Last updated: 11/07/2018 05:04:12

Efficacy and safety of albiglutide in treatment of type 2 diabetes

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GSK study ID
112753
See study documents
Clinicaltrials.gov ID
NCT00838903
See results summary
EudraCT ID
2008-007660-41
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, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus
Trial description: The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline (BL) in glycosylated hemoglobin (HbA1c) at Week 104

Timeframe: Baseline and Week 104

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 104

Timeframe: Baseline and Week 104

Change from Baseline in 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 104

Timeframe: Week 104

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 104

Timeframe: Baseline and Week 104

Change from Baseline in body weight at Week 156

Timeframe: Baseline and Week 156

Interventions:
  • Biological/vaccine: albiglutide
  • Drug: sitagliptin
  • Drug: glimepiride
  • Drug: metformin
  • Biological/vaccine: placebo albiglutide
  • Drug: placebo sitagliptin
  • Drug: placebo glimepiride
    • Enrollment:
    1049
    Primary completion date:
    2012-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Ahrén B, Stewart M, Cirkel D, Yang F, Perry C, Johnson S; Feinglos M.HARMONY 3 PRIMARY ENDPOINT PUBLICATION : Weekly GLP-1 Receptor Agonist Albiglutide is Superior to Sitagliptin or Glimepiride in Patients with Type 2 Diabetes Mellitus on Metformin at the 104 Week Primary Endpoint .Diabetes Care.2014;37:2141-2148
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to April 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 <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III or IV)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • type 2 diabetes
    • BMI 20-45kg/m2 inclusive
    Exclusion criteria:
    • females who are pregnant, lactating or <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III or IV)

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10115
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Somerset West, South Africa, 07129
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63117
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hull, United Kingdom, HU3 2RW
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43212
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hialeah, Florida, United States, 33013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hueytown, Alabama, United States, 35023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92117
    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
    Madisonville, Kentucky, United States, 42431
    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
    Los Alamitos, California, United States, 90720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Paducah, Kentucky, United States, 42003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buena Park, California, United States, 90620
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Memphis, Tennessee, United States, 38125
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Yaroslavl, Russia, 150062
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tai Po,, Hong Kong
    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
    Los Angeles, California, United States, 90025
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Carlisle, Pennsylvania, United States, 17013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bad Lauterberg, Niedersachsen, Germany, 37431
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bull Shoals, Arkansas, United States, 72619
    Status
    Study Complete
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    GSK Investigational Site
    Birmingham, Alabama, United States, 35242
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78258
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Hallandale Beach, Florida, United States, 33009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Billings, Montana, United States, 59102
    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
    Fort Lauderdale, Florida, United States, 33316
    Status
    Study Complete
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    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87106
    Status
    Study Complete
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    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    GSK Investigational Site
    St. Petersburg, Florida, United States, 33709
    Status
    Study Complete
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    GSK Investigational Site
    Dearborn, Michigan, United States, 48124
    Status
    Study Complete
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    GSK Investigational Site
    Hialeah, Florida, United States, 33012
    Status
    Study Complete
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    GSK Investigational Site
    Selah, Washington, United States, 98942
    Status
    Study Complete
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    Waterloo, Iowa, United States, 50701
    Status
    Study Complete
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    Chandler, Arizona, United States, 85224
    Status
    Study Complete
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    GSK Investigational Site
    Calabash, North Carolina, United States, 28467
    Status
    Study Complete
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    GSK Investigational Site
    Guadalajara, Mexico, 44600
    Status
    Study Complete
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    Dothan, Alabama, United States, 36301
    Status
    Study Complete
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    South Bend, Indiana, United States, 46614
    Status
    Study Complete
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    Kalamazoo, Michigan, United States, 49048
    Status
    Study Complete
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    Guadalajara, Jalisco, Mexico, 44670
    Status
    Study Complete
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    GSK Investigational Site
    Orangeburg, South Carolina, United States, 29115
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Los Angeles, California, United States, 90022
    Status
    Study Complete
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    GSK Investigational Site
    Feasterville, Pennsylvania, United States, 19053
    Status
    Study Complete
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    GSK Investigational Site
    Savannah, Georgia, United States, 31406
    Status
    Study Complete
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    GSK Investigational Site
    Chattanooga, Tennessee, United States, 37421
    Status
    Study Complete
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    GSK Investigational Site
    Deerfield Beach, Florida, United States, 33442
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Zapopan, Jalisco, Mexico, 45200
    Status
    Study Complete
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    GSK Investigational Site
    Midland, Texas, United States, 79707
    Status
    Study Complete
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    GSK Investigational Site
    Los Angeles, California, United States, 90017
    Status
    Study Complete
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    GSK Investigational Site
    Searcy, Arkansas, United States, 72143
    Status
    Study Complete
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    GSK Investigational Site
    Arkansas City, Kansas, United States, 67005
    Status
    Study Complete
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    GSK Investigational Site
    Zanesville, Ohio, United States, 43701
    Status
    Study Complete
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    GSK Investigational Site
    Greenville, South Carolina, United States, 29615
    Status
    Study Complete
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    GSK Investigational Site
    Liverpool, Merseyside, United Kingdom, L7 8XP
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Salt Lake City, Utah, United States, 84102
    Status
    Study Complete
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    GSK Investigational Site
    Gulfport, Mississippi, United States, 39501
    Status
    Study Complete
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    GSK Investigational Site
    La Porte, Indiana, United States, 46350
    Status
    Study Complete
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    GSK Investigational Site
    Plantation, Florida, United States, 33317
    Status
    Study Complete
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    GSK Investigational Site
    Trumbull, Connecticut, United States, 06611
    Status
    Study Complete
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    GSK Investigational Site
    Canal Fulton, Ohio, United States, 44614
    Status
    Study Complete
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    GSK Investigational Site
    New York, New York, United States, 10022
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Houston, Texas, United States, 77074
    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
    Lewisville, Texas, United States, 75067
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30328
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Guadalajara, Mexico, 44680
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cumberland, Rhode Island, United States, 02864
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78054
    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
    St Clair Shores, Michigan, United States, 48081
    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
    Sacramento, California, United States, 95825
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Valley City, Utah, United States, 84120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84124
    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
    Quezon City, Philippines, 1102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nezahualcoyotl, Mexico, 57170
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
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    Study Complete
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    GSK Investigational Site
    Tucson, Arizona, United States, 85745
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    Study Complete
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    GSK Investigational Site
    Phoenix, Arizona, United States, 85028
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    Study Complete
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    GSK Investigational Site
    Springfield, Missouri, United States, 65807
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96813
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lenoir, North Carolina, United States, 28645
    Status
    Study Complete
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    West Jordan, Utah, United States, 84088
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    Study Complete
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    Virgina Beach, Virginia, United States, 23455
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    Study Complete
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    Cadillac, Michigan, United States, 49601
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    Study Complete
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    Lexington, Kentucky, United States, 40504
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    Study Complete
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    Johannesburg, Gauteng, South Africa, 01820
    Status
    Study Complete
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    GSK Investigational Site
    Hainesport, New Jersey, United States, 08036
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Gainesville, Florida, United States, 32605
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Durham, North Carolina, United States, 27710
    Status
    Study Complete
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    GSK Investigational Site
    Phoenix, Arizona, United States, 85023
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    Study Complete
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    GSK Investigational Site
    Clarksville, Tennessee, United States, 37043
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    Study Complete
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    GSK Investigational Site
    Syracuse, New York, United States, 13210
    Status
    Study Complete
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    GSK Investigational Site
    Fayetteville, Tennessee, United States, 37334
    Status
    Study Complete
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    GSK Investigational Site
    Indio, California, United States, 92201
    Status
    Study Complete
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    GSK Investigational Site
    Middletown, Delaware, United States, 19709
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    Study Complete
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    Uniontown, Pennsylvania, United States, 15401
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    Study Complete
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    GSK Investigational Site
    Taytay Rizal, Philippines, 1920
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    GSK Investigational Site
    Council Bluffs, Iowa, United States, 51501
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    Study Complete
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    GSK Investigational Site
    Cleveland, Ohio, United States, 44122
    Status
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    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55116
    Status
    Study Complete
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    GSK Investigational Site
    Cebu City, Philippines, 6000
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    Study Complete
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    GSK Investigational Site
    Green Valley, Arizona, United States, 85614
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    Terminated/Withdrawn
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    GSK Investigational Site
    Topeka, Kansas, United States, 66606
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    Study Complete
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    GSK Investigational Site
    Foothill Ranch, California, United States, 92610
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    Study Complete
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    GSK Investigational Site
    Atlanta, Georgia, United States, 30135
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    GSK Investigational Site
    Blackpool, Lancashire, United Kingdom, FY4 3AD
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    Study Complete
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    GSK Investigational Site
    Omaha, Nebraska, United States, 68131
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    Study Complete
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    GSK Investigational Site
    Stratford, New Jersey, United States, 08084
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    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74135
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Lewisburg, West Virginia, United States, 24901
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    GSK Investigational Site
    Rotenburg, Hessen, Germany, 36199
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Hurst, Texas, United States, 76054
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    GSK Investigational Site
    West Palm Beach, Florida, United States, 33401
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    GSK Investigational Site
    Schertz, Texas, United States, 78154
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    GSK Investigational Site
    Mexico City, Mexico, 11570
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    GSK Investigational Site
    Cutler Bay, Florida, United States, 33189
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    GSK Investigational Site
    Dallas, Texas, United States, 75230
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    GSK Investigational Site
    Miami, Florida, United States, 33135
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    Haverhill, Massachusetts, United States, 01830
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    Kansas City, Missouri, United States, 64106
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    Berlin, New Jersey, United States, 08009
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    Morehead City, North Carolina, United States, 28557
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    Waterbury, Connecticut, United States, 06708
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    Temple, Texas, United States, 76508
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    GSK Investigational Site
    Plymouth, Devon, United Kingdom, PL6 8BX
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    Columbia, South Carolina, United States, 29201
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    Oklahoma City, Oklahoma, United States, 73103
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    Benzonia, Michigan, United States, 49616
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    Santa Ana, California, United States, 92701
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    Fayetteville, North Carolina, United States, 28304
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    LaJolla, California, United States, 92037
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    Mission, Kansas, United States, 66202
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    Jefferson City, Missouri, United States, 65109
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    Grand Forks, North Dakota, United States, 58201
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    Hollywood, Florida, United States, 33023
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    Gilbert, Arizona, United States, 85295
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    Tucson, Arizona, United States, 85712
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    Boksburg North, Gauteng, South Africa, 1459
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    Kalamazoo, Michigan, United States, 49009
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    Delray Beach, Florida, United States, 33445
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    Harrisburg, Arkansas, United States, 72432
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    Spring Valley, California, United States, 91978
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    Lima, Lima, Peru, 01
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    Atlanta, Georgia, United States, 30308
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    Clearwater, Florida, United States, 33765
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    Poway, California, United States, 92064
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    Coventry, West Midlands, United Kingdom, CV2 2DX
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    Smolensk, Russia, 214019
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    Walnut Creek, California, United States, 94598
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    Sugarland, Texas, United States, 77479
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    Piura, Piura, Peru
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    Chula Vista, California, United States, 91910
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    Federal Way, Washington, United States, 98003
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    Johnson City, Tennessee, United States, 37604
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    Escondido, California, United States, 92026
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    Cincinnati, Ohio, United States, 45227
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    Moscow, Russia, 119034
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    Decatur, Georgia, United States, 30032
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    Houston, Texas, United States, 77070
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    Honolulu, Hawaii, United States, 96814
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    Manning, South Carolina, United States, 29102
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    Loma Linda, California, United States, 92354
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    Irkutsk, Russia, 664003
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    Cleburne, Texas, United States, 76033
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    Iowa City, Iowa, United States, 52243
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    Phoenix, Arizona, United States, 85051
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    St. Cloud, Florida, United States, 34769
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    Torreon, Coahuila, Mexico, 27000
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    Newton, Kansas, United States, 67114
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    Tarzana, California, United States, 91356
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    Oxon Hill, Maryland, United States, 20745
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    Covington, Louisiana, United States, 70433
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45211
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cuernavaca, Morelos, Mexico, 62250
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SE1 9NH
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89102-4509
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Maumee, Ohio, United States, 43537-9402
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Panama City, Florida, United States, 32401
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Victorville, California, United States, 92395
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cocoa, Florida, United States, 32927
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Rolling Fork, Mississippi, United States, 39159
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    West Plains, Missouri, United States, 65775
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sevilla, Spain, 41003
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Greensboro, North Carolina, United States, 27405
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Columbia, Tennessee, United States, 38401
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32822
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Interlochen, Michigan, United States, 49643
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Asheboro, North Carolina, United States, 27203
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Fresno, California, United States, 93720
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21237
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Asheville, North Carolina, United States, 28803
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kempton Park, South Africa, 1619
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36617
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mission Viejo, California, United States, 92691
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40503
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Dubuque, Iowa, United States, 52001
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74104
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77055
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Distrito Federal, Mexico, 06700
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78237
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    South Burlington, Vermont, United States, 05403
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53226
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Manassas, Virginia, United States, 20110
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66211
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43213
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Arkhangelsk, Russia, 163045
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Burke, Virginia, United States, 22015
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oviedo, Florida, United States, 32765
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Crescent Springs, Kentucky, United States, 41017
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33027
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Arvada, Colorado, United States, 80005
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33156
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Parow, South Africa, 7505
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Aurora, Illinois, United States, 60504
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23502
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ponte Vedra Beach, Florida, United States, 32081
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Juan, Philippines, 1500
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mexico City, Mexico, 03300
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tijuana, Baja California Norte, Mexico, 22010
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ashland, Oregon, United States, 97520
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 45432
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pasadena, California, United States, 91105
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Blue Ridge, Georgia, United States, 30513
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15243
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sugar Land, Texas, United States, 77479
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Burlington, North Carolina, United States, 27215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Snellville, Georgia, United States, 30078
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lake Jackson, Texas, United States, 77566
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Witten, Nordrhein-Westfalen, Germany, 58455
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Jonesboro, Arkansas, United States, 72401
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Morelia, Michoacán, Mexico, C.P. 58249
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tuscaloosa, Alabama, United States, 35406
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Tabor City, North Carolina, United States, 28463
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Richland, Washington, United States, 99352
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71101
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Katy, Texas, United States, 77450
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77024
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Thornville, Ohio, United States, 43076
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    North Miami, Florida, United States, 33161
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Callao, Lima, Peru, Callao 2
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67211
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Palm Desert, California, United States, 92260
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75224
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68134
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Barcelona, Spain, 08022
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Landsdale, Pennsylvania, United States, 19446
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Idaho Falls, Idaho, United States, 83404
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kelkheim, Hessen, Germany, 65779
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bensalem, Pennsylvania, United States, 19020
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68124
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    GLASGOW, United Kingdom, G45 9AW
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71115
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chino, California, United States, 91710
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Akron, Ohio, United States, 44320
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Marianna, Florida, United States, 32446
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Ocala, Florida, United States, 34471
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Port Elizabeth, Eastern Cape, South Africa, 6014
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kwun Tong, Kowloon, Hong Kong
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New Brunswick, New Jersey, United States, 08903
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chesterfield, Missouri, United States, 63017
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46254
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Germantown, Tennessee, United States, 38138
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92646
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75235
