Randomized Influenza Vaccine Evaluation of Immune Response



Status:Enrolling by invitation
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:9/16/2018
Start Date:July 30, 2018
End Date:September 2020

Use our guide to learn which trials are right for you!

Randomized Open-Label Trial to Compare Immunogenicity of Egg-Based and Non-Egg Based Quadrivalent Influenza Vaccines Among Adults 18-64 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2018-19 and 2019-20)

Licensed influenza vaccines are manufactured with a variety of technologies. The majority are
split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US
licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and
FluBlok (recombinant). There is increasing evidence that egg propagation induces virus
mutations that impair the immune responses to circulating viruses. However, the impact of
egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential
recommendation for any specific influenza vaccine product or technology. A direct comparison
of serologic response to egg based and non-egg based vaccines in adults has not been
performed. This randomized trial will compare serologic responses to the egg- and non-egg
A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to
evaluate sequential vaccination effects on immune response.


Inclusion Criteria:

- Aged 18-64 years

- Marshfield Clinic patients living in or around Marshfield, Wisconsin since July 2015

- Willing and able to give informed consent and comply with study requirements

Exclusion Criteria:

- Receipt of 2018-19 influenza vaccine prior to study enrollment

- Known to be pregnant at the time of enrollment

- Current participation or plans to participate in another clinical trial involving an
experimental agent

- Presence of a contraindication to influenza vaccination

- Plans to relocate outside the geographic location in the next two years
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...
?
mi
from
Marshfield, WI
Click here to add this to my saved trials