InfluenzaPhase 3NCT00529516

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

A Phase 3 study testing Fluarix and GSK Biologicals Influenza Vaccine GSK576389A in people with Influenza, run by GlaxoSmithKline at 29 sites in 4 countries.

Completed

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

Official record

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Trial summary

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 GSK Biologicals Influenza Vaccine GSK576389A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,252 participants
Where: 29 sitesin 4 countries
Study dates: 15 Oct 2007to 4 Jun 2008
Phase: Phase 3
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
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.
Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the >= 65 years age group or in the 18-40 years age group .

Who cannot join

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 30 days after vaccination
Planned administration of an influenza vaccine other than the study vaccines during the entire study period
Any vaccination against influenza since January 2007
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Show all 14Show fewer

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 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 dose of study vaccine or planned administration during the study period
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period
Any medical conditions in which IM injections are contraindicated
Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.

Trial locations and contacts

29 sites in 4 countries.

Country

City, postcode or hospital

29 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

Other trials in Germany

United States9 sites

GSK Investigational Site
Carnegie, Pennsylvania, 15106
GSK Investigational Site
Chaska, Minnesota, 55318
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

Other trials in United States

Norway7 sites

GSK Investigational Site
Bekkestua, 1319
GSK Investigational Site
Bergen, 5094
GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Fredrikstad, N-1601
GSK Investigational Site
Hamar, 2317
GSK Investigational Site
Haugesund, 5507
GSK Investigational Site
Skien, 3717

Other trials in Norway

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™

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 observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.

Read the detailed description

This study involves 2 age groups (based on primary study):

Subjects enrolled in the >= 65 yrs age group in the primary study. Subjects enrolled in the 18-40 yrs age group in the primary study. The study will be conducted in an open manner for this age group.

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

Conditions: Influenza
Being tested: Fluarix, GSK Biologicals Influenza Vaccine GSK576389A
Keywords: Fluarix, GSK Bio's influenza vaccine GSK576389A, 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.

FluarixBiological
Single dose, Intramuscular injection
GSK Biologicals Influenza Vaccine GSK576389ABiological
Single dose, Intramuscular injection

Study groups in NCT00529516
Study group	Role	What they receive
FluAS25 Group	Experimental	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study. Receives: Biological: GSK Biologicals Influenza Vaccine GSK576389A
Fluarix ≥ 65 years age Group	Active comparator	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study. Receives: Biological: Fluarix
Fluarix 18-40 years age Group	Active comparator	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study. 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)
Solicited local AEs 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 Adverse Events
Duration was expressed as the median number of days the symptom was experienced.
Measured: During a 7-day follow-up period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
Solicited general AEs 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 40°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 Adverse Events
Duration was expressed as the median number of days the symptom was experienced.
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: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.
Measured: During a 21-day follow-up period after vaccination

Secondary outcomes (16)

Number of Subjects With 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.
Measured: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)
Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.
Measured: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Serum Hemagglutination-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 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 for HI Antibodies Against Each of the Three Vaccine Strains
Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.
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 to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: At Days 0 and 21
Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers
Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Measured: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker
Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Measured: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Measured: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Measured: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Measured: At Day 0 and 21
Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers
Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Measured: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker
Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Measured: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Measured: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Measured: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Measured: At Day 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 20074 Jun 2008

First posted14 Sep 2007 (estimated)
Study start15 Oct 2007
Primary completion21 Dec 2007
Study completion4 Jun 2008

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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00529516
Sponsor's protocol ID: 109821
Status last verified: Apr 2017
First submitted: 13 Sep 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: Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™
ClinicalTrials.gov ID: NCT00529516
Acronym / sponsor ID: 109821
Conditions: Influenza
Keywords: Fluarix, GSK Bio's influenza vaccine GSK576389A, Influenza infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,252 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Oct 2007
Primary completion: 21 Dec 2007 (actual)
Study completion: 4 Jun 2008 (actual)
First posted: 14 Sep 2007 (estimated)
Results: Posted 30 May 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

This study involves 2 age groups (based on primary study):

Subjects enrolled in the >= 65 yrs age group in the primary study. Subjects enrolled in the 18-40 yrs age group in the primary study. The study will be conducted in an open manner for this age group.

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: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
FluAS25 Group	Experimental	Biological: GSK Biologicals Influenza Vaccine GSK576389ASubjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
Fluarix ≥ 65 years age Group	Active comparator	Biological: FluarixSubjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
Fluarix 18-40 years age Group	Active comparator	Biological: FluarixSubjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
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.
Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the >= 65 years age group or in the 18-40 years age group .

Key exclusion criteria (14 listed)

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 30 days after vaccination
Planned administration of an influenza vaccine other than the study vaccines during the entire study period
Any vaccination against influenza since January 2007
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

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
FluarixSingle dose, Intramuscular injection	Biological	Fluarix 18-40 years age Group, Fluarix ≥ 65 years age Group
GSK Biologicals Influenza Vaccine GSK576389ASingle dose, Intramuscular injection	Biological	FluAS25 Group

Primary outcome

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: During a 7-day follow-up period after vaccination
Solicited local AEs 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 Adverse Events
Time frame: During a 7-day follow-up period after vaccination
Duration was expressed as the median number of days the symptom was experienced.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
Time frame: During a 7-day follow-up period after vaccination
Solicited general AEs 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 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Duration of Solicited General Adverse Events
Time frame: During a 7-day follow-up period after vaccination
Duration was expressed as the median number of days the symptom was experienced.
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: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.

16 secondary outcomes

Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Time frame: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)
Time frame: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Serum Hemagglutination-inhibition (HI) Antibody Titers 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 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 Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers
Time frame: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker
Time frame: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker
Time frame: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker
Time frame: At Day 0 and 21
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker
Time frame: At Day 0 and 21
Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers
Time frame: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker
Time frame: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker
Time frame: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker
Time frame: At Day 0 and 21
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker
Time frame: At Day 0 and 21

Results and safety

Results posted to the registry on 30 May 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 Group	475	472
Fluarix ≥ 65 Years Age Group	488	486
Fluarix 18-40 Years Age Group	289	288

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

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

Measure	FluAS25 Group n = 472	Fluarix ≥ 65 Years Age Group n = 487	Fluarix 18-40 Years Age Group n = 288
Any Ecchymosis	7	7	2
Grade 3 Ecchymosis	0	0	0
Any Pain	271	76	170
Grade 3 Pain	2	0	0
Any Redness	111	14	16
Grade 3 Redness	12	0	0
Any Swelling	44	8	7
Grade 3 Swelling	1	0	0

Population analysed: The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.

Primary outcome: Duration of Solicited Local Adverse Events

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

Measure	FluAS25 Group n = 271	Fluarix ≥ 65 Years Age Group n = 76	Fluarix 18-40 Years Age Group n = 170
Ecchymosis (N= 7; 7; 2)	3.0 (1.0 to 7.0)	2.0 (1.0 to 5.0)	4.5 (4.0 to 5.0)
Pain (N= 271; 76; 170)	2.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)	2.0 (1.0 to 5.0)
Redness (N= 111; 14; 16)	3.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)	1.5 (1.0 to 3.0)
Swelling (N= 44; 8; 5)	3.0 (1.0 to 7.0)	1.0 (1.0 to 3.0)	2.0 (1.0 to 4.0)

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

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

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

Measure	FluAS25 Group n = 472	Fluarix ≥ 65 Years Age Group n = 487	Fluarix 18-40 Years Age Group n = 288
Any Arthralgia	80	34	23
Grade 3 Arthralgia	2	0	1
Related Arthralgia	65	20	22
Any Fatigue	131	46	71
Grade 3 Fatigue	4	0	1
Related Fatigue	109	29	54
Any Headache	102	49	54
Grade 3 Headache	4	1	1

Population analysed: The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.

Primary outcome: Duration of Solicited General Adverse Events

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

Measure	FluAS25 Group n = 132	Fluarix ≥ 65 Years Age Group n = 51	Fluarix 18-40 Years Age Group n = 70
Arthralgia (N= 80; 34; 23)	2.0 (1.0 to 7.0)	3.0 (1.0 to 7.0)	2.0 (1.0 to 6.0)
Fatigue (N= 131; 46; 71)	2.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)	2.0 (1.0 to 7.0)
Headache (N= 102; 49; 54)	1.0 (1.0 to 7.0)	1.0 (1.0 to 7.0)	2.0 (1.0 to 6.0)
Myalgia (N= 132; 51; 70)	2.0 (1.0 to 7.0)	2.0 (1.0 to 6.0)	2.0 (1.0 to 6.0)
Nausea (N= 35; 23; 17)	1.0 (1.0 to 4.0)	1.0 (1.0 to 7.0)	2.0 (1.0 to 4.0)
Shivering (N= 95; 31; 31)	1.0 (1.0 to 5.0)	2.0 (1.0 to 7.0)	1.0 (1.0 to 6.0)
Fever (N= 17; 0; 1)	1.0 (1.0 to 2.0)	NA (NA to NA)	1.0 (1.0 to 1.0)

Population analysed: The analysis was performed on the Total Vaccinated Cohort, on subjects that experienced the specific symptom.

16 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 method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FluAS25 Group	23 of 475 (4.8%)	346 of 475 (72.8%)	Not reported
Fluarix ≥ 65 Years Age Group	27 of 488 (5.5%)	162 of 488 (33.2%)	Not reported
Fluarix 18-40 Years Age Group	4 of 289 (1.4%)	200 of 289 (69.2%)	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

29 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluarix and GSK Biologicals Influenza Vaccine GSK576389A in people with Influenza, run by GlaxoSmithKline at 29 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 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 29 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 May 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: During a 7-day follow-up period after vaccination). The study lists 5 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 NCT00529516.

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.