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NCT Number: NCT01525004

Standard Dose Versus High-Dose Inactivated Flu 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).

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Key information

Conditions

Pediatric Solid Organ Transplant Patients Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Monroe Carell Jr. Children's Hospital at Vanderbilt University

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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

    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.

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.

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • MCM Vaccines B.V.
  • University of Pittsburgh

Registry information

Official study title

Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine in Pediatric Solid Organ Transplant Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2012
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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