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Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

Immunogenicity and Efficacy of High-dose Trivalent Inactivated Seasonal Influenza Vaccine (Fluzone High Dose) in Immunocompromised Children and Young Adults.

NCT01685372•University of Colorado, Denver

View on ClinicalTrials.gov

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.

Eligibility

Age

5 - 35 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 5 years and ≤ 35 years
•Receiving influenza vaccination in Children's Hospital Colorado (CHC) clinic as part of routine clinical care
•Only supposed to receive one dose of influenza vaccine
•Rheumatology patients: must be on some type of immunosuppressive or immunomodulatory medication at the time of immunization and considered at least moderately immunosuppressed in the opinion of the primary rheumatologist. Basic guidelines for rheumatology patients: (1) Any patient receiving monoclonal antibody therapy (i.e., infliximab, etanercept, tocilizumab, anakinra) must also be taking another immunosuppressive/immunomodulatory medication; (2) Patients taking steroids as monotherapy must be on a dose of ≥ 2mg/kg/day OR ≥ 20mg/day; (3) Patients on combination therapy where the dose of a single drug may not be very high, but the combination is considered moderately or severely immunosuppressive will be eligible.
•Bone Marrow Transplant patients: all patients in clinic eligible
•Oncology patients: must be on some type of chemotherapy
•Hemodialysis patients: must be on dialysis
•Child Health Immunodeficiency Program (CHIP) patients: must have a known diagnosis of HIV
•Solid Organ Transplant patients: post-transplant, influenza vaccine recommended by primary transplant physician

Exclusion Criteria

•Rheumatology patients: if receiving any of the monoclonal antibodies, etanercept, infliximab, adalimumab, tocilizumab, atlizumab, or anakinra, must also be taking at least one other immunosuppressive/immunomodulatory medication
•Unable to come for scheduled follow-up appointments
•History of anaphylaxis reaction to influenza vaccination in the past
•Severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine
•History of Guillain-Barre syndrome ever in the past in the subject or in a parent or a sibling of the subject
•Allergy to latex
•Intravenous immuneglobulin (IVIG) within in 4 weeks preceding any blood draw
•Receiving an investigational agent as part of another study or other medical treatment (investigational = not-FDA approved for any indication)
•Subject not enrolled in other studies that prohibit him/her from enrolling in this study
•Blood draw contraindicated
+7 more criteria

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2017

Last Updated

January 23, 2018

Enrollment

ACTUAL participants

Conditions

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

Interventions

Fluzone High Dose

BIOLOGICAL

Fluzone

BIOLOGICAL

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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RECRUITINGPHASE2

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

NCT04375800

Human Immunodeficiency Virus (HIV) Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

Strategies to AchieVe Viral Suppression for Youth With HIV

Project neuroARTEMIS

Persuasive Health Communication Intervention for HIV/HCV