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To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).
The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Monovalent vaccine prior to the release of the trivalent vaccine (FluMist). |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV024 | Biological | 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril). |
|
| Measure | Description | Time Frame |
|---|---|---|
| - The primary endpoint of this study is fever defined as oral temperature ≥101°F | Days 0-7 |
| Measure | Description | Time Frame |
|---|---|---|
| All other reported reactogenicity events and other adverse events. | After 7 days after 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 |
|---|---|---|---|---|---|---|
| SFBC International Inc | Miami | Florida | 33181 | United States |
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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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| Placebo | Other | Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril). |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |