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

NCT01525004 | Completed Phase 1 DMC

• 1 other identifier: 111069 - IRB
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric Solid Organ Transplant Patients

Keywords

Solid organ transplant; Flu vaccine

Outcome Measures

Primary Outcomes (1)

• Safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients

  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.

  6-9 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Standard dose trivalent inactivated influenza vaccine

ACTIVE COMPARATOR

Drug: Standard dose trivalent inactivated influenza vaccine

High-Dose trivalent inactivated influenza vaccine

EXPERIMENTAL

Drug: High-Dose trivalent inactivated influenza vaccine

Interventions

High-Dose trivalent inactivated influenza vaccine DRUG

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.

High-Dose trivalent inactivated influenza vaccine

Standard dose trivalent inactivated influenza vaccine DRUG

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

Standard dose trivalent inactivated influenza vaccine

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• University of Pittsburgh: collaborator
• MCM Vaccines B.V.: collaborator

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Natasha Halasa, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: February 2, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

US (1)