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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00112112 |
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 |
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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 |
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 |
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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).
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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)
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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).
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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).
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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.
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Robert Walker, MD | MedImmune LLC |
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 |
Virus Diseases Glutamic Acid Influenza, Human Potassium phosphate |