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This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6-23 months |
| ||
| 2-8 years |
| ||
| 9-17 years |
| ||
| 18-44 years |
| ||
| 45-60 years |
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| >60 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is non-intervention observational study | Other | This is non-intervention observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects | Within 3 weeks and 6 weeks after vaccine administration |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of hospitalization within 6 weeks and 2 years after vaccination in a cohort of subjects vaccinated sw unvaccinated subjects, with Flu Egg Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Population of children, adolescents, adults and elderly
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emilia Romagna | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22885015 | Derived | Moro ML, Nobilio L, Voci C, Di Mario S, Candela S, Magrini N; SaFoH1N1 working group. A population based cohort study to assess the safety of pandemic influenza vaccine Focetria in Emilia-Romagna region, Italy - part two. Vaccine. 2013 Feb 27;31(10):1438-46. doi: 10.1016/j.vaccine.2012.07.090. Epub 2012 Aug 10. | |
| 22766247 | Derived |
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| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Candela S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, Magrini N; SaFoH1N1 working group. An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one. Vaccine. 2013 Feb 27;31(10):1431-7. doi: 10.1016/j.vaccine.2012.06.030. Epub 2012 Jul 2. |