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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00377585
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Influenza Biological: Fluarix Biological: adjuvanted influenza vaccine Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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™
Study Start Date : September 22, 2006
Study Completion Date : January 30, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: Fluarix Biological: adjuvanted influenza vaccine
    Other Name: Fluarix

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 10365
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 12687
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Berlin, Germany, 13507
Norway
GSK Investigational Site
Bekkestua, Norway, 1319
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

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104888
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study104888 are summarised with study 107509 on the GSK Clinical Study Register.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104888
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104888
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104888
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104888
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104888
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00377585     History of Changes
Other Study ID Numbers: 104888
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Elderly
Improved vaccine
Influenza
Influenza disease

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs