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A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer

Phase 1
2 Years
21 Years
Not Enrolling

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Trial Information

A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer

The secondary objectives of this study are to:

1. Describe the safety of FluMist and inactivated influenza vaccine.

2. Describe the incidence and duration of viral replication following immunization with

3. To examine the association between immunization response (seroconversion or
seroprotection) and baseline clinical factors (age, type of malignancy, absolute
neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).

Inclusion Criteria:

- Age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the

- Participant or participants parent/legal guardian available by telephone during the
course of the study;

- Written informed consent (and assent, if applicable) obtained

- Currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or
have received chemotherapy in the past 12 weeks;

- If the participant's underlying cancer is a solid tumor, current status must be
stable disease, partial response, or complete response to therapy; if the
participant's underlying disease is a hematological malignancy, current status must
be in remission, and if receiving chemotherapy, must be in the "continuation" or
"maintenance" phase of therapy or equivalent;

- Estimated life expectancy of > 1 year

Exclusion Criteria:

- History of hypersensitivity to any component of FluMist or TIV, including egg or egg
products, gelatin, 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-BarreĀ“ syndrome;

- History of asthma;

- Female who is breastfeeding or lactating;

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

The primary objective of this study is to describe the immune response of FluMist compared with inactivated influenza vaccine in mild to moderately immunocompromised children with cancer

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Silvana Carr, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

July 2011

Related Keywords:

  • Cancer
  • Inactivated influenza vaccine
  • Study of FluMist versus inactivated influenza vaccine in children with cancer
  • Influenza, Human



St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794