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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01457027
Eligibility Criteria:
Inclusion Criteria:
* Healthy female and male adults aged \>60 years on the day of enrollment
* Written informed consent
* Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)
Exclusion Criteria:
* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine for season 2011/2012
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/day prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (including leukemia, HIV seropositivity) or cancer
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Participation in another clinical trial
* Employee at the investigational site or relative of the investigator
* Anticipated non-compliance with study procedures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01457027
Study Brief:
Protocol Section:
NCT01457027