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Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00377585
First received: September 14, 2006
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Fluarix
Biological: adjuvanted influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
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™

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix

Estimated Enrollment: 3350
Study Start Date: September 2006
Study Completion Date: January 2007
Intervention Details:
    Biological: Fluarix Biological: adjuvanted influenza vaccine
    Other Names:
    • adjuvanted influenza vaccine
    • Fluarix
Detailed Description:

This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377585

Locations
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33761
GSK Investigational Site
Coral Gables, Florida, United States, 33134
United States, Massachusetts
GSK Investigational Site
Milford, Massachusetts, United States, 01757
United States, Minnesota
GSK Investigational Site
Chaska, Minnesota, United States, 55318
United States, New Jersey
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Germany
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
GSK Investigational Site
Haag, Bayern, Germany, 83527
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
GSK Investigational Site
Langquaid, Bayern, Germany, 84085
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
GSK Investigational Site
Leipzig, Sachsen, Germany, 04129
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Berlin, Germany, 13507
GSK Investigational Site
Berlin, Germany, 12687
GSK Investigational Site
Berlin, Germany, 10365
Norway
GSK Investigational Site
Bekkestua, Norway, N-1357
GSK Investigational Site
Elverum, Norway, 2408
GSK Investigational Site
Fredrikstad, Norway, N-1601
GSK Investigational Site
Hamar, Norway, 2301
GSK Investigational Site
Haugesund, Norway, 5507
GSK Investigational Site
Paradis, Norway, 5231
GSK Investigational Site
Skien, Norway, N-03730
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00377585     History of Changes
Other Study ID Numbers: 104888
Study First Received: September 14, 2006
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Elderly
Improved vaccine
Influenza
Influenza disease

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014