InfluenzaPhase 2NCT00538473

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

A Phase 2 study testing GSK Biologicals' influenza vaccine GSK576389A and Fluarix™ 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 67 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: GSK Biologicals' influenza vaccine GSK576389A and Fluarix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteBelgium
Study dates: 23 Oct 2007to 12 Dec 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 67 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A vaccines in the 107973 study (NCT00386113).
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 >= 67 years at the time of re-vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

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.
Confirmed influenza infection since the date of previous 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.

Show all 14Show fewer

Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
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.
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.

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 (≥67 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 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.

Read the detailed description

This study is a year 3 revaccination study. Second year revaccination was done in study 107973 (NCT00386113). First year revaccination was done in study 104540 (NCT00318058). Primary study was study 103304.

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

Conditions: Influenza
Being tested: GSK Biologicals' influenza vaccine GSK576389A, Fluarix™
Keywords: GSK Bio's influenza vaccine GSK576389A, Influenza Infection, Fluarix
Medical subject headings: Influenza, Human

What participants receive

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

GSK Biologicals' influenza vaccine GSK576389ABiological
Single dose, intramuscular injection
Fluarix™Biological
Single dose, intramuscular injection

Study groups in NCT00538473
Study group	Role	What they receive
FluAS25 (GSK576389A) Group	Experimental	Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A). Receives: Biological: GSK Biologicals' influenza vaccine GSK576389A
Fluarix Group	Active comparator	Subjects received 1 dose of Fluarix™. 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 Symptoms
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Measured: During a 7-day follow-up period after vaccination
Duration of Solicited Local Symptoms
Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.
Measured: During a 7-day follow-up period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Measured: During a 7-day follow-up period after vaccination
Duration of Solicited General Symptoms
Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.
Measured: During a 7-day follow-up period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.
Measured: During a 21-day follow-up period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.
Measured: During a 21-day follow-up period after vaccination
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: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.
Measured: Throughout the entire study (up to Day 21)

Secondary outcomes (7)

Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: At Days 0 and 21
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: At Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: At Day 21
Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: At Day 21
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Measured: At Days 0 and 21
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.
Measured: At Days 0 and 21
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.
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.

23 Oct 200712 Dec 2007

First posted2 Oct 2007 (estimated)
Study start23 Oct 2007
Primary completion1 Dec 2007
Study completion12 Dec 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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00538473
Sponsor's protocol ID: 110223
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?

See locations

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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 (≥67 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference.
ClinicalTrials.gov ID: NCT00538473
Acronym / sponsor ID: 110223
Conditions: Influenza
Keywords: GSK Bio's influenza vaccine GSK576389A, Influenza Infection, Fluarix
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Oct 2007
Primary completion: 1 Dec 2007 (actual)
Study completion: 12 Dec 2007 (actual)
First posted: 2 Oct 2007 (estimated)
Results: Posted 27 Jul 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

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: 2

Arm	Type	Receives
FluAS25 (GSK576389A) Group	Experimental	Biological: GSK Biologicals' influenza vaccine GSK576389ASubjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
Fluarix Group	Active comparator	Biological: Fluarix™Subjects received 1 dose of Fluarix™.

Who may qualify

Ages: 67 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A vaccines in the 107973 study (NCT00386113).
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 >= 67 years at the time of re-vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Key exclusion criteria (14 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.
Confirmed influenza infection since the date of previous vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.

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
GSK Biologicals' influenza vaccine GSK576389ASingle dose, intramuscular injection	Biological	FluAS25 (GSK576389A) Group
Fluarix™Single dose, intramuscular injection	Biological	Fluarix Group

Primary outcome

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During a 7-day follow-up period after vaccination
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Duration of Solicited Local Symptoms
Time frame: During a 7-day follow-up period after vaccination
Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During a 7-day follow-up period after vaccination
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General Symptoms
Time frame: During a 7-day follow-up period after vaccination
Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During a 21-day follow-up period after vaccination
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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Time frame: During a 21-day follow-up period after vaccination
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: Throughout the entire study (up to Day 21)
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: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.

7 secondary outcomes

Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
Time frame: At Days 0 and 21
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
Time frame: At Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
Time frame: At Day 21
Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains
Time frame: At Day 21
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
Time frame: At Days 0 and 21
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
Time frame: At Days 0 and 21
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
Time frame: At Days 0 and 21

Results and safety

Results posted to the registry on 27 Jul 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
FluAS25 (GSK576389A) Group	33	32
Fluarix Group	35	35

Primary outcome: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

Time frame: During a 7-day follow-up period after vaccination. Number. Unit: Subjects

Measure	FluAS25 (GSK576389A) Group n = 33	Fluarix Group n = 35
Any ecchymosis	0	1
Grade 3 ecchymosis	0	0
Any pain	17	7
Grade 3 pain	0	0
Any redness	10	4
Grade 3 redness	1	0
Any swelling	2	2
Grade 3 swelling	0	0

Population analysed: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.

Primary outcome: Duration of Solicited Local Symptoms

Time frame: During a 7-day follow-up period after vaccination. Median (Full Range). Unit: Days

Measure	FluAS25 (GSK576389A) Group n = 17	Fluarix Group n = 7
Ecchymosis (N= 0; 1)	NA (NA to NA)	5.0 (5.0 to 5.0)
Pain (N= 17; 7)	2.0 (1.0 to 4.0)	2.0 (1.0 to 4.0)
Redness (N= 10; 4)	2.5 (1.0 to 6.0)	2.0 (1.0 to 2.0)
Swelling (N= 2; 2)	1.5 (1.0 to 2.0)	2.5 (2.0 to 3.0)

Population analysed: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.

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

Time frame: During a 7-day follow-up period after vaccination. Number. Unit: Subjects

Measure	FluAS25 (GSK576389A) Group n = 33	Fluarix Group n = 35
Any arthralgia	8	5
Grade 3 arthralgia	0	0
Related arthralgia	7	1
Any fatigue	8	3
Grade 3 fatigue	0	0
Related fatigue	8	2
Any headache	8	3
Grade 3 headache	0	0

Population analysed: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.

Primary outcome: Duration of Solicited General Symptoms

Time frame: During a 7-day follow-up period after vaccination. Median (Full Range). Unit: Days

Measure	FluAS25 (GSK576389A) Group n = 8	Fluarix Group n = 5
Arthralgia (N= 8; 5)	2.0 (1.0 to 5.0)	3.0 (1.0 to 7.0)
Fatigue (N= 8; 3)	2.5 (1.0 to 6.0)	1.0 (1.0 to 2.0)
Headache (N= 8; 3)	1.5 (1.0 to 3.0)	1.0 (1.0 to 2.0)
Myalgia (N= 8; 1)	2.0 (1.0 to 7.0)	1.0 (1.0 to 1.0)
Nausea (N= 3; 1)	4.0 (2.0 to 4.0)	2.0 (2.0 to 2.0)
Shivering (N= 6; 3)	1.0 (1.0 to 2.0)	1.0 (1.0 to 2.0)
Fever (N= 1; 0)	NA (NA to NA)	NA (NA to NA)

Population analysed: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FluAS25 (GSK576389A) Group	0 of 33 (0%)	24 of 33 (72.7%)	Not reported
Fluarix Group	0 of 35 (0%)	17 of 35 (48.6%)	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 GSK Biologicals' influenza vaccine GSK576389A and Fluarix™ 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 5 inclusion and 14 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 27 Jul 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 Symptoms (time frame: During a 7-day follow-up period after vaccination). 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 NCT00538473.

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.