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

Completed · Phase 2 · Has a placebo group

Conditions studied: Influenza, Multiple Myeloma, Waldenstrom's Macroglobulinemia, Plasma Cell Disorders, MGUS

In brief

The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season

Key facts

Study ID: NCT02566265
Run by: Yale University
People needed: 122
Starts: 2015-09-01
Expected to finish: 2018-06-01
Last updated by the study team: 2019-01-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Understand and voluntarily sign an informed consent form.
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 Waldenstrӧm Macroglobulinemia (WM).

You may not qualify if…

Any serious egg allergy or prior serious adverse reaction to an influenza vaccine.
Use of any other influenza vaccine for the 2015 to 2016 flu season.
Women who are pregnant or plan to become pregnant in the study period.

Where it is running

Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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