- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01525004
Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients
August 12, 2016 updated by: Natasha Halasa, Vanderbilt University
Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine in Pediatric Solid Organ Transplant Patients
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Monroe Carell Jr. Children's Hospital at Vanderbilt University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard dose trivalent inactivated influenza vaccine
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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
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Experimental: High-Dose trivalent inactivated influenza vaccine
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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6-9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natasha Halasa, MD, Vanderbilt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
October 14, 2011
First Submitted That Met QC Criteria
January 30, 2012
First Posted (Estimate)
February 2, 2012
Study Record Updates
Last Update Posted (Estimate)
August 16, 2016
Last Update Submitted That Met QC Criteria
August 12, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111069 - IRB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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