Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00976027
Eligibility Criteria:
Inclusion Criteria :
* 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.
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00976027
Study Brief:
Protocol Section:
NCT00976027