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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017781-23 | EudraCT Number |
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The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to World Health Organization (WHO)/European Union (EU) recommendation for the 2009/2010 season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination | Experimental | Single 0.5 mL intramuscular injection of PreFluCel 2009/2010 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal influenza vaccine (split virion, inactivated, prepared in Vero Cell cultures) | Biological | Single 0.5 mL intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season in an adult population through the first seven post vaccination days | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Aichinger, MD | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorium Leech | Graz | 8010 | Austria | |||
| ZU Gent, Centrum voor vaccinologie |
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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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| Ghent |
| 9000 |
| Belgium |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |