Non-inferiority Study of Adjuvanted vs. High Dose Flu Vaccine in Residents of Long Term Care

10-27-29

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

2018-09-23

2023-01-31

2023-01-31

Completed

Early phase I

478

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A non-inferiority randomized clinical trial to enroll 500 long term care (LTC) dwellers from at least one of 40 nursing homes sites in northern Ohio.\n\nAge 65 and older to receive either Fluad or HD vaccine at 1:1 ratio.\n\nBlood will be sampled pre- and post-vaccine and post-influenza season and coded for blinded laboratory analysis.\n\nRandomization by from randomizer.org software./RedCAP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 478, 'type': 'ACTUAL'}}

2024-04-30