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

This study has been completed.
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: August 12, 2016
Last verified: August 2016
  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 (Subject, Caregiver, Investigator, Outcomes Assessor)
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:


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.


Enrollment: 38
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: June 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.

Detailed Description:
A prospective, randomized, double-blind phase 1 safety and immunogenicity study of the HD compared with the SD TIV in pediatric patients between the ages of three and 17 yr that have undergone SOT (Clin-Trials.gov. NCT01525004) was conducted. Subjects were randomized in a 2:1 fashion to receive 0.5 mL of either the HD (60 μg) or SD (15 μg) TIV intramuscularly. Subjects <9 yr of age received either one or two doses of the vaccine based on ACIP recommendations [19]. The study was approved by Institutional Review Boards at both institutions (Vanderbilt University, Nashville, TN, and the University of Pittsburgh, Pittsburgh, PA) and conducted during the 2011-2012 influenza season. Subjects were randomly allocated to either the HD or SD group by a computer-generated allocation system. Participants, their families, and research staff who performed clinical evaluations remained blinded to the child's assigned dosage, while designated unblinded nurses administered the requisite vaccine.
  Eligibility

Ages Eligible for Study:   3 Years to 17 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: August 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Solid organ transplant
Flu vaccine

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016