Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™

Completed · Phase 4

Conditions studied: Influenza

In brief

A study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™

Key facts

Study ID

NCT00377611

Run by

GlaxoSmithKline

People needed

3054

Starts

2006-10-05

Expected to finish

2007-06-20

Last updated by the study team

2018-10-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A male or female age 50 years or older at the time of the first vaccination.
• non-childbearing female
• Availability to follow up by phone
• Subjects with residence status allowing free mixing with general community

You may not qualify if…

• Use of non-registered products
• Pregnancy
• Hypersensitivity to a previous dose of influenza vaccine
• Acute disease at the time of enrolment/vaccination.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine
• Any contra-indication to intramuscular administration of Fluarix™
• For subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Delray Beach, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Somers Point, New Jersey, United States
• GSK Investigational Site — Camillus, New York, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Norfolk, Virginia, United States
• GSK Investigational Site — Güglingen, Baden-Wurttemberg, Germany
• GSK Investigational Site — Rudersberg, Baden-Wurttemberg, Germany
• GSK Investigational Site — Weinheim, Baden-Wurttemberg, Germany
• GSK Investigational Site — Potsdam, Brandenburg, Germany
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Essen, North Rhine-Westphalia, Germany
• GSK Investigational Site — Witten, North Rhine-Westphalia, Germany
• GSK Investigational Site — Mainz, Rhineland-Palatinate, Germany
• GSK Investigational Site — Rhaunen, Rhineland-Palatinate, Germany
• GSK Investigational Site — Dresden, Saxony, Germany
• GSK Investigational Site — Leipzg, Saxony, Germany
• GSK Investigational Site — Leipzig, Saxony, Germany
• GSK Investigational Site — Leipzig, Saxony, Germany
• GSK Investigational Site — Magdeburg, Saxony-Anhalt, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany

Full record on ClinicalTrials.gov

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