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Vaccine

High vs. Standard Dose Flu Vaccine for Bone Marrow Transplant Recipients

Phase 2
Waitlist Available
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Allogeneic HSCT recipients who are 3-23 months post-transplant;
≥ 18 years of age;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the side effects and efficacy of two different influenza vaccines in adults who have had a stem cell transplant.

Who is the study for?
This trial is for adults over 18 who had a stem cell transplant between 3 to 23 months ago. They should be available for the study duration and have stable graft-versus-host disease (GVHD) without major treatment changes recently. Participants need a minimum platelet count of 30,000 and must be reachable by phone or electronic means.
What is being tested?
The study compares high-dose trivalent influenza vaccine with standard-dose quadrivalent inactivated flu vaccine in adult stem cell transplant recipients. It aims to see which dosage offers better protection against seasonal flu given their weakened immune systems.
What are the potential side effects?
Potential side effects include typical reactions to vaccines such as soreness at the injection site, fever, muscle aches, and fatigue. There may also be rare risks associated with higher doses of vaccines that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stem cell transplant from a donor between 3 to 23 months ago.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
Secondary study objectives
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
Percentage of Individuals in Each Group That Test Positive for Influenza by PCR
Solicited Local Injection Site Adverse Events
+1 more
Other study objectives
B Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays
T Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays

Side effects data

From 2013 Phase 4 trial • 300 Patients • NCT01859143
7%
Nasal congestion
2%
Sinus congestion
1%
Upper respiratory tract infection
1%
Sneezing
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
TRIVALENT VACCINE
PLACEBO

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (HD-TIV)Experimental Treatment2 Interventions
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Group II: Group 2(SD-QIV)Active Control2 Interventions
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trivalent Influenza Vaccine
2010
Completed Phase 4
~2800

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
217 Previous Clinical Trials
63,432 Total Patients Enrolled

Media Library

Quadrivalent Inactivated Influenza Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03179761 — Phase 2
Bone Marrow Transplant Research Study Groups: Group 2(SD-QIV), Group I (HD-TIV)
Bone Marrow Transplant Clinical Trial 2023: Quadrivalent Inactivated Influenza Vaccine Highlights & Side Effects. Trial Name: NCT03179761 — Phase 2
Quadrivalent Inactivated Influenza Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03179761 — Phase 2
~15 spots leftby Nov 2025