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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04899336
Registration number
NCT04899336
Ethics application status
Date submitted
21/05/2021
Date registered
24/05/2021
Titles & IDs
Public title
A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
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Scientific title
Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
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Secondary ID [1]
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2020-005273-27
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Secondary ID [2]
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CR109000
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - ExPEC9V
Other interventions - Placebo
Experimental: ExPEC9V - Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.
Placebo comparator: Placebo - Participants will receive a single IM injection of matching placebo on Day 1.
Treatment: Other: ExPEC9V
ExPEC9V will be administered as an IM injection.
Other interventions: Placebo
Matching placebo will be administered as an IM injection.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease(IED) Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes
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Assessment method [1]
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Number of participants with first IED event, with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes will be reported.
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Timepoint [1]
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Up to 3 years
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Primary outcome [2]
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Number of Participants with First IED Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by ExPEC9V O-serotypes
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Assessment method [2]
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Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [1]
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Number of Participants with All IEDs (Including Multiple IEDs per Participant) Caused by ExPEC9V O-serotypes
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Assessment method [1]
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Number of participants with all IEDs (including multiple IEDs per participant) caused by ExPEC9V O-serotypes will be reported.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Number of Participants with First Hospitalized IED Event Caused by ExPEC9V O-serotypes
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Assessment method [2]
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Number of participants with first hospitalized IED event caused by ExPEC9V O-serotypes will be reported.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Number of Participants with First IED Event Meeting Criteria for Sepsis Caused by ExPEC9V O-serotypes
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Assessment method [3]
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Number of participants with first IED event meeting criteria for sepsis caused by ExPEC9V O-serotypes will be reported.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Number of Participants with First Bacteremic IED Event Caused by ExPEC9V O-serotypes
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Assessment method [4]
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Number of participants with first bacteremic IED event caused by ExPEC9V O-serotypes will be reported.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Number of Participants with First Pyelonephritis Event Caused by ExPEC9V O-serotypes
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Assessment method [5]
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Number of participants with first pyelonephritis event caused by ExPEC9V O-serotypes will be reported.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Number of Participants with First Urinary Tract Infection (UTI) Event Caused by ExPEC9V O-serotypes
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Assessment method [6]
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Number of participants with first UTI event caused by ExPEC9V O-serotypes will be reported.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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Number of Participants with All UTIs (Including Multiple UTIs per Participant) Caused by ExPEC9V O-serotypes
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Assessment method [7]
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Number of participants with all UTIs (including multiple UTIs per participant) caused by ExPEC9V O-serotypes will be reported.
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Timepoint [7]
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Up to 3 years
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Secondary outcome [8]
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Number of Participants with First IED Event Caused by Escherichia coli (E.coli)
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Assessment method [8]
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Number of participants with first IED event caused by E.coli will be reported.
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Timepoint [8]
0
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Up to 3 years
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Secondary outcome [9]
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Number of Participants with First Pyelonephritis Event caused By E.coli
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Assessment method [9]
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Number of participants with first pyelonephritis event caused by E.coli will be reported.
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Timepoint [9]
0
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Up to 3 years
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Secondary outcome [10]
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Number of Participants with First UTI Event caused by E.coli
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Assessment method [10]
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Number of participants with first UTI event caused by E.coli will be reported.
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Timepoint [10]
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Up to 3 years
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Secondary outcome [11]
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Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay
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Assessment method [11]
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Antibody titers to vaccine O-serotype antigens as determined by multiplex ECL-based immunoassay will be reported.
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Timepoint [11]
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Up to 3 years
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Secondary outcome [12]
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Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
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Assessment method [12]
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Antibody titers to EPA as determined by multiplex ECL-based immunoassay will be reported.
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Timepoint [12]
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Up to 3 years
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Secondary outcome [13]
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Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA)
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Assessment method [13]
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Antibody titers to vaccine O-serotype antigens as determined by MOPA will be reported.
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Timepoint [13]
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Up to 3 years
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Secondary outcome [14]
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Number of Participants with Solicited Local Adverse Events (AEs)
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Assessment method [14]
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Number of participants with solicited local AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs. Participants will be asked to note in the diary occurrences of injection site pain/tenderness, erythema and swelling at the study vaccine injection site daily for 14 days post-vaccination (day of vaccination and the subsequent 14 days).
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Timepoint [14]
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Up to Day 15 (until 14 days post-vaccination)
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Secondary outcome [15]
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Number of Participants with Solicited Systemic AEs
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Assessment method [15]
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Number of participants with solicited systemic AEs will be reported. Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 14 days post-vaccination (day of vaccination and the subsequent 14 days). Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
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Timepoint [15]
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Up to Day 15 (until 14 days post-vaccination)
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Secondary outcome [16]
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Number of Participants with Unsolicited AEs
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Assessment method [16]
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Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
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Timepoint [16]
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Up to Day 30 (until 29 days post-vaccination)
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Secondary outcome [17]
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Number of Participants with Serious Adverse Events (SAEs)
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Assessment method [17]
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Timepoint [17]
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Up to 3 years
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Secondary outcome [18]
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Short Form-36 (SF-36) Total Scores
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Assessment method [18]
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The SF-36 is a 36-item questionnaire with a recall period for all items of 1 week. The SF 36 version 2 includes 8 domains that measure physical functioning, role limitations due to physical health problems, bodily pain, general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and mental health (MH). The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary (PCS) and a mental component summary (MCS). Responses to all items are rated on a 3-, 5- or 6-point Likert scale. The scores range from 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
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Timepoint [18]
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Up to 3 years
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Secondary outcome [19]
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European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
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Assessment method [19]
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The EQ-5D-5L is a standardized measure of health status. It is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Timepoint [19]
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Up to 3 years
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Secondary outcome [20]
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Change from Baseline in Frailty Index
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Assessment method [20]
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Frailty will be assessed at baseline based on Short Physical Performance Battery (SPPB) score and will be calculated using participants self-reported information regarding health status (components of SF-36 and EQ-5D), and baseline health conditions collected through medical conditions of interest. The specific medical conditions of interest used for the calculation of the frailty index score will include: diabetes mellitus, history of myocardial infarction, congestive heart failure, hypertension, history of cerebrovascular disease (sequelae of stroke), chronic obstructive pulmonary disease (COPD), cancer, osteoarthritis or rheumatoid arthritis, gastric or duodenal ulcer, long term disability or handicap, hearing problems, migraine, cataract, and glaucoma. Total Frailty Index, ranging from 0 (not frail or best possible score) to 43 (frail or worst possible score), will be calculated as accumulation of individual's deficits.
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Timepoint [20]
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Baseline to 3 years
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Secondary outcome [21]
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Medical Resource Utilization (MRU) for IED Events
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Assessment method [21]
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MRU for IED events will be reported.
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Timepoint [21]
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Up to Day 366 Post-IED
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Secondary outcome [22]
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MRU for UTI Events
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Assessment method [22]
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MRU for UTI events (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.
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Timepoint [22]
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Up to Day 29 Post-UTI
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Secondary outcome [23]
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MRU for Acute Bacterial Prostatitis (ABP)
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Assessment method [23]
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Medical resource utilization for ABP events (for immunogenicity subset only that is for participants from selected study sites who have given informed consent prior to randomization for additional immunogenicity assessments) will be reported.
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Timepoint [23]
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Up to Day 29 Post-ABP
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Secondary outcome [24]
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Number of Participants with the Hospitalization for IED or, UTI, or ABP Events
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Assessment method [24]
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Number of participants with hospitalization for IED or, UTI, or ABP events will be reported.
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Timepoint [24]
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Up to 3 years
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Secondary outcome [25]
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Length of Stay in Hospital for IED, UTI, or ABP Events
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Assessment method [25]
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Length of stay in hospital for IED, UTI, or ABP events will be reported.
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Timepoint [25]
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Up to 3 years
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Secondary outcome [26]
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Number of Participants with the Intensive Care Unit (ICU) Hospitalization for IED or UTI or ABP Events
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Assessment method [26]
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Number of participants with ICU hospitalization for IED or UTI or ABP events will be reported.
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Timepoint [26]
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Up to 3 months
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Secondary outcome [27]
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Length of ICU Stay in Hospital for IED, UTI, or ABP Events
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Assessment method [27]
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Length of ICU stay in hospital for IED, UTI, or ABP events will be reported.
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Timepoint [27]
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Up to 3 months
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Secondary outcome [28]
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Number of Participants with IED-related and All-cause Mortality
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Assessment method [28]
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Number of participants with IED-related and all-cause mortality will be reported.
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Timepoint [28]
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Up to 3 years
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Eligibility
Key inclusion criteria
* Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period
* Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by the investigator. In case of a recent history of UTI or ABP, the condition must have resolved greater than (>)14 days prior to randomization
* Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods
* Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Participant has end-stage renal disease for which dialysis is required
* Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws
* Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
* Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/11/2027
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Actual
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Sample size
Target
18556
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Saint Andrew's War Memorial Hospital - Brisbane
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Recruitment hospital [2]
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GP Surgery - Campbelltown - Campbelltown
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Recruitment hospital [3]
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Barwon Health - University Hospital Geelong - Geelong
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Recruitment hospital [4]
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CMAX Clinical Research - Melbourne
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Recruitment hospital [5]
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John Hunter Hospital - New Lambton
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Recruitment hospital [6]
0
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Fiona Stanley Hospital - Palmyra DC
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Recruitment hospital [7]
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McIntyre Medical Center - Para Hills West
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Recruitment hospital [8]
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North West Medical Center - Salisbury
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Recruitment hospital [9]
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Mater Medical Centre South Brisbane - South Brisbane
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Recruitment hospital [10]
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Bene Aged Care - Italian Village - St Agnes
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Recruitment hospital [11]
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Westmead Hospital - Sydney
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Recruitment hospital [12]
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AusTrials Pty Ltd - Taringa
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Recruitment hospital [13]
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AusTrials Pty Ltd - Tarragindi
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Recruitment hospital [14]
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Adelaide Medical Solutions - Woodville
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Recruitment postcode(s) [1]
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4001 - Brisbane
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Recruitment postcode(s) [2]
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5074 - Campbelltown
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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5000 - Melbourne
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Recruitment postcode(s) [5]
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2305 - New Lambton
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Recruitment postcode(s) [6]
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6961 - Palmyra DC
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Recruitment postcode(s) [7]
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5096 - Para Hills West
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Recruitment postcode(s) [8]
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0
5108 - Salisbury
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Recruitment postcode(s) [9]
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0
4101 - South Brisbane
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Recruitment postcode(s) [10]
0
0
5097 - St Agnes
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Recruitment postcode(s) [11]
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0
2145 - Sydney
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Recruitment postcode(s) [12]
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0
4068 - Taringa
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Recruitment postcode(s) [13]
0
0
4121 - Tarragindi
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Recruitment postcode(s) [14]
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0
5011 - Woodville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Georgia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Idaho
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Illinois
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Indiana
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Kansas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Louisiana
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Maryland
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Massachusetts
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Michigan
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Mississippi
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Nebraska
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Nevada
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Country [19]
0
0
United States of America
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State/province [19]
0
0
New Jersey
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Country [20]
0
0
United States of America
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State/province [20]
0
0
New York
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Country [21]
0
0
United States of America
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State/province [21]
0
0
North Carolina
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Country [22]
0
0
United States of America
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State/province [22]
0
0
North Dakota
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Country [23]
0
0
United States of America
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State/province [23]
0
0
Ohio
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Country [24]
0
0
United States of America
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State/province [24]
0
0
Oklahoma
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Country [25]
0
0
United States of America
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State/province [25]
0
0
Pennsylvania
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Country [26]
0
0
United States of America
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State/province [26]
0
0
South Carolina
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Country [27]
0
0
United States of America
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State/province [27]
0
0
Texas
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Country [28]
0
0
United States of America
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State/province [28]
0
0
Utah
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Country [29]
0
0
United States of America
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State/province [29]
0
0
Virginia
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Country [30]
0
0
United States of America
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State/province [30]
0
0
Washington
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Country [31]
0
0
United States of America
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State/province [31]
0
0
West Virginia
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Country [32]
0
0
United States of America
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State/province [32]
0
0
Wisconsin
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Country [33]
0
0
Canada
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State/province [33]
0
0
Alberta
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Country [34]
0
0
Canada
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State/province [34]
0
0
British Columbia
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Country [35]
0
0
Canada
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State/province [35]
0
0
Ontario
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Country [36]
0
0
Canada
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State/province [36]
0
0
Quebec
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Country [37]
0
0
China
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State/province [37]
0
0
Chengdu
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Country [38]
0
0
China
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State/province [38]
0
0
Fuyang
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Country [39]
0
0
China
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State/province [39]
0
0
Guangzhou
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Country [40]
0
0
China
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State/province [40]
0
0
Hangzhou
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Country [41]
0
0
China
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State/province [41]
0
0
Hefei
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Country [42]
0
0
China
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State/province [42]
0
0
Nanjing
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Country [43]
0
0
China
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State/province [43]
0
0
Shanghai
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Country [44]
0
0
China
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State/province [44]
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Suzhou
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0
China
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Taizhou
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China
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Wuxi
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Colombia
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Barranquilla
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Colombia
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Casanare
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Colombia
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Floridablanca
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Colombia
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Girardot
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Colombia
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Helechos
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Colombia
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Manizales
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Colombia
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Meta
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Colombia
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Pereira
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Colombia
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Villavicencio
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Czechia
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Brno
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Czechia
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Ceske Budejovice
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Czechia
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Dolni Brezany
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Czechia
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Hradec Kralove
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Czechia
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Novy Knin
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Czechia
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Olomouc
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Czechia
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Ostrava-Proskovice
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Czechia
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Plzen 1
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Czechia
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Plzen
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Czechia
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Praha 3
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Czechia
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Protivin
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Czechia
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Slany
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Czechia
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Vysoke Myto
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Denmark
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Hellerup
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Denmark
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Herlev
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Denmark
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Hilleroed
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Denmark
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Hvidovre
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Denmark
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Odense M
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Denmark
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Roskilde
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France
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Dijon
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France
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Limousis
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France
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Lyon
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France
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Nîmes
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France
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Pierre Benite cedex
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France
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Saint-Priest en Jarez
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Germany
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Jena
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Germany
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Leipzig
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Germany
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Marburg
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Germany
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Oldenburg in Holstein
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Germany
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Reinfeld
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Germany
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Rostock
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India
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Belagavi
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India
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Jaipur
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India
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Lucknow
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India
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Mumbai
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India
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Mysuru
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India
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New Delhi
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India
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Rajkot
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India
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Surat
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Israel
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Ashdod
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv Yafo
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Italy
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Chieti
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Italy
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Roma
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Italy
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Rome
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Japan
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Fukuoka-Shi
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Japan
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Fukuoka
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Japan
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Hakodate
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Japan
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Hashima-gun
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Japan
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Hokkaido
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Japan
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Iizuka
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Japan
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Itoshima-City
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Japan
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Kasuya-gun
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Japan
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Kawasaki
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Japan
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Kitakyushu
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Japan
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Kitakyusyu
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Japan
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Nagasaki-Shi
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Japan
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Neyagawa
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Japan
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Oita
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Japan
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Omura
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Japan
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Omuta-Shi
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Japan
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Osaka City
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Japan
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Osaka-shi
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Japan
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Sanuki
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Japan
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Sapporo-Shi
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Japan
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Shimajiri-Gun
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Japan
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Shimonoseki-shi
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Japan
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Shinagawa City
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Japan
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Suita-Shi
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Japan
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Suwa-Shi
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Japan
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Yahatanishi-ku
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Japan
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Yamaguchi
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Japan
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Yokohama
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Korea, Republic of
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Busan
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Korea, Republic of
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ChunCheon
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Korea, Republic of
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Daejeon
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Gwangju
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si
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Korea, Republic of
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Wonju
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Netherlands
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Leiden
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Uden
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Utrecht
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Bay Of Plenty
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Christchurch Central
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Hastings
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New Zealand
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Lower Hutt
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New Zealand
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Nelson
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New Zealand
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Palmerston North
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New Zealand
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Papamoa
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New Zealand
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Papatoetoe
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New Zealand
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Rosedale
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New Zealand
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Rotorua
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New Zealand
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Tauranga
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New Zealand
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Upper Hutt
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New Zealand
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Wellington
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Girona
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Spain
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Jerez de la Frontera
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Spain
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La Roca del Valles
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Ourense
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Spain
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Palma de Mallorca
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Spain
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Sabadell
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Spain
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Sevilla
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Spain
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Vigo
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Sweden
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Helsingborg
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Sweden
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Karlskrona
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Sweden
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Linkoaping
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Sweden
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Malmoe
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Sweden
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Solna
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Sweden
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Uppsala
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Sweden
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Örebro
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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United Kingdom
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Aberdeen
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United Kingdom
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Atherstone
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United Kingdom
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Banbury
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United Kingdom
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Birkenhead
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United Kingdom
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Birmingham
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United Kingdom
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Blackpool
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United Kingdom
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Bournemouth
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United Kingdom
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Bristol
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United Kingdom
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Exeter
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United Kingdom
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Eynsham
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United Kingdom
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Guisborough
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesbrough
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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Pontypridd
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United Kingdom
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Poole
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United Kingdom
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Sheffield
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United Kingdom
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Stafford
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United Kingdom
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Wakefield
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0
United Kingdom
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0
Wantage
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Country [207]
0
0
United Kingdom
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State/province [207]
0
0
Witney
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.
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Trial website
https://clinicaltrials.gov/study/NCT04899336
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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Country
0
0
Query!
Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Study Contact
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-434-4210
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04899336