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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity

Secondary outcome measures

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 outcome measures

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

Nasal congestion

Sinus congestion

Upper respiratory tract infection

Sneezing

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

TRIVALENT VACCINE

PLACEBO

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

~2630

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,809 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial occurring in more than one state?

"This trial is being conducted at 4 locations: Northwestern University in Chicago, Vanderbilt-Ingram Cancer Center in Nashville, and University of Alabama in Birmingham, along with other sites."

Answered by AI

Are researchers currently looking for new participants in this clinical trial?

"Unfortunately, this particular clinical trial is not presently recruiting patients. Although the study's webpage on clinicaltrials.gov was last updated on April 11th, 2022, it was originally posted over 4 years ago on October 9th, 2017. There are other active studies that might be of interest though - 4 in total."

Answered by AI

What are the risks associated with Trivalent Influenza Vaccine?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence that suggests Trivalent Influenza Vaccine is safe. We scored it a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Natasha Halasa, MD 2017. "High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03179761.