Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A two-part study with a birth cohort (Observational Stage) for early diagnosis of respiratory syncytial virus (RSV), followed by an optional phase 2a, randomized, double-blind, placebo-controlled study (Interventional Stage) to evaluate the antiviral activity, clinical outcomes, safety, tolerability and pharmacokinetics of JNJ-53718678 in infants with acute respiratory tract infection due to RSV

    Summary
    EudraCT number
    2019-001509-25
    Trial protocol
    GB   BE  
    Global end of trial date
    15 May 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Dec 2021
    First version publication date
    01 Dec 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    53718678RSV2006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04068792
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Highway 202, Raritan, NJ, United States, 08869-1420
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 May 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives were as follows: In Part 1 (Observational stage) was to evaluate the onset and evolution of clinical symptoms of pediatric RSV disease and to evaluate the relationship between RSV viral load and clinical symptoms at early diagnosis of pediatric RSV disease. In Part 2:(Interventional stage) was to evaluate antiviral activity of JNJ-53718678 as measured by RSV viral load in nasal swab samples by a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in an early intervention setting in infants (less than or equal to [<=]4 months of age at enrollment) recruited from a birth cohort.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electrocardiograms (ECGs), and vital signs, were performed throughout the interventional stage of the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 104
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Panama: 933
    Country: Number of subjects enrolled
    Taiwan: 148
    Worldwide total number of subjects
    1210
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    133
    Infants and toddlers (28 days-23 months)
    1077
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1210 subjects were enrolled in Observational phase. Out of 1210 subjects, 22 subjects entered the Interventional phase, 11 subjects in each placebo and JNJ-53718678 arms. All subjects in the interventional phase completed the study.

    Period 1
    Period 1 title
    Part 1: Observational Phase
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Observational Stage
    Arm description
    Subjects did not receive any intervention in the observational phase. Early signs and symptoms of Respiratory Syncytial Virus (RSV) disease were recorded daily using RSV app on parent/caregiver mobile phone. At a threshold score, infants received an RSV test (diagnostic phase) within 24 hours of receiving alert. RSV-negative subject (RSV[-]) returned to pre-diagnostic phase and further monitored using RSV mobile App. RSV-positive subject (RSV[+]) were enrolled in screening phase of interventional stage, after obtaining informed consent. RSV(+) subject whose parent/caregiver did not consent for enrollment in interventional stage and subject who were screen failures in interventional stage entered post-diagnostic phase of observational phase.
    Arm type
    RSV Mobile App

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects did not receive any intervention in Open-label phase. This phase was to only observe RSV symptoms using RSV mobile App.

    Number of subjects in period 1
    Observational Stage
    Started
    1210
    Completed
    35
    Not completed
    1175
         Protocol deviation
    1
         Technical problems
    1
         Other
    116
         Consent withdrawn by subject
    23
         RSV season
    1030
         Lost to follow-up
    4
    Period 2
    Period 2 title
    Part 2: Interventional Phase
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    As per original dosing, subjects were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 greater than or equal to [>=] 28 days and less than [<] 3 months: 5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 6 mg/kg and for Age Group 3 (>=6 months): 9 mg/kg) qd for 7 days. After Protocol amendment 2, subjects were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) bid for 7 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects in each age groups (1,2,3) were administered with JNJ-53718678 matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally once daily and twice daily (after protocol amendment 2) for 7 days.

    Arm title
    JNJ-53718678
    Arm description
    As per original dosing, subjects were randomized to receive JNJ-53718678 (for Age Group 1 greater than or equal to [>=] 28 days and less than [<] 3 months: 5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 6 mg/kg and for Age Group 3 (>=6 months): 9 mg/kg) once daily for 7 days. After Protocol amendment 2, subjects were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) twice daily for 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-53718678 5 mg/kg was administered to age group 1 once daily for 7 days. After protocol amendment 2, JNJ-53718678 2.5 mg/kg was administered to age group 1 twice daily for 7 days.

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-53718678 9 mg/kg was administered to age group 3 once daily for 7 days. After protocol amendment 2, JNJ-53718678 4.5 mg/kg was administered to age group 3 twice daily for 7 days.

    Investigational medicinal product name
    JNJ-53718678
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-53718678 6 mg/kg was administered to age group 2 one daily for 7 days. After protocol amendment 2, JNJ-53718678 3 mg/kg was administered to age group 2 twice daily for 7 days.

    Number of subjects in period 2 [1]
    Placebo JNJ-53718678
    Started
    11
    11
    Completed
    11
    11
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 35 subjects completed the baseline Observational period, 13 subjects completed only observational phase and 22 subjects entered and completed the interventional phase.

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Observational Stage
    Reporting group description
    Subjects did not receive any intervention in the observational phase. Early signs and symptoms of Respiratory Syncytial Virus (RSV) disease were recorded daily using RSV app on parent/caregiver mobile phone. At a threshold score, infants received an RSV test (diagnostic phase) within 24 hours of receiving alert. RSV-negative subject (RSV[-]) returned to pre-diagnostic phase and further monitored using RSV mobile App. RSV-positive subject (RSV[+]) were enrolled in screening phase of interventional stage, after obtaining informed consent. RSV(+) subject whose parent/caregiver did not consent for enrollment in interventional stage and subject who were screen failures in interventional stage entered post-diagnostic phase of observational phase.

    Reporting group values
    Observational Stage Total
    Number of subjects
    1210 1210
    Title for AgeCategorical
    Units: subjects
        Newborns
    133 133
        Infants and Toddlers
    1077 1077
    Title for AgeContinuous
    Units: months
        arithmetic mean (standard deviation)
    2 ± 1.14 -
    Title for Gender
    Units: subjects
        Female
    579 579
        Male
    629 629
        Unknown
    2 2

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Observational Stage
    Reporting group description
    Subjects did not receive any intervention in the observational phase. Early signs and symptoms of Respiratory Syncytial Virus (RSV) disease were recorded daily using RSV app on parent/caregiver mobile phone. At a threshold score, infants received an RSV test (diagnostic phase) within 24 hours of receiving alert. RSV-negative subject (RSV[-]) returned to pre-diagnostic phase and further monitored using RSV mobile App. RSV-positive subject (RSV[+]) were enrolled in screening phase of interventional stage, after obtaining informed consent. RSV(+) subject whose parent/caregiver did not consent for enrollment in interventional stage and subject who were screen failures in interventional stage entered post-diagnostic phase of observational phase.
    Reporting group title
    Placebo
    Reporting group description
    As per original dosing, subjects were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 greater than or equal to [>=] 28 days and less than [<] 3 months: 5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 6 mg/kg and for Age Group 3 (>=6 months): 9 mg/kg) qd for 7 days. After Protocol amendment 2, subjects were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) bid for 7 days.

    Reporting group title
    JNJ-53718678
    Reporting group description
    As per original dosing, subjects were randomized to receive JNJ-53718678 (for Age Group 1 greater than or equal to [>=] 28 days and less than [<] 3 months: 5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 6 mg/kg and for Age Group 3 (>=6 months): 9 mg/kg) once daily for 7 days. After Protocol amendment 2, subjects were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) twice daily for 7 days.

    Primary: Respiratory Syncytial Virus (RSV) Viral Load-time Curve from Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])

    Close Top of page
    End point title
    Respiratory Syncytial Virus (RSV) Viral Load-time Curve from Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])
    End point description
    RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. Intent-To-Treat-infected (ITT-i) analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of greater than or equal to (>=) 1 log10 copies per millilitre (mL) above the lower limit of quantification (LLOQ) of the RSV RT-qPCR assay at baseline.
    End point type
    Primary
    End point timeframe
    Baseline up to Day 5 of Interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: log10 copies*day per millilitre
        arithmetic mean (confidence interval 90%)
    26.13 (23.701 to 28.555)
    25.10 (22.497 to 27.707)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    JNJ-53718678 v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.03
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.467
         upper limit
    2.416

    Secondary: Change from Baseline in RSV Viral Load Over Time

    Close Top of page
    End point title
    Change from Baseline in RSV Viral Load Over Time
    End point description
    RSV viral load over time was measured by qRT-PCR in the nasal swab specimens. Log10 of the actual values as measured with qRT-PCR in nasal swab samples collected at the clinic visits and at home. ITT-i analysis set included all randomised subjects who received at least one dose of JNJ-53718678 and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomised. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    On Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21 of interventional phase
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    9
    Units: log10 copies per milliliter
    arithmetic mean (standard deviation)
        Day 2 (n= 10, 7)
    0.022 ± 0.9247
    -0.797 ± 1.8465
        Day 3 (n= 11, 9)
    -1.329 ± 2.3903
    -1.293 ± 1.6220
        Day 4 (n= 9, 8)
    -2.002 ± 2.7624
    -1.857 ± 1.9805
        Day 5 (n= 11, 6)
    -1.638 ± 1.4728
    -2.222 ± 1.4063
        Day 6 (n= 10, 6)
    -3.391 ± 2.8796
    -3.153 ± 1.5444
        Day 7 (n= 8, 6)
    -2.667 ± 1.8529
    -3.552 ± 1.1919
        Day 8 (n= 9, 8)
    -3.630 ± 1.5622
    -4.634 ± 1.6078
        Day 9 (n= 5, 4)
    -5.046 ± 1.8708
    -5.564 ± 2.2160
        Day 10 (n= 4, 4)
    -5.782 ± 2.3406
    -5.195 ± 2.3057
        Day 11 (n= 5, 3)
    -5.580 ± 1.8008
    -5.263 ± 2.7523
        Day 12 (n= 3, 3)
    -7.225 ± 0.9469
    -4.905 ± 3.4450
        Day 14 (n= 9, 8)
    -5.439 ± 2.0248
    -5.588 ± 2.7565
        Day 21 (n=11, 9)
    -5.907 ± 1.6829
    -6.514 ± 1.5001
    No statistical analyses for this end point

