Last updated: 01/26/2021 12:10:27

Study to evaluate efficacy, safety and immunogenicity of GSK Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults aged 50 years and older

GSK study ID
110390
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Efficacy, safety, and immunogenicity study of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged 50 years or older
Trial description: The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals’ candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.
Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with confirmed Herpes zoster (HZ) cases

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Secondary outcomes:

Number of subjects with any episodes of Post-Herpetic Neuralgia (PHN)

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with a reduction of duration of severe ‘worst’ HZ-associated pain

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with confirmed HZ episode related mortality

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with HZ related complications

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with confirmed HZ episode related hospitalizations

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with a confirmed HZ episode having a reduction of duration of pain medication associated with HZ

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with a confirmed HZ episode taking pain medication associated with HZ

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of days with severe ‘worst’ HZ-associated pain.

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with confirmed HZ episode related mortality and hospitalizations

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with HZ related complications, by complication type

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Distribution of pain medication associated with HZ

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of days of pain medication associated with HZ

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with any and grade 3 solicited local symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Number of subjects with any, grade 3 and related solicited general symptoms

Timeframe: Within the 7-day (Days 0-6) post-vaccination period

Number of subjects with any and Grade 3 symptoms (solicited and unsolicited)

Timeframe: Within the 7-day (Days 0-6) post-vaccination period

Number of subjects with any and related potential Immune mediated diseases (pIMDs)

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with AEs with any and related medically attended visit

Timeframe: From Month 0 to Month 8 post-vaccination

Number of subjects with unsolicited adverse events (AEs)

Timeframe: Within 30 days (Days 0 - 29) after each vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)

Number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine

Timeframe: During the entire study period (3 to 5 year period following Day 0)

Number of subjects with fatal SAEs

Timeframe: During the entire study period (3 to 5 years following day 0)

Interventions:
Biological/vaccine: Herpes Zoster Vaccine GSK1437173A
Biological/vaccine: Placebo
Enrollment:
16165
Observational study model:
Not applicable
Primary completion date:
2014-09-05
Time perspective:
Not applicable
Clinical publications:
Cunningham AL et al (2016) Efficacy of the Herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 375(11):1019-1032.
Cunningham AL et al. (2018) Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.J Infect Dis. 217(11):1750-1760.
Cunningham AL et al. (2018) Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in adults aged 50 years or older. J Infect Dis. 217(11):1750-1760.
Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.
Kovac M et al (2018) Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 36(12):1537-1541.
Lal H et al. (2015) Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 372(22):2087-2096.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
August 2010 to July 2015
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes will comply with the requirements of the protocol;
  • Written informed consent obtained from the subject;
  • 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;

