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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000876-17 |
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This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates
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Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
| |
| 6 | Experimental |
| |
| 7 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S205 placebo | Biological | 2 i.m. injections per subject (0.5 mL each) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination inhibition titers | one year |
| Measure | Description | Time Frame |
|---|---|---|
| CHMP criteria | one year | |
| Virus neutralization | one year | |
| Anti-HA antibody level kinetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 21 | Helsinki | Finland | ||||
| Site 22 |
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| S205 10ugHA |
| Biological |
2 i.m. injections per subject (0.5 mL each) |
|
| S205 30ugHA | Biological | 2 i.m. injections per subject (0.5 mL each) |
|
| S205 10ugHA+500ugAlOH | Biological | 2 i.m. injections per subject (0.5 mL each) |
|
| S205 30ugHA+500ugAlOH | Biological | 2 i.m. injections per subject (0.5 mL each) |
|
| S205 10ugHA+1250ugAlOH | Biological | 2 i.m. injections per subject (0.5 mL each) |
|
| S205 30ugHA+1250ugAlOH | Biological | 2 i.m. injections per subject (0.5 mL each) |
|
| one year |
| Safety | one year |
| Tampere |
| Finland |
| Site 23 | Turku | Finland |
| Site 12 | Goch | Germany |
| Site 10 | Hamburg | Germany |
| Site 11 | Nuremberg | Germany |