Last updated: 11/04/2018 11:21:50

Advair Pediatric Once-Daily

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GSK study ID
SAS30021
See study documents
Clinicaltrials.gov ID
NCT00920959
EudraCT ID
Not applicable
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 stratified, randomized, double-blind, placebo-controlled, parallel-group, 12 week trial evaluating the safety and efficacy of fluticasone propionate/salmeterol DISKUS combination product 100/50mcg once daily versus fluticasone propionate DISKUS 100mcg once daily and placebo in symptomatic pediatric subjects (4-11 years) with asthma
Trial description: To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline at endpoint in daily PM PEF

Timeframe: 12 weeks

Secondary outcomes:

Various pulmonary function endpoints

Timeframe: 12 weeks

Interventions:
  • Drug: FP 100mcg
  • Drug: FSC 100/50mcg
  • Drug: Placebo
    • Enrollment:
    908
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    November 2001 to January 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    4 - 11 years
    Accepts healthy volunteers
    No
    • Out-patients
    • Asthma diagnosis
    • Life-threatening asthma
    • Specified asthma medications
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Out-patients
    • Asthma diagnosis
    • Reversibility
    • Short-acting beta-agonist or asthma controlled medication use
    Exclusion criteria:
    • Life-threatening asthma
    • Specified asthma medications
    • Chickenpox
    • Drug allergy
    • Respiratory infections
    • Tobacco use
    • Clinical laboratory abnormalities
    • Ophthalmologic conditions
    • Investigation medications
    • Affiliation with investigator site

    Trial location(s)

    Location
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    Location
    GSK Investigational Site
    Vista, California, United States, 92084
    Status
    Recruiting
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    GSK Investigational Site
    Sunset, Louisiana, United States, 70584
    Status
    Recruiting
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    GSK Investigational Site
    Dinuba, California, United States, 93618
    Status
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    GSK Investigational Site
    Murray, Utah, United States, 84107
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Edmonds, Washington, United States, 98026
    Status
    Study Complete
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    GSK Investigational Site
    Louisville, Kentucky, United States, 40222
    Status
    Recruiting
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    GSK Investigational Site
    Kansas City, Missouri, United States, 64108
    Status
    Recruiting
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    Houston, Texas, United States, 77074
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    Colorado Springs, Colorado, United States, 80907
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    Recruiting
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    Brick, New Jersey, United States, 8724
    Status
    Recruiting
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    GSK Investigational Site
    Murray, Kentucky, United States, 42071
    Status
    Recruiting
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    GSK Investigational Site
    Pueblo, Colorado, United States, 81008
    Status
    Recruiting
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    GSK Investigational Site
    San Jose, California, United States, 95117
    Status
    Recruiting
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    GSK Investigational Site
    Panorama City, California, United States, 91402
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55416
    Status
    Recruiting
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    GSK Investigational Site
    Chicago, Illinois, United States, 60612
    Status
    Recruiting
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    GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile
    Status
    Study Complete
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    GSK Investigational Site
    Savannah, Georgia, United States, 31406
    Status
    Recruiting
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    GSK Investigational Site
    Burke, Virginia, United States, 22015
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    Medford, Oregon, United States, 97504
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    Omaha, Nebraska, United States, 68130
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    GSK Investigational Site
    Austin, Texas, United States, 78749
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Atlanta, Georgia, United States, 30309-7520
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    GSK Investigational Site
    Huntington Beach, California, United States, 92647
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    Verona, New Jersey, United States, 7044
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    Philadelphia, Pennsylvania, United States, 19135
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    Jacksonville, Florida, United States, 32216
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    Columbia, Missouri, United States, 65212
    Status
    Study Complete
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    Ciudad Autónoma de Buenos Aires, Argentina, 1425
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    Study Complete
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    La Crosse, Wisconsin, United States, 54601
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    Taunton, Massachusetts, United States, 02780
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    Park Ridge, Illinois, United States, 60068
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    El Paso, Texas, United States, 79925
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    Liverpool, New York, United States, 13088
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    Newport Beach, California, United States, 92660
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    Barnesville, Georgia, United States, 30204
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    Upland, Pennsylvania, United States, 19013
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    Shreveport, Louisiana, United States, 71104
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    Rockville Center, New York, United States, 11570
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    Norfolk, Virginia, United States, 23510
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    San Diego, California, United States, 92120
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    Richmond, Virginia, United States, 23229
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    Charleston, West Virginia, United States, 25301
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    Pittsburgh, Pennsylvania, United States, 15202
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    Winston-Salem, North Carolina, United States, 27103
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    GSK Investigational Site
    Durham, North Carolina, United States, 27704
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    Charlotte, North Carolina, United States, 28204
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    San Juan, Puerto Rico, Puerto Rico, 00935
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    San Francisco, California, United States, 94102
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    Rolling Hills Estates, California, United States, 90274
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    Palmdale, California, United States, 93551
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    Spartanburg, South Carolina, United States, 29303
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    Mission Viejo, California, United States, 92691
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    Paramount, California, United States, 90723
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    Vestal, New York, United States, 13850
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    Blue Belle, Pennsylvania, United States, 19422
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    La Jolla, California, United States, 92093
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    Dallas, Texas, United States, 75230
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    GSK Investigational Site
    Santa Fe, Santa Fe, Argentina, 3000
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    Study Complete
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    Tallahassee, Florida, United States, 32308
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    GSK Investigational Site
    Augusta, Georgia, United States, 30901
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    Indianapolis, Indiana, United States, 46208
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    GSK Investigational Site
    Denver, Colorado, United States, 80230
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    Recruiting
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    GSK Investigational Site
    San Antonio, Texas, United States, 78207
    Status
    Study Complete
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    GSK Investigational Site
    Houston, Texas, United States, 77054
    Status
    Recruiting
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    GSK Investigational Site
    Houston, Texas, United States, 77065
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    GSK Investigational Site
    Knoxville, Tennessee, United States, 37916
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    GSK Investigational Site
    Hoffman Estates, Illinois, United States, 60195
    Status
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    GSK Investigational Site
    St. Louis, Missouri, United States, 63108
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, 1425
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Dartmouth, Massachusetts, United States, 02747
    Status
    Recruiting
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    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73120
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    Recruiting
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    GSK Investigational Site
    Glenview, Illinois, United States, 60025
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Bend, Oregon, United States, 97701
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    Richmond, Virginia, United States, 23298
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    GSK Investigational Site
    Long Beach, California, United States, 90806
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    Recruiting
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    GSK Investigational Site
    St. Louis, Missouri, United States, 63139
    Status
    Study Complete
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    GSK Investigational Site
    Sherman Oaks, California, United States, 91403
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    Study Complete
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    GSK Investigational Site
    Knoxville, Tennessee, United States, 37922
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    GSK Investigational Site
    Martinez, Georgia, United States, 30907
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    Study Complete
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    GSK Investigational Site
    Tacoma, Washington, United States, 98405
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    Recruiting
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    Cleveland, Ohio, United States, 44106
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    Metairie, Louisiana, United States, 70006
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    Centennial, Colorado, United States, 80112
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    GSK Investigational Site
    Denver, Colorado, United States, 80218
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    Study Complete
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    GSK Investigational Site
    Newton, Massachusetts, United States, 02462
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    GSK Investigational Site
    Cincinnati, Ohio, United States, 45231
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    Portland, Oregon, United States, 97213
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    Lake Jackson, Texas, United States, 77566
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    Fresno, California, United States, 93720
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    Greenville, South Carolina, United States, 29607
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    New Hyde Park, New York, United States, 11042
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    Hialeah, Florida, United States, 33013
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    GSK Investigational Site
    Greenfield, Wisconsin, United States, 53228
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    GSK Investigational Site
    Galveston, Texas, United States, 77555-0188
    Status
    Study Complete
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    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
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    GSK Investigational Site
    Metairie, Louisiana, United States, 70001
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    Ozark, Alabama, United States, 36360
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    Lewisburg, Pennsylvania, United States, 17837
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    Tampa, Florida, United States, 33613
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    Albuquerque, New Mexico, United States, 87131
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    GSK Investigational Site
    San Antonio, Texas, United States, 78233
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Tucson, Arizona, United States, 85716
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    Recruiting
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    GSK Investigational Site
    Vista, California, United States, 92083
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    GSK Investigational Site
    St. Petersburg, Florida, United States, 33710
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    Recruiting
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    GSK Investigational Site
    Lawrence, Kansas, United States, 66047
    Status
    Study Complete
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    GSK Investigational Site
    Canton, Ohio, United States, 44718
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    GSK Investigational Site
    Plano, Texas, United States, 75093
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    Orlando, Florida, United States, 32801
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    Ponce, Puerto Rico, Puerto Rico, 00716
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    Altamonte Springs, Florida, United States, 32701
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    Berlin, New Jersey, United States, 08009
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    East Orange, New Jersey, United States, 7017
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    Mount Pleasant, South Carolina, United States, 29464
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    Orange, California, United States, 92868
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    GSK Investigational Site
    Harrisburg, Pennsylvania, United States, 17110
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    Study Complete
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    GSK Investigational Site
    San Antonio, Texas, United States, 78205
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    GSK Investigational Site
    Elizabeth City, North Carolina, United States, 27909
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    Crescent City, California, United States, 95531
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    GSK Investigational Site
    West Quincy, Massachusetts, United States, 02169
    Status
    Study Complete
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    GSK Investigational Site
    Detroit, Michigan, United States, 48202
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    Study Complete
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    GSK Investigational Site
    Orlando, Florida, United States, 32806
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    GSK Investigational Site
    Ocean, New Jersey, United States, 07712
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    Tucson, Arizona, United States, 85746
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    Asheville, North Carolina, United States, 28801
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    Lincoln, Rhode Island, United States, 02865-4208
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    St. Louis, Missouri, United States, 63141
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    Little Rock, Arkansas, United States, 72205
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    GSK Investigational Site
    Breña, Peru, Lima 5
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    Study Complete
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    GSK Investigational Site
    Sarasota, Florida, United States, 34233
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    Riverside, California, United States, 92506
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    Portland, Oregon, United States, 97223
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    Papillion, Nebraska, United States, 68046
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    Altoona, Pennsylvania, United States, 16601
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    Oklahoma City, Oklahoma, United States, 73112
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    South Bend, Indiana, United States, 46617
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    Omaha, Nebraska, United States, 68134
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    Viña del Mar, Valparaíso, Chile
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    Missoula, Montana, United States, 59804
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    Walnut Creek, California, United States, 94598
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    New Braunfels, Texas, United States, 78130
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    Knoxville, Tennessee, United States, 37917
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    GSK Investigational Site
    Covington, Louisiana, United States, 70433
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    Charleston, South Carolina, United States, 29407
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    Beverly Hills, California, United States, 90212
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    Denver, Colorado, United States, 80206
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    Layton, Utah, United States, 84041
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    El Paso, Texas, United States, 79902
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    GSK Investigational Site
    Buffalo, New York, United States, 14222
    Status
    Study Complete
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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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-03-01

    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.

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