A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix™ (GlaxoSmi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-000939-97

A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly 60 years of age and older

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Extrait

To demonstrate the immunological non-inferiority (GMT) of the low dose adjuvanted (AS03) influenza vaccine versus Fluarix given intramuscularly in elderly (aged >60 years), 21 days following vaccination. To demonstrate the immunological non-inferiority (GMT) of the low dose non-adjuvanted influenza vaccine versus Fluarix given intramuscularly in elderly (aged >60 years), 21 days following vaccination.


Critère d'inclusion

  • Immunization against influenza in male and female subjects aged 60 years and older