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Geelong, Victoria, Australia, 3220
Status
Study Complete
Location
GSK Investigational Site
Renton, Washington, United States, 98057
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
KARLSKRONA, Sweden, SE-371 41
Status
Study Complete
Location
GSK Investigational Site
Cary, North Carolina, United States, 27518
Status
Study Complete
Location
GSK Investigational Site
Tartu, Estonia, 50106
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
Centelles, Spain
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80339
Status
Study Complete
Location
GSK Investigational Site
Shatin, Hong Kong
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Study Complete
Location
GSK Investigational Site
Ivanhoe, Victoria, Australia, 3079
Status
Study Complete
Location
GSK Investigational Site
Kanagawa, Japan, 247-8533
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04315
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
peralada( Girona), Spain, 17491
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Balenyà (Barcelona), Spain, 08550
Status
Study Complete
Location
GSK Investigational Site
Bucheon-si,, South Korea, 420-767
Status
Study Complete
Location
GSK Investigational Site
UPPSALA, Sweden, SE-751 85
Status
Study Complete
Location
GSK Investigational Site
Mirabel, Québec, Canada, J7J 2K8
Status
Study Complete
Location
GSK Investigational Site
Château Gontier, France, 53200
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00100
Status
Study Complete
Location
GSK Investigational Site
Taoyuan, Taiwan, 333
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 810-0021
Status
Study Complete
Location
GSK Investigational Site
Chieti, Abruzzo, Italy, 66013
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00930
Status
Study Complete
Location
GSK Investigational Site
Koethen, Sachsen-Anhalt, Germany, 06366
Status
Study Complete
Location
GSK Investigational Site
DeLand, Florida, United States, 32720
Status
Study Complete
Location
GSK Investigational Site
BORÅS, Sweden, SE-506 30
Status
Study Complete
Location
GSK Investigational Site
Wangen, Baden-Wuerttemberg, Germany, 88239
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Brno, Czech Republic, 662 10
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
VÄLLINGBY, Sweden, SE-162 68
Status
Study Complete
Location
GSK Investigational Site
Kyoto, Japan, 611-0041
Status
Study Complete
Location
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
Status
Study Complete
Location
GSK Investigational Site
Rosiers d'Egletons, France, 19300
Status
Study Complete
Location
GSK Investigational Site
Kangnam-gu, Seoul, South Korea
Status
Study Complete
Location
GSK Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Belfast, United Kingdom, BT7 2EB
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Glebe, New South Wales, Australia, 2037
Status
Study Complete
Location
GSK Investigational Site
Vic/ Barcelona, Spain, 08500
Status
Study Complete
Location
GSK Investigational Site
Arlington, Virginia, United States, 22203
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04038 002
Status
Study Complete
Location
GSK Investigational Site
JÖNKÖPING, Sweden, SE-551 85
Status
Study Complete
Location
GSK Investigational Site
Floersheim, Hessen, Germany, 65439
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44122
Status
Study Complete
Location
GSK Investigational Site
GÖTEBORG, Sweden, SE-413 45
Status
Study Complete
Location
GSK Investigational Site
Alcover( Tarragona), Spain, 43460
Status
Study Complete
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08025
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Sherbrooke, Québec, Canada, J1H 2G2
Status
Study Complete
Location
GSK Investigational Site
Tokyo, Japan, 142-8666
Status
Study Complete
Location
GSK Investigational Site
Milano, Lombardia, Italy, 20122
Status
Study Complete
Location
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
La Roca del Valles (Barcelona), Spain, 08430
Status
Study Complete
Location
GSK Investigational Site
Bangor, United Kingdom, BT19 1PP
Status
Study Complete
Location
GSK Investigational Site
Genova, Liguria, Italy, 16132
Status
Study Complete
Location
GSK Investigational Site
Kuenzing, Bayern, Germany, 94550
Status
Study Complete
Location
GSK Investigational Site
SKÖVDE, Sweden, SE-541 85
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10629
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10787
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22415
Status
Study Complete
Location
GSK Investigational Site
Laval, France, 53100
Status
Study Complete
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Catania, Sicilia, Italy, 95129
Status
Study Complete
Location
GSK Investigational Site
Murray, Utah, United States, 84123
Status
Study Complete
Location
GSK Investigational Site
Monterrey, Mexico
Status
Study Complete
Location
GSK Investigational Site
Soulaines sur Aubance, France, 49610
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Tokyo, Japan, 154-0024
Status
Study Complete
Location
GSK Investigational Site
Seinajoki, Finland, 60100
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20251
Status
Study Complete
Location
GSK Investigational Site
Cagliari, Sardegna, Italy, 09127
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28040
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13347
Status
Study Complete
Location
GSK Investigational Site
Angers, France, 49000
Status
Study Complete
Location
GSK Investigational Site
Pleasant Hills, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Ledbury, United Kingdom, HR8 2AA
Status
Study Complete
Location
GSK Investigational Site
Curitiba/PR, Brazil, 80240-280
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
Status
Study Complete
Location
GSK Investigational Site
Rednitzhembach, Bayern, Germany, 91126
Status
Study Complete
Location
GSK Investigational Site
Roma, Lazio, Italy, 00133
Status
Study Complete
Location
GSK Investigational Site
Seoul, South Korea, 152-703
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23502
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3P9
Status
Study Complete
Location
GSK Investigational Site
Winchester, Virginia, United States, 22601
Status
Study Complete
Location
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
Status
Study Complete
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
Status
Study Complete
Location
GSK Investigational Site
Kokkola, Finland, 67100
Status
Study Complete
Location
GSK Investigational Site
Kwun Tong, Hong Kong
Status
Study Complete
Location
GSK Investigational Site
LINKÖPING, Sweden, SE-58758
Status
Study Complete
Location
GSK Investigational Site
Tampere, Finland, 33100
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Majadahonda, Spain
Status
Study Complete
Location
GSK Investigational Site
Wallerfing, Bayern, Germany, 94574
Status
Study Complete
Location
GSK Investigational Site
Roma, Lazio, Italy, 00163
Status
Study Complete
Location
GSK Investigational Site
Incheon, South Korea, 400-711
Status
Study Complete
Location
GSK Investigational Site
Tucscon, Arizona, United States, 85704
Status
Study Complete
Location
GSK Investigational Site
Ansan, South Korea, 425-707
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85018
Status
Study Complete
Location
GSK Investigational Site
Wichita, Kansas, United States, 67207
Status
Study Complete
Location
GSK Investigational Site
Mesa, Arizona, United States, 85213
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Study Complete
Location
GSK Investigational Site
Sherwood, Queensland, Australia, 4075
Status
Study Complete
Location
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08817
Status
Study Complete
Location
GSK Investigational Site
Cuneo, Piemonte, Italy, 12100
Status
Study Complete
Location
GSK Investigational Site
Pori, Finland, 28100
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45355
Status
Study Complete
Location
GSK Investigational Site
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
Status
Study Complete
Location
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Jarvenpaa, Finland, 04400
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29650
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
Status
Study Complete
Location
GSK Investigational Site
Durango, Durango, Mexico, 34000
Status
Study Complete
Location
GSK Investigational Site
Potsdam, Brandenburg, Germany, 14467
Status
Study Complete
Location
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Status
Study Complete
Location
GSK Investigational Site
Nantes, France, 44300
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22143
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04312903
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Status
Study Complete
Location
GSK Investigational Site
Meridian, Idaho, United States, 83642
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Ontario, Canada, N4S 5P5
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28602
Status
Study Complete
Location
GSK Investigational Site
Taipei, Taiwan, 112
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
Status
Study Complete
Location
GSK Investigational Site
Kanagawa, Japan, 224-8503
Status
Study Complete
Location
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-050
Status
Study Complete
Location
GSK Investigational Site
Oulu, Finland, 90220
Status
Study Complete
Location
GSK Investigational Site
Wandsworth, Ohio, United States, 44281
Status
Study Complete
Location
GSK Investigational Site
Laval, France, 53000
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21209
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 812-0025
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 10717
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
Newtonabbey, United Kingdom, BT37 9QW
Status
Study Complete
Location
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 04
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
ESKILSTUNA, Sweden, SE-631 88
Status
Study Complete
Location
GSK Investigational Site
Valencia, Spain, 46020
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Broughshane, United Kingdom, BT42 4JP
Status
Study Complete
Location
GSK Investigational Site
Dachau, Bayern, Germany, 85221
Status
Study Complete
Location
GSK Investigational Site
Gatineau, Québec, Canada, J8Y 6S8
Status
Study Complete
Location
GSK Investigational Site
Maroubra, New South Wales, Australia, 2035
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 12351
Status
Study Complete
Location
GSK Investigational Site
Pescara, Abruzzo, Italy, 65100
Status
Study Complete
Location
GSK Investigational Site
Turku, Finland, 20520
Status
Study Complete
Location
GSK Investigational Site
MALMÖ, Sweden, SE-211 52
Status
Study Complete
Location
GSK Investigational Site
Quebec, Québec, Canada, G1W 4R4
Status
Study Complete
Location
GSK Investigational Site
STOCKHOLM, Sweden, SE-111 57
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2522
Status
Study Complete
Location
GSK Investigational Site
Quebec City, Québec, Canada, G1E 7G9
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Muret, France, 31600
Status
Study Complete
Location
GSK Investigational Site
Montrevault, France, 49110
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 813-8588
Status
Study Complete
Location
GSK Investigational Site
Taichung, Taiwan, 40447
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Study Complete
Location
GSK Investigational Site
Saint Cyr Sur Loir, France, 37540
Status
Study Complete
Location
GSK Investigational Site
Cherbourg, France, 50100
Status
Study Complete
Location
GSK Investigational Site
Cuernavaca, Morelos, Mexico, 62210
Status
Study Complete
Location
GSK Investigational Site
Tallinn, Estonia, 13619
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4S 1Y2
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Tokyo, Japan, 141-0001
Status
Study Complete
Location
GSK Investigational Site
Umina, New South Wales, Australia, 2257
Status
Study Complete
Location
GSK Investigational Site
Tours, France, 37100
Status
Study Complete
Location
GSK Investigational Site
Berlin, Berlin, Germany, 12157
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
Status
Study Complete
Location
GSK Investigational Site
Espoo, Finland, 02230
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28046
Status
Study Complete
Location
GSK Investigational Site
Segré, France, 49500
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66212
Status
Study Complete
Location
GSK Investigational Site
ÖREBRO, Sweden, SE-703 62
Status
Study Complete
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 816-0864
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64114
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
Status
Study Complete
Location
GSK Investigational Site
Monza, Lombardia, Italy, 20052
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21045
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04266-010
Status
Study Complete
Location
GSK Investigational Site
Clermont-Ferrand, France, 63003
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Kangwon-do, South Korea, 220-701
Status
Study Complete
Location
GSK Investigational Site
Ragusa (RG), Sicilia, Italy, 97100
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
Status
Study Complete
Location
GSK Investigational Site
Aschaffenburg, Bayern, Germany, 63739
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1E
Status
Study Complete
Location
GSK Investigational Site
Auburn, Maine, United States, 04210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
BORÅS, Sweden, SE-506
Status
Study Complete
Location
GSK Investigational Site
Bangor, United Kingdom, BT19 1
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G
Status
Study Complete
Location
GSK Investigational Site
Belfast, United Kingdom, BT7 1D
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-
Status
Study Complete
Location
GSK Investigational Site
Bradford on Avon, Wiltshire, United Kingdom, BA15 1
Status
Study Complete
Location
GSK Investigational Site
Broughshane, United Kingdom, BT42 4
Status
Study Complete
Location
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7N
Status
Study Complete
Location
GSK Investigational Site
Camillus, New York, United States, 13031
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cuenavaca, Morelos, Mexico, 62430
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Curitiba/PR, Brazil, 80240-
Status
Study Complete
Location
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01219
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fukuoka, Japan, 810-00
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 812-00
Status
Study Complete
Location
GSK Investigational Site
Fukuoka, Japan, 813-85
Status
Study Complete
Location
GSK Investigational Site
Gatineau, Québec, Canada, J8Y 6S
Status
Study Complete
Location
GSK Investigational Site
Gunma, Japan, 370-12
Status
Terminated/Withdrawn
Location
GSK Investigational Site
GÖTEBORG, Sweden, SE-413
Status
Study Complete
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20354
Status
Terminated/Withdrawn
Location
GSK Investigational Site
KARLSKRONA, Sweden, SE-371
Status
Study Complete
Location
GSK Investigational Site
Kanagawa, Japan, 224-85
Status
Study Complete
Location
GSK Investigational Site
Kyoto, Japan, 611-00
Status
Study Complete
Location
GSK Investigational Site
LINKÖPING, Sweden, SE-587
Status
Study Complete
Location
GSK Investigational Site
Ledbury, United Kingdom, HR8 2A
Status
Study Complete
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04329
Status
Terminated/Withdrawn
Location
GSK Investigational Site
MALMÖ, Sweden, SE-211
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mirabel, Québec, Canada, J7J 2K
Status
Study Complete
Location
GSK Investigational Site
Mont de Marsan, France, 40000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newtonabbey, United Kingdom, BT37 9
Status
Study Complete
Location
GSK Investigational Site
Orthez, France, 63400
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 900350
Status
Study Complete
Location
GSK Investigational Site
Quebec, Québec, Canada, G1W 4R
Status
Study Complete
Location
GSK Investigational Site
Quebec City, Québec, Canada, G1E 7G
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rockville, Maryland, United States, 20850
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18055
Status
Terminated/Withdrawn
Location
GSK Investigational Site
STOCKHOLM, Sweden, SE-111
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sherbrooke, Québec, Canada, J1H 2G
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Terminated/Withdrawn
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04038
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04266-
Status
Study Complete
Location
GSK Investigational Site
TANUMSHEDE, Sweden, SE-457
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Thornton, Colorado, United States, 80233
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tokyo, Japan, 141-00
Status
Study Complete
Location
GSK Investigational Site
Tokyo, Japan, 142-86
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4S 1Y
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L
Status
Study Complete
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A
Status
Study Complete
Location
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85712
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Unterschleissheim, Bayern, Germany, 87516
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3P
Status
Study Complete
Location
GSK Investigational Site
VÄLLINGBY, Sweden, SE-162
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0L
Status
Study Complete
Location
GSK Investigational Site
Willoughby Hills, Ohio, United States, 44094
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Woodstock, Ontario, Canada, N4S 5P
Status
Study Complete
Location
GSK Investigational Site
ÖREBRO, Sweden, SE-703
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2014-09-05
Actual study completion date
2015-27-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
IPD for this study will be made available via the Clinical Study Data Request site.
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Access to clinical trial data by researchers
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