Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The occurrence of influenza-like illness (ILI) will be determined in elderly participants vaccinated with either Fluzone High Dose or Fluzone® vaccine.
The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.
Age
65–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Aged ≥ 65 years on the day of vaccination
Informed consent form signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.
You may not be if
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.
Clareo Health | Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
