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Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season.
This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluviral® | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety & reactogenicity: Solicited AEs | 4 days | |
| Evaluate safety & reactogenicity: Unsolicited AEs | 21 days | |
| Evaluate safety & reactogenicity: SAEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110502 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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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| entire study |
| Sherbrooke |
| Quebec |
| J1H 1Z1 |
| Canada |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110502 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110502 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110502 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110502 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110502 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110502 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |