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This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.
The objectives of the trial are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated influenza vaccine (split virion) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion) | 21 Days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allschwil | Switzerland | |||||
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Edinburgh |
| United Kingdom |
| D012140 |
| Respiratory Tract Diseases |