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The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMist | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study is fever (Study Days 0-7), defined as oral temperature of at least ³101°F. |
| Measure | Description | Time Frame |
|---|---|---|
| Reported Reactogenocity Events (REs) and Adverse Events (AEs) that occur within 7 days after vaccination and that occur within 14 days after vaccination. SAEs and SNMCs that occur within 28 days after vaccination and within 180 days |
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Inclusion Criteria:
Exclusion Criteria:
Note: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of anti-pyretic or analgesic medications at the time of enrollment and for 14 days following vaccination is not considered a contraindication to enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Walker, MD | MedImmune LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, San Diego | San Diego | California | 92123 | United States | ||
| Radiant Research, Daytona Beach |
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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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| Daytona Beach |
| Florida |
| 32114 |
| United States |
| Radiant Research | Portland | Oregon | 97239 | United States |
| Healthcare Discoveries, Inc. | San Antonio | Texas | 78229 | United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |