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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00734734
Eligibility Criteria:
Key Inclusion Criteria:
* 65 years of age or older
* Mentally competent
* Willing and able to give written informed consent prior to study entry
* Able to comply with all the study requirements
* In general good health
Key Exclusion Criteria:
* Any serious chronic or acute disease
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
* Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
* A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
* Within the past 12 months, they have received more than one injection of influenza vaccine
* Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
* Within the past 4 weeks participants had received another vaccine; any investigational agent
* An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00734734
Study Brief:
Protocol Section:
NCT00734734