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Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.

NCT01808456 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-07-22

Study results available
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Summary

Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths of influenza vaccine have not been established.

The primary study objective is to determine the safety and immunogenicity of Fluzone and Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are commercially available for use in the general population. Fluzone is approved for use in 6 months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and older.

This is an exploratory, open-label, parallel group, observer blinded, prospective study. All recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be eligible for enrollment.

Enrolled patients will be followed for three months (a total of 4 visits) following enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and 12.

Conditions

  • Influenza, Human
  • Transplantation Infection

Interventions

BIOLOGICAL

influenza trivalent inactive vaccine

one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients

BIOLOGICAL

influenza trivalent inactive vaccine high dose

one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients

Sponsors & Collaborators

  • Inova Health Care Services

    lead OTHER

Principal Investigators

  • Ravinder Wali, MD · Inova Fairfax Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01808456 on ClinicalTrials.gov