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The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs) |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs) | ||
| Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age |
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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 | Clearwater | Florida | 33761 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21285532 | Derived | Campbell JD, Chambers CV, Brady RC, Caldwell MC, Bennett NL, Fourneau MA, Jain VK, Innis BL. Immunologic non-inferiority of a newly licensed inactivated trivalent influenza vaccine versus an established vaccine: a randomized study in US adults. Hum Vaccin. 2011 Jan 1;7(1):81-8. doi: 10.4161/hv.7.1.13553. Epub 2011 Jan 1. |
| 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 |
|---|---|---|---|
| 104437 | 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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| Safety comparison (sol local, general & unsol AEs, SAEs) |
| Evansville |
| Indiana |
| 47714 |
| United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Buffalo | New York | 14209 | United States |
| GSK Investigational Site | Poughkeepsie | New York | 12601 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45229 | United States |
| GSK Investigational Site | Carnegie | Pennsylvania | 15106 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16506 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Katy | Texas | 77450 | United States |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 104437 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104437 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104437 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104437 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104437 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 104437 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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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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