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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000165-38 |
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To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H5N1 influenza vaccine | Biological | One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination. | 7 days | |
| Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines. | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini | Chieti | 66100 | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20810680 | Result | Fragapane E, Gasparini R, Schioppa F, Laghi-Pasini F, Montomoli E, Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol. 2010 Nov;17(11):1817-9. doi: 10.1128/CVI.00461-09. Epub 2010 Sep 1. |
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| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| H5N1 influenza vaccine | Biological | One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen |
|
| 01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova |
| Genova |
| 16129 |
| Italy |
| 03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37, | Lanciano | 66034 | Italy |
| D001715 |
| Bird Diseases |
| D000820 | Animal Diseases |