Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients



Status:Active, not recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:December 2015

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Trial Summary
Trial Overview
Inclusion Criteria

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)

A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing
schedule for patients with monoclonal gammopathies stratified by disease status

In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to
patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective
of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days
(+/- 7 days) later and will then be followed for outcomes until the end of flu season.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent document

- Age >= 18 years at the time of signing the informed consent form

- Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined
Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active
Waldenstrom Macroglobulinemia (WM)

Exclusion Criteria:

- An serious egg allergy or prior serious adverse reaction to an influenza vaccine

- Use of any other influenza vaccine for the 2014 to 2015 flu season

- Women who are pregnant or plan to become pregnant in the study period
We found this trial at
1
site
Yale University
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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from
New Haven, CT
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