search
Back to results

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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fluarix
adjuvanted influenza vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Elderly, Improved vaccine, Influenza, Influenza disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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

Full Information

First Posted
September 14, 2006
Last Updated
April 20, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00377585
Brief Title
Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 22, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 30, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. 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.
Detailed Description
This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Elderly, Improved vaccine, Influenza, Influenza disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
3350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Fluarix
Intervention Type
Biological
Intervention Name(s)
adjuvanted influenza vaccine
Other Intervention Name(s)
Fluarix
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
GSK Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
GSK Investigational Site
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
GSK Investigational Site
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
GSK Investigational Site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
GSK Investigational Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
GSK Investigational Site
City
Carnegie
State/Province
Pennsylvania
ZIP/Postal Code
15106
Country
United States
Facility Name
GSK Investigational Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Messkirch
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88605
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
GSK Investigational Site
City
Haag
State/Province
Bayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
GSK Investigational Site
City
Hoehenkirchen-Siegertsbrunn
State/Province
Bayern
ZIP/Postal Code
85635
Country
Germany
Facility Name
GSK Investigational Site
City
Langquaid
State/Province
Bayern
ZIP/Postal Code
84085
Country
Germany
Facility Name
GSK Investigational Site
City
Ruedersdorf
State/Province
Brandenburg
ZIP/Postal Code
15562
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04129
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12687
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13086
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
GSK Investigational Site
City
Bekkestua
ZIP/Postal Code
1319
Country
Norway
Facility Name
GSK Investigational Site
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
GSK Investigational Site
City
Fredrikstad
ZIP/Postal Code
N-1601
Country
Norway
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
2301
Country
Norway
Facility Name
GSK Investigational Site
City
Haugesund
ZIP/Postal Code
5507
Country
Norway
Facility Name
GSK Investigational Site
City
Paradis
ZIP/Postal Code
5231
Country
Norway
Facility Name
GSK Investigational Site
City
Skien
ZIP/Postal Code
N-03730
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104888
Available IPD/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.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104888
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104888
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104888
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104888
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104888
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs