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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | FluMist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMist | Biological | A single intranasal dose of FluMist will be administered to approx. 300 subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses. | 28 days after vaccination | |
| To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age. | 28 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the immune responses of FluMist in indivduals 5-49 years of age. | 28 days after vaccination | |
| To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response. | 28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Walker, MD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SFBC International, Inc | Miami | Florida | 33181 | United States | ||
| Children's Memorial Hospital |
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| Chicago |
| Illinois |
| 60614 |
| United States |
| Kentucky Pediatric / Adult Research, Inc | Bardstown | Kentucky | 40004 | United States |
| University of Maryland, School of Medicine | Baltimore | Maryland | 21201 | United States |
| Center for Vaccine Development | St Louis | Missouri | 63110 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| Pediatric Clinical Trials International | Columbus | Ohio | 43205 | United States |
| Primary Physician's Research Inc. | Pittsburgh | Pennsylvania | 15241 | United States |
| Vanderbilt University Medical Center North | Nashville | Tennessee | 37232 | United States |
| University of Virginia, Elson Student Health Center | Charlottesville | Virginia | 22904 | United States |
| Marshall University Medical Center | Huntington | West Virginia | 25701 | United States |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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