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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002602-20 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted and un-adjuvanted influenza vaccines | Biological | 16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. | 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| Strain-specific influenza antibody titers will be used to assess Immunogenicity | 50 days |
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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 |
|---|---|---|---|---|---|---|
| UCL St. Luc - Pharmacy | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21906647 | Result | Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9. |
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| 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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