Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
Influenza
About this trial
This is an interventional educational/counseling/training trial for Influenza focused on measuring vaccine, elderly, immunogenicity, safety
Eligibility Criteria
Inclusion Criteria: Stable health status Access to a consistent means of telephone contact. Comprehension of study requirements, availability for study duration Availability and ability to attend scheduled visits Females post menopausal, sterile or using accepted contraceptive measures Competence to provide informed consent Exclusion Criteria: Presence of significant acute or chronic medical or neuropsych. illness New medical or surgical treatment w/i 1 month Change in medication dose due to uncontrolled symptoms w/i 1 month Hospitalization w/i 1 month Any unusual risk (for age group) of serious adverse events w/i 1 month Any neuropsychiatric condition altering competence for consent Any neuropsychiatric condition preventing accurate safety reports Febrile illness on day of treatment Employment in professions at high risk of influenza transmission Residence in a long-term-care facility or with an immunocompromised person Systolic BP over 150, diastolic over 90, resting pulse under 50 or over 100 Cancer w/i 3 years Immunosuppressive of immunodeficient conditions Treatment with systemic glucocorticoids > replacement Treatment with cytotoxic or immunosuppressant drugs Treatment with immune globulins Clotting disorders that increase the risks of intramuscular injections History of demyelinating disease or GBS Pregnancy or nursing Absence of contraceptive practices in women with childbearing potential Planned administration of non-influenza vaccines within 30 days Receipt of any investigational drug within 30 days Receipt of immune globulin treatment within 3 months Known or suspected allergy to egg proteins, gelatin, or thimerosal History of severe adverse reactions toflu vaccines Prior receipt of 2005-6 influenza vaccine
Sites / Locations
- University Clinical Research, Inc.
- Radiant Research
- Radiant Research
- Vince and Associates Clinical Research
- The Center for Pharmaceutical Research
- Regional Clinical Research
- University of Rochester Medical Center
- Radiant Research
- Omega Medical Research
- PI-Coor Clinical Research