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The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H1N1 Pandemic Influenza Vaccine | Subjects will be enrolled and vaccinated according to national policy and standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated) | Biological | It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children. |
Inclusion Criteria:
Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:
Exclusion Criteria:
Male and female subjects will be excluded from participation in this study if:
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The enrollment of subjects in this study will follow national vaccination policy decisions in the UK.
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| Name | Affiliation | Role |
|---|---|---|
| Baxter BioScience Medical Director | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Practice | Bludenz | 6700 | Austria | |||
| General Practice |
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|
|
| Fulpmes |
| 6166 |
| Austria |
| General Practice | Hall in Tirol | 6060 | Austria |
| General Practice | Innsbruck | 6020 | Austria |
| Practice for Travel Medicine | Innsbruck | 6020 | Austria |
| City Council (Magistrat) Klagenfurt (Health & Food Department) | Klagenfurt | 9020 | Austria |
| General Practice | Kufstein | 6330 | Austria |
| General Practice | Mariapfarr | 5571 | Austria |
| General Practice | Oberperfuss | 6173 | Austria |
| General Practice | Salzburg | 5020 | Austria |
| General Practice | Telfs | 6410 | Austria |
| Medical University of Vienna, Department of Internal Medicine I, Division of Infectious Diseases and Tropical Medicine | Vienna | 1090 | Austria |
| Medical University of Vienna, Department of Specific Prophylaxis and Tropical Medicine | Vienna | 1090 | Austria |
| Hanusch Hospital | Vienna | 1100 | Austria |
| Wiener Gebietskrankenkasse (Health insurance center Vienna) | Vienna | 1100 | Austria |
| General Practice | Voitsberg | 8570 | Austria |
| General Practice | Wels | 4600 | Austria |
| 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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