    Secondary: RSV Viral Load Area Under the curve (AUC) from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3 and 8

    Close Top of page
    End point title
    RSV Viral Load Area Under the curve (AUC) from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3 and 8
    End point description
    RSV viral load AUC will be determined by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized.
    End point type
    Secondary
    End point timeframe
    On the day of diagnosis (Baseline) through Days 3 and 8 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: log10 copies*hour per millilitre (h/mL)
    arithmetic mean (confidence interval 90%)
        Day 3
    14.44 (12.841 to 16.042)
    13.70 (11.990 to 15.406)
        Day 8
    39.20 (34.913 to 43.491)
    35.11 (31.342 to 38.880)
    No statistical analyses for this end point

    Secondary: Time to Undetectable RSV Viral Load

    Close Top of page
    End point title
    Time to Undetectable RSV Viral Load
    End point description
    Time to undetectable RSV viral load is defined as the time in hours from initiation of study treatment until the first post baseline time point at which the virus is undetectable in an assessment and after which time no detectable virus assessment follows as measured by qRT-PCR. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here, 99999 refers that upper limit of confidence interval was not estimable due to low numbers.
    End point type
    Secondary
    End point timeframe
    Up to 21 days of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Hours
        median (confidence interval 90%)
    500.1 (239.90 to 99999)
    391.4 (185.50 to 526.20)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Undetectable RSV Viral Load at each Time Point throughout the Study

    Close Top of page
    End point title
    Percentage of Subjects with Undetectable RSV Viral Load at each Time Point throughout the Study
    End point description
    Percentage of subjects with undetectable RSV viral load at each time point throughout the study were reported. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Here 'n' (number analyzed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21 of interventional phase
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Percentage of Subjects
    number (not applicable)
        Baseline (n=11, 10)
    0
    0
        Day 2 (n=10, 7)
    0
    14.3
        Day 3 (n=11, 9)
    9.1
    11.1
        Day 4 (n=9, 8)
    11.1
    12.5
        Day 5 (n=11, 6)
    0
    0
        Day 6 (n=10, 6)
    20.0
    16.7
        Day 7 (n=8, 6)
    0
    16.7
        Day 8 (n=9, 8)
    0
    25.0
        Day 9 (n=5, 4)
    20.0
    25.0
        Day 10 (n=4, 4)
    25.0
    25.0
        Day 11 (n=5, 3)
    20.0
    33.3
        Day 12 (n=3, 3)
    66.7
    33.3
        Day 14 (n=9, 8)
    33.3
    50.0
        Day 21 (n=11, 9)
    45.5
    66.7
    No statistical analyses for this end point

    Secondary: Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)

    Close Top of page
    End point title
    Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
    End point description
    Duration of signs and symptoms (sleep disturbance, crying, illness behavior, breathing problems, nasal secretions, tachypnea, tachycardia, retractions, breathing sounds, cough, feeding problems, dehydration) of RSV disease was assessed by PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 3, 5, 8, 14, 21 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Days
    arithmetic mean (standard deviation)
        Sleep Disturbance: Baseline (n=10,8)
    1.20 ± 0.919
    0.50 ± 0.535
        Sleep Disturbance: Day 3 (n=11,8)
    0.73 ± 0.647
    0.75 ± 0.886
        Sleep Disturbance: Day 5 (n=11,9)
    0.36 ± 0.505
    0.33 ± 0.500
        Sleep Disturbance: Day 8 (n=11,10)
    0.09 ± 0.302
    0.00 ± 0.000
        Sleep Disturbance: Day 14 (n=11,10)
    0.18 ± 0.405
    0.00 ± 0.000
        Sleep Disturbance: Day 21 (n=10,10)
    0.20 ± 0.422
    0.00 ± 0.000
        Crying: Baseline (n=10,8)
    0.50 ± 0.527
    0.50 ± 0.535
        Crying: Day 3 (n=11,8)
    0.45 ± 0.820
    0.38 ± 0.518
        Crying: Day 5 (n=11,9)
    0.27 ± 0.467
    0.22 ± 0.441
        Crying: Day 8 (n=11,10)
    0.09 ± 0.302
    0.10 ± 0.316
        Crying: Day 14 (n=11,10)
    0.09 ± 0.302
    0.00 ± 0.000
        Crying: Day 21 (n=10,10)
    0.10 ± 0.316
    0.00 ± 0.000
        Illness Behavior: Baseline (n=10,8)
    1.00 ± 0.943
    1.13 ± 0.991
        Illness Behavior: Day 3 (n=11,8)
    1.45 ± 0.688
    1.00 ± 0.756
        Illness Behavior: Day 5 (n=11,9)
    0.64 ± 0.809
    0.67 ± 0.866
        Illness Behavior: Day 8 (n=11,10)
    0.27 ± 0.647
    0.40 ± 0.843
        Illness Behavior: Day 14 (n=11,10)
    0.18 ± 0.603
    0.10 ± 0.316
        Illness Behavior: Day 21 (n=10,10)
    0.20 ± 0.632
    0.00 ± 0.000
        Breathing Problems: Baseline (n=10,8)
    0.00 ± 0.000
    0.25 ± 0.707
        Breathing Problems: Day 3 (n=11,8)
    0.64 ± 1.120
    0.00 ± 0.000
        Breathing Problems: Day 5 (n=11,9)
    0.00 ± 0.000
    0.00 ± 0.000
        Breathing Problems: Day 8 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Breathing Problems: Day 14 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Breathing Problems: Day 21 (n=10,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Nasal Secretions: Baseline (n=10,8)
    1.70 ± 0.483
    1.63 ± 0.518
        Nasal Secretions: Day 3 (n=11,8)
    1.36 ± 0.674
    1.00 ± 0.756
        Nasal Secretions: Day 5 (n=11,9)
    1.09 ± 0.701
    0.78 ± 0.667
        Nasal Secretions: Day 8 (n=11,10)
    0.91 ± 0.701
    0.50 ± 0.707
        Nasal Secretions: Day 14 (n=11,10)
    0.27 ± 0.647
    0.20 ± 0.422
        Nasal Secretions: Day 21 (n=10,10)
    0.30 ± 0.675
    0.00 ± 0.000
        Tachypnea: Baseline (n=10,8)
    0.40 ± 0.843
    0.00 ± 0.000
        Tachypnea: Day 3 (n=11,8)
    0.36 ± 0.809
    0.25 ± 0.707
        Tachypnea: Day 5 (n=11,9)
    0.18 ± 0.603
    0.22 ± 0.667
        Tachypnea: Day 8 (n=11,10)
    0.36 ± 0.809
    0.00 ± 0.000
        Tachypnea: Day 14 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Tachypnea: Day 21 (n=10,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Tachycardia: Baseline (n=10,8)
    0.20 ± 0.632
    0.00 ± 0.000
        Tachycardia: Day 3 (n=11,8)
    0.00 ± 0.000
    0.25 ± 0.707
        Tachycardia: Day 5 (n=11,9)
    0.00 ± 0.000
    0.00 ± 0.000
        Tachycardia: Day 8 (n=11,10)
    0.18 ± 0.603
    0.00 ± 0.000
        Tachycardia: Day 14 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Tachycardia: Day 21 (n=10,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Retractions: Baseline (n=10,8)
    0.40 ± 0.843
    0.25 ± 0.707
        Retractions: Day 3 (n=11,8)
    0.91 ± 1.044
    0.25 ± 0.707
        Retractions: Day 5 (n=11,9)
    0.18 ± 0.603
    0.22 ± 0.667
        Retractions: Day 8 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Retractions: Day 14 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Retractions: Day 21 (n=10,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Breathing Sounds: Baseline (n=10,8)
    2.10 ± 1.449
    1.00 ± 1.414
        Breathing Sounds: Day 3 (n=11,8)
    1.82 ± 1.471
    0.88 ± 1.246
        Breathing Sounds: Day 5 (n=11,9)
    1.55 ± 1.508
    0.67 ± 1.000
        Breathing Sounds: Day 8 (n=11,10)
    1.64 ± 1.567
    0.70 ± 1.160
        Breathing Sounds: Day 14 (n=11,10)
    0.55 ± 1.214
    0.20 ± 0.632
        Breathing Sounds: Day 21 (n=10,10)
    0.60 ± 1.265
    0.00 ± 0.000
        Cough: Baseline (n=10,8)
    2.40 ± 0.699
    1.88 ± 0.835
        Cough: Day 3 (n=11,8)
    2.18 ± 0.751
    2.00 ± 1.069
        Cough: Day 5 (n=11,9)
    2.00 ± 0.894
    1.11 ± 0.601
        Cough: Day 8 (n=11,10)
    1.45 ± 0.688
    0.70 ± 0.675
        Cough: Day 14 (n=11,10)
    0.27 ± 0.905
    0.30 ± 0.483
