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This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 6-23 months |
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| Group 2: 2-8 years |
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| Group 3: 9-17 years |
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| Group 4: 18-44 years |
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| Group 5: 45-60 years |
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| Group: >60 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intervention observational study | Other | Non-intervention observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
• Received any prior H1N1 vaccination
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Population of children, adolescents, adults and elderly
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Garrahan | Combate de Los Pozos 1881 | Buenos Aires F.D. | Argentina | |||
| Hospital de Ninos "Dr. Ricardo Gutierrez" |
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| Gallo 1330 |
| Buenos Aires F.D. |
| Argentina |
| Hospital Nuestra Señora de la Misericordia | Belgrano 1500 | Córdoba Province | Argentina |
| Hospital Pediatrico del Niño Jesus | Castro Barros 650 - San Martín | Córdoba Province | Argentina |
| Sanatorio Mayo Privado S.A. | Humberto Primo 520 | Córdoba Province | Argentina |
| Hospital Pediatrico "Dr. Humberto Notti" | Bandera de Los Andes 2603 Villa Nueva | Guaymallen Mendoza | Argentina |
| Huisartsenpraktijk Bergentheim | Kanaalweg West 61 | Bergentheim | 7691BV | Netherlands |
| Huisartsenpraktijk Bredero | Brederostraat 2/A | Breda | 4819HH | Netherlands |
| Saxenburg Groep, Zorgcentrum Aleida Kramer | M.v.d. Thijnensingel 1 | Coevorden | 7741GB | Netherlands |
| Huisartsenpraktijk Dennenlaan | Dennenlaan 56 | Emmen | 7822EL | Netherlands |
| Huisartsenpraktijk de Steenpoort | Prinses Julianastraat 25 | Genemuiden | 8281CK | Netherlands |
| Huisartsenpraktijk Gramsbergen | Voorstraat 3 | Gramsbergen | 7783AL | Netherlands |
| Huisartsenpraktijk Oosterhesselen | Edveensweg 13 | Oosterhesselen | 7861AM | Netherlands |
| Isala Klinieken Zwolle | Groot Wezenland 20 | Zwolle | 8011JW | Netherlands |