FLUTRAN: Flu Vaccine Dose Comparison in Children Who Have Had Stem Cell Transplants

Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients

Categories:

Infectious Diseases

Vaccines

Diseases Treated:

Influenza

Eligibility Overview:

  • At least 3 years old and younger than 17
  • Allogeneic hematopoietic stem cell transplant recipient
  • At least 3 and not more than 35 months after transplant
  • Platelet count of at least 30,000
  1. Brief Summary

    Hematopoietic stem cell transplant (HSCT) recipients are highly susceptible to influenza infection and associated complications. Influenza vaccination is the primary mode for prevention of influenza infection. However, few influenza vaccine clinical trials have been conducted in pediatric HSCT recipients. The recommended timing of vaccination and number of doses needed remain unclear.

    Prior studies found that high-dose trivalent inactivated influenza vaccine (HD-TIV) increased immunogenicity and efficacy in adults 65 years of age and older compared to standard dose vaccine. In this study, researchers will compare HD-TIV to standard dose quadrivalent inactivated influenza vaccine (QIV) in pediatric HSCT recipients to see if younger patients respond similarly.

    Primary Objective

    • To determine whether HD-TIV compared with standard dose QIV will increase the probability of achieving a ≥4-fold rise in HAI titers, ≥1:40 HAI titer, or higher GMT titers to influenza A antigens in pediatric HSCT recipients.

    Eligibility Criteria

    Inclusion criteria include:

    • At least 3 years old and younger than 17
    • Allogeneic Hematopoietic stem cell transplant recipient
    • At least 3 and not more than 35 months after transplant
    • Platelet count of at least 30,000

    Exclusion Criteria include:

    • Hypersensitivity to previous influenza vaccination
    • Moderate to severe hypersensitivity to eggs or egg protein
    • History of Guillain-Barre syndrome
    • Pregnancy
    • Received 2016-2017 influenza vaccine

    Study Sites

    St. Jude Children’s Research Hospital and collaborating sites in the U.S.
    Memphis, Tennessee

  2. About this study

    Influenza, also called the flu, is a serious disease that is spread easily from person to person. It is especially dangerous to people who have had stem cell transplants because their immune systems may be weak.

    The flu vaccine helps protect people from the flu infection. However, children who have had stem cell transplants do not respond to vaccines as well as healthy children do.

    This study will look at the safety and immune response of a vaccine called Fluzone High Dose® (HD) in children and adolescents who have had stem cell transplants. Immune response is the amount of antibodies in the blood. Antibodies help your body to fight off germs.

    Fluzone HD is an investigational vaccine. Investigational means the vaccine is not approved by the U.S. Food and Drug Administration for use in children. However, Fluzone HD is approved for use in adults older than 65 years of age.

    This study will compare Fluzone HD to a similar flu vaccine that is approved for use in children and adults in the U.S. This approved vaccine is called Fluzone Quadrivalent®.

    Fluzone Quadrivalent® protects the body from four types of flu. Fluzone HD protects the body from three of the same flu types. Both of these vaccines are given as shots, but Fluzone HD is given in a higher dose. Participants in this study will be randomly selected to receive either two doses of Fluzone Quadrivalent or two doses of Fluzone HD.

    Purpose of this clinical trial

    The main goal of this clinical trial is to see which of these two vaccines gives the best flu protection to children and adolescents who have had stem cell transplants.

    Eligibility overview

    • At least 3 years old and younger than 17
    • Allogeneic hematopoietic stem cell transplant recipient
    • At least 3 and not more than 35 months after transplant
    • Platelet count of at least 30,000
  3. FLUTRAN Quick View
    Sponsor Vanderbilt-Ingram Cancer Center
    Clinicaltrials.gov identifier NCT02860039
    Trial start date September 2016
    Estimated enrollment 200
    Study type Interventional
    Study Phase

    Phase II

    Conditions Influenza, Hematopoietic Cell Transplant
    Ages At least 3 years old and younger than 17
    Principal investigator Gabriela Maron Alfaro, MD
    Study site St. Jude Children’s Research Hospital and collaborating sites in the U.S.
    For a consultation or to discuss FLUTRAN St. Jude Physician/Patient Referral Office
    1-888-226-4343                                                                                               referralinfo@stjude.org

Contact

Gabriela Maron Alfaro, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.