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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 |
|---|---|---|---|
| Study Group 1 | Experimental | Participants aged 18 to 60 years at enrollment |
|
| Study Group 2 | Experimental | Participants aged 61 years or older at enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated influenza vaccine (split virion) NH 2007-2008 formulation | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated). | 21 Days post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edinburgh | United Kingdom | |||||
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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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| ID | Term |
|---|---|
| C478242 | vaxigrip |
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| London |
| United Kingdom |
| D012140 |
| Respiratory Tract Diseases |