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Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

NCT04080531 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-02-28

Study results available
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Summary

This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.

Conditions

  • Plasma Cell Neoplasm

Interventions

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Given IM

BIOLOGICAL

Trivalent Influenza Vaccine

Given IM

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Craig Hofmeister, MD, MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2021-05-11
Completion
2022-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080531 on ClinicalTrials.gov