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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003181-34 |
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This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.
A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Trivalent Seasonal Influenza Vaccine | Experimental |
| |
| 2: Adjuvanted Trivalent Seasonal Influenza Vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | Seasonal Influenza Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test | ||
| To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines (formerly Chiron Vaccines) | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tampere Medical School | Tampere | 33014 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19561422 | Result | Vesikari T, Pellegrini M, Karvonen A, Groth N, Borkowski A, O'Hagan DT, Podda A. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009 Jul;28(7):563-71. doi: 10.1097/INF.0b013e31819d6394. |
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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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |