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

Sponsored by David H. Canaday

About this trial

Last updated 2 years ago

Study ID

10-27-29

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

65+ Years
All Sexes

Trial Timing

Ended 3 years ago

What is this trial about?

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

What are the participation requirements?

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.