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The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and TIV against homotypic and heterotypic influenza virus strains.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | CAIV-T |
|
| 2 | Other | TIV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAIV-T | Biological | A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The following immunogenicity endpoints: The strain-specific HAI seroconversion rates (≥ 4-fold increase) among baseline seronegative participants (HAI titer ≤ 1:4), by dose number | Day 28 post final vaccination | |
| The proportion of participants achieving ≥ 4-fold increase in strain-specific HAI titer from baseline in all participants regardless of baseline serostatus, by dose number | Day 28 post final vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include: AEs SAEs and significant new medical conditions for all participants | Day 28 post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Walker, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wee Care Pediatrics | Layton | Utah | 84041 | United States | ||
| Bear Care Pediatrics |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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| TIV | Other | A total vol. of 0.25 will be administered intramuscularly for each of two doeses. |
|
| Ogden |
| Utah |
| 84405 |
| United States |
| Alpine Pediatrics | Pleasant Grove | Utah | 84062 | United States |
| Utah Valley Pediatrics | Provo | Utah | 84604 | United States |
| Families First Pediatrics | South Jordan | Utah | 84095 | United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |