Last updated: 07/17/2024 15:43:44
6-month safety and benefit study of ADVAIR in children 4-11 years oldVESTRI
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma
Trial description: The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants experiencing an event in the composite safety endpoint of serious asthma outcomes ( asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death)
Timeframe: From Day 1 up to 6 months
Number of participants with at least one asthma exacerbation over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Secondary outcomes:
Number of participants experiencing asthma-related deaths over the 6-month study treatment period.
Timeframe: From Day 1 up to 6 months
Number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Percentage of rescue-free days over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Percentage of asthma control days over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Interventions:
Enrollment:
6250
Primary completion date:
2015-03-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
David A. Stempel, Stanley J. Szefler, Soren Pedersen, Robert S. Zeiger, Anne M. Yeakey, Laurie A. Lee, Andrew H. Liu, Herman Mitchell, Kenneth M. Kral, Ibrahim H. Raphiou, Barbara A. Prillaman, Kathleen S. Buaron, Suyong Yun Kirby, Steven J. Pascoe. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med. 2016;375(9):840-9.
Stanley Szefler, Ibrahim Raphiou, Robert S. Zeiger, David Stempel, Kenneth Kral, Steven Pascoe.Seasonal variation in asthma exacerbations in the AUSTRI and VESTRI studies .ERJ Open Res.2019;5:1-4
DOI: 10.1183/23120541.00153-2018
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Parexel
Study date(s)
November 2011 to November 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 11 years
Accepts healthy volunteers
No
- 1. Consent to participate in the study
- 2. Age 4-11 years old
- 1. History of life-threatening asthma
- 2. Unstable asthma
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Consent to participate in the study 2. Age 4-11 years old 3. Male or eligible female
- Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation 4. Asthma diagnosis for at least 6 months 5. Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS 6. A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids. 7. History of at least once occurrence of asthma exacerbation within the prior 12 months 8. Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)
Exclusion criteria:
- 1. History of life-threatening asthma 2. Unstable asthma 3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms 4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma. 5. Respiratory infection 6. Subjects with only exercise-induced asthma 7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months 8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months 9. Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system 10. Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject’s proper completion of the protocol requirements 11. Participation in an interventional study or used any investigational drug for any disease state within the last 30 days 12. Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication 13. Severe hypersensitivity to cow’s milk proteins 14. Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics 15. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole) 16. Affiliation with investigator’s site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator. 17. A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Trial location(s)
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Study Complete
Location
GSK Investigational Site
Alhambra, California, United States, 91801
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76018
Status
Study Complete
Location
GSK Investigational Site
Asheboro, North Carolina, United States, 27203
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
Astoria, New York, United States, 11103
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30909
Status
Study Complete
Location
GSK Investigational Site
Aurora, Colorado, United States, 80045
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Bad Pyrmont, Niedersachsen, Germany, 31812
Status
Study Complete
Location
GSK Investigational Site
Bakerfield, California, United States, 93301
Status
Study Complete
Location
GSK Investigational Site
Beavercreek, Ohio, United States, 45431
Status
Study Complete
Location
GSK Investigational Site
Bell Vernon, Pennsylvania, United States, 15012
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68005
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
Status
Study Complete
Location
GSK Investigational Site
Bellingham, Washington, United States, 98225
Status
Study Complete
Location
GSK Investigational Site
Bentonville, Arkansas, United States, 72712
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Blue Bell, Pennsylvania, United States, 19422
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33435
Status
Study Complete
Location
GSK Investigational Site
Brick, New Jersey, United States, 8724
Status
Study Complete
Location
GSK Investigational Site
Brighton, Sussex East, United Kingdom, BN2 5BE
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
CROWN POINT, Indiana, United States, 46307
Status
Study Complete
Location
GSK Investigational Site
Calhoun, Georgia, United States, 30701
Status
Study Complete
Location
GSK Investigational Site
Canoga Park, California, United States, 91306
Status
Study Complete
Location
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF5 4AE
Status
Study Complete
Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Centerville, Ohio, United States, 45458
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22902
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4TF
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60616
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1122AAK
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Colorada Springs, Colorado, United States, 80920
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80922
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29203
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Concepcion del Uruguay, Entre Ríos, Argentina, 3260
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Dickinson, Texas, United States, 77539
Status
Study Complete
Location
GSK Investigational Site
Dinuba, California, United States, 93618
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08817
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08820
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Evergreen Park, Illinois, United States, 60805
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58104
Status
Study Complete
Location
GSK Investigational Site
Fort Mill, South Carolina, United States, 29707
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32605
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32610
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Study Complete
Location
GSK Investigational Site
Glenview, Illinois, United States, 60025
Status
Study Complete
Location
GSK Investigational Site
Gold River, California, United States, 95670
Status
Study Complete
Location
GSK Investigational Site
Granada Hills, California, United States, 91344
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29607
Status
Study Complete
Location
GSK Investigational Site
Gun Barrel City, Texas, United States, 75156
Status
Study Complete
Location
GSK Investigational Site
Harbor City, California, United States, 90710
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33012
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Huntington Park, California, United States, 90255
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
Johnstown, Pennsylvania, United States, 15904
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64114
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64138
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Krugersdorp, Gauteng, South Africa, 1752
Status
Study Complete
Location
GSK Investigational Site
La Crosse, Wisconsin, United States, 54601
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Lanús, Buenos Aires, Argentina, B1824KAJ
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89107
Status
Study Complete
Location
GSK Investigational Site
Latrobe, Pennsylvania, United States, 15650
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Lewisville, Texas, United States, 75067
Status
Study Complete
Location
GSK Investigational Site
Lilburn, Georgia, United States, 30047
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Rhode Island, United States, 2865
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72204
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72209
Status
Study Complete
Location
GSK Investigational Site
Livingston, New Jersey, United States, 07039
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90807
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90057
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40291
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792-9988
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32935
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Midlothian, Virginia, United States, 23113
Status
Study Complete
Location
GSK Investigational Site
Midlothian, Virginia, United States, 23114
Status
Study Complete
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36109
Status
Study Complete
Location
GSK Investigational Site
Napa, California, United States, 94558
Status
Study Complete
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41469
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92660
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Northfield, New Jersey, United States, 8225
Status
Study Complete
Location
GSK Investigational Site
Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
Status
Study Complete
Location
GSK Investigational Site
Ocean, New Jersey, United States, 07712
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73131
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32811
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66210
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Palmdale, California, United States, 93551
Status
Study Complete
Location
GSK Investigational Site
Parana, Entre Ríos, Argentina, E3100BHK
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32503
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32514
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
Location
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
Status
Study Complete
Location
GSK Investigational Site
Port Gibson, Mississippi, United States, 39150
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23223
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23226
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23235
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92501
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Est., California, United States, 920274
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95678
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95825
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78207
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78224
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78251
Status
Study Complete
Location
GSK Investigational Site
San Marino, California, United States, 91108
Status
Study Complete
Location
GSK Investigational Site
San Martin de Porres, Lima, Peru, Lima 31
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000IFL
Status
Study Complete
Location
GSK Investigational Site
Santiago de Surco, Lima, Peru, Lima 33
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85288
Status
Study Complete
Location
GSK Investigational Site
Seremban, Negeri Sembilan, Malaysia, 70300
Status
Study Complete
Location
GSK Investigational Site
Shaker Heights, Ohio, United States, 44120
Status
Study Complete
Location
GSK Investigational Site
Shelbyville, Tennessee, United States, 37160
Status
Study Complete
Location
GSK Investigational Site
Shiloh, Illinois, United States, 62269
Status
Study Complete
Location
GSK Investigational Site
Shippensburg, Pennsylvania, United States, 17257
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71106
Status
Study Complete
Location
GSK Investigational Site
Silver Spring, Maryland, United States, 20910
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Study Complete
Location
GSK Investigational Site
Staten Island, New York, United States, 10304
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Stockton on Tees, United Kingdom, TS19 8PE
Status
Study Complete
Location
GSK Investigational Site
Stoke on Trent, United Kingdom, ST4 6QG
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77478
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85724-5073
Status
Study Complete
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35401
Status
Study Complete
Location
GSK Investigational Site
Verona, New Jersey, United States, 07044
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23454
Status
Study Complete
Location
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
Status
Study Complete
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Study Complete
Location
GSK Investigational Site
Waxahachie, Texas, United States, 75165
Status
Study Complete
Location
GSK Investigational Site
Welkom, Free State, South Africa, 9460
Status
Study Complete
Location
GSK Investigational Site
Wellington, Florida, United States, 33414
Status
Study Complete
Location
GSK Investigational Site
West Covina, California, United States, 91790
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
White Marsh, Maryland, United States, 21162
Status
Study Complete
Location
GSK Investigational Site
Woods Cross, Utah, United States, 84087
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Zanesville, Ohio, United States, 43701
Status
Study Complete
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-03-11
Actual study completion date
2015-03-11
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
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Additional information
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