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

April 20, 2017 updated by: GlaxoSmithKline

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™

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

3350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10367
        • GSK Investigational Site
      • Berlin, Germany, 13086
        • GSK Investigational Site
      • Berlin, Germany, 10365
        • GSK Investigational Site
      • Berlin, Germany, 13507
        • GSK Investigational Site
      • Berlin, Germany, 12687
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Messkirch, Baden-Wuerttemberg, Germany, 88605
        • GSK Investigational Site
    • Bayern
      • 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
    • Brandenburg
      • Ruedersdorf, Brandenburg, Germany, 15562
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04129
        • GSK Investigational Site
  • Norway
      • 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
        • GSK Investigational Site
  • United States
    • Florida
      • Clearwater, Florida, United States, 33761
        • GSK Investigational Site
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • GSK Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • GSK Investigational Site
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • GSK Investigational Site
    • New York
      • Poughkeepsie, New York, United States, 12601
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • GSK Investigational Site
    • Pennsylvania
      • Carnegie, Pennsylvania, United States, 15106
        • GSK Investigational Site
      • Erie, Pennsylvania, United States, 16506
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15236
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 22, 2006

Study Completion (Actual)

January 30, 2007

Study Registration Dates

First Submitted

September 14, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (Estimate)

September 18, 2006

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 104888
    Information comments: 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.
  2. Study Protocol
    Information identifier: 104888
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 104888
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 104888
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 104888
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 104888
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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