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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00380211 |
The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.
Condition | Intervention | Phase |
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Influenza |
Biological: Influenza vaccine (A/H3N2, A/H1N1, and B strains) Biological: Fluarix |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age. |
Estimated Enrollment: | 600 |
Study Start Date: | September 2006 |
This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
GSK Clinical Trials Call Center | |
Miami, Florida, United States, 33173 | |
United States, Kansas | |
GSK Clinical Trials Call Center | |
Lenexa, Kansas, United States, 66219 | |
United States, New York | |
GSK Clinical Trials Call Center | |
Endwell, New York, United States, 13760 | |
United States, Texas | |
GSK Clinical Trials Call Center | |
Austin, Texas, United States, 78705 | |
United States, Virginia | |
GSK Clinical Trials Call Center | |
Burke, Virginia, United States, 22015 |
Study Director: | Clinical Trials | GlaxoSmithKline |
Study ID Numbers: | IDB-200-001, 109249 |
Study First Received: | September 21, 2006 |
Last Updated: | January 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00380211 |
Health Authority: | United States: Food and Drug Administration |
Influenza vaccine Thimerosal reduced content Young and elderly adults Immunogenicity, safety, reactogenicity |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |