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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract number 2006-004063-66 |
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The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms | Experimental |
| |
| MF59 adjuvant H5N1 influenza vaccine 15 micrograms | Experimental |
| |
| non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF59 adjuvanted H5N1 influenza vaccine | 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. | day 1 to day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study. | Day 1 to Day 382 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines - Information Services | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3 | Siena | Siena | 53100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19237568 | Result | Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |