Last updated: 11/07/2018 05:06:14

A study to determine the safety and efficacy of albiglutide in patients with type 2 diabetes

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GSK study ID
112754
See study documents
Clinicaltrials.gov ID
NCT00838916
See results summary
EudraCT ID
2008-007661-24
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, open-label, parallel-group, multicenter study to determine the efficacy and long-term safety of albiglutide compared with insulin in subjects with type 2 diabetes mellitus.
Trial description: A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Change from Baseline (BL) in glycosylated hemoglobin (HbA1c) at Week 52

Timeframe: Baseline and Week 52

Secondary outcomes:

Change from Baseline in HbA1c at Week 156

Timeframe: Baseline and Week 156

Change from Baseline in fasting plasma glucose (FPG) at Week 52

Timeframe: Baseline and Week 52

Change from Baseline in fasting plasma glucose (FPG) at Week 156

Timeframe: Baseline and Week 156

Number of participants who achieved clinically meaningful HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52

Timeframe: Week 52

Number of participants who achieved clinically meaningful HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156

Timeframe: Week 156

Time to hyperglycemia rescue

Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Change from Baseline in body weight at Week 52

Timeframe: Baseline and Week 52

Change from Baseline in body weight at Week 156

Timeframe: Baseline and Week 156

Change from Baseline in glucose profile measured by 24-hour area under curve (AUC) at Week 52

Timeframe: Baseline and Week 52

Albiglutide plasma concentrations at Week 8 and Week 24

Timeframe: Weeks 8 and 24

Interventions:
  • Biological/vaccine: albiglutide
  • Drug: insulin glargine
    • Enrollment:
    779
    Primary completion date:
    2012-23-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Peter Weissman, Molly C. Carr, June Ye, Deborah Cirkel, Murray Stewart, Caroline Perry, and Richard Pratley. HARMONY 4 PRIMARY ENDPOINT PUBLICATION: Once weekly GLP-1 Receptor Agonist Albiglutide vs Insulin Glargine in Patients With Type 2 Diabetes Mellitus at Week 52.Diabetologia.2014
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to May 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • type 2 diabetes
    • BMI 20-45kg/m2 inclusive
    • females who are pregnant, lactating or within <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III-IV)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • type 2 diabetes
    • BMI 20-45kg/m2 inclusive
    Exclusion criteria:
    • females who are pregnant, lactating or within <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III-IV)

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Hampton, Virginia, United States, 23666
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Calabash, North Carolina, United States, 28467
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76135
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Orem, Utah, United States, 84058
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dearborn, Michigan, United States, 48124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lakewood, California, United States, 90712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Smolensk, Russia, 214019
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Haddon Heights, New Jersey, United States, 08035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75246
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rolling Fork, Mississippi, United States, 39159
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Katy, Texas, United States, 77450
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Johnson City, Tennessee, United States, 37604
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sugar Land, Texas, United States, 77479
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lincoln, Nebraska, United States, 68516
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mission Viejo, California, United States, 92691
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Des Moines, Iowa, United States, 50314
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trumbull, Connecticut, United States, 06611
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    El Paso, Texas, United States, 79925
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hueytown, Alabama, United States, 35023
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fullerton, California, United States, 92835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Palm Desert, California, United States, 92260
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kempton Park, South Africa, 1619
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Midland, Texas, United States, 79705
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96813
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sugarland, Texas, United States, 77479
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Butte, Montana, United States, 59701
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85032
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10022
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Alabaster, Alabama, United States, 35007
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mission, Kansas, United States, 66202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Foothill Ranch, California, United States, 92610
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77058
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hurst, Texas, United States, 76054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Uniontown, Pennsylvania, United States, 15401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ashland, Oregon, United States, 97520
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33756
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 85224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Palm Beach, Florida, United States, 33401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oxon Hill, Maryland, United States, 20745
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cocoa, Florida, United States, 32927
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fayetteville, Tennessee, United States, 37334
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84120
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Brooklyn Center, Minnesota, United States, 55430
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kettering, Ohio, United States, 45429
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hialeah, Florida, United States, 33013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lenasia, Gauteng, South Africa, 1827
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hallandale Beach, Florida, United States, 33009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77036
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Alamitos, California, United States, 90720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kalamazoo, Michigan, United States, 49048
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Taylors, South Carolina, United States, 29687
    Status
    Study Complete
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    Location
    GSK Investigational Site
    La Grange, Illinois, United States, 60525
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Cloud, Florida, United States, 34769
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Valley City, Utah, United States, 84120
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29601
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33156
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92646
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77094
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Harrisburg, Arkansas, United States, 72432
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    McKenzie, Tennessee, United States, 38201
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lake Charles, Louisiana, United States, 70601
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77074
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gilbert, Arizona, United States, 85295
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waterbury, Connecticut, United States, 06708
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Renton, Washington, United States, 98057
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Idaho Falls, Idaho, United States, 83404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99216
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dothan, Alabama, United States, 36301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Richland Hills, Texas, United States, 76180
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fishers, Indiana, United States, 46037
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleburne, Texas, United States, 76033
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68134
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kalamazoo, Michigan, United States, 49009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cadillac, Michigan, United States, 49601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Loma Linda, California, United States, 92354
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44122
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sunbury-on-Thames, Middlesex, United Kingdom, TW16 6RH
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cutler Bay, Florida, United States, 33189
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Searcy, Arkansas, United States, 72143
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95821
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Liverpool, United Kingdom, L9 7AL
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Corpus Christi, Texas, United States, 78404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ormond Beach, Florida, United States, 32174
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92648
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bountiful, Utah, United States, 84010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pasadena, California, United States, 91105
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Peoria, Illinois, United States, 61602
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Council Bluffs, Iowa, United States, 51501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Myrtle Beach, South Carolina, United States, 29582
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Great Falls, Montana, United States, 59405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33603
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Burke, Virginia, United States, 22015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Middletown, Delaware, United States, 19709
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Syracuse, New York, United States, 13210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Parow, South Africa, 7505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 45432
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Columbia, South Carolina, United States, 29201
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    West Hills, California, United States, 91307
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    West Plains, Missouri, United States, 65775
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Carlisle, Pennsylvania, United States, 17013
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Parktown, Gauteng, South Africa, 2193
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33135
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30309
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cape Town, South Africa, 7530
    Status
    Study Complete
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    GSK Investigational Site
    Shreveport, Louisiana, United States, 71115
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buena Park, California, United States, 90620
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bensalem, Pennsylvania, United States, 19020
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45227
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bay City, Michigan, United States, 48706
    Status
    Study Complete
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    Location
    GSK Investigational Site
    La Jolla, California, United States, 92037
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Asheville, North Carolina, United States, 28803
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30312
    Status
    Study Complete
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    GSK Investigational Site
    Marianna, Florida, United States, 32446
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    GSK Investigational Site
    Bull Shoals, Arkansas, United States, 72619
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    Study Complete
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    GSK Investigational Site
    Harrisburg, Pennsylvania, United States, 17112
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    GSK Investigational Site
    Baltimore, Maryland, United States, 21237
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Spring Valley, California, United States, 91978
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chattanooga, Tennessee, United States, 37421
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    Study Complete
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Lenoir, North Carolina, United States, 28645
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85051
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Murrells Inlet, South Carolina, United States, 29576
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Schertz, Texas, United States, 78154
    Status
    Study Complete
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    GSK Investigational Site
    New Brunswick, New Jersey, United States, 08903
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90017
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    Location
    GSK Investigational Site
    Newton, Kansas, United States, 67114
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33437
    Status
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    GSK Investigational Site
    Fort Mitchell, Kentucky, United States, 41017
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    GSK Investigational Site
    Tustin, California, United States, 92780
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    GSK Investigational Site
    Hyattsville, Maryland, United States, 20782
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    GSK Investigational Site
    Greenville, South Carolina, United States, 29615
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    GSK Investigational Site
    Chicago, Illinois, United States, 60607
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    GSK Investigational Site
    Tipton, Pennsylvania, United States, 16684
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    Johannesburg, Gauteng, South Africa, 2013
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    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73103
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
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    GSK Investigational Site
    Shelby, North Carolina, United States, 28150
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    GSK Investigational Site
    Richmond, Virginia, United States, 23294
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    GSK Investigational Site
    Tullahoma, Tennessee, United States, 37398
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    Tacoma, Washington, United States, 98405
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    GSK Investigational Site
    Berlin, New Jersey, United States, 08009
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    Lake Jackson, Texas, United States, 77566
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    GSK Investigational Site
    Haverhill, Massachusetts, United States, 01830
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    GSK Investigational Site
    Dallas, Texas, United States, 75235
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    GSK Investigational Site
    Vista, California, United States, 92083
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    Zanesville, Ohio, United States, 43701
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    Ocala, Florida, United States, 34471
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    San Antonio, Texas, United States, 78258
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    GSK Investigational Site
    Las Vegas, Nevada, United States, 89130
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    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
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    Paducah, Kentucky, United States, 42003
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    GSK Investigational Site
    Canal Fulton, Ohio, United States, 44614
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    GSK Investigational Site
    Orangeburg, South Carolina, United States, 29115
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    GSK Investigational Site
    Lauderdale Lakes, Florida, United States, 33319
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Blackpool, Lancashire, United Kingdom, FY4 3AD
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Burlington, North Carolina, United States, 27215
    Status
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    GSK Investigational Site
    Ponte Verda, Florida, United States, 32081
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    GSK Investigational Site
    Deerfield Beach, Florida, United States, 33442
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    Odessa, Texas, United States, 79761
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    St Clair Shores, Michigan, United States, 48081
    Status
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    Location
    GSK Investigational Site
    Hollywood, Florida, United States, 33023
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Yaroslavl, Russia, 150062
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tabor City, North Carolina, United States, 28463
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Weber City, Virginia, United States, 24290
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hialeah, Florida, United States, 33012
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Arkansas City, Kansas, United States, 67005
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Landsdale, Pennsylvania, United States, 19446
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Iowa City, Iowa, United States, 52243
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hainesport, New Jersey, United States, 08036
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Covington, Louisiana, United States, 70433
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stratford, New Jersey, United States, 08084
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Savannah, Georgia, United States, 31406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arkhangelsk, Russia, 163045
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Manassas, Virginia, United States, 20110
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Lauderdale, Florida, United States, 33316
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chino, California, United States, 91710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jonesboro, Arkansas, United States, 72401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chula Vista, California, United States, 91911
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Bend, Indiana, United States, 46614
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71101
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Port Elizabeth, Eastern Cape, South Africa, 6014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Benzonia, Michigan, United States, 49616
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bloomfield Hills, Michigan, United States, 48302
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30338
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Escondido, California, United States, 92026
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45245
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Selah, Washington, United States, 98942
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78218
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chesterfield, Missouri, United States, 63017
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46254
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madisonville, Kentucky, United States, 42431
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Interlochen, Michigan, United States, 49643
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Snellville, Georgia, United States, 30078
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Green Valley, Arizona, United States, 85614
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15243
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30032
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mason, Ohio, United States, 45040
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90025
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74136
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richland, Washington, United States, 99352
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lewisburg, West Virginia, United States, 24901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hot Springs, Arkansas, United States, 71913
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95825
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    LaJolla, California, United States, 92037
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75224
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Picayune, Mississippi, United States, 39466
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mint HIll, North Carolina, United States, 28227
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33765
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aurora, Illinois, United States, 60504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oviedo, Florida, United States, 32765
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Avon, Indiana, United States, 46123
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Northridge, California, United States, 91325
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arlington, Texas, United States, 76012
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, KwaZulu- Natal, South Africa, 4068
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Savannah, Georgia, United States, 31419
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Jefferson City, Missouri, United States, 65109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Murray, Utah, United States, 84123
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90022
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77055
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Irkutsk, Russia, 664003
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67211
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Coventry, West Midlands, United Kingdom, CV2 2DX
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Clarksville, Tennessee, United States, 37043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33709
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30328
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Pretoria, Gauteng, South Africa, 00083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gurnee, Illinois, United States, 60031
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nizhniy Novgorod, Russia, 603126
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Naperville, Illinois, United States, 60564
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89128
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    La Porte, Indiana, United States, 46350
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63117
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89106
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77034
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Somerset West, Western Province, South Africa, 7129
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    North Massapequa, New York, United States, 11758
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Maumee, Ohio, United States, 43537-9402
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Diego, California, United States, 92117
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Columbus, Georgia, United States, 31904
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32605
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Edgewater, Florida, United States, 32132
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bedford, Texas, United States, 76201
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Stone Mountain, Georgia, United States, 30088
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33026
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53226
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SE1 9NH
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Plantation, Florida, United States, 33317
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kansas City, Missouri, United States
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75251
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Satna Monica, California, United States, 90404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77070
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fountain Valley, California, United States, 92708
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30308
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gulfport, Mississippi, United States, 39501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77027
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Commerce, California, United States, 90040
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Akron, Ohio, United States, 44320
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Burlington, Vermont, United States, 05403
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78217
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85745
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tuscaloosa, Alabama, United States, 35406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greensboro, North Carolina, United States, 27405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Downington, Pennsylvania, United States, 19335
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Morehead City, North Carolina, United States, 28557
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Broken Bow, Nebraska, United States, 68822
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fayetteville, North Carolina, United States, 28304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tarzana, California, United States, 91356
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 45439
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Suffolk, Virginia, United States, 23434
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lewisville, Texas, United States, 75067
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waterloo, Iowa, United States, 50701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hickory, North Carolina, United States, 28601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Delray Beach, Florida, United States, 33445
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Victorville, California, United States, 92395
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64106
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    North Miami, Florida, United States, 33161
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    New Britain, Connecticut, United States, 06050
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Deer Park, Texas, United States, 77536
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Irvine, California, United States, 92618
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saratov, Russia, 410030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Elizabeth, New Jersey, United States, 07202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lafayette, Indiana, United States, 47904
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Panama City, Florida, United States, 32401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32822
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Port Glasgow, Renfrewshire, United Kingdom, PA14 6HW
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33426
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    West Jordan, Utah, United States, 84088
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Riverside, California, United States, 92506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73116
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dubuque, Iowa, United States, 52001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cathedral City, California, United States, 92234
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Topeka, Kansas, United States, 66606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Manning, South Carolina, United States, 29102
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43212
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36617
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Simpsonville, South Carolina, United States, 29681
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Corpus Christi, Texas, United States, 78414
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Evergreen Park, Illinois, United States, 60805
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fresno, California, United States, 93720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, Tennessee, United States, 38401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Thornville, Ohio, United States, 43076
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Blue Ridge, Georgia, United States, 30513
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35235
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

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

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-23-01
    Actual study completion date
    2013-30-05

    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
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