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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract number | |||
| 2006-000610-20 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07 | 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 Vaccines & Diagnostics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio | Via Dei Vestini | Chieti | 66100 | Italy | ||
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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). |
| Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37 |
| Lanciano |
| Italy |
| 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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| ID | Term |
|---|---|
| D000954 | Antigens, Surface |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
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