Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

Completed · Phase 2

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

In brief

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.

Key facts

Study ID

NCT01685372

Run by

University of Colorado, Denver

People needed

16

Starts

2012-09-01

Expected to finish

2017-09-01

Last updated by the study team

2018-01-23

Who can join

Age: 5 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Pregnancy
• Breastfeeding
• Received a polysaccharide vaccine (pneumovax) w/in 3 weeks of the vaccination
• Absolute neutrophil count (ANC) < 500/uL at the time of vaccination or could potentially have ANC 500/uL during the 5 days after vaccination
• Platelet count < 50,000/uL at the time of vaccination
• If a subject has a temperature ≥ 100.4°F at the time of enrollment, then the subject must choose to not enroll or delay immunization until afebrile.
• Receiving influenza vaccination past December 15 of influenza season.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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