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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03379675
Registration number
NCT03379675
Ethics application status
Date submitted
15/12/2017
Date registered
20/12/2017
Date last updated
28/06/2022
Titles & IDs
Public title
A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
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Scientific title
A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
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Secondary ID [1]
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2017-003252-24
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Secondary ID [2]
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CR108419
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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:
Respiratory Syncytial Virus Infections
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-53718678 500 mg
Treatment: Drugs - JNJ-53718678 80 mg
Treatment: Drugs - Placebo
Experimental: Treatment A: JNJ-53718678 500 mg - Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.
Experimental: Treatment B: JNJ-53718678 80 mg + Placebo - Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Placebo Comparator: Treatment C: Placebo - Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Treatment: Drugs: JNJ-53718678 500 mg
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
Treatment: Drugs: JNJ-53718678 80 mg
Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
Treatment: Drugs: Placebo
In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
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Intervention code [1]
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Treatment: Drugs
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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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Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
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Assessment method [1]
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Area under the RSV VL-time curve (AUC) was determined as log10 copies*hour per milliliter (Log10 copies*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
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Timepoint [1]
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Baseline through Day 3
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Primary outcome [2]
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Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
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Assessment method [2]
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Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
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Timepoint [2]
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Baseline through Day 5
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Primary outcome [3]
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Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
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Assessment method [3]
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Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
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Timepoint [3]
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Baseline through Day 8
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Primary outcome [4]
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Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
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Assessment method [4]
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Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
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Timepoint [4]
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Baseline through Day 14
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Primary outcome [5]
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Change From Baseline in RSV Viral Load at Day 3
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Assessment method [5]
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Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [5]
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Baseline to Day 3
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Primary outcome [6]
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Change From Baseline in RSV Viral Load at Day 5
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Assessment method [6]
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Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [6]
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Baseline to Day 5
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Primary outcome [7]
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Change From Baseline in RSV Viral Load at Day 8
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Assessment method [7]
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Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [7]
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Baseline to Day 8
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Primary outcome [8]
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Change From Baseline in RSV Viral Load at Day 14
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Assessment method [8]
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Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [8]
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Baseline to Day 14
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Primary outcome [9]
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Change From Baseline in RSV Viral Load at Day 21
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Assessment method [9]
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Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [9]
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Baseline to Day 21
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Primary outcome [10]
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RSV Viral Load at Baseline
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Assessment method [10]
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RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [10]
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Baseline
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Primary outcome [11]
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RSV Viral Load at Day 3
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Assessment method [11]
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RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [11]
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Day 3
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Primary outcome [12]
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RSV Viral Load at Day 5
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Assessment method [12]
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RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [12]
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Day 5
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Primary outcome [13]
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RSV Viral Load at Day 8
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Assessment method [13]
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RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [13]
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Day 8
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Primary outcome [14]
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RSV Viral Load at Day 14
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Assessment method [14]
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RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [14]
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Day 14
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Primary outcome [15]
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RSV Viral Load at Day 21
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Assessment method [15]
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RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
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Timepoint [15]
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Day 21
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Primary outcome [16]
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Time to Undetectable RSV Viral Load
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Assessment method [16]
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The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
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Timepoint [16]
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Up to Day 21
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Primary outcome [17]
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Percentage of Participants With Undetectable RSV Viral Load at Day 3
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Assessment method [17]
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Percentage of participants with undetectable RSV viral load at Day 3 were reported.
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Timepoint [17]
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Day 3
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Primary outcome [18]
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Percentage of Participants With Undetectable RSV Viral Load at Day 5
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Assessment method [18]
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Percentage of participants with undetectable RSV viral load at Day 5 were reported.
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Timepoint [18]
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Day 5
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Primary outcome [19]
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Percentage of Participants With Undetectable RSV Viral Load at Day 8
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Assessment method [19]
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Percentage of participants with undetectable RSV viral load at Day 8 were reported.
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Timepoint [19]
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Day 8
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Primary outcome [20]
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Percentage of Participants With Undetectable RSV Viral Load at Day 14
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Assessment method [20]
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Percentage of participants with undetectable RSV viral load at Day 14 were reported.
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Timepoint [20]
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Day 14
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Primary outcome [21]
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Percentage of Participants With Undetectable RSV Viral Load at Day 21
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Assessment method [21]
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Percentage of participants with undetectable RSV viral load at Day 21 were reported.
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Timepoint [21]
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Day 21
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Secondary outcome [1]
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Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
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Assessment method [1]
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Timepoint [1]
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Up to Day 28
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Secondary outcome [2]
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Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
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Assessment method [2]
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Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (< 48 hours); no medical intervention/therapy required), Grade 2= moderate (Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required), Grade 3= severe (severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).
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Timepoint [2]
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Up to Day 28
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Secondary outcome [3]
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Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
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Assessment method [3]
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Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure [SBP] and diastolic blood pressure [DBP]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - < 100 mmHg, Grade 2 (moderate)- greater than or equal to (>=)100 mmHg to < 110 mmHg, Grade 3 (severe)- >=110 mmHg; DBP: Abnormally low- <=90 mmHg, Grade 1 (mild)- 140 mmHg - < 160 mmHg, Grade 2 (moderate)- >=160 mmHg to < 180 mmHg, Grade 3 (severe)- >=180 mmHg.
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Timepoint [3]
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Up to Day 28
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Secondary outcome [4]
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Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
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Assessment method [4]
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The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval ([450 milliseconds {ms}, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval ([450 ms, 480 ms], [480 ms, 500 ms], and [more than 500 ms]).
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Timepoint [4]
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Up to Day 28
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Secondary outcome [5]
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Peripheral Capillary Oxygen Saturation (SpO2) Over Time
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Assessment method [5]
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Peripheral capillary oxygen saturation was measured by the investigator over time.
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Timepoint [5]
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Baseline, Days 3, 8, 14, and 21
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Secondary outcome [6]
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Change From Baseline in Peripheral Capillary Oxygen Saturation
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Assessment method [6]
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Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.
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Timepoint [6]
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Baseline to Days 3, 8, 14 and 21
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Secondary outcome [7]
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Pulse Rate Over Time
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Assessment method [7]
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Pulse rate was measured by the investigator over time.
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Timepoint [7]
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Baseline, Days 3, 8, 14 and 21
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Secondary outcome [8]
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Change From Baseline in Pulse Rate
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Assessment method [8]
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Change from baseline in pulse rate was calculated and reported by the investigator.
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Timepoint [8]
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Baseline to Days 3, 8, 14 and 21
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Secondary outcome [9]
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Respiratory Rate Over Time
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Assessment method [9]
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Respiratory rate was measured by the investigator over time.
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Timepoint [9]
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Baseline, Days 3, 8, 14 and 21
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Secondary outcome [10]
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Change From Baseline in Respiratory Rate
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Assessment method [10]
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Change from baseline in respiratory rate was calculated and reported by the investigator.
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Timepoint [10]
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Baseline to Days 3, 8, 14 and 21
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Secondary outcome [11]
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Body Temperature Over Time
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Assessment method [11]
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Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.
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Timepoint [11]
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Baseline, Days 3, 8, 14 and 21
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Secondary outcome [12]
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Change From Baseline in Body Temperature
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Assessment method [12]
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Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.
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Timepoint [12]
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Baseline to Days 3, 5, 8, 14 and 21
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Secondary outcome [13]
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Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
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Assessment method [13]
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AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.
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Timepoint [13]
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0 to 24 hours post dose on Days 1 and 7
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Secondary outcome [14]
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Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
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Assessment method [14]
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The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain.
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Timepoint [14]
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Baseline, Days 3, 5, 8, 14 and 21
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Secondary outcome [15]
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Duration of Signs and Symptoms of RSV Assessed by RI-PRO
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Assessment method [15]
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Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
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Timepoint [15]
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Baseline up to Day 21
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Secondary outcome [16]
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Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
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Assessment method [16]
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Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
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Timepoint [16]
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Up to Day 21
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Secondary outcome [17]
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Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
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Assessment method [17]
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Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours.
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Timepoint [17]
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Up to Day 21
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Secondary outcome [18]
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Predose Plasma Concentration (Ctrough) of JNJ-53718678
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Assessment method [18]
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Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.
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Timepoint [18]
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Predose on Days 1 and 7
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Secondary outcome [19]
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Maximum Plasma Concentration (Cmax) of JNJ-53718678
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Assessment method [19]
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Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.
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Timepoint [19]
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Days 1 and 7
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Eligibility
Key inclusion criteria
- Participants must have an acute respiratory illness with signs and symptoms consistent
with a viral infection (example, fever, cough, nasal congestion, runny nose, sore
throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or
equal to 5 days from the anticipated time of randomization. Onset of symptoms is
defined as the time the participant becomes aware of the first sign and/or symptom
consistent with a viral infection
- Participant has been diagnosed with respiratory syncytial virus (RSV) infection using
a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test
- Before randomization, a woman must be not of childbearing potential defined as:
Premenarchal, Postmenopausal or Permanently sterile
- A male participant must agree to the use of acceptable contraceptive measures
- With the exception of the RSV-related illness the participant must be medically stable
on the basis of physical examination, medical history, vital signs, and
electrocardiogram (ECG) performed at screening
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Minimum age
18
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?
No
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Key exclusion criteria
- Hospitalized participants or participants expected to be hospitalized within 24 hours
of screening
- History of or concurrent illness (beyond a comorbid condition) that in the opinion of
the investigator, might confound the results of the study or pose an additional risk
in administering study drug to the participant or that could prevent, limit, or
confound the protocol-specified assessments
- Participants who had major surgery within the 28 days prior to randomization or have
planned major surgery through the course of the study
- Participants who are considered by the investigator to be immunocompromised within the
past 12 months
- Participant has known or suspected chronic or acute hepatitis B or C infection
- Women who are pregnant or breastfeeding
- Participants with clinically significant abnormal ECG findings (other than QT-interval
corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500
millisecond [ms]) not consistent with the underlying condition in the study
population, as judged by the investigator
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Study design
Purpose of the study
Treatment
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
6/02/2018
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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
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Actual
26/12/2019
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Sample size
Target
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Paratus Clinical Blacktown Clinic - Blacktown
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Recruitment hospital [2]
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Barwon Health - University Hospital Geelong - Geelong
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Recruitment hospital [3]
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0
Paratus Clinical Kanwal Clinic - Kanwal
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Recruitment hospital [4]
0
0
Paratus Clinical Kippa Ring Clinic - Kippa Ring
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Recruitment hospital [5]
0
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Mater Hospital Brisbane - South Brisbane
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Recruitment hospital [6]
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
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0
2060 - Blacktown
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Recruitment postcode(s) [2]
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0
3220 - Geelong
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Recruitment postcode(s) [3]
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0
2059 - Kanwal
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Recruitment postcode(s) [4]
0
0
4021 - Kippa Ring
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Recruitment postcode(s) [5]
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0
4101 - South Brisbane
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Recruitment postcode(s) [6]
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2145 - Sydney
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Idaho
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Michigan
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Minnesota
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Montana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
North Carolina
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Oklahoma
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Country [9]
0
0
United States of America
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State/province [9]
0
0
South Carolina
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Bahia Blanca
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Country [11]
0
0
Argentina
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State/province [11]
0
0
Barrio Parque Velez Sarfield
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Caba
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Country [13]
0
0
Argentina
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State/province [13]
0
0
Ciudad De La Plata
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Country [14]
0
0
Argentina
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State/province [14]
0
0
Ciudadela
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Country [15]
0
0
Argentina
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State/province [15]
0
0
Cordoba
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Country [16]
0
0
Argentina
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State/province [16]
0
0
General Roca
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Country [17]
0
0
Argentina
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State/province [17]
0
0
Rosario
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Country [18]
0
0
Argentina
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State/province [18]
0
0
San Miguel de Tucuman
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Country [19]
0
0
Belgium
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State/province [19]
0
0
Bruxelles
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Country [20]
0
0
Belgium
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State/province [20]
0
0
Ham
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Country [21]
0
0
Belgium
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State/province [21]
0
0
Massemen
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Belgium
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Tessenderlo
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Brazil
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Belo Horizonte
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Brazil
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Botucatu
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Brazil
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Florianopolis
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Brazil
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Natal
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Bulgaria
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Kozloduy
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Bulgaria
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Pernik
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Bulgaria
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Ruse
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Bulgaria
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Smolyan
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Bulgaria
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Sofia
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Bulgaria
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Troyan
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Canada
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Ontario
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Canada
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Quebec
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France
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Agen cedex 9
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France
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Angers
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France
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Murs Erigne
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France
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Nantes
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France
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Paris
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Luebeck
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Japan
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Fukui-shi
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Japan
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Kawasaki
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Japan
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Kitakyusyu
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Japan
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Koganei-Shi
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Japan
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Kumamoto-shi
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Japan
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Osaka
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Japan
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Shinagawa-ku
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Japan
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Tokorozawa-shi
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Japan
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Toyota
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Japan
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Yukuhashi
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Korea, Republic of
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Bucheon
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Country [63]
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Korea, Republic of
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Suwon-si
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Mexico
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Aguascalientes
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Ostrow Wielkopolski
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Poland
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Wroclaw
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Russian Federation
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Krasnogorsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Country [78]
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South Africa
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Welkom
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Country [79]
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Spain
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State/province [79]
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Alicante
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Country [80]
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Spain
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Elche
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Spain
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Granada
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Country [82]
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Spain
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Madrid
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Country [83]
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Spain
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Santiago de Compostela
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Spain
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Vigo
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Sweden
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Malmö
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Country [86]
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Sweden
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Umeå
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Country [87]
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Sweden
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Uppsala
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Country [88]
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Taiwan
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Kaohsiung
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Country [89]
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Taiwan
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New Taipei
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Country [90]
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Taiwan
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State/province [90]
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Taichung City
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Country [91]
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Taiwan
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State/province [91]
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Taipei City
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Country [92]
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Taiwan
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Taipei
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Country [93]
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Ukraine
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Kharkiv
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Country [94]
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Ukraine
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Kherson
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Country [95]
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Ukraine
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Kyiv
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Country [96]
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Ukraine
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Vinnytsia
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Country [97]
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Ukraine
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State/province [97]
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Vinnytsya
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels
(80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial
Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative
reverse transcription polymerase chain reaction (qRT-PCR) assay.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03379675
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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0
Janssen Research & Development, LLC
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Phone
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03379675
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