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Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years.
This study is designed to test the immunogenicity and reactogenicity of the Fluarixâ„¢ vaccine containing the influenza strains recommended for the 2006-2007 season.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarix | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and reactogenicity of the vaccine in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events |
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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 | Dresden | Saxony | 01097 | Germany | ||
| 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 |
|---|---|---|---|
| 107507 | Informed Consent 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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| ID | Term |
|---|---|
| C510903 | fluarix |
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| Dresden |
| Saxony |
| 01099 |
| Germany |
| GSK Investigational Site | Dresden | Saxony | 01277 | Germany |
| GSK Investigational Site | Freital | Saxony | 01705 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107507 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107507 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107507 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107507 | 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 |