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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University

Criteria

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