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The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose B of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) |
|
| 2 | Experimental | Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine (whole virion, Vero cell derived) | Biological | Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the booster vaccination defined as titer measured by microneutralization test >= 1:20. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with antibody response associated with protection 21, 42, 180 and 360 days after the priming vaccination and 21 days after the booster vaccination | at the timepoints stated above |
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Inclusion Criteria:
Male and female subjects will be eligible for participation in this study if they:
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Aichinger, MD | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Vienna (AKH Wien), Dept. of Clinical Pharmacology | Vienna | 1090 | Austria | |||
| Espoon rokotetutkumusklinikka |
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| Influenza vaccine (whole virion, Vero cell derived) | Biological | Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360) |
|
| Espoo |
| 02100 |
| Finland |
| Etelä - Helsingin rokotetutkimusklinikka | Helsinki | 00100 | Finland |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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