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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT Number 2009-013394-17 |
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The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1/Dose Level A | Experimental | Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. |
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| Cohort 1/Dose B | Experimental | Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. |
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| Cohort 2/Dose C | Experimental | A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated) | Biological | Two injections at a 21-day interval (Days 1 and 22) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Aichinger, MD | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorium Leech | Graz | 8010 | Austria | |||
| ClinPharm International GmbH |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Vienna |
| 1090 |
| Austria |
| Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine | Vienna | 1090 | Austria |
| University Hospital, Department of Clinical Pharmacology | Vienna | 1090 | Austria |
| Praxis Regner Schmitt | Mainz | 55116 | Germany |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |