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| ID | Type | Description | Link |
|---|---|---|---|
| 200910H1N1MHH | Other Identifier | Hannover Medical School |
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End of H1N1 Swine Flu Pandemic
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The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transplanted adults | Experimental | male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focetria (2x H1N1 vaccine with MF59 adjuvants) | Biological | 7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration. | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Manns, Prof | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | 30655 | Germany |
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| ID | Term |
|---|---|
| C558220 | focetria |
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