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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197288 |
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.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: Influenza |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Parallel Assignment, Safety Study |
Official Title: | A Phase III, Observer-Blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix™ (GlaxoSmithKline Biologicals) Compared With Fluzone® (Aventis Pasteur) Administered Intramuscularly in Adults 18 Years and Older in the U.S. |
Estimated Enrollment: | 1820 |
Study Start Date: | October 2005 |
"• Experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
"All adults 18 years and older.
United States, Florida | |
GSK Investigational Site | |
Clearwater, Florida, United States, 33761 | |
United States, Maryland | |
GSK Investigational Site | |
Baltimore, Maryland, United States, 21201 | |
United States, New York | |
GSK Investigational Site | |
Buffalo, New York, United States, 14209 | |
GSK Investigational Site | |
Poughkeepsie, New York, United States, 12601 | |
United States, Ohio | |
GSK Investigational Site | |
Cincinnati, Ohio, United States, 45229 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15236 | |
GSK Investigational Site | |
Philadelphia, Pennsylvania, United States, 19107 | |
GSK Investigational Site | |
Erie, Pennsylvania, United States, 16506 | |
GSK Investigational Site | |
Carnegie, Pennsylvania, United States, 15106 | |
United States, Rhode Island | |
GSK Investigational Site | |
Warwick, Rhode Island, United States, 02886 | |
United States, Texas | |
GSK Investigational Site | |
Katy, Texas, United States, 77450 | |
GSK Investigational Site | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
GSK Investigational Site | |
Marshfield, Wisconsin, United States, 54449 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104437 |
Study First Received: | September 19, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00197288 |
Health Authority: | United States: Food and Drug Administration |
Prophylaxis: Influenza virus infection |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |