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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract number:2006-000787-88 |
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Lack of Vaccine Supplies
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| influenza surface antigen inactivated vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. | ||
| Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines Drug Information Services | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiltern International Limited , Chiltern Place, Upton Road | Slough | SL1 2AD | United Kingdom |
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| Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24). |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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