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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00377585

Collaborator

(none)

3,350

Enrollment

Locations

4.3

Duration (Months)

111.7

Patients Per Site

26.1

Patients Per Site Per Month

Study Details

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

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 :

Sep 22, 2006

Actual Study Completion Date :

Jan 30, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Clearwater	Florida	United States	33761
2	GSK Investigational Site	Coral Gables	Florida	United States	33134
3	GSK Investigational Site	Milford	Massachusetts	United States	01757
4	GSK Investigational Site	Chaska	Minnesota	United States	55318
5	GSK Investigational Site	Somers Point	New Jersey	United States	08244
6	GSK Investigational Site	Poughkeepsie	New York	United States	12601
7	GSK Investigational Site	Cincinnati	Ohio	United States	45229
8	GSK Investigational Site	Carnegie	Pennsylvania	United States	15106
9	GSK Investigational Site	Erie	Pennsylvania	United States	16506
10	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15236
11	GSK Investigational Site	Gent		Belgium	9000
12	GSK Investigational Site	Messkirch	Baden-Wuerttemberg	Germany	88605
13	GSK Investigational Site	Augsburg	Bayern	Germany	86150
14	GSK Investigational Site	Haag	Bayern	Germany	83527
15	GSK Investigational Site	Hoehenkirchen-Siegertsbrunn	Bayern	Germany	85635
16	GSK Investigational Site	Langquaid	Bayern	Germany	84085
17	GSK Investigational Site	Ruedersdorf	Brandenburg	Germany	15562
18	GSK Investigational Site	Leipzig	Sachsen	Germany	04129
19	GSK Investigational Site	Berlin		Germany	10365
20	GSK Investigational Site	Berlin		Germany	10367
21	GSK Investigational Site	Berlin		Germany	12687
22	GSK Investigational Site	Berlin		Germany	13086
23	GSK Investigational Site	Berlin		Germany	13507
24	GSK Investigational Site	Bekkestua		Norway	1319
25	GSK Investigational Site	Elverum		Norway	2408
26	GSK Investigational Site	Fredrikstad		Norway	N-1601
27	GSK Investigational Site	Hamar		Norway	2301
28	GSK Investigational Site	Haugesund		Norway	5507
29	GSK Investigational Site	Paradis		Norway	5231
30	GSK Investigational Site	Skien		Norway	N-03730