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cape Town, South Africa, 7530
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Huntersville, North Carolina, United States, 28078
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77094
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29601
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    La Grange, Illinois, United States, 60525
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Peoria, Illinois, United States, 61602
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Suffolk, Virginia, United States
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mason, Ohio, United States, 45040
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30312
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Downington, Pennsylvania, United States, 19335
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kettering, Ohio, United States, 45429
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77036
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ormond Beach, Florida, United States, 32174
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bountiful, Utah, United States, 84010
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    North Richland Hills, Texas, United States, 76180
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35235
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Evergreen Park, Illinois, United States, 60805
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Simpsonville, South Carolina, United States, 29681
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pretoria, Gauteng, South Africa, 00083
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tipton, Pennsylvania, United States, 16684
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Columbus, Georgia, United States, 31904
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89103
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lima, Lima, Peru, Lima 1
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Northridge, California, United States, 91325
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33426
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Mint HIll, North Carolina, United States, 28227
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lauderdale Lakes, Florida, United States, 33319
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Alabaster, Albania, 35007
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lake Charles, Louisiana, United States, 70601
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Fountain Valley, California, United States, 92708
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Vista, California, United States, 92083
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Arlington, Texas, United States, 76012
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bedford, Texas, United States, 76201
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Satna Monica, California, United States, 90404
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Des Moines, Iowa, United States, 50314
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Elizabeth, New Jersey, United States, 07202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Odessa, Texas, United States, 79761
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Weber City, Virginia, United States, 24290
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Orem, Utah, United States, 84058
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Carmichael, California, United States, 95608
    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
    Houston, Texas, United States, 77027
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New Britain, Connecticut, United States, 06050
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lakewood, California, United States, 90712
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99208
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77058
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 45439
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Durban, KwaZulu- Natal, South Africa, 4000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Corpus Christi, Texas, United States, 78414
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kansas City, Missouri, United States
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    McKenzie, Tennessee, United States, 38201
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Merida, Yucatán, Mexico, 97000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60607
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78224
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fishers, Indiana, United States, 46037
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hampton, Virginia, United States, 23666
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lincoln, Nebraska, United States, 68516
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Nizhniy Novgorod, Russia, 603126
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45245
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33026
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45219
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89128
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Durango, Durango, Mexico, 34080
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hyattsville, Maryland, United States, 20782
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Riverside, California, United States, 92506
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tucker, Georgia, United States, 30084
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78218
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    West Hills, California, United States, 91307
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sunbury-on-Thames, Middlesex, United Kingdom, TW16 6RH
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lenasia, Gauteng, South Africa, 1827
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Harrisburg, Pennsylvania, United States, 17112
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Puebla, Puebla, Mexico, 72190
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bay City, Michigan, United States, 48706
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ica, Ica, Peru, 11
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Stone Mountain, Georgia, United States, 30088
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76135
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Butte, Montana, United States, 59701
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Murrells Inlet, South Carolina, United States, 29576
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shelby, North Carolina, United States, 28150
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77034
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33756
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chadbourn, North Carolina, United States, 28431
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Naperville, Illinois, United States, 60564
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Muncie, Indiana, United States, 47304
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hot Springs, Arkansas, United States, 71913
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Broken Bow, Nebraska, United States, 68822
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pachuca, Hidalgo, Mexico, 42086
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Canterbury, Kent, United Kingdom, CT1 3HX
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hickory, North Carolina, United States, 28601
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Soweto, South Africa, 1111
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Picayune, Mississippi, United States, 39466
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89106
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Taylors, South Carolina, United States, 29687
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78217
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Liverpool, United Kingdom, L9 7AL
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shatin, Hong Kong
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77069
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84107
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Great Falls, Montana, United States, 59405
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Tullahoma, Tennessee, United States, 37398
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    North Myrtle Beach, South Carolina, United States, 29582
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Haddon Heights, New Jersey, United States, 08035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33437
    Status
    Study Complete
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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
    Deer Park, Texas, United States, 77536
    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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    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
    2012-31-01
    Actual study completion date
    2013-01-04

    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
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