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:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00936468
Eligibility Criteria:
Inclusion Criteria:
* Be adult volunteers aged ≥65 years
* Live in the community, independently or in an assisted living environment
* Be Class 1-5, as defined by the CSHA-CFS
* If female, will be post-menopausal
* Will be available for the duration of the trial (21-day On Study Period) and Follow-Up (4 and 9 months after vaccination)
* Be 'probably not demented' on the Mini-Cog test
* Provide informed consent
* Agree to defer receipt of vaccination of novel H1N1 (swine) influenza until after completion of the Day 28 study procedures
Exclusion Criteria:
* Known allergy to eggs or other components of the vaccine.
* History of severe reaction of any kind to conventional influenza vaccines
* Be Class 6-7 in the CSHA-CFS or be institutionalized (e.g., in a nursing home)
* Requiring nursing home-level equivalent care at home or within a community assisted living environment
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
* Significant cardiovascular disease (e.g., NYHA class 3 through 4 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled ventricular cardiac arrhythmias); resting heart rate \>100;
* A history of chronic obstructive pulmonary disease or history of other lung disease requiring chronic steroid treatment in excess of a bioequivalent dose of 10 mg prednisone daily; a combined history of lung disease and anemia.
* Evidence of significant (more than 10 pounds) of unintentional weight loss in the last year.
* Changed residence or become hospitalized in the last 6 months.
* Combined history of depression and anemia.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Use of any investigational product within 60 days preceding the administration of the study vaccine, or planned use during the study period.
* Seropositive to HIV or HCV or positive for HBsAg
* Body temperature \>38.1°C (100.6°F) or acute illness within 3 days prior to vaccination (subject may be rescheduled)
* History of excessive alcohol consumption, drug abuse, or significant psychiatric illness.
* Be 'probably demented' on the Min-Cog test
* Need for guardian assistance in completing informed consent
* Has received vaccination for novel H1N1 (swine) influenza
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00936468
Study Brief:
Protocol Section:
NCT00936468