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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
 Biological: FluMist
Biological: Inactivated influenza vaccine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Flu
U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 56
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: FluMist
FluMist is a live attenuated intranasal influenza vaccine
Active Comparator: 2 Biological: Inactivated influenza vaccine
Inactivated influenza vaccine

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

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906750

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Silvana Carr, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site

No publications provided by St. Jude Children's Research Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00906750     History of Changes
Other Study ID Numbers: FMRESP
Study First Received: January 5, 2009
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
FLuMIST
Inactivated influenza vaccine
Study of FluMist versus inactivated influenza vaccine in children with cancer

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013