Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population
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™
1 other identifier
interventional
3,350
4 countries
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2006
CompletedFirst Posted
Study publicly available on registry
September 18, 2006
CompletedStudy Start
First participant enrolled
September 22, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2007
CompletedApril 24, 2017
April 1, 2017
September 14, 2006
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate that the immune response induced by the adjuvanted influenza vaccine in the elderly is superior to that induced by Fluarix, for each vaccine strain
Secondary Outcomes (1)
To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix
Interventions
Eligibility Criteria
You may qualify if:
- The subjects must be healthy adults 18-40 years or \>/= 50 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (30)
GSK Investigational Site
Clearwater, Florida, 33761, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Milford, Massachusetts, 01757, United States
GSK Investigational Site
Chaska, Minnesota, 55318, United States
GSK Investigational Site
Somers Point, New Jersey, 08244, United States
GSK Investigational Site
Poughkeepsie, New York, 12601, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Carnegie, Pennsylvania, 15106, United States
GSK Investigational Site
Erie, Pennsylvania, 16506, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Messkirch, Baden-Wurttemberg, 88605, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Haag, Bavaria, 83527, Germany
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany
GSK Investigational Site
Langquaid, Bavaria, 84085, Germany
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Leipzig, Saxony, 04129, Germany
GSK Investigational Site
Berlin, 10365, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 12687, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Berlin, 13507, Germany
GSK Investigational Site
Bekkestua, 1319, Norway
GSK Investigational Site
Elverum, 2408, Norway
GSK Investigational Site
Fredrikstad, N-1601, Norway
GSK Investigational Site
Hamar, 2301, Norway
GSK Investigational Site
Haugesund, 5507, Norway
GSK Investigational Site
Paradis, 5231, Norway
GSK Investigational Site
Skien, N-03730, Norway
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2006
First Posted
September 18, 2006
Study Start
September 22, 2006
Study Completion
January 30, 2007
Last Updated
April 24, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.