Influenza Vaccine in Pediatric Transplant Subjects

NCT00133510 | Completed Phase 4

• 1 other identifier: 04-050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study. Study procedures will include a review of medical records, physical examination, and up to 2 flu shots. All participants will receive the flu vaccine. Four weeks after the first flu shot, participants will return to the clinic for a physical exam, blood sample collection, and a second flu shot as recommended. Following each vaccination, parents will be asked to record their children's temperatures and any experienced side effects in a diary card for two weeks. Participants will be involved in study related procedures for up to 8 months.

Conditions

Influenza

Keywords

children, immunocompromised, influenza, liver transplant

Interventions

Trivalent Subviron Influenza vaccine (Fluzone) BIOLOGICAL

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent from parent/guardian and assent from participants, when applicable, must have been obtained and signed freely.
• Between the ages of 6 months and 17 years.
• Three months have elapsed since liver transplantation.
• Recipient of a liver transplant or live with a sibling who is the recipient of a liver transplant.
• Must have the ability to comply with the study procedures for the entire length of the study.

You may not qualify if:

• Previous immunization with an influenza vaccine for the 2004-2005 or 2005-2006 influenza season.
• Known hypersensitivity reaction to the vaccine or vaccine component including eggs or gelatin.
• History of Guillian-Barré syndrome.
• Receipt of an immunoglobulin product (including intravenous or intramuscular immunoglobulin preparations, cytomegalovirus hyperimmunoglobulin and varicella-zoster immunoglobulin) within 3 months of vaccination.
• Receipt of any live viral vaccines within 4 weeks or an inactivated viral vaccine within 2 weeks of enrollment.
• Subjects who have experienced an acute febrile illness within the preceding 48 hours will have immunization deferred and be rescheduled once their fever has resolved.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: November 1, 2004
• Study Completion: September 1, 2006
• Last Updated: August 27, 2010

Record last verified: 2008-03

Locations

US (1)