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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00480025




Registration number
NCT00480025
Ethics application status
Date submitted
29/05/2007
Date registered
30/05/2007

Titles & IDs
Public title
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
Scientific title
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2007-001283-73
Secondary ID [2] 0 0
109493
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer, Non-Small Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Treatment: Other - Placebo Control

Experimental: GSK1572932 Group - Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.

Placebo comparator: Placebo Group - Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.


Treatment: Other: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses

Treatment: Other: Placebo Control
Intramuscular administration, 13 doses
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
Timepoint [1] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Primary outcome [2] 0 0
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
Timepoint [2] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [1] 0 0
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
Timepoint [1] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [2] 0 0
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population
Timepoint [2] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [3] 0 0
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population
Timepoint [3] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [4] 0 0
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population
Timepoint [4] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [5] 0 0
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population
Timepoint [5] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [6] 0 0
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population
Timepoint [6] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [7] 0 0
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population
Timepoint [7] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [8] 0 0
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
Timepoint [8] 0 0
KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [9] 0 0
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
Timepoint [9] 0 0
KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [10] 0 0
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
Timepoint [10] 0 0
KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [11] 0 0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population
Timepoint [11] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [12] 0 0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population
Timepoint [12] 0 0
From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [13] 0 0
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population
Timepoint [13] 0 0
Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [14] 0 0
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Timepoint [14] 0 0
Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)
Secondary outcome [15] 0 0
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Timepoint [15] 0 0
At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Secondary outcome [16] 0 0
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Timepoint [16] 0 0
Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Secondary outcome [17] 0 0
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Timepoint [17] 0 0
At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Secondary outcome [18] 0 0
Health-related Quality of Life (HQL) Scores
Timepoint [18] 0 0
At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120
Secondary outcome [19] 0 0
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
Timepoint [19] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [20] 0 0
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
Timepoint [20] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [21] 0 0
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
Timepoint [21] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [22] 0 0
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
Timepoint [22] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [23] 0 0
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
Timepoint [23] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [24] 0 0
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
Timepoint [24] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [25] 0 0
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
Timepoint [25] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [26] 0 0
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
Timepoint [26] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [27] 0 0
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
Timepoint [27] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [28] 0 0
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
Timepoint [28] 0 0
From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [29] 0 0
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Timepoint [29] 0 0
Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Secondary outcome [30] 0 0
Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)
Timepoint [30] 0 0
From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Eligibility
Key inclusion criteria
Inclusion criteria:

* Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.
* Written informed consent for MAGE-A3 expression screening on tumor biopsy has been obtained from the patient prior to shipment of the sample for expression testing (before or just after surgical resection), and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
* Patient is = 18 years of age at the time of signature of the first informed consent form.
* The patient's tumor shows expression of MAGE-A3 gene
* The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy;
* The mediastinal lymph node sampling is done according to study protocol guidelines;
* The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain.

Other examinations should be performed as clinically indicated. Note that if randomization is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to 4 weeks before surgery do not have to be repeated.

* ECOG performance status of 0, 1 or 2 at the time of randomization.
* Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as:

Absolute neutrophil count = 1.0 x 10E9/L Platelet count = 75 x 10E9/L Serum creatinine = 1.5 times the Upper Limit of Normal (ULN)

= 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin = 1.5 times the ULN Alanine transaminase (ALAT) = 2.5 times the ULN

* If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
* In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

* The primary tumor was removed by segmentectomy or wedge resection.
* The patient shows any evidence of residual tumor after surgery.
* The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:

For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years), Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization.

* The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured.
* History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
* The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
* The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.

Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.

* The patient has received a major organ allograft.
* The patient is known to be HIV-positive.
* The patient has an uncontrolled bleeding disorder.
* The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
* The patient needs home oxygenation.
* The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
* The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
* The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
* For female patients: the patient is pregnant or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/09/2014
Sample size
Target
Accrual to date
Final
2278
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [3] 0 0
GSK Investigational Site - Tweed Heads
Recruitment hospital [4] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [5] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [6] 0 0
GSK Investigational Site - Chermside
Recruitment hospital [7] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [8] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [9] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [10] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [11] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [12] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [13] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [14] 0 0
GSK Investigational Site - Richmond
Recruitment hospital [15] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [16] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3065 - Fitzroy
Recruitment postcode(s) [13] 0 0
3084 - Heidelberg
Recruitment postcode(s) [14] 0 0
3121 - Richmond
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment postcode(s) [16] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
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United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
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United States of America
State/province [9] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Idaho
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Illinois
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Indiana
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United States of America
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Iowa
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United States of America
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
Country [40] 0 0
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Córdova
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Argentina
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Río Negro
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Argentina
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Santa Fe
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Argentina
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Quilmes
Country [47] 0 0
Argentina
State/province [47] 0 0
Tucuman
Country [48] 0 0
Austria
State/province [48] 0 0
Graz
Country [49] 0 0
Austria
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Innsbruck
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Vienna
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Austria
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Wels
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Duffel
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Belgium
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Edegem
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Belgium
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Genk
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Belgium
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Hasselt
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Belgium
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Jette
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Namur
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Québec
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China
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Guangdong
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China
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Guangxi
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China
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Hubei
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China
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Jiangsu
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China
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Jilin
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China
State/province [81] 0 0
Sichuan
Country [82] 0 0
China
State/province [82] 0 0
Zhejiang
Country [83] 0 0
China
State/province [83] 0 0
Beijing
Country [84] 0 0
China
State/province [84] 0 0
Changsha
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China
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Guangzhou
Country [86] 0 0
China
State/province [86] 0 0
Harbin
Country [87] 0 0
China
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Shanghai
Country [88] 0 0
China
State/province [88] 0 0
Tianjin
Country [89] 0 0
China
State/province [89] 0 0
Wuhan
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Czechia
State/province [90] 0 0
Brno
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Czechia
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Ostrava
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Czechia
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Plzen
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Czechia
State/province [93] 0 0
Praha 5
Country [94] 0 0
Czechia
State/province [94] 0 0
Praha 8
Country [95] 0 0
Czechia
State/province [95] 0 0
Usti nad Labem
Country [96] 0 0
Estonia
State/province [96] 0 0
Tallinn
Country [97] 0 0
Estonia
State/province [97] 0 0
Tartu
Country [98] 0 0
Finland
State/province [98] 0 0
Helsinki
Country [99] 0 0
Finland
State/province [99] 0 0
Oulu
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Finland
State/province [100] 0 0
Tampere
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Finland
State/province [101] 0 0
Turku
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France
State/province [102] 0 0
Angers cedex 9
Country [103] 0 0
France
State/province [103] 0 0
Bayonne
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France
State/province [104] 0 0
Beauvais
Country [105] 0 0
France
State/province [105] 0 0
Bethune Cedex
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France
State/province [106] 0 0
Bordeaux
Country [107] 0 0
France
State/province [107] 0 0
Brest cedex
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France
State/province [108] 0 0
Bron
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France
State/province [109] 0 0
Caen
Country [110] 0 0
France
State/province [110] 0 0
Elbeuf
Country [111] 0 0
France
State/province [111] 0 0
Lille
Country [112] 0 0
France
State/province [112] 0 0
Limoges Cedex
Country [113] 0 0
France
State/province [113] 0 0
Lorient cedex
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France
State/province [114] 0 0
Lyon cedex 08
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France
State/province [115] 0 0
Lyon
Country [116] 0 0
France
State/province [116] 0 0
Marseille cedex 20
Country [117] 0 0
France
State/province [117] 0 0
Meaux
Country [118] 0 0
France
State/province [118] 0 0
Metz
Country [119] 0 0
France
State/province [119] 0 0
Montpellier
Country [120] 0 0
France
State/province [120] 0 0
Mulhouse Cedex
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France
State/province [121] 0 0
Nantes
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France
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France
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Nîmes
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France
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Paris cedex 20
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France
State/province [125] 0 0
Paris Cedex 5
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France
State/province [126] 0 0
Paris
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France
State/province [127] 0 0
Perpignan
Country [128] 0 0
France
State/province [128] 0 0
Périgueux cedex
Country [129] 0 0
France
State/province [129] 0 0
Reims
Country [130] 0 0
France
State/province [130] 0 0
Rennes Cedex 09
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France
State/province [131] 0 0
Rouen
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France
State/province [132] 0 0
Saint Herblain
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France
State/province [133] 0 0
Saint-Priest en Jarez
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France
State/province [134] 0 0
Saint-Quentin
Country [135] 0 0
France
State/province [135] 0 0
St Grégoire
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France
State/province [136] 0 0
Toulon cedex 09
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France
State/province [137] 0 0
Toulouse cedex 9
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France
State/province [138] 0 0
Vannes
Country [139] 0 0
France
State/province [139] 0 0
Villefranche sur Saône
Country [140] 0 0
Germany
State/province [140] 0 0
Baden-Wuerttemberg
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Germany
State/province [141] 0 0
Bayern
Country [142] 0 0
Germany
State/province [142] 0 0
Brandenburg
Country [143] 0 0
Germany
State/province [143] 0 0
Hessen
Country [144] 0 0
Germany
State/province [144] 0 0
Mecklenburg-Vorpommern
Country [145] 0 0
Germany
State/province [145] 0 0
Niedersachsen
Country [146] 0 0
Germany
State/province [146] 0 0
Nordrhein-Westfalen
Country [147] 0 0
Germany
State/province [147] 0 0
Rheinland-Pfalz
Country [148] 0 0
Germany
State/province [148] 0 0
Saarland
Country [149] 0 0
Germany
State/province [149] 0 0
Sachsen-Anhalt
Country [150] 0 0
Germany
State/province [150] 0 0
Sachsen
Country [151] 0 0
Germany
State/province [151] 0 0
Schleswig-Holstein
Country [152] 0 0
Germany
State/province [152] 0 0
Thueringen
Country [153] 0 0
Germany
State/province [153] 0 0
Berlin
Country [154] 0 0
Germany
State/province [154] 0 0
Bremen
Country [155] 0 0
Germany
State/province [155] 0 0
Hamburg
Country [156] 0 0
Greece
State/province [156] 0 0
Athens
Country [157] 0 0
Greece
State/province [157] 0 0
Chania
Country [158] 0 0
Greece
State/province [158] 0 0
Heraklion
Country [159] 0 0
Greece
State/province [159] 0 0
Larissa
Country [160] 0 0
Greece
State/province [160] 0 0
Marousi
Country [161] 0 0
Greece
State/province [161] 0 0
Neo Faliro
Country [162] 0 0
Greece
State/province [162] 0 0
Patra
Country [163] 0 0
Greece
State/province [163] 0 0
Piraeus
Country [164] 0 0
Greece
State/province [164] 0 0
Pylaia
Country [165] 0 0
Greece
State/province [165] 0 0
Thessaloniki
Country [166] 0 0
Hong Kong
State/province [166] 0 0
Kowloon
Country [167] 0 0
Hong Kong
State/province [167] 0 0
Shatin
Country [168] 0 0
Hungary
State/province [168] 0 0
Budapest
Country [169] 0 0
Hungary
State/province [169] 0 0
Deszk
Country [170] 0 0
Hungary
State/province [170] 0 0
Gyula
Country [171] 0 0
Hungary
State/province [171] 0 0
Gyor
Country [172] 0 0
Hungary
State/province [172] 0 0
Miskolc
Country [173] 0 0
Hungary
State/province [173] 0 0
Mátraháza
Country [174] 0 0
Hungary
State/province [174] 0 0
Nyíregyháza
Country [175] 0 0
Hungary
State/province [175] 0 0
Pozva
Country [176] 0 0
Hungary
State/province [176] 0 0
Pécs
Country [177] 0 0
Hungary
State/province [177] 0 0
Szombathely
Country [178] 0 0
Hungary
State/province [178] 0 0
Székesfehérvár
Country [179] 0 0
India
State/province [179] 0 0
Ahmedabad
Country [180] 0 0
India
State/province [180] 0 0
Bangalore
Country [181] 0 0
India
State/province [181] 0 0
Hyderabad
Country [182] 0 0
India
State/province [182] 0 0
Mumbai
Country [183] 0 0
Ireland
State/province [183] 0 0
Dublin
Country [184] 0 0
Ireland
State/province [184] 0 0
Galway
Country [185] 0 0
Israel
State/province [185] 0 0
Beer-Sheva
Country [186] 0 0
Israel
State/province [186] 0 0
Haifa
Country [187] 0 0
Israel
State/province [187] 0 0
Jerusalem
Country [188] 0 0
Israel
State/province [188] 0 0
Kfar Saba
Country [189] 0 0
Israel
State/province [189] 0 0
Ramat Gan
Country [190] 0 0
Israel
State/province [190] 0 0
Zrifin
Country [191] 0 0
Italy
State/province [191] 0 0
Campania
Country [192] 0 0
Italy
State/province [192] 0 0
Emilia-Romagna
Country [193] 0 0
Italy
State/province [193] 0 0
Friuli-Venezia-Giulia
Country [194] 0 0
Italy
State/province [194] 0 0
Lazio
Country [195] 0 0
Italy
State/province [195] 0 0
Liguria
Country [196] 0 0
Italy
State/province [196] 0 0
Lombardia
Country [197] 0 0
Italy
State/province [197] 0 0
Piemonte
Country [198] 0 0
Italy
State/province [198] 0 0
Puglia
Country [199] 0 0
Italy
State/province [199] 0 0
Sardegna
Country [200] 0 0
Italy
State/province [200] 0 0
Sicilia
Country [201] 0 0
Italy
State/province [201] 0 0
Toscana
Country [202] 0 0
Italy
State/province [202] 0 0
Umbria
Country [203] 0 0
Italy
State/province [203] 0 0
Veneto
Country [204] 0 0
Japan
State/province [204] 0 0
Aichi
Country [205] 0 0
Japan
State/province [205] 0 0
Chiba
Country [206] 0 0
Japan
State/province [206] 0 0
Ehime
Country [207] 0 0
Japan
State/province [207] 0 0
Fukuoka
Country [208] 0 0
Japan
State/province [208] 0 0
Hiroshima
Country [209] 0 0
Japan
State/province [209] 0 0
Hyogo
Country [210] 0 0
Japan
State/province [210] 0 0
Kanagawa
Country [211] 0 0
Japan
State/province [211] 0 0
Niigata
Country [212] 0 0
Japan
State/province [212] 0 0
Osaka
Country [213] 0 0
Japan
State/province [213] 0 0
Shizuoka
Country [214] 0 0
Japan
State/province [214] 0 0
Tokyo
Country [215] 0 0
Korea, Republic of
State/province [215] 0 0
Kyunggi-do
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Korea, Republic of
State/province [216] 0 0
Seongnam-si
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Korea, Republic of
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Amsterdam
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Harderwijk
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Netherlands
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Heerlen
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Netherlands
State/province [221] 0 0
Leeuwarden
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Netherlands
State/province [222] 0 0
Nieuwegein
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Norway
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Oslo
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Norway
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Trondheim
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Poland
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Bialystok
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Poland
State/province [226] 0 0
Bydgoszcz
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Poland
State/province [227] 0 0
Checiny
Country [228] 0 0
Poland
State/province [228] 0 0
Gdansk
Country [229] 0 0
Poland
State/province [229] 0 0
Glucholazy
Country [230] 0 0
Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Rzeszow
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Poland
State/province [235] 0 0
Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Poland
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Zakopane
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Russian Federation
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Stavropol
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Russian Federation
State/province [245] 0 0
Ufa,
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Singapore
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Singapore
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Spain
State/province [247] 0 0
Barcelona
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Spain
State/province [248] 0 0
Granada
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Spain
State/province [249] 0 0
Leganes
Country [250] 0 0
Spain
State/province [250] 0 0
Lerida
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Spain
State/province [251] 0 0
Madrid
Country [252] 0 0
Spain
State/province [252] 0 0
Málaga
Country [253] 0 0
Spain
State/province [253] 0 0
Oviedo
Country [254] 0 0
Spain
State/province [254] 0 0
Sabadell
Country [255] 0 0
Spain
State/province [255] 0 0
San Sebastian de los Reyes
Country [256] 0 0
Spain
State/province [256] 0 0
Santander
Country [257] 0 0
Spain
State/province [257] 0 0
Santiago de Compostela
Country [258] 0 0
Spain
State/province [258] 0 0
Sevilla
Country [259] 0 0
Spain
State/province [259] 0 0
Valencia
Country [260] 0 0
Sweden
State/province [260] 0 0
Lund
Country [261] 0 0
Sweden
State/province [261] 0 0
Stockholm
Country [262] 0 0
Sweden
State/province [262] 0 0
Uppsala
Country [263] 0 0
Switzerland
State/province [263] 0 0
Aarau
Country [264] 0 0
Switzerland
State/province [264] 0 0
Basel
Country [265] 0 0
Switzerland
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Bern
Country [266] 0 0
Switzerland
State/province [266] 0 0
Bruderholz
Country [267] 0 0
Switzerland
State/province [267] 0 0
Thun
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Switzerland
State/province [268] 0 0
Zuerich
Country [269] 0 0
Taiwan
State/province [269] 0 0
Kaohsiung
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Taiwan
State/province [270] 0 0
Taichung
Country [271] 0 0
Taiwan
State/province [271] 0 0
Tainan
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Taiwan
State/province [272] 0 0
Taipei
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Taiwan
State/province [273] 0 0
Taoyuan
Country [274] 0 0
Thailand
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Bangkok
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Thailand
State/province [275] 0 0
Chiang Mai
Country [276] 0 0
Thailand
State/province [276] 0 0
Hat yai
Country [277] 0 0
Ukraine
State/province [277] 0 0
Dnipropetrovsk
Country [278] 0 0
Ukraine
State/province [278] 0 0
Donetsk
Country [279] 0 0
Ukraine
State/province [279] 0 0
Kharkiv
Country [280] 0 0
Ukraine
State/province [280] 0 0
Kyiv
Country [281] 0 0
Ukraine
State/province [281] 0 0
Lviv
Country [282] 0 0
Ukraine
State/province [282] 0 0
Odesa
Country [283] 0 0
Ukraine
State/province [283] 0 0
Simferopol
Country [284] 0 0
Ukraine
State/province [284] 0 0
Uzhgorod
Country [285] 0 0
Ukraine
State/province [285] 0 0
Vinnytsia
Country [286] 0 0
United Kingdom
State/province [286] 0 0
Cambridgeshire
Country [287] 0 0
United Kingdom
State/province [287] 0 0
Greater Manchester
Country [288] 0 0
United Kingdom
State/province [288] 0 0
Leicestershire
Country [289] 0 0
United Kingdom
State/province [289] 0 0
Midlothian
Country [290] 0 0
United Kingdom
State/province [290] 0 0
Surrey
Country [291] 0 0
United Kingdom
State/province [291] 0 0
Aberdeen
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Bebington
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Belfast
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Birmingham
Country [295] 0 0
United Kingdom
State/province [295] 0 0
Cambridge
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Dundee
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Glasgow
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Inverness
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Leeds
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Liverpool
Country [301] 0 0
United Kingdom
State/province [301] 0 0
London
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Maidstone
Country [303] 0 0
United Kingdom
State/province [303] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study is available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=4790


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00480025