Status:
COMPLETED
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients
Lead Sponsor:
Yale University
Conditions:
Influenza
Gammopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02267733
Start Date
October 1 2014
End Date
December 1 2015
Last Update
August 25 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06519