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A phase II, observer-blind, multicountry, multicentre, randomized study to demonstrate the non-Inferiority of GlaxoSmithKline Biologicals’ one-container AS25 adjuvanted influenza vaccine compared to G...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-003290-29

A phase II, observer-blind, multicountry, multicentre, randomized study to demonstrate the non-Inferiority of GlaxoSmithKline Biologicals’ one-container AS25 adjuvanted influenza vaccine compared to GlaxoSmithKline Biologicals’ two-container AS25 adjuvanted influenza vaccine in adults aged 65 years and above

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Extrait

To demonstrate the immunological non-inferiority (in terms of HI antibody GMT) of the one container presentation of the AS25 adjuvanted influenza vaccine from the NH 2006/07 season (FluAS25 -1 container NH 2006/07) versus the two container presentation of the AS25 adjuvanted influenza vaccine from the NH 2006/07 season (FluAS25 -2 containers NH 2006/07) 21 days after vaccination in elderly subjects of 65 years and older. To demonstrate the immunological non-inferiority (in terms of HI antibody GMT) of the one-container presentation of the AS25 adjuvanted influenza vaccine from the NH 2007/08 season (FluAS25 -1 container NH 2007/08) versus the two-container presentation of the AS25 adjuvanted influenza vaccine from the NH2007/08 season (FluAS25 -2 containers NH 2007/08), 21 days after vaccination in elderly subjects 65 years and older.

Critère d'inclusion

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

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