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Virus Therapy
High Dose Flu Vaccine for Bone Marrow Transplant Recipients
Phase 2
Waitlist Available
Led By Natasha Halasa, MD, MPH
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
Parent/legal guardian willing and capable of signing written informed consent
Allogeneic HSCT recipients who are 3-35 months post-transplant and 3-17 years of age, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the influenza season, up to 6 months
Awards & highlights
Study Summary
This trial is testing how well a higher dose flu vaccine works in children who have undergone a stem cell transplant. The hope is that the higher dose will build a better immune response and provide better protection against the flu.
Who is the study for?
This trial is for children aged 3-17 who've had a donor stem cell transplant 3-35 months ago. They should be available throughout the study, have stable GVHD, and not be allergic to eggs or have certain infections like HIV. Pregnant females and those with recent vaccines or acute illnesses are excluded.Check my eligibility
What is being tested?
The trial tests whether high dose flu vaccines (Trivalent or Quadrivalent) create stronger immune responses in these children compared to standard doses. It's randomized, meaning kids get assigned by chance to different vaccine types.See study design
What are the potential side effects?
Possible side effects from the flu vaccines may include soreness at the injection site, fever, muscle aches, and fatigue. Severe allergic reactions are rare but can occur in some individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My parent or guardian can sign the consent form for me.
Select...
I had a stem cell transplant between 3 months and 3 years ago and am between 3 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the influenza season, up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the influenza season, up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers
Secondary outcome measures
Influenza
Proportion of Solicited Local and Systemic Adverse Events
T and B Cell Phenotype Assessed by Mass Cytometry
+1 moreSide 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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 - High Dose TIVExperimental Treatment2 Interventions
Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.
Group II: Group 2 - Standard Dose QIVActive Control2 Interventions
Patients receive standard dose QIV IM on day 0 and day 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trivalent Influenza Vaccine
2010
Completed Phase 4
~2630
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,193 Total Patients Enrolled
Vanderbilt-Ingram Cancer CenterLead Sponsor
214 Previous Clinical Trials
60,823 Total Patients Enrolled
Natasha Halasa, MD, MPHPrincipal InvestigatorVanderbilt University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't received IVIG/SCIG in the last 27 days.I have been part of this study for 1 or 2 years and received the study vaccine.My blood cancer has returned after a transplant.My parent or guardian can sign the consent form for me.I had a stem cell transplant between 3 months and 3 years ago and am between 3 and 17 years old.My GVHD has been stable for at least 4 weeks without needing more immune-suppressing drugs.My platelet count is high enough for immunizations without recent transfusions.I was eligible for the first vaccine and can get the second unless it's unsafe for me.I was vaccinated in a previous flu season and am returning for the same vaccine this year.I haven't had a fever or been sick in the last 48 hours and haven't received any vaccines recently.My parent/guardian is reachable by phone or email.I have received this year's flu vaccine after my transplant.I had the flu after September 1, 2018.I have received a stem cell transplant from myself or my identical twin.I do not have an active HIV, Hepatitis B, or Hepatitis C infection.I have not had a stem cell boost or donor lymphocyte infusion in the last 90 days.I have had Guillain-Barre syndrome in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 - Standard Dose QIV
- Group 2: Group 1 - High Dose 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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