InfluenzaPhase 2NCT00377585
Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population
A Phase 2 study testing Fluarix and adjuvanted influenza vaccine in people with Influenza, run by GlaxoSmithKline at 30 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluarix and adjuvanted influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 3,350 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 22 Sep 2006to 30 Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects must be healthy adults 18-40 years or >/= 50 years.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
Germany12 sites
GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Berlin, 10365
GSK Investigational Site
Berlin, 10367
GSK Investigational Site
Berlin, 12687
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Berlin, 13507
GSK Investigational Site
Haag, Bavaria, 83527
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635
GSK Investigational Site
Langquaid, Bavaria, 84085
GSK Investigational Site
Leipzig, Saxony, 04129
GSK Investigational Site
Messkirch, Baden-Wurttemberg, 88605
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562
United States10 sites
GSK Investigational Site
Carnegie, Pennsylvania, 15106
GSK Investigational Site
Chaska, Minnesota, 55318
GSK Investigational Site
Cincinnati, Ohio, 45229
GSK Investigational Site
Clearwater, Florida, 33761
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Poughkeepsie, New York, 12601
GSK Investigational Site
Somers Point, New Jersey, 08244
Norway7 sites
GSK Investigational Site
Bekkestua, 1319
GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Fredrikstad, N-1601
GSK Investigational Site
Hamar, 2301
GSK Investigational Site
Haugesund, 5507
GSK Investigational Site
Paradis, 5231
GSK Investigational Site
Skien, N-03730
About this study
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™
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.
Read the detailed description
This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.
- Conditions
- Influenza
- Being tested
- Fluarix, adjuvanted influenza vaccine
- Keywords
- Elderly, Improved vaccine, Influenza, Influenza disease
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluarixBiological
adjuvanted influenza vaccineBiological
Also called Fluarix
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study start22 Sep 2006
- Study completion30 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 3,350 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377585
- Sponsor's protocol ID
- 104888
- Status last verified
- Apr 2017
- First submitted
- 14 Sep 2006
- Last updated
- 24 Apr 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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™
- ClinicalTrials.gov ID
- NCT00377585
- Acronym / sponsor ID
- 104888
- Conditions
- Influenza
- Keywords
- Elderly, Improved vaccine, Influenza, Influenza disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,350 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2006
- Study completion
- 30 Jan 2007 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subjects must be healthy adults 18-40 years or >/= 50 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluarix | Biological | – |
| adjuvanted influenza vaccineAlso: Fluarix | Biological | – |
Primary outcome
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
1 secondary outcome
To evaluate in all subjects, the safety, the humoral response and the cell-mediated immune (CMI) response of the adjuvanted influenza vaccine and Fluarix
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluarix and adjuvanted influenza vaccine in people with Influenza, run by GlaxoSmithKline at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, United States, Norway, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.