Influenza Vaccine in Pediatric Transplant Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The purpose of this study is to investigate the humoral and cell-mediated immune response to
      the trivalent subviron influenza vaccine in pediatric liver transplant recipients.
      Additionally, researchers will attempt to correlate the humoral and cell-mediated immune
      response with parameters that may predict a subject's ability to respond to the vaccine, such
      as time from transplant, immunosuppressive agents, previous episodes of rejection or
      cytomegalovirus infection, T-cell numbers and T-cell responses to mitogens or antigens.
      Understanding the immune response to influenza will provide insight not only into the
      response to the trivalent subviron influenza vaccine but to other vaccines being developed
      against agents of bioterrorism, in particular those that may use influenza or related viruses
      as a backbone. This is a single center, prospective comparative study of the humoral and
      cell-mediated immune responses to the trivalent subviron influenza vaccine for the 2004-2005
      and 2005-2006 influenza seasons in outpatient pediatric liver transplant recipients and their
      healthy siblings. There are two study arms, the liver transplant recipients (n=44) and the
      healthy controls (n=22). All study subjects will receive the vaccine at enrollment.
      Enrollment into this study will be extended into the 2005-2006 influenza season. The
      trivalent subviron influenza vaccine for the 2005-2006 influenza season will differ from that
      for the 2004-2005 influenza season with respect to the H3N2 viral strains. The cell-mediated
      and humoral immune responses of patients to the two H3N2 viral strains will be analyzed
      together and separately to assess potential differences in immunogenicity between the two
      viral strains. Humoral and cell-mediated immune responses will be obtained at baseline and
      following immunization. Healthy siblings are used as controls to ensure equal burden of
      influenza disease among study participants. Participants will be involved in study related
      procedures for up to 8 months.
    

Intervention name(s): Trivalent Subviron Influenza vaccine (Fluzone)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children, immunocompromised, influenza, liver transplant