In this study the investigators are trying to understand how immune function declines in the elderly using annual influenza vaccinations as a model system. The longitudinal study began in 2007 and continued through early 2017.
Participants ranging in age from 18 to 100 at time of initial enrollment will be immunized annually with the seasonal influenza vaccine, Fluzone, on Day 0. Follow-up visits will be conducted on Day 6-8 and Day 28. Unsolicited adverse events are collected from immunization until the Day 28 visit, serious adverse events are collected for the entire time of study participation. A blood sample is collected pre-immunization and at each follow-up visit. Volunteers will be followed for up to 11 years, those too frail to come in for visits received annual phone calls to monitor health. Last annual influenza vaccines were given in Fall 2015. The main basic research effort will be to collect safety data and follow medical history events in elderly and younger control subjects. Investigators will also look at immune responses to influenza vaccination. In 2008, 2012 and 2014, the cohort added additional participants to replace those who had withdrawn. Beginning in 2014, those participants 65 years and older were immunized with High Dose trivalent Fluzone and younger participants received the quadrivalent formulation of Fluzone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
136
Licensed Seasonal Influenza Vaccine TIV
Licensed Seasonal Influenza Vaccine IIV4
Licensed Seasonal High-Dose Influenza Vaccine TIV
Stanford University School of Medicine
Stanford, California, United States
Number of Participants Who Received the Influenza Vaccine
Time frame: Day 0 annually while on study
Number of Participants With Related Adverse Events
Related adverse events were recorded annually during this 10 year longitudinal study.
Time frame: Day 0 to Day 28 following each annual vaccination while on study
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