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High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients

NCT03179761 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-12-04

Study results available
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Summary

This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.

Conditions

  • Hematopoietic Cell Transplantation

Interventions

BIOLOGICAL

Quadrivalent Inactivated Influenza Vaccine

Standard Dose Quadrivalent Influenza Vaccine given intramuscularly

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Trivalent Influenza Vaccine

High Dose Trivalent Influenza Vaccine given intramuscularly

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2022-02-15
Completion
2024-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03179761 on ClinicalTrials.gov