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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00192140 |
Condition | Intervention | Phase |
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Influenza |
Biological: FluMist |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label, Single-Arm Trial to Assess the Shedding, Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age |
Estimated Enrollment: | 345 |
Study Start Date: | June 2004 |
Study Completion Date: | January 2005 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
FluMist
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Biological: FluMist
A single intranasal dose of FluMist will be administered to approx. 300 subjects.
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The purpose of this study is to evaluate the viral shedding, immunogenicity and safety of FluMist when administered to healthy individuals between 5-49 years of age.
Ages Eligible for Study: | 5 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
SFBC International, Inc | |
Miami, Florida, United States, 33181 | |
United States, Illinois | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, Kentucky | |
Kentucky Pediatric / Adult Research, Inc | |
Bardstown, Kentucky, United States, 40004 | |
United States, Maryland | |
University of Maryland, School of Medicine | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
Center for Vaccine Development | |
Saint Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Creighton University Medical Center | |
Omaha, Nebraska, United States, 68131 | |
United States, Ohio | |
Pediatric Clinical Trials International | |
Columbus, Ohio, United States, 43205 | |
United States, Pennsylvania | |
Primary Physician's Research Inc. | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Tennessee | |
Vanderbilt University Medical Center North | |
Nashville, Tennessee, United States, 37232 | |
United States, Virginia | |
University of Virginia, Elson Student Health Center | |
Charlottesville, Virginia, United States, 22904 | |
United States, West Virginia | |
Marshall University Medical Center | |
Huntington, West Virginia, United States, 25701 |
Study Director: | Robert Walker, MD | Sponsor GmbH |
Responsible Party: | MedImmune Inc. ( Chris Ambrose, Dir. Medical Affairs ) |
Study ID Numbers: | FM026 |
Study First Received: | September 9, 2005 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00192140 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |