InfluenzaPhase 2NCT00538213

Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

A Phase 2 study testing Fluarix™ and GSK Bio's Influenza Vaccine GSK576389A in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluarix™ and GSK Bio's Influenza Vaccine GSK576389A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 1 siteBelgium
Study dates: 15 Oct 2007to 28 Nov 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A investigational vaccines in the 104887 study (NCT00386698).
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged between 19 and 42 years or 66 years and older at the time of the vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
History of confirmed influenza infection since the date of previous vaccination.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

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Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Oral temperature of <37.5°C).
Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
Any medical conditions in which intramuscular injections are contraindicated.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥66 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference

Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104887 are eligible for participation in this study.

Read the detailed description

This study is a year 2 revaccination study. First year revaccination was done in study 104887 (NCT00386698). Primary study was study 104886 (NCT00318149). This study involves 2 age groups (based on primary study):

Subjects enrolled in the ≥ 65 years age group in the primary study. Subjects enrolled in the 18-40 years age group in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Conditions: Influenza
Being tested: Fluarix™, GSK Bio's Influenza Vaccine GSK576389A
Keywords: Influenza vaccine GSK576389A, Fluarix, Influenza infection
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluarix™Biological
Single dose, Intramuscular injection
GSK Bio's Influenza Vaccine GSK576389ABiological
Single dose, Intramuscular injection

Study groups in NCT00538213
Study group	Role	What they receive
Adjuvanted influenza vaccine GSK576389A Group	Experimental	Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A. Receives: Biological: GSK Bio's Influenza Vaccine GSK576389A
Fluarix young Group	Active comparator	Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine. Receives: Biological: Fluarix™
Fluarix elderly Group	Active comparator	Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine. Receives: Biological: Fluarix™

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. >100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Measured: Day 0-6
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Measured: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-6
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Measured: Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.
Measured: Day 0-20
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Measured: Day 0-20

Secondary outcomes (7)

Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Days 0 and 21
The Number of Subjects Seropositive to HI Antibodies
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Days 0 and 21
The Number of Subjects Seroconverted to HI Antibodies
Seroconversion was defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 21
HI Antibody Seroconversion Factors (SCF)
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Day 21
The Number of Subjects Seroprotected to HI Antibodies
Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Measured: At Days 0 and 21
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Measured: At Days 0 and 21
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.
Measured: At Days 0 and 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 200728 Nov 2007

First posted2 Oct 2007 (estimated)
Study start15 Oct 2007
Primary completion1 Nov 2007
Study completion28 Nov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00538213
Sponsor's protocol ID: 110263
Status last verified: Nov 2016
First submitted: 1 Oct 2007
Last updated: 8 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥66 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference
ClinicalTrials.gov ID: NCT00538213
Acronym / sponsor ID: 110263
Conditions: Influenza
Keywords: Influenza vaccine GSK576389A, Fluarix, Influenza infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Oct 2007
Primary completion: 1 Nov 2007 (actual)
Study completion: 28 Nov 2007 (actual)
First posted: 2 Oct 2007 (estimated)
Results: Posted 5 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects enrolled in the ≥ 65 years age group in the primary study. Subjects enrolled in the 18-40 years age group in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Adjuvanted influenza vaccine GSK576389A Group	Experimental	Biological: GSK Bio's Influenza Vaccine GSK576389ASubjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
Fluarix young Group	Active comparator	Biological: Fluarix™Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
Fluarix elderly Group	Active comparator	Biological: Fluarix™Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A investigational vaccines in the 104887 study (NCT00386698).
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged between 19 and 42 years or 66 years and older at the time of the vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

Key exclusion criteria (15 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
History of confirmed influenza infection since the date of previous 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™Single dose, Intramuscular injection	Biological	Fluarix elderly Group, Fluarix young Group
GSK Bio's Influenza Vaccine GSK576389ASingle dose, Intramuscular injection	Biological	Adjuvanted influenza vaccine GSK576389A Group

Primary outcome

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: Day 0-6
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. >100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Duration of Solicited Local AEs
Time frame: Day 0-6
Duration was defined as number of days with any grade of local symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: Day 0-6
Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General AEs
Time frame: Day 0-6
Duration was defined as number of days with any grade of general symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Time frame: Day 0-20
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
Time frame: Day 0-20
MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: Day 0-20
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.

7 secondary outcomes

Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Days 0 and 21
The Number of Subjects Seropositive to HI Antibodies
Time frame: At Days 0 and 21
The Number of Subjects Seroconverted to HI Antibodies
Time frame: At Day 21
HI Antibody Seroconversion Factors (SCF)
Time frame: At Day 21
The Number of Subjects Seroprotected to HI Antibodies
Time frame: At Days 0 and 21
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Time frame: At Days 0 and 21
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Time frame: At Days 0 and 21

Results and safety

Results posted to the registry on 5 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adjuvanted Influenza Vaccine GSK576389A Group	55	55
Fluarix Elderly Group	40	40
Fluarix Young Group	38	38

Primary outcome: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Time frame: Day 0-6. Number. Unit: subjects

Measure	Adjuvanted Influenza Vaccine GSK576389A Group n = 55	Fluarix Elderly Group n = 40	Fluarix Young Group n = 38
Any ecchymosis	0	0	0
Grade 3 ecchymosis	0	0	0
Any pain	40	12	34
Grade 3 pain	0	0	0
Any redness	13	6	1
Grade 3 redness	0	0	0
Any swelling	6	4	0
Grade 3 swelling	0	0	0

Population analysed: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Primary outcome: Duration of Solicited Local AEs

Time frame: Day 0-6. Median (Full Range). Unit: Days

Measure	Adjuvanted Influenza Vaccine GSK576389A Group n = 40	Fluarix Elderly Group n = 12	Fluarix Young Group n = 34
Pain (N=40; 12; 34)	2.0 (1.0 to 5.0)	1.5 (1.0 to 4.0)	2.0 (1.0 to 4.0)
Redness (N=13; 6; 1)	3.0 (1.0 to 4.0)	1.0 (1.0 to 3.0)	1.0 (1.0 to 1.0)
Swelling (N=6; 4; 0)	3.0 (2.0 to 5.0)	1.0 (1.0 to 3.0)	NA (NA to NA)

Population analysed: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

Primary outcome: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

Time frame: Day 0-6. Number. Unit: subjects

Measure	Adjuvanted Influenza Vaccine GSK576389A Group n = 55	Fluarix Elderly Group n = 40	Fluarix Young Group n = 38
Any arthralgia	6	6	2
Grade 3 arthralgia	0	0	0
Related arthralgia	4	3	2
Any fatigue	19	6	9
Grade 3 fatigue	0	0	0
Related fatigue	19	3	8
Any headache	13	5	8
Grade 3 headache	0	0	0

Population analysed: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Primary outcome: Duration of Solicited General AEs

Time frame: Day 0-6. Median (Full Range). Unit: Days

Measure	Adjuvanted Influenza Vaccine GSK576389A Group n = 19	Fluarix Elderly Group n = 6	Fluarix Young Group n = 10
Arthralgia (N=6; 6; 2)	2.5 (1.0 to 6.0)	2.0 (1.0 to 7.0)	1.5 (1.0 to 2.0)
Fatigue (N=19; 6; 9)	2.0 (1.0 to 7.0)	1.0 (1.0 to 2.0)	2.0 (1.0 to 3.0)
Headache (N=13; 5; 8)	1.0 (1.0 to 5.0)	1.0 (1.0 to 2.0)	2.0 (1.0 to 4.0)
Myalgia (N=10; 3; 10)	2.0 (1.0 to 5.0)	2.0 (2.0 to 3.0)	2.0 (1.0 to 3.0)
Nausea (N=4; 0; 3)	1.0 (1.0 to 2.0)	NA (NA to NA)	1.0 (1.0 to 2.0)
Shivering (N=10; 0; 2)	1.0 (1.0 to 3.0)	NA (NA to NA)	3.5 (1.0 to 6.0)
Temperature (N=4; 0; 0)	1.0 (1.0 to 1.0)	NA (NA to NA)	NA (NA to NA)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adjuvanted Influenza Vaccine GSK576389A Group	0 of 55 (0%)	46 of 55 (83.6%)	Not reported
Fluarix Elderly Group	0 of 40 (0%)	24 of 40 (60%)	Not reported
Fluarix Young Group	0 of 38 (0%)	36 of 38 (94.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluarix™ and GSK Bio's Influenza Vaccine GSK576389A in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.

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 6 inclusion and 15 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) (time frame: Day 0-6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00538213.

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 8 Jun 2018.