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Safety Study to Evaluate FluMist in Immunocompromised Children
This study has been completed.
First Received: May 27, 2005   Last Updated: February 5, 2009   History of Changes
Sponsored by: MedImmune LLC
Information provided by: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00112112
  Purpose

This study is to get information about the safety of a flu vaccine spray, as well as the duration of the vaccine spray in the nose and the body response.


Condition Intervention Phase
Cancer
Biological: FluMist
Biological: Placebo
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Reactogenicity and other adverse events [ Time Frame: 35-42 days after study vaccination ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: 180 days after study vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Viral replication which will be evaluated by the duration and titer of vaccine-type influenza virus isolated by periodic nasal swab culture [ Time Frame: 35-42 days after study vaccination ] [ Designated as safety issue: No ]
  • Endpoints in the evaluation of immune responses including lymphocyte subsets CD19 CD3 CD4 CD8 and antigen specific responses using a tetramer assay ELISpot hemagglutination inhibition microneutralization serum IgG with subclasses [ Time Frame: 35-42 days after study vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2005
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Biological: FluMist
The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). (appx. 10 subjects)
2: Placebo Comparator
Placebo intranasal mist is composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Biological: Placebo
placebo intranasal mist is composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

Detailed Description:

The purpose of this study is to get information about the safety of a flu vaccine spray, called FluMist, in children with cancer. In addition, the study will also find out how much and how long the vaccine spray can be found in the nose, as well as, how the body fights infections.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 greater than or equal to 500 cells/mm3;
  • At study entry, less than 14 days from last high dose (> 2 mg/kg/day prednisone or equivalent) systemic corticosteroid therapy;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112112

Locations
United States, New York
University of Rochester School of Medicine & Dentistry
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Tennessee
St. Jude's Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Washington
Children's Hospital Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune Inc. ( Margarita Gomez, Dir. Clinical Dev. )
Study ID Numbers: MI-CP114
Study First Received: May 27, 2005
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00112112     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Glutamic Acid
Influenza, Human
Potassium phosphate

ClinicalTrials.gov processed this record on August 30, 2009