FLUAD vs. FLUZONE HD Influenza Vaccine in Residents of Long Term Care

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Adjuvanted flu vaccine, Fluad, is not immunologically inferior to HD influenza vaccine in older persons living in long-term care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David H. Canaday
• Collaborators: Brown University; Case Western Reserve University; National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH); US Department of Veterans Affairs
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• > 65 years old

• Able to obtain consent from subject or legally authorized representative (subject to provide assent if cognitively/physically able to do so)

• Able to participate throughout the study period

Exclusion Criteria:

• Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy

• Administration of immunomodulatory agents (e.g. oral corticosteroids except prednisone < 10 mg daily, cyclosporine, and biologics (DMARDS) for Rheumatologic/Dermatologic conditions) in the last 3 months

• Cancer requiring treatment in the past three years, except for non- melanoma skin cancers or cancers that have clearly been cured or carry an excellent prognosis including prostate cancer.

• Myocardial infarction, major heart surgery (i.e. valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 4 months

• Allergies or history of significant adverse reactions to any component of influenza vaccine including egg protein and latex or after a previous dose of any influenza vaccine.

• History of Guillian-Barré Syndrome within 6 weeks of a prior influenza vaccine.