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

Launched by DAVID H. CANADAY · Oct 1, 2018

Keywords

ClinConnect Summary

As the primary endpoint, this trial is be using pre- to post-vaccine changes in HAI titers to compare seroconversion rates and post-vaccination HAI titers to calculate the ratio of the geometric mean titers in the two treatment groups. HAI is an in vitro bioassay that determines a subject's serum levels of anti-influenza antibodies. The FDA uses this as a standard immunogenicity assay for licensure. The trial will follow guidelines set out in the FDA guidance document discussing non-inferiority immunogenicity studies. As additional methods to assess immunogenicity, an assessment of anti-NA ...

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Eligibility 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.