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NCT number NCT03183908
Study type Interventional
Source Duke University
Contact Kenneth Schmader, MD
Phone 919-660-7500
Email kenneth.schmader@duke.edu
Status Not yet recruiting
Phase Phase 4
Start date August 21, 2017
Completion date September 2019

Clinical Trial Summary

The overall aim of the study is to compare safety and immunogenicity of adjuvanted inactivated influenza vaccine (IIV) (FLUAD) versus High-Dose inactivated influenza (Fluzone High Dose) vaccine in ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Quality of life will be assessed 8 days post-vaccination and vaccine perceptions surveys will be administered 8 days and 4 weeks post-vaccination.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


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