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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00718120 |
This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.
Condition | Intervention | Phase |
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Immunization of Adults Aged 18 Years and Older Against Influenza. |
Biological: Fluviral® |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Safety Study of a Single Injection of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral® (2008 - 2009 Season) in Adults Aged 18 to 60 Years and Over 60 Years. |
Enrollment: | 110 |
Study Start Date: | July 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Aged 18 to 60 years
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Biological: Fluviral®
One intramuscular injection into the deltoid region of the non-dominant arm
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Group B: Experimental
Aged > 60 years
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Biological: Fluviral®
One intramuscular injection into the deltoid region of the non-dominant arm
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Any confirmed or suspected immunosuppressive condition including:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110584 |
Study First Received: | July 17, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00718120 |
Health Authority: | Canada: Health Canada |
Fluviral Influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |