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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 belowSelect...
I had a stem cell transplant from a donor between 3 to 23 months ago.
Select...
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.
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 moreOther 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 • NCT018591437%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can be contacted by phone or email.My GVHD has been stable for at least 4 weeks without needing more immune-suppressing drugs.My platelet count is high enough for immunizations, even if I needed transfusions.I had a stem cell transplant from a donor between 3 to 23 months ago.You are able to participate for the entire length of the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2(SD-QIV)
- Group 2: Group I (HD-TIV)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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