A Phase I Randomized, Double-Blind Trial of the Safety and Immunogenicity of FluMist® A Live, Intranasal Influenza Virus Vaccine vs. Placebo in Immunocompromised Children Ages 5 Through 17 Years of Age

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