Safety Study to Evaluate FluMist in Immunocompromised Children
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to get information about the safety of a flu vaccine spray,
      called FluMist, in children with cancer. The study is also being done to find out how much
      and how long the vaccine spray can be found in the nose.
    

Detailed description: 
      This study is a randomized, double-blind Phase 1 study of FluMist vs. placebo in mild to
      moderately immunocompromised children 5 to 17 years of age with cancer. The primary objective
      of this study is to describe the safety of FluMist compared with placebo in mild to
      moderately immunocompromised children with cancer. The secondary objectives of this study are
      to describe the immune responses following vaccination with FluMist and to determine the
      incidence and duration of viral replication following vaccination with FluMist.

      The standard 0.5 mL dose of vaccine or placebo was administered intranasally. Patients were
      evaluated at four visits scheduled between days 3-5, days 7-10, days 14-28, and days 35-42
      for viral shedding via nasal swabs. Safety outcomes were collected at study clinic visits or
      by telephone contact through 42 days post dose. Serious adverse events and significant new
      medical conditions were collected through 180 days after receipt of investigational product.

      Immune responses were measured by detection of influenza-specific antibodies as measured by
      the standard hemagglutination inhibition (HAI) assay. Influenza-specific serum antibody
      isotype levels were determined and nasal swab specimens were analyzed for the expression of
      influenza-specific immunoglobulin A (IgA). Serum was analyzed for its ability to neutralize
      viral particles from infecting Madin-Darby canine kidney cells (microneutralization).
      Baseline immunosuppression as measured by expression of T- and B-lymphocyte subsets was
      compared to immunosuppression at time points after vaccination. The duration of viral
      replication and the titers of live-attenuated influenza virus shed was evaluated from nasal
      swab specimens collected at scheduled time points after administration of FluMist.
    

Intervention name(s): FluMist; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like.
brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm.; Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cancer, pediatric, influenza, vaccine