Last updated: 11/03/2018 07:46:39
Demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase II/III, observer-blind, Multi-Country, Multi-Centre, randomized study to demonstrate the superiority in terms of immunogenicity of adjuvanted influenza vaccine administered in adults aged 50 years and older compared to Fluarix™
Trial description: The study is designed to demonstrate a meaningful difference in immunogenicity between the candidate adjuvanted vaccine compared to the licensed Fluarix vaccine in subjects aged 50 years and above. A control group in younger adults aged 18 to 40 years was included.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Fluarix
Biological/vaccine: adjuvanted influenza vaccine
Enrollment:
3350
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK576389A
Collaborators
Not applicable
Study date(s)
September 2006 to January 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- The subjects must be healthy adults 18-40 years or >/= 50 years.
- Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, or a licensed vaccine within 2 (inactivated) to 4 (live) weeks before vaccination, if women are pregnant or lactating, or if subjects have acute clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination.
Inclusion and exclusion criteria
Inclusion criteria:
- The subjects must be healthy adults 18-40 years or >/= 50 years.
Exclusion criteria:
- Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, or a licensed vaccine within 2 (inactivated) to 4 (live) weeks before vaccination, if women are pregnant or lactating, or if subjects have acute clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination.
Trial location(s)
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Milford, Massachusetts, United States, 01757
Status
Study Complete
Location
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
Status
Study Complete
Location
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Status
Study Complete
Location
GSK Investigational Site
Chaska, Minnesota, United States, 55318
Status
Study Complete
Location
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-30-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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