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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00719043 |
The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged >=18 years.
Condition | Intervention | Phase |
---|---|---|
Influenza Disease |
Biological: Placebo Biological: GSK influenza virus vaccine 1557484A |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Trial to Evaluate the Safety & Immunogenicity of Monovalent H5N1 Vaccine in Adults >=18 Yrs of Age |
Enrollment: | 841 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group E: Experimental |
Biological: Placebo
One dose administered IM in the deltoid region
Biological: GSK influenza virus vaccine 1557484A
Two doses administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
|
Group F: Experimental |
Biological: Placebo
One dose administered IM in the deltoid region
Biological: GSK influenza virus vaccine 1557484A
Two doses administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
|
Group C: Experimental |
Biological: Placebo
One dose administered IM in the deltoid region
Biological: GSK influenza virus vaccine 1557484A
Two doses administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
|
Group D: Experimental |
Biological: Placebo
One dose administered IM in the deltoid region
Biological: GSK influenza virus vaccine 1557484A
Two doses administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
|
Group G: Placebo Comparator |
Biological: Placebo
One dose administered IM in the deltoid region
Biological: GSK influenza virus vaccine 1557484A
Two doses administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
|
Group A: Experimental |
Biological: Placebo
One dose administered IM in the deltoid region
Biological: GSK influenza virus vaccine 1557484A
Two doses administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
|
Group B: Experimental |
Biological: Placebo
One dose administered IM in the deltoid region
Biological: GSK influenza virus vaccine 1557484A
Two doses administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
|
All subjects will receive 3 doses of study vaccine, including 2 doses of active vaccine and 1 dose of placebo. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 182, 192, 224, 365, 375, 407, and 548.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Diagnosed with cancer, or treatment for cancer, within 3 years.
United States, Colorado | |
GSK Investigational Site | |
Denver, Colorado, United States, 80239 | |
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60610 | |
United States, Louisiana | |
GSK Investigational Site | |
Metairie, Louisiana, United States, 70006 | |
United States, Massachusetts | |
GSK Investigational Site | |
Milford, Massachusetts, United States, 01757 | |
United States, Missouri | |
GSK Investigational Site | |
Kansas City, Missouri, United States, 64114 | |
United States, Montana | |
GSK Investigational Site | |
Missoula, Montana, United States, 59801 | |
United States, North Carolina | |
GSK Investigational Site | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Tennessee | |
GSK Investigational Site | |
Bristol, Tennessee, United States, 37620 | |
United States, Texas | |
GSK Investigational Site | |
Austin, Texas, United States, 78705 | |
GSK Investigational Site | |
Fort Worth, Texas, United States, 76135 | |
Canada, Nova Scotia | |
GSK Investigational Site | |
Halifax, Nova Scotia, Canada, B3K 6R8 | |
Canada, Quebec | |
GSK Investigational Site | |
Sherbrooke, Quebec, Canada, J1H 4J6 | |
GSK Investigational Site | |
Montreal, Quebec, Canada, H2K 4L5 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110624 |
Study First Received: | July 18, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00719043 |
Health Authority: | United States: Food and Drug Administration |
Avian Influenza A virus H5N1 Pandemic Potential |
Vaccines Human Safety Immunogenicity |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Influenza in Birds Orthomyxoviridae Infections |
RNA Virus Infections |