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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | CAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
|
| 2 | Active Comparator | FluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAIV-T | Biological |
| ||
| CAIVT |
| Measure | Description | Time Frame |
|---|---|---|
| - Among participants 5 through 8 years of age regardless of baseline serostatus who receive two doses, the post-dose two strain-specific geometric mean titers (GMTs) for serum HAI in the CAIV-T group are within 2-fold of those in the FluMist group | greater than 28-days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants experiencing each of the reactogenicity events by dose. | Within 28 days of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Angles, MD | Heart of America Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart of America Research Institute | Shawnee Mission | Kansas | 66216 | United States | ||
| Kentucky Pediatric/Adult Research, Inc. |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
|
| FluMist | Biological | The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
|
| Bardstown |
| Kentucky |
| 40004 |
| United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |