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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00538213 |
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104887 are eligible for participation in this study.
Condition | Intervention | Phase |
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Influenza |
Biological: GSK Bio's Influenza Vaccine GSK576389A Biological: Fluarix™ |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥66 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference. |
Enrollment: | 133 |
Study Start Date: | October 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Active Comparator
Young adults (19-42 years)
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Biological: Fluarix™
Single dose, Intramuscular injection
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Group A: Experimental
Elderly adults (≥66 years)
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Biological: GSK Bio's Influenza Vaccine GSK576389A
Single dose, Intramuscular injection
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Group C: Active Comparator
Elderly adults (≥66 years)
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Biological: Fluarix™
Single dose, Intramuscular injection
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This study is a year 2 revaccination study. First year revaccination was done in study 104887 (NCT00386698).
Primary study was study 104886 (NCT00318149). This study involves 2 age groups (based on primary study):
Subjects enrolled in the >=65 yrs age group in the primary study. Subjects enrolled in the 18-40 yrs age group in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110263 |
Study First Received: | October 1, 2007 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00538213 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Influenza vaccine GSK576389A Fluarix Influenza infection |
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 |