Safety Study to Evaluate FluMist in Immunocompromised Children
Condition: Cancer
Intervention: FluMist; Placebo
Intervention description: 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).
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: cancer, pediatric, influenza, vaccine

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 5 through 17 years of age (not yet reached their 18th birthday) at the time of
             entry into the study;

          -  Patient's parent or legal guardian available by telephone during the course of the
             study;

          -  Written informed consent (assent if applicable) and Health Insurance Portability and
             Accountability Act (HIPAA) authorization (if applicable) obtained from the patient's
             parent or legal guardian;

          -  Ability of the patient or patient's parent/guardian to comply with the requirements of
             the protocol;

          -  Currently receiving chemotherapy and/or radiation therapy for the treatment of cancer
             or have received chemotherapy in the past 12 weeks;

          -  If the subject's underlying cancer is a solid tumor, current status must be stable
             disease, partial response, or complete response to therapy; if the subject's
             underlying disease is a hematologic malignancy, current status must be in remission;

          -  Estimated life expectancy of >1 year; and

          -  Currently has no worse than mild to moderate immunosuppression (meets none of the
             exclusion criteria).

        Exclusion Criteria:

          -  History of hypersensitivity to any component of FluMist, including egg or egg
             products, or monosodium glutamate;

          -  History of hypersensitivity to gentamicin;

          -  Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem
             cell transplant patient, during those periods in which the immunocompromised patient
             requires care in a protective environment);

          -  History of Guillain-Barré syndrome;

          -  History of asthma;

          -  Use of aspirin or salicylate-containing products in the 30 days prior to study
             vaccination or expected receipt within the study duration;

          -  Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and
             zanamivir) within 14 days prior to enrollment or expected receipt (unless medically
             indicated) during this study;

          -  Currently receiving inhaled steroid therapy;

          -  Receipt of immunoglobulin within the past 90 days;

          -  Receipt of stem cell transplant;

          -  Acute febrile [>100.0°F (37.8°C) oral] illness or acute respiratory illness, e.g.,
             cough or sore throat, within three days prior to enrollment;

          -  Administration of any live vaccine within 30 days prior to enrollment or if receipt of
             another live vaccine is expected within 30 days after the vaccination in this study;

          -  Administration of any inactivated vaccine within two weeks prior to enrollment or if
             receipt of another inactivated vaccine is expected within two weeks after the
             vaccination in this study;

          -  Receipt of an investigational product studied under an investigational new drug (IND)
             within 10 days prior to study entry or expected receipt of such an investigational
             product within 10 days after study vaccination (Note: an investigational product not
             studied under an IND is allowed at the investigator's discretion);

          -  Pregnancy or, in biologically capable females (e.g., menses within the last year), not
             willing to agree to acceptable birth control for three months after study vaccination
             (for those biologically capable, a urine pregnancy test must be performed on the day
             of vaccination with a negative result);

          -  Female who is breastfeeding or lactating;

          -  Any condition or receipt of other medication that, in the opinion of the investigator,
             might interfere with the evaluation of the vaccine or interpretation of study results;

          -  At the study screening visit (within 16 days before study vaccination) a CD4+ T cell
             percentage of <15%;

          -  At study entry, an absolute neutrophil count less than or equal to 500 cells/mm3;

          -  Receipt of high-dose systemic corticosteroids (≥ 2 mg/kg total of prednisone or
             equivalent given daily or on alternating days) for ≥ 14 consecutive days within 30
             days prior to or following study vaccination