Clinical trial NCT00906750: A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
Official title: A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: FLuMIST
Inactivated influenza vaccine
Study of FluMist versus inactivated influenza vaccine in children with cancer
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 56
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Eligible research subjects will be randomized to receive either FluMist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.

Detailed description: 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 FluMist.
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).

Eligibility criteria: Inclusion Criteria:

* Age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the study
* 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-Barre´ syndrome;
* History of asthma;
* Female who is breastfeeding or lactating;

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
measure: Immunization response
timeFrame: 10/31/2010
measure: Flumist safety
timeFrame: 2 years
measure: Viral Replication
timeFrame: 1 year
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Silvana Carr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carr S, Allison KJ, Van De Velde LA, Zhang K, English EY, Iverson A, Daw NC, Howard SC, Navid F, Rodriguez-Galindo C, Yang J, Adderson EE, McCullers JA, Flynn PM. Safety and immunogenicity of live attenuated and inactivated influenza vaccines in children with cancer. J Infect Dis. 2011 Nov 15;204(10):1475-82. doi: 10.1093/infdis/jir561. Epub 2011 Sep 23.