Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

NCT ID: NCT01685372

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Fluzone High Dose

Fluzone High Dose 0.5 mL intramuscularly (IM) given once

Group Type: EXPERIMENTAL

Fluzone High Dose

Intervention Type: BIOLOGICAL

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

Fluzone

Fluzone 0.5mL IM given once

Group Type: ACTIVE_COMPARATOR

Fluzone

Intervention Type: BIOLOGICAL

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

Interventions

Fluzone High Dose

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

Intervention Type: BIOLOGICAL

Fluzone

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

Intervention Type: BIOLOGICAL

Other Intervention Names

high-dose influenza vaccine; influenza vaccine; influenza vaccine

Eligibility Criteria

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
• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colorado Clinical & Translational Sciences Institute

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna Curtis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado, University of Colorado Denver School of Medicine

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

12-0829

Identifier Type: -

Identifier Source: org_study_id