Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
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.
Inclusion Criteria:
Exclusion Criteria:
St-Romulad, Quebec G6W 5M6, Canada
Bad Kreuznach, Hesse 55545, Germany
Brinkum/Stuhr, Lower Saxony 28816, Germany
Duelmen, Lower Saxony 48249, Germany
Koenigslutter, Lower Saxony 38154, Germany
Bekkestua, 1319, Norway
Waterloo, Liverpool, L22 0LG, United Kingdom