK Biologicals’ adjuvanted influenza candidate vaccine [GSK2186877A], administered intramuscula...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-000872-25

A randomized, observer-blind, active-controlled phase III study to demonstrate the superior efficacy of GSK Biologicals’ adjuvanted influenza candidate vaccine [GSK2186877A], administered intramuscularly in elderly aged 65 years or above, as compared to Fluarix™

Femme et Homme

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Extrait

To assess in adults aged 65 years and above, the superior efficacy of the FLU NG vaccine after the first dose in the prevention of PCR-confirmed influenza A and /or B, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v), during the corresponding surveillance period, when compared to Fluarix™. To assess the lot-to-lot consistency of 3 lots of the FLU NG vaccine in terms of immunogenicity (as measured by GMT), 21 days after vaccination during the first year of the study.

Critère d'inclusion

  • Immunization against influenza in male and female subjects aged 65 years or older

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