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

Phase 1

Completed

• Conditions: Pediatric Solid Organ Transplant Patients
• Interventions: Drug: Standard dose trivalent inactivated influenza vaccine; Drug: High-Dose trivalent inactivated influenza vaccine

• Registration Number: NCT01525004
• Lead Sponsor: Vanderbilt University

Brief Summary

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).

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-02
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose trivalent inactivated influenza vaccine	Standard dose trivalent inactivated influenza vaccine	-
High-Dose trivalent inactivated influenza vaccine	High-Dose trivalent inactivated influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
Safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States