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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03207243




Registration number
NCT03207243
Ethics application status
Date submitted
29/06/2017
Date registered
2/07/2017
Date last updated
2/03/2020

Titles & IDs
Public title
Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma
Scientific title
A Randomized, Double-blind, Parallel Group, Multicenter, Stratified Study Evaluating the Efficacy and Safety of Repeat Doses of GSK3772847 Compared With Placebo in Participants With Moderately Severe Asthma
Secondary ID [1] 0 0
2017-001072-34
Secondary ID [2] 0 0
207597
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK3772847
Treatment: Drugs - Placebo
Treatment: Drugs - Fluticasone propionate/salmeterol
Treatment: Drugs - Fluticasone propionate

Experimental: Subjects receiving GSK3772847 - Eligible subjects will receive GSK3772847 once every 4 weeks via IV route along with 500/50 mcg FP/Sal twice daily for first 2 weeks and dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation.

Placebo comparator: Subjects receiving placebo drug - Eligible subjects will receive placebo once every 4 weeks via IV route along with 500/50 mcg FP/Sal twice daily for first 2 weeks and dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation.


Treatment: Drugs: GSK3772847
GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects.

Treatment: Drugs: Placebo
Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects.

Treatment: Drugs: Fluticasone propionate/salmeterol
FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.

Treatment: Drugs: Fluticasone propionate
FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Loss of Asthma Control Over Weeks 0-16
Timepoint [1] 0 0
Up to Week 16
Secondary outcome [1] 0 0
Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline
Timepoint [1] 0 0
Baseline and up to Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Have Pre-bronchodilator FEV1 Decrease From Baseline >7.5 %
Timepoint [2] 0 0
Baseline and up to Week 16
Secondary outcome [3] 0 0
Percentage of Participants With Inability to Titrate Inhaled Corticosteroids (ICS)
Timepoint [3] 0 0
Up to Week 16
Secondary outcome [4] 0 0
Percentage of Participants With Clinically Significant Asthma Exacerbation
Timepoint [4] 0 0
Up to Week 16
Secondary outcome [5] 0 0
Percentage of Participants With Loss of Asthma Control Over Weeks 0-6
Timepoint [5] 0 0
Up to Week 6
Secondary outcome [6] 0 0
Time to Loss of Asthma Control
Timepoint [6] 0 0
Up to Week 16
Secondary outcome [7] 0 0
Percentage of Participants With Clinically Significant Asthma Exacerbation or Inability to Titrate
Timepoint [7] 0 0
Up to Week 16
Secondary outcome [8] 0 0
Number of Participants Experiencing Asthma Related Hospitalization During the Study Period
Timepoint [8] 0 0
Up to Week 16
Secondary outcome [9] 0 0
Rate Per 1000 Person-years of Participants With Hospitalization
Timepoint [9] 0 0
Up to Week 16
Secondary outcome [10] 0 0
Number of Hospitalizations or Emergency Room Visits Per Participants
Timepoint [10] 0 0
Up to Week 16
Secondary outcome [11] 0 0
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score
Timepoint [11] 0 0
Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16
Secondary outcome [12] 0 0
Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)
Timepoint [12] 0 0
Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16
Secondary outcome [13] 0 0
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Timepoint [13] 0 0
Baseline and Weeks 4, 8, 12 and 16
Secondary outcome [14] 0 0
Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ)
Timepoint [14] 0 0
Baseline and Weeks 4, 8, 12 and 16
Secondary outcome [15] 0 0
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
Timepoint [15] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, 12, 14 and 16
Secondary outcome [16] 0 0
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF
Timepoint [16] 0 0
Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16.
Secondary outcome [17] 0 0
Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period
Timepoint [17] 0 0
Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16
Secondary outcome [18] 0 0
Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol)
Timepoint [18] 0 0
Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16
Secondary outcome [19] 0 0
Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use
Timepoint [19] 0 0
Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16
Secondary outcome [20] 0 0
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Timepoint [20] 0 0
Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14 and 16
Secondary outcome [21] 0 0
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
Timepoint [21] 0 0
Up to Week 16
Secondary outcome [22] 0 0
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Timepoint [22] 0 0
Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28
Secondary outcome [23] 0 0
Change From Baseline in Pulse Rate (PR)
Timepoint [23] 0 0
Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28
Secondary outcome [24] 0 0
Change From Baseline Between Post-dose and Pre-dose in DBP and SBP
Timepoint [24] 0 0
Baseline and Weeks 0, 4, 8 and 12
Secondary outcome [25] 0 0
Change From Baseline Between Post-dose and Pre-dose in Pulse Rate
Timepoint [25] 0 0
Baseline and Weeks 0, 4, 8 and 12
Secondary outcome [26] 0 0
Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval
Timepoint [26] 0 0
Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16
Secondary outcome [27] 0 0
Change From Baseline in ECG Heart Rate
Timepoint [27] 0 0
Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16
Secondary outcome [28] 0 0
Change From Baseline in QRS Axis
Timepoint [28] 0 0
Baseline and Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16
Secondary outcome [29] 0 0
Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval
Timepoint [29] 0 0
Baseline and Weeks 0, 4, 8 and 12
Secondary outcome [30] 0 0
Change Between Pre-dose and Post-dose of Heart Rate
Timepoint [30] 0 0
Baseline and Weeks 0, 4, 8 and 12
Secondary outcome [31] 0 0
Change Between Pre-dose and Post-dose of QRS Axis
Timepoint [31] 0 0
Baseline and Weeks 0, 4, 8 and 12
Secondary outcome [32] 0 0
Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate
Timepoint [32] 0 0
Baseline and Weeks 0, 4 and 12
Secondary outcome [33] 0 0
Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles
Timepoint [33] 0 0
Baseline and Weeks 0, 4 and 12
Secondary outcome [34] 0 0
Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)
Timepoint [34] 0 0
Baseline and Weeks 2, 4, 8, 12, 16 and 28
Secondary outcome [35] 0 0
Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)
Timepoint [35] 0 0
Baseline and Weeks 2, 4, 8, 12, 16 and 28
Secondary outcome [36] 0 0
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin
Timepoint [36] 0 0
Baseline and Weeks 2, 4, 8, 12, 16 and 28
Secondary outcome [37] 0 0
Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin
Timepoint [37] 0 0
Baseline and Weeks 2, 4, 8, 12, 16 and 28
Secondary outcome [38] 0 0
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Timepoint [38] 0 0
Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [39] 0 0
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Timepoint [39] 0 0
Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [40] 0 0
Change From Baseline in Hematology Parameter: Erythrocytes
Timepoint [40] 0 0
Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [41] 0 0
Change From Baseline in Hematology Parameter: Hemoglobin
Timepoint [41] 0 0
Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [42] 0 0
Change From Baseline in Hematology Parameter: Hematocrit Level
Timepoint [42] 0 0
Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [43] 0 0
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
Timepoint [43] 0 0
Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [44] 0 0
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration
Timepoint [44] 0 0
Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [45] 0 0
Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)
Timepoint [45] 0 0
Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [46] 0 0
Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide
Timepoint [46] 0 0
Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [47] 0 0
Change From Baseline in Cardiac Marker: Cardiac Troponin I
Timepoint [47] 0 0
Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28
Secondary outcome [48] 0 0
Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies
Timepoint [48] 0 0
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and 28
Secondary outcome [49] 0 0
Serum Concentrations of GSK3772847
Timepoint [49] 0 0
Weeks 2, 4 (Pre-dose), 8 (Pre-dose), 12 (Pre-dose and Post-dose), 16, 20, 24 and 28
Secondary outcome [50] 0 0
Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Timepoint [50] 0 0
Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16
Secondary outcome [51] 0 0
Percent Change From Baseline in Total Soluble ST2 Concentration
Timepoint [51] 0 0
Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16

Eligibility
Key inclusion criteria
* Age: At least 18 years of age at the time of signing the informed consent.
* Males and females: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow highly effective contraceptive methods from 4 weeks prior to the first dose of study medication and until at least 16 weeks after the last dose of study medication and completion of the follow-up visit.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
* A subject with a documented diagnosis of moderate severe asthma based on Global Initiative for Asthma (GINA) 2016 Guidelines, whose asthma has been managed with regular treatment of high dose ICS defined as FP 500 mcg twice daily (i.e. 1000 mcg total daily dose) or equivalent, and LABA for at least 4 months. Additional therapy with a leukotriene receptor antagonist (LTRA) is permissible.
* Airway reversibility of at least 12 percent and 200 milliliter (mL) in FEV1 at Screening (Visit 1), or documented reversibility prior to Screening (Visit 1), or documented history of bronchial hyper reactivity (e.g. fall in FEV1 from baseline of more than or equal to 20percent with standard doses of methacholine or histamine, or more than or equal to 15 percent with standardized hyperventilation, hypertonic saline or mannitol challenge) from a bronchoprovocation study [e.g. methacholine challenge prior to Screening (Visit 1)].
* ACQ-5 score more than or equal to 1.0 and less than 4.0 at Screening (Visit 1).
* Had at least one asthma exacerbation within 12 months prior to screening that required treatment with systemic corticosteroid and/or hospitalization.
* All subjects must be able to replace their current Short-Acting Beta2-Agonists (SABA) treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, per product label, for the duration of the study.

Randomization inclusion criteria:

* ACQ-5 score more than or equal to 1.0 and less than 4.0 at Visit 2.
* Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on more than or equal to 4 of the last 7 days during the run-in period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current smokers or former smokers with a smoking history more than or equal to 10 pack years.
* Presence of a known pre-existing, clinically important respiratory conditions (e.g. pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma.
* A pre-bronchodilator FEV1 less than 50 percent predicted of normal value at Screening (Visit 1).
* Subjects with a diagnosis of malignancy or in the process of investigation for a malignancy. Subjects with carcinoma that have not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment.
* Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at Screening (Visit 1) or within 3 months prior to first dose of study treatment.
* Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of subject eligibility.
* Weight: less than 50 kilograms (kg) and more than 150 kg.
* Regular use of systemic corticosteroids for conditions including asthma within 3 months prior to Screening (Visit 1).
* Subjects with high parasympathetic tone (e.g. trained athletes with baseline bradycardia) or chronic conditions associated with parasympathetic surges (e.g. migraines).
* Other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1).
* Clinically significant organic heart disease [e.g. Coronary artery disease (CAD), New York Heart Association (NYHA) Class III/IV heart failure].
* Ongoing infections (i.e. not resolved within 7 days prior to Screening [Visit 1]) or recurrent infections (i.e. requiring treatment for an identical diagnosis within 3 months) requiring systemic antibiotics Known, pre-existing parasitic infestations within 6 months prior to Screening.
* A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
* A known immunodeficiency such as human immunodeficiency virus infection.
* Subjects with allergy or intolerance to a monoclonal antibody or biologic or to any components of the formulation used in this study.
* Subjects with a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Screening (Visit 1).
* Subjects who are unable to follow study instructions such as visit schedule, dosing directions, study eDiary completion, or use of a standard metered dose inhaler. Subjects who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
* Subjects who have previously participated in a study of GSK3772847.
* Use of the prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study. Potential subjects should not be washed out of their medication solely for the purpose on enrolling in the trial.
* A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub investigator, study coordinator, or employee of the participating investigator.
* In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a diary card/questionnaire.
* Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.

Randomization exclusion criteria:

* Evidence of clinically significant abnormal laboratory tests during screening which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.
* Evidence of clinically significant abnormal ECG findings at Visit 2.
* An abnormal and significant finding from 24-hour Holter monitoring at Screening (Visit 1). Investigators will be provided with Holter reviews conducted by an independent cardiologist to assist in evaluation of subject eligibility.
* Liver function at screening (Visit 1): ALT more than 2 x upper limit of normal (ULN) and bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percent); Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Subjects with ongoing asthma exacerbation at the time of Visit 2.
* A pre-bronchodilator FEV1 less than 50 percent predicted of normal value at Visit 2.
* Positive pregnancy test at Visit 0, Screening (Visit 1) or Visit 2.
* Ongoing or recurrent infections requiring systemic antibiotics.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2019
Sample size
Target
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Woodville South
Recruitment hospital [2] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [3] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [4] 0 0
GSK Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Canada
State/province [22] 0 0
Québec
Country [23] 0 0
Mexico
State/province [23] 0 0
Jalisco
Country [24] 0 0
Mexico
State/province [24] 0 0
Morelos
Country [25] 0 0
Mexico
State/province [25] 0 0
Nuevo León
Country [26] 0 0
Mexico
State/province [26] 0 0
Tabasco
Country [27] 0 0
Mexico
State/province [27] 0 0
Yucatán
Country [28] 0 0
Mexico
State/province [28] 0 0
Mexico City
Country [29] 0 0
Mexico
State/province [29] 0 0
México DF
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Chelyabinsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Kemerovo
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Saint Petersburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Saint-Petersburg
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Samara
Country [35] 0 0
Russian Federation
State/province [35] 0 0
St. Petersburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Tomsk
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Ulyanovsk
Country [38] 0 0
Ukraine
State/province [38] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03207243