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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01165229




Registration number
NCT01165229
Ethics application status
Date submitted
15/07/2010
Date registered
19/07/2010

Titles & IDs
Public title
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
Scientific title
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
Secondary ID [1] 0 0
2009-015791-94
Secondary ID [2] 0 0
113077
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster 0 0
Herpes Zoster Vaccine 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Herpes Zoster Vaccine GSK1437173A
Treatment: Other - Placebo

Experimental: Zoster vaccine group - Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule

Placebo comparator: Placebo group - Subjects will receive NaCl solution placebo according to a 0, 2-month schedule


Treatment: Other: Herpes Zoster Vaccine GSK1437173A
Intramuscular injection

Treatment: Other: Placebo
Intramuscular injection.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Any Episodes of Herpes Zoster (HZ)
Timepoint [1] 0 0
During the entire study period (3 to 5 year period following Day 0)
Primary outcome [2] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
Timepoint [2] 0 0
During the entire study period (3 to 5 year period following Day 0)
Primary outcome [3] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
Timepoint [3] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [1] 0 0
Number of Subjects With Post-herpetic Neuralgia (PHN)
Timepoint [1] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [2] 0 0
Number of Days With Severe 'Worst' HZ-associated Pain
Timepoint [2] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [3] 0 0
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
Timepoint [3] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [4] 0 0
Number of Subjects With Overall Mortality and HZ-related Mortality
Timepoint [4] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [5] 0 0
Number of Subjects With Confirmed HZ Episode Related Hospitalizations
Timepoint [5] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [6] 0 0
Number of Subjects With HZ Related Complications
Timepoint [6] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [7] 0 0
Number of Subjects Receiving Pain Medication Associated With HZ
Timepoint [7] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [8] 0 0
Number of Days With Pain Medication Associated With HZ
Timepoint [8] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [9] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Timepoint [9] 0 0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary outcome [10] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Timepoint [10] 0 0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary outcome [11] 0 0
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Timepoint [11] 0 0
Within the 30 days (Days 0-29) after each vaccination
Secondary outcome [12] 0 0
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Timepoint [12] 0 0
From Month 0 to Month 14
Secondary outcome [13] 0 0
Number of Subjects With Fatal Serious Adverse Events (SAEs)
Timepoint [13] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [14] 0 0
Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication
Timepoint [14] 0 0
During the entire study period (3 to 5 year period following day 0)
Secondary outcome [15] 0 0
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Timepoint [15] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [16] 0 0
Number of Subjects With Any and Related Medically Attended Visits
Timepoint [16] 0 0
From Month 0 to Month 8 post-vaccination
Secondary outcome [17] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects = 50 YOA
Timepoint [17] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [18] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects = 50 YOA With Confirmed HZ
Timepoint [18] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [19] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects = 70 YOA With Confirmed HZ.
Timepoint [19] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [20] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects = 70 YOA With Confirmed HZ.
Timepoint [20] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [21] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Timepoint [21] 0 0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary outcome [22] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Timepoint [22] 0 0
Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Secondary outcome [23] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects = 70 YOA
Timepoint [23] 0 0
Within 30 days (Days 0 - 29) after each vaccination
Secondary outcome [24] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs
Timepoint [24] 0 0
From Month 0 to Month 14
Secondary outcome [25] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs
Timepoint [25] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [26] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs
Timepoint [26] 0 0
During the entire study period (3 to 5 year period following Day 0)
Secondary outcome [27] 0 0
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits
Timepoint [27] 0 0
From Month 0 to Month 8 post-vaccination

Eligibility
Key inclusion criteria
* Subjects who the investigator believes will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* A male or female aged 70 years or older at the time of the first vaccination.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ.
* Previous vaccination against varicella or HZ.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation.
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
* Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period.
* Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
* Acute disease and/or fever at the time of enrolment.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Study design
Purpose of the study
Prevention
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 administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/07/2015
Sample size
Target
Accrual to date
Final
14819
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Glebe
Recruitment hospital [2] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [3] 0 0
GSK Investigational Site - Umina
Recruitment hospital [4] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [5] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [6] 0 0
GSK Investigational Site - Caboolture
Recruitment hospital [7] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [8] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [9] 0 0
GSK Investigational Site - Ivanhoe
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
2257 - Umina
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
2522 - Wollongong
Recruitment postcode(s) [6] 0 0
4510 - Caboolture
Recruitment postcode(s) [7] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3079 - Ivanhoe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
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North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
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South Carolina
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United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
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Washington
Country [19] 0 0
Brazil
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Minas Gerais
Country [20] 0 0
Brazil
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Paraná
Country [21] 0 0
Brazil
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Rio Grande Do Sul
Country [22] 0 0
Brazil
State/province [22] 0 0
Curitiba/PR
Country [23] 0 0
Brazil
State/province [23] 0 0
São Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Newfoundland and Labrador
Country [26] 0 0
Canada
State/province [26] 0 0
Nova Scotia
Country [27] 0 0
Canada
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Ontario
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Canada
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Quebec
Country [29] 0 0
Czechia
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Brno
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Czechia
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Ceske Budejovice
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Czechia
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Hradec Kralove
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Estonia
State/province [32] 0 0
Tallinn
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Estonia
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Tartu
Country [34] 0 0
Finland
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Espoo
Country [35] 0 0
Finland
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Helsinki
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Finland
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Jarvenpaa
Country [37] 0 0
Finland
State/province [37] 0 0
Kokkola
Country [38] 0 0
Finland
State/province [38] 0 0
Oulu
Country [39] 0 0
Finland
State/province [39] 0 0
Pori
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Finland
State/province [40] 0 0
Seinajoki
Country [41] 0 0
Finland
State/province [41] 0 0
Tampere
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Finland
State/province [42] 0 0
Turku
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France
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Angers
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Cherbourg
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France
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Château Gontier
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France
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Clermont-Ferrand
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France
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Laval
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France
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Montrevault
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France
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Muret
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France
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Nantes
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France
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Rosiers d'Egletons
Country [52] 0 0
France
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Saint Cyr Sur Loir
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France
State/province [53] 0 0
Segré
Country [54] 0 0
France
State/province [54] 0 0
Soulaines sur Aubance
Country [55] 0 0
France
State/province [55] 0 0
Tours
Country [56] 0 0
Germany
State/province [56] 0 0
Baden-Wuerttemberg
Country [57] 0 0
Germany
State/province [57] 0 0
Bayern
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Germany
State/province [58] 0 0
Brandenburg
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Germany
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Hessen
Country [60] 0 0
Germany
State/province [60] 0 0
Niedersachsen
Country [61] 0 0
Germany
State/province [61] 0 0
Nordrhein-Westfalen
Country [62] 0 0
Germany
State/province [62] 0 0
Rheinland-Pfalz
Country [63] 0 0
Germany
State/province [63] 0 0
Sachsen-Anhalt
Country [64] 0 0
Germany
State/province [64] 0 0
Sachsen
Country [65] 0 0
Germany
State/province [65] 0 0
Schleswig-Holstein
Country [66] 0 0
Germany
State/province [66] 0 0
Berlin
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Germany
State/province [67] 0 0
Hamburg
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Hong Kong
State/province [68] 0 0
Kwun Tong
Country [69] 0 0
Hong Kong
State/province [69] 0 0
Shatin
Country [70] 0 0
Italy
State/province [70] 0 0
Abruzzo
Country [71] 0 0
Italy
State/province [71] 0 0
Lazio
Country [72] 0 0
Italy
State/province [72] 0 0
Liguria
Country [73] 0 0
Italy
State/province [73] 0 0
Lombardia
Country [74] 0 0
Italy
State/province [74] 0 0
Piemonte
Country [75] 0 0
Italy
State/province [75] 0 0
Sardegna
Country [76] 0 0
Italy
State/province [76] 0 0
Sicilia
Country [77] 0 0
Japan
State/province [77] 0 0
Fukuoka
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Japan
State/province [78] 0 0
Kanagawa
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Japan
State/province [79] 0 0
Kyoto
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Japan
State/province [80] 0 0
Tokyo
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Ansan
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Bucheon-si,
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Incheon
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Kangnam-gu, Seoul
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Kangwon-do
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Seoul
Country [87] 0 0
Mexico
State/province [87] 0 0
Jalisco
Country [88] 0 0
Mexico
State/province [88] 0 0
Morelos
Country [89] 0 0
Mexico
State/province [89] 0 0
Durango
Country [90] 0 0
Mexico
State/province [90] 0 0
Monterrey
Country [91] 0 0
Spain
State/province [91] 0 0
Alcover( Tarragona)
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Spain
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Balenyà (Barcelona)
Country [93] 0 0
Spain
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Barcelona
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Spain
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Centelles
Country [95] 0 0
Spain
State/province [95] 0 0
La Roca Del Valles (Barcelona)
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Majadahonda
Country [98] 0 0
Spain
State/province [98] 0 0
Peralada( Girona)
Country [99] 0 0
Spain
State/province [99] 0 0
Valencia
Country [100] 0 0
Spain
State/province [100] 0 0
Vic/ Barcelona
Country [101] 0 0
Sweden
State/province [101] 0 0
Borås
Country [102] 0 0
Sweden
State/province [102] 0 0
Eskilstuna
Country [103] 0 0
Sweden
State/province [103] 0 0
Göteborg
Country [104] 0 0
Sweden
State/province [104] 0 0
Jönköping
Country [105] 0 0
Sweden
State/province [105] 0 0
Karlskrona
Country [106] 0 0
Sweden
State/province [106] 0 0
Linköping
Country [107] 0 0
Sweden
State/province [107] 0 0
Malmö
Country [108] 0 0
Sweden
State/province [108] 0 0
Skövde
Country [109] 0 0
Sweden
State/province [109] 0 0
Stockholm
Country [110] 0 0
Sweden
State/province [110] 0 0
Uppsala
Country [111] 0 0
Sweden
State/province [111] 0 0
Vällingby
Country [112] 0 0
Sweden
State/province [112] 0 0
Örebro
Country [113] 0 0
Taiwan
State/province [113] 0 0
Taichung
Country [114] 0 0
Taiwan
State/province [114] 0 0
Taipei
Country [115] 0 0
Taiwan
State/province [115] 0 0
Taoyuan
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Lancashire
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Warwickshire
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Wiltshire
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Bangor
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Belfast
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Broughshane
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Ledbury
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Newtonabbey
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Waterloo, Liverpool

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 will be made 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://clinicalstudydatarequest.com


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/NCT01165229