Open-Label Influenza Vaccine Evaluation



Status:Active, not recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:65 - 74
Updated:7/19/2018
Start Date:September 2016
End Date:September 2018

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Open-Label, Randomized Study of Immune Response to Licensed Influenza Vaccines in Adults 65-74 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2016-17 and 2017-18)

This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the
immune response to consecutive influenza vaccination across 2 seasons. Participants will be
randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will
receive the same vaccination in the second year and the third arm will be randomized again to
1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood
draws for a total of 6 draws over 18 months.


Inclusion Criteria:

- Age 65-74 years at the time of study enrollment and are ambulatory and live in
selected Wisconsin community or surrounding communities.

- Willing and able to give informed consent prior to study enrollment

- Able to comply with study requirements.

Exclusion Criteria:

- Prior receipt of 2016-17 influenza vaccine

- Current participation in another clinical trial

- Presence of a contraindication to influenza vaccine
We found this trial at
1
site
1000 N Oak Ave
Marshfield, Wisconsin 54449
(715) 387-5511
Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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mi
from
Marshfield, WI
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