Influenza Clinical Trial
Official title:
Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.
This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009.
After the analyses for this study were completed, questions arose regarding the integrity of
study data from a single study site in Romania, which enrolled 102 subjects in the trial.
Because evaluation of data from this site did not reveal irregularities when compared with
overall study data and because GSK has no current plans to use the data from the study in
support of any regulatory filings, they were not excluded from the analyses reflected in this
results summary.
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