|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00197288 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| 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. |
| Enrollment: | 1847 |
| Study Start Date: | October 2005 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| Carnegie, Pennsylvania, United States, 15106 | |
| GSK Investigational Site | |
| Erie, Pennsylvania, United States, 16506 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Katy, Texas, United States, 77450 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Marshfield, Wisconsin, United States, 54449 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00197288 History of Changes |
| Other Study ID Numbers: | 104437 |
| Study First Received: | September 19, 2005 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Prophylaxis: Influenza virus infection |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |