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As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarixâ„¢ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a revaccination with the adjuvanted GlaxoSmithKline influenza vaccine administered intramuscularly about 1 year after administration of the first dose of vaccine. For immunogenicity and safety evaluations, subjects who have already received Fluarixâ„¢ during the preceeding year will receive a dose of commercial vaccine and will form the control group of this trial.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| influenza vaccine Fluarix, Adjuvanted Fluarix | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage, intensity and relationship to vaccination of local (at the injection site) and general signs and symptoms during a 21 day follow-up period after vaccination | ||
| Occurrence of serious adverse events during the entire study. |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of the humoral immune response (haemagglutinin antibody titre) and cellular mediated immune response |
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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 | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Results for study 104540 can be found on the GSK Clinical Study Register | View source |
| 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 |
|---|---|---|---|
| 104540 | Annotated Case Report Form | 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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For additional information about this study please refer to the GSK Clinical Study Register |
| 104540 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104540 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104540 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104540 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104540 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |