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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00345904 |
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 Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.
Condition | Intervention | Phase |
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Influenza |
Biological: Fluarix |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2006/2007 in People Aged 18 Years or Above |
Estimated Enrollment: | 120 |
Study Start Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Sachsen | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01099 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01277 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01097 | |
GSK Investigational Site | |
Freital, Sachsen, Germany, 01705 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 107507 |
Study First Received: | June 28, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00345904 History of Changes |
Health Authority: | Germany: Federal Agency for Sera and Vaccines |
influenza, vaccine prophylaxis of influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |