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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified April 2023 by GlaxoSmithKline
Sponsor
GlaxoSmithKline
Information Provided by (Responsible Party)
GlaxoSmithKline
Clinicaltrials.gov Identifier
NCT04020341
Other Study ID Numbers:
204989
First Submitted
July 10, 2019
First Posted
July 15, 2019
Results First Posted
May 28, 2023
Last Update Posted
June 21, 2023
Last Verified
April 2023

ClinicalTrials.gov processed this data on May 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 Enrollment1531 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 DateOctober 16, 2019
Actual Primary Completion DateNovember 29, 2022
Actual Study Completion DateNovember 29, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
Gepotidacin
Participants will be administered oral doses of 1500 milligrams (mg) gepotidacin plus nitrofurantoin matching placebo twice daily (BID); approximately every 12 hours for 5 days
Drug: Gepotidacin
Gepotidacin will be available as tablets containing 750 mg gepotidacin. Each dose should 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 capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. 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)
    Therapeutic response (success/failure) is a measure of the overall efficacy response. A therapeutic success referred to participants who had been deemed both a "microbiological success"(reduction of all qualifying bacterial uropathogens \[greater than or equal to {\>=}10\^5 colony-forming units per milliliter {CFU/mL}\] recovered at Baseline to less than (\<)10\^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials before the TOC Visit) and a "clinical success" (resolution of signs and symptoms of acute cystitis present at Baseline \[and no new signs and symptoms\] without the participant receiving other systemic antimicrobials before the 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. Plasma Concentration of Gepotidacin
    Blood samples were collected for plasma concentration of gepotidacin.
  15. Urine Concentration of Gepotidacin
    Urine samples were collected from participants.
  16. 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.
  17. 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.
  18. 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.
  19. Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit
    Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  20. Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
    Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  21. Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
    Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  22. Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
    Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  23. Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
    Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
  24. Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
    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 - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
    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. Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
    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.
  27. Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
    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.
  28. Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
    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 mg/dL, 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL and 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 manner for all other parameters.
  29. Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit
    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.
  30. Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit
    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.
  31. 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.
  32. 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.
  33. Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit
    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.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
Participants having \>=12 years of age at the time of signing the informed consent/assent and have a body weight \>=40 kilograms (kg).
Participants having 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.
Participants having nitrite or pyuria (greater than \[\>\]15 white blood cells \[WBC\]/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.
Participant is capable of giving signed informed consent/assent.
Exclusion Criteria
Participant resides in a nursing home or dependent care type-facility.
Participant has a body mass index \>=40.0 kilogram per square meter (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.
Participant has a history of sensitivity to the study treatments, 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.
Participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
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 treatment.
Participant has a known glucose-6-phosphate dehydrogenase deficiency.
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.
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.
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.
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).
Participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract.
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 Degrees Fahrenheit (F) (\>=38 Degrees Celsius \[C\]), flank pain, chills, or any other manifestations suggestive of upper UTI.
Participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<60 milliliter per minute \[mL/min\] or clinically significant elevated serum creatinine as determined by the investigator).
Participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease).
Participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval.
Participant has uncompensated heart failure.
Participant has severe left ventricular hypertrophy.
Participant has a family history of QT prolongation or sudden death.
Participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady-arrhythmia within the last 12 months.
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 electrocardiogram (ECG) reading.
Participant has a QTc \>450 millisecond (msec) or a QTc \>480 msec for participants with bundle-branch block.
Participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
Participant has a known alanine aminotransferase (ALT) value \>2 times upper limit of normal (ULN).
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 \[%\]).
Participant has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C).
Participant has a previous history of cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin.
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 | Phoenix Arizona, United States, 85051GSK Investigational Site | Tucson Arizona, United States, 85712GSK Investigational Site | Beverly Hills California, United States, 90211-2921GSK Investigational Site | Chula Vista California, United States, 91911GSK Investigational Site | La Mesa California, United States, 91942GSK Investigational Site | Lomita California, United States, 90717GSK Investigational Site | Long Beach California, United States, 90806GSK Investigational Site | Northridge California, United States, 91324-3331GSK Investigational Site | Northridge California, United States, 91324-3528GSK Investigational Site | Palm Springs California, United States, 92264GSK Investigational Site | San Diego California, United States, 92120GSK Investigational Site | DeLand Florida, United States, 32720GSK Investigational Site | Hialeah Florida, United States, 33016GSK Investigational Site | Miami Florida, United States, 33144GSK Investigational Site | Miami Springs Florida, United States, 33166GSK Investigational Site | Orlando Florida, United States, 32806GSK Investigational Site | Pompano Beach Florida, United States, 33060GSK Investigational Site | Atlanta Georgia, United States, 30328GSK Investigational Site | Columbus Georgia, United States, 31901-2561GSK Investigational Site | Fayetteville Georgia, United States, 31204GSK Investigational Site | Wichita Kansas, United States, 67226-3007GSK Investigational Site | New Orleans Louisiana, United States, 70115GSK Investigational Site | Shreveport Louisiana, United States, 71106GSK Investigational Site | Watertown Massachusetts, United States, 02472GSK Investigational Site | Dearborn Heights Michigan, United States, 48127-3163GSK Investigational Site | Norfolk Nebraska, United States, 68701-2669GSK Investigational Site | East Brunswick New Jersey, United States, 08816-1407GSK Investigational Site | Albuquerque New Mexico, United States, 87109GSK Investigational Site | Endwell New York, United States, 13760GSK Investigational Site | Fayetteville North Carolina, United States, 28304GSK Investigational Site | Scottdale Pennsylvania, United States, 15683GSK Investigational Site | Smithfield Pennsylvania, United States, 15478GSK Investigational Site | Clarksville Tennessee, United States, 37043-1524GSK Investigational Site | Memphis Tennessee, United States, 38120GSK Investigational Site | Arlington Texas, United States, 76014GSK Investigational Site | Austin Texas, United States, 78705GSK Investigational Site | Corpus Christi Texas, United States, 78414GSK Investigational Site | Forney Texas, United States, 75126GSK Investigational Site | Houston Texas, United States, 77055GSK Investigational Site | Houston Texas, United States, 77065-5597GSK Investigational Site | Blagoevgrad , Bulgaria, 2700GSK Investigational Site | Dupnitsa , Bulgaria, 2600GSK Investigational Site | Pernik , Bulgaria, 5800GSK Investigational Site | Pleven , Bulgaria, 5800GSK Investigational Site | Plovdiv , Bulgaria, 4000GSK Investigational Site | Sliven , Bulgaria, 8800GSK Investigational Site | Smolyan , Bulgaria, 4700GSK Investigational Site | Sofia , Bulgaria, 1000GSK Investigational Site | Sofia , Bulgaria, 1408GSK Investigational Site | Sofia , Bulgaria, 1431GSK Investigational Site | Yambol , Bulgaria, 8600GSK Investigational Site | Bory , Czechia, 305 99GSK Investigational Site | Kromeríž , Czechia, 767 01GSK Investigational Site | Prague , Czechia, 120 00GSK Investigational Site | Giessen Hesse, Germany, 35385GSK Investigational Site | Essen North Rhine-Westphalia, Germany, 45355GSK Investigational Site | Mülheim North Rhine-Westphalia, Germany, 45468GSK Investigational Site | Berlin , Germany, 10439GSK Investigational Site | Hamburg , Germany, 20146GSK Investigational Site | Heraklion , Greece, 71110GSK Investigational Site | Larissa , Greece, 41110GSK Investigational Site | Thessaloniki , Greece, 546 42GSK Investigational Site | Thessaloniki , Greece, 54635GSK Investigational Site | Thessaloniki , Greece, 56403GSK Investigational Site | Ballószög , Hungary, 6035GSK Investigational Site | Csongrád , Hungary, 6640GSK Investigational Site | Nyíregyháza , Hungary, 4400GSK Investigational Site | Orosháza-Szentetornya , Hungary, 5905GSK Investigational Site | Ahmedabad , India, 380016GSK Investigational Site | Surat , India, 395002GSK Investigational Site | Varanasi , India, 221010GSK Investigational Site | Ciudad de Mexico Campeche, Mexico, 06100GSK Investigational Site | Guadalajara Jalisco, Mexico, 44160GSK Investigational Site | Guadalajara Jalisco, Mexico, 44280GSK Investigational Site | Monterrey Nuevo León, Mexico, 64000GSK Investigational Site | Monterrey Nuevo León, Mexico, 64460GSK Investigational Site | San Juan del Río Querétaro, Mexico, 76800GSK Investigational Site | Jalisco , Mexico, 44130GSK Investigational Site | Bucharest , Romania, 021105GSK Investigational Site | Bucharest , Romania, 022328GSK Investigational Site | Bucharest , Romania, 050653GSK Investigational Site | Iași , Romania, 700116GSK Investigational Site | Oradea , Romania, 410469GSK Investigational Site | Timișoara , Romania, 300736GSK Investigational Site | Bratislava , Slovakia, 851 05GSK Investigational Site | Košice , Slovakia, 040 01GSK Investigational Site | Nitra , Slovakia, 949 01GSK Investigational Site | Pruské , Slovakia, 018 52GSK Investigational Site | Šaľa , Slovakia, 927 01GSK Investigational Site | Trenčín , Slovakia, 911 01GSK Investigational Site | Trenčín , Slovakia, 911 05GSK Investigational Site | Alicante , Spain, 03010GSK Investigational Site | Córdoba , Spain, 140044GSK Investigational Site | Madrid , Spain, 28023GSK Investigational Site | Madrid , Spain, 28041GSK Investigational Site | Madrid , Spain, 28044GSK Investigational Site | Madrid , Spain, 28050GSK Investigational Site | Valencia , Spain, 46026GSK Investigational Site | Vic , Spain, 08500GSK Investigational Site | Crownhill, Plymouth , United Kingdom, PL5 3JBGSK Investigational Site | Liskeard , United Kingdom, PL14 3XAGSK Investigational Site | Peterborough , United Kingdom, PE8 6PL
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 7, 2022