Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

Exclusion Criteria

• •Participation in another interventional clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the trial vaccination or planned participation in another clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure during each year of participation in the study trial.
• •Vaccination against influenza in the 6 months preceding the trial vaccination.
• •Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances.
• •Personal history of Guillain-Barré syndrome.
• •Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures.
• •Thrombocytopenia, bleeding disorder, or anticoagulation therapy contraindicating intramuscular (IM) vaccination.
• •Known or suspected human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C seropositivity.
• •Alcohol abuse or drug addiction that could interfere with the subject's ability to comply with trial procedures.
• •Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
• •Bedridden subjects.