Influenza Clinical Trial
Official title:
Extent and Durability of Immune Response Following Seasonal Influenza Vaccination in Healthy Volunteers
This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.
Subjects will be screened within 28 days prior to enrollment into the study. After qualifying
for the study subjects will visit the clinical unit on Day l and will have pre-dose blood
samples taken for humoral (serum) and cellular(peripheral blood mononuclear cells PBMCs)
immunity testing and nasopharyngeal swabs for assessment of mucosa! immunity, and will then
be given the vaccine.
Over the next 6 months, I 0-mL blood samples will be collected on Days 4, 8, 15, 29, 91 and
181 for HAI testing. Peripheral blood mononuclear cells will be collected on Day 8 to assess
cellular responses. A nasopharyngeal swab will also be done on Day 29. Screening assessments
will include clinical laboratory tests (hematology, chemistry, urinalysis (UA), drug and
alcohol testing), vital signs, 12-lead electrocardiogram and physical examination.
Adverse events (AEs) will be monitored throughout the study.
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