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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract:2005-005871-14 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine surface antigen adjuvanted with MF59 | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drug Information Services | Novartis Vaccines & Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G. D'Annunzio University | Chieti | 66100 | Italy | |||
| Department of Health Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19197383 | Derived | Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6. |
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| Genoa |
| 16129 |
| Italy |
| ASL Lanciano-Vasto | Lanciano | 66034 | Italy |
| University Hospital of Siena | Siena | 53100 | Italy |
| 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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| ID | Term |
|---|---|
| C089950 | MF59 oil emulsion |
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