NCT02566265

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 30, 2019

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

September 30, 2015

Results QC Date

May 31, 2018

Last Update Submit

January 28, 2019

Conditions

InfluenzaMultiple MyelomaWaldenstrom's MacroglobulinemiaPlasma Cell DisordersMGUS

Keywords

influenzamultiple myelomaWaldenstrom's macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Failure by Primary Endpoint

    Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.

    1 year

Study Arms (2)

Fluzone High Dose Vaccine then Fluzone High Dose Booster

EXPERIMENTAL

Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.

Biological: Fluzone High Dose Vaccine

Standard of Care

ACTIVE COMPARATOR

Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.

Biological: Standard of care/Placebo

Interventions

Fluzone High Dose VaccineBIOLOGICAL
Fluzone High Dose Vaccine then Fluzone High Dose Booster
Standard of care/PlaceboBIOLOGICAL
Standard of Care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, United States

Location

Related Publications (1)

  • Branagan AR, Duffy E, Gan G, Li F, Foster C, Verma R, Zhang L, Parker TL, Seropian S, Cooper DL, Brandt D, Kortmansky J, Witt D, Ferencz TM, Dhodapkar KM, Dhodapkar MV. Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias. Blood Adv. 2021 Mar 9;5(5):1535-1539. doi: 10.1182/bloodadvances.2020003880.

    PMID: 33683337DERIVED

MeSH Terms

Conditions

Influenza, HumanMultiple MyelomaWaldenstrom Macroglobulinemia

Interventions

Influenza VaccinesVaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Andrew Branagan, MD
Organization
Yale University School of Medicine
andrew.branagan@yale.edu
617-459-5234

Study Officials

  • Andrew Branagan, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2017

Study Completion

June 1, 2018

Last Updated

January 30, 2019

Results First Posted

January 30, 2019

Record last verified: 2019-01

Locations

US(1)