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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2006-000438-11 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preservative free inactivated split influenza vaccine using the strain composition 2006/2007 | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting |
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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 |
|---|---|---|---|---|---|---|
| Werksarztzentrum Herborn, Westerwaldstr 36, | Herborn | 35745 | Germany | |||
| Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5, |
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| Marburg |
| 35037 |
| Germany |
| 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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