Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified June 2023 by GlaxoSmithKline
Sponsor
GlaxoSmithKline
Information Provided by (Responsible Party)
GlaxoSmithKline
Clinicaltrials.gov Identifier
NCT04187144
Other Study ID Numbers:
212390
First Submitted
December 2, 2019
First Posted
December 4, 2019
Results First Posted
May 28, 2023
Last Update Posted
July 17, 2023
Last Verified
June 2023

ClinicalTrials.gov processed this data on July 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Urinary Tract Infections
Drug: GepotidacinDrug: Nitrofurantoin

Study Design

Study TypeInterventional
Actual Enrollment1606 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
Study Start DateApril 22, 2020
Actual Primary Completion DateNovember 30, 2022
Actual Study Completion DateNovember 30, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
Gepotidacin
Participants will be administered oral doses of 1500 milligrams (mg) gepotidacin plus nitrofurantoin matching placebo BID; approximately every 12 hours for 5 days.
Drug: Gepotidacin
Gepotidacin will be available as tablets at a unit dose strength of 750mg. Participants will administer two 750 mg tablets, BID. Each dose will be taken with water after consumption of food.
Nitrofurantoin
Participants will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.
Drug: Nitrofurantoin
Nitrofurantoin will be available as over-encapsulated 100 mg capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Participants will administer one 100 mg capsule, BID. Each dose should be taken with water after consumption of food.

Outcome Measures

Primary Outcome Measures
  1. Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
    TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline \[BL\] to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
  2. Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population
    TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline \[BL\] to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Secondary Outcome Measures
  1. Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
    Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
  2. Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
    Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
  3. Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
    Participant-level MOs at TOC were categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
  4. Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population
    Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP)s had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
  5. Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
    TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to \<10\^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit \[or AB for uUTI on day of FU visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
  6. Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
    Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met).
  7. Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
    Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
  8. Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
    Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10\^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU.
  9. Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
    Participant- level microbiological response at FU was categorized as microbiological success and microbiological failure. Microbiological success at FU was defined as all baseline QUPs had a microbiological outcome of sustained eradication at FU visit. Microbiological failure at FU was defined as not meeting criteria of microbiological success including those participants with UTD outcome.
  10. Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
    Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
  11. Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population
    Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure.
  12. Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
    Clinical outcomes at FU were categorized as Sustained Clinical Response (SCR), Delayed Clinical Response (DCR), CI, CW, Clinical Recurrence (CR) and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. UTD outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for current infection (uUTI) prior to assessment (unless CS or CR outcome criteria were met).
  13. Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
    Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
  14. Number of Participants With Treatment-emergent Adverse Events (TEAEs)
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
  15. Number of Participants With Serious Adverse Events (SAEs)
    An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
  16. Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
    Blood samples were collected for the analysis of hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  17. Change From Baseline in Hematology Parameter: Hemoglobin Level
    Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  18. Change From Baseline in Hematology Parameter: Hematocrit Level
    Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  19. Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count
    Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  20. Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
    Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  21. Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
    Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  22. Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  23. Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  24. Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  25. Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  26. Number of Participants With Urinalysis Dipstick Results
    Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, Small, Moderate, Large, Positive, 50 milligram per deciliter (mg/dL), 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL, \>=80 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Data is presented in similar way for others parameters.
  27. Absolute Mean Values of Urine Specific Gravity
    Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  28. Absolute Mean Values of Urine Potential of Hydrogen (pH)
    Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  29. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
    SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  30. Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
    Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  31. Change From Baseline in Body Temperature
    Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  32. Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
    Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450, \>450 to \<=480, \>480 to \<=500 millisecond (msec) are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.
  33. Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
    Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450 msec, \>450 msec to \<=480 msec are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
The participant is \>=12 years of age at the time of signing the informed consent/assent and has a body weight \>=40 kilogram (kg).
The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset \<96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.
The participant has nitrite or pyuria (greater than \[\>\]15 white blood cell \[WBC\]/high-power field \[HPF\]) or the presence of 3 plus (+)/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
The participant is female.
The participant is capable of giving signed informed consent/assent.
Exclusion Criteria
The participant resides in a nursing home or dependent care type-facility.
The participant has a body mass index \>=40.0 kilogram per meter square (kg/m\^2) or a body mass index \>=35.0 kg/m\^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes.
The participant has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation.
The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
The participant has any of the following: 1. Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain,; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; Or 2. Known acute porphyria. 3. Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention .
The participant has a known glucose-6 phosphate dehydrogenase deficiency.
The participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period.
The participant has acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than Escherichia coli) as the contributing pathogen.
The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms.
The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (for example \[e.g.\], polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesico-ureteral reflux, detrusor insufficiency).
The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract.
The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset \>=96 hours before study entry, or a temperature \>=101.4 degree Fahrenheit (\>=38 Degrees Celsius \[C\]), flank pain, chills, or any other manifestations suggestive of upper UTI.
The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<60 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator).
The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease).
The participant has congenital long QT syndrome or known prolongation of the QTc interval.
The participant has uncompensated heart failure.
The participant has severe left ventricular hypertrophy.
The participant has a family history of QT prolongation or sudden death.
The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor.
For any participant \>=12 to \<18 years of age, the participant has an abnormal ECG reading.
The participant has a QTc \>450 msec or a QTc \>480 msec for participants with bundle-branch block.
The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
The participant has a known ALT value \>2 times upper limit of normal (ULN).
The participant has a known bilirubin value \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]).
The participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice.
The participant has a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.
The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry.

Contacts and Locations

Sponsors and CollaboratorsGlaxoSmithKline
Locations
GSK Investigational Site | Birmingham Alabama, United States, 35205GSK Investigational Site | Homewood Alabama, United States, 35209GSK Investigational Site | Huntsville Alabama, United States, 35801GSK Investigational Site | Gilbert Arizona, United States, 85296GSK Investigational Site | Peoria Arizona, United States, 85381-3689GSK Investigational Site | Phoenix Arizona, United States, 85015-1104GSK Investigational Site | La Mesa California, United States, 91942GSK Investigational Site | Modesto California, United States, 95350-5365GSK Investigational Site | Northridge California, United States, 91324GSK Investigational Site | Sacramento California, United States, 95821GSK Investigational Site | Valencia California, United States, 91355-5319GSK Investigational Site | Washington D.C. District of Columbia, United States, 20011GSK Investigational Site | Apollo Beach Florida, United States, 33572GSK Investigational Site | Boynton Beach Florida, United States, 33435GSK Investigational Site | Clearwater Florida, United States, 33761GSK Investigational Site | Coconut Creek Florida, United States, 33063GSK Investigational Site | Gainesville Florida, United States, 32607GSK Investigational Site | Hialeah Florida, United States, 33013GSK Investigational Site | Lake Worth Florida, United States, 33461GSK Investigational Site | Leesburg Florida, United States, 34748GSK Investigational Site | Miami Florida, United States, 33126GSK Investigational Site | Miami Florida, United States, 33135GSK Investigational Site | Miami Florida, United States, 33155GSK Investigational Site | Miami Florida, United States, 33186-2178GSK Investigational Site | Orlando Florida, United States, 32810GSK Investigational Site | Ormond Beach Florida, United States, 32174GSK Investigational Site | Palm Springs Florida, United States, 33406GSK Investigational Site | Pembroke Pines Florida, United States, 33026-4383GSK Investigational Site | Plant City Florida, United States, 33563GSK Investigational Site | Sweetwater Florida, United States, 33172GSK Investigational Site | Tampa Florida, United States, 33614GSK Investigational Site | West Palm Beach Florida, United States, 33409GSK Investigational Site | Blackfoot Idaho, United States, 83221GSK Investigational Site | Boise Idaho, United States, 83704GSK Investigational Site | Meridian Idaho, United States, 83642GSK Investigational Site | Hanover Maryland, United States, 21076GSK Investigational Site | Fall River Massachusetts, United States, 02723GSK Investigational Site | Butte Montana, United States, 59701GSK Investigational Site | Lincoln Nebraska, United States, 68510GSK Investigational Site | East Orange New Jersey, United States, 07018-1502GSK Investigational Site | Lawrenceville New Jersey, United States, 08648GSK Investigational Site | Mount Laurel New Jersey, United States, 08054GSK Investigational Site | Brooklyn New York, United States, 11229GSK Investigational Site | New York New York, United States, 10016-7313GSK Investigational Site | New York New York, United States, 10016GSK Investigational Site | The Bronx New York, United States, 10456GSK Investigational Site | Cary North Carolina, United States, 27518GSK Investigational Site | Wilmington North Carolina, United States, 28412GSK Investigational Site | Winston-Salem North Carolina, United States, 27103GSK Investigational Site | Fargo North Dakota, United States, 58104GSK Investigational Site | Cincinnati Ohio, United States, 45215GSK Investigational Site | Columbus Ohio, United States, 43213GSK Investigational Site | Columbus Ohio, United States, 43214GSK Investigational Site | Columbus Ohio, United States, 43231GSK Investigational Site | Dayton Ohio, United States, 45424GSK Investigational Site | Eugene Oregon, United States, 97404GSK Investigational Site | Bala-Cynwyd Pennsylvania, United States, 19004GSK Investigational Site | Philadelphia Pennsylvania, United States, 19107GSK Investigational Site | Greenville South Carolina, United States, 29615GSK Investigational Site | Lancaster South Carolina, United States, 29720GSK Investigational Site | Union South Carolina, United States, 29379GSK Investigational Site | Milan Tennessee, United States, 38358GSK Investigational Site | New Tazewell Tennessee, United States, 37824-1409GSK Investigational Site | Austin Texas, United States, 78735GSK Investigational Site | Austin Texas, United States, 78744 -1645GSK Investigational Site | Houston Texas, United States, 77087GSK Investigational Site | Katy Texas, United States, 77450GSK Investigational Site | Mesquite Texas, United States, 75149GSK Investigational Site | Missouri City Texas, United States, 77459GSK Investigational Site | North Richland Hills Texas, United States, 76180GSK Investigational Site | Plano Texas, United States, 75024GSK Investigational Site | San Antonio Texas, United States, 78209GSK Investigational Site | San Antonio Texas, United States, 78229GSK Investigational Site | San Antonio Texas, United States, 78251GSK Investigational Site | Bountiful Utah, United States, 84010GSK Investigational Site | Salt Lake City Utah, United States, 84107GSK Investigational Site | St. George Utah, United States, 84790GSK Investigational Site | Richmond Virginia, United States, 23225GSK Investigational Site | Richmond Virginia, United States, 23235GSK Investigational Site | Maroubra New South Wales, Australia, 2035GSK Investigational Site | Sydney New South Wales, Australia, 2010GSK Investigational Site | Tarragindi Queensland, Australia, 4121GSK Investigational Site | Gabrovo , Bulgaria, 5300GSK Investigational Site | Haskovo , Bulgaria, 6300GSK Investigational Site | Kyustendil , Bulgaria, 2500GSK Investigational Site | Montana , Bulgaria, 3400GSK Investigational Site | Pleven , Bulgaria, 5800GSK Investigational Site | Rousse , Bulgaria, 7000GSK Investigational Site | Shumen , Bulgaria, 9700GSK Investigational Site | Sofia , Bulgaria, 1606GSK Investigational Site | Stara Zagora , Bulgaria, 6000GSK Investigational Site | Targovisthe , Bulgaria, 7700GSK Investigational Site | Aurangabad , India, 431001GSK Investigational Site | Chandrapur , India, 442402GSK Investigational Site | Hyderabad , India, 500004GSK Investigational Site | Mumbai , India, 400022GSK Investigational Site | Nagpur , India, 440003GSK Investigational Site | Nagpur , India, 440015GSK Investigational Site | Nashik , India, 422101GSK Investigational Site | New Delhi , India, 110062GSK Investigational Site | Pune , India, 411016GSK Investigational Site | Rajkot , India, 360005GSK Investigational Site | Surat , India, 395010GSK Investigational Site | Katowice , Poland, 40-748GSK Investigational Site | Ostrowiec Świętokrzyski , Poland, 27-400GSK Investigational Site | Świdnik , Poland, 21-040GSK Investigational Site | Warsaw , Poland, 02798GSK Investigational Site | Ansan-si , South Korea, 15355GSK Investigational Site | Goyang-si, Gyeonggi-do , South Korea, 10326GSK Investigational Site | Hwasun-gun, Jeollanam-do , South Korea, 58128GSK Investigational Site | Incheon , South Korea, 21565GSK Investigational Site | Seoul , South Korea, 06973GSK Investigational Site | Suwon , South Korea, 16247
Investigators
Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full Text)
Documents provided by GlaxoSmithKline: Study Protocol  November 2, 2021Documents provided by GlaxoSmithKline: Statistical Analysis Plan  September 13, 2022