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A Study of a Live Intranasal Influenza Vaccine in Children With Cancer (FMRESP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00906750
First received: January 5, 2009
Last updated: October 12, 2011
Last verified: October 2011

January 5, 2009
October 12, 2011
October 2008
July 2011   (final data collection date for primary 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00906750 on ClinicalTrials.gov Archive Site
  • Immunization response [ Time Frame: 10/31/2010 ] [ Designated as safety issue: No ]
    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).
  • Flumist safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Describe the safety of FluMist and inactivated influenza vaccine.
  • Viral Replication [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Describe the incidence and duration of viral replication following immunization with FluMist.
Not Provided
Not Provided
Not Provided
 
A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer

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.

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).
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Cancer
  • Biological: FluMist
    FluMist is a live attenuated intranasal influenza vaccine
  • Biological: Inactivated influenza vaccine
    Inactivated influenza vaccine
  • Experimental: 1
    Intervention: Biological: FluMist
  • Active Comparator: 2
    Intervention: Biological: Inactivated influenza vaccine
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;204(10):1475-82. Epub 2011 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
July 2011
July 2011   (final data collection date for primary outcome measure)

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;
Both
2 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00906750
FMRESP
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Silvana Carr, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP