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Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Pittsburgh
Sanofi Pasteur MSD
Information provided by (Responsible Party):
Natasha Halasa, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01525004
First received: October 14, 2011
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (SOT).


Condition Intervention Phase
Pediatric Solid Organ Transplant Patients
 Drug: High-Dose trivalent inactivated influenza vaccine
Drug: Standard dose trivalent inactivated influenza vaccine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine in Pediatric Solid Organ Transplant Patients

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
    We will record local and systemic reactions after each vaccination for seven days. Patients will fill out a diary card. We will collect adverse events for 28 days and SAE for 6 months.


Secondary Outcome Measures:
  • Humoral immune responses of pediatric Solid Organ Transplant patients to influenza virus antigens included in trivalent inactivated influenza vaccine after high and standard doses of trivalent inactivated influenza vaccine. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    We will measure HAI titers. We will calculate the perecet of subjects who acheive HAI titers greater than and equal to 1:40 and those with 4-fold increase. We will also calculate GMTs.


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard dose trivalent inactivated influenza vaccine Drug: Standard dose trivalent inactivated influenza vaccine
0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
Experimental: High-Dose trivalent inactivated influenza vaccine Drug: High-Dose trivalent inactivated influenza vaccine
0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral)
  • Must be at least 6 months after transplant.
  • 3-17 years of age, inclusive.
  • Available for duration of study.
  • Parent or guardian able to be reached by phone.

Exclusion Criteria:

  • History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein.
  • History of Guillian-Barre syndrome.
  • Receipt of rituximab within the past one year.
  • Rejection treatment with intravenous steroid bolus within 30 days.
  • Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days.
  • Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
  • Have any condition that the investigator believes may interfere with successful completion of the study.
  • History of received 2011-2012 influenza vaccine.
  • Pregnant female.
  • History of proven influenza disease after September 1, 2011.
  • History of known infection with HIV, hepatitis B, or hepatitis C.
  • History of known latex hypersensitivity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525004

Locations
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
University of Pittsburgh
Sanofi Pasteur MSD
Investigators
Principal Investigator: Natasha Halasa, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Natasha Halasa, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01525004     History of Changes
Other Study ID Numbers: 111069 - IRB
Study First Received: October 14, 2011
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Solid organ transplant
Flu vaccine

ClinicalTrials.gov processed this record on May 16, 2013