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Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarix | Biological | |||
| adjuvanted influenza vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the humoral immune response and cell-mediated immune response 21 days after revaccination with candidate vaccine |
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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 |
|---|---|
| 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 |
|---|---|---|---|
| 104887 | Dataset Specification | 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 |
|---|---|
| C510903 | fluarix |
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For additional information about this study please refer to the GSK Clinical Study Register |
| 104887 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104887 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104887 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104887 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104887 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |