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Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

NCT01685372 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-01-23

Study results available
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Summary

The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.

Conditions

  • Solid Organ Transplant Recipient (Liver, Kidney, Heart)
  • Rheumatologic Disorder
  • Human Immunodeficiency Virus (HIV)
  • Bone Marrow Transplant (BMT)
  • Dialysis

Interventions

BIOLOGICAL

Fluzone High Dose

A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm

BIOLOGICAL

Fluzone

A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm

Sponsors & Collaborators

  • Colorado Clinical & Translational Sciences Institute

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Donna Curtis, MD, MPH · Children's Hospital Colorado, University of Colorado Denver School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-09-30
Completion
2017-09-30

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 NCT01685372 on ClinicalTrials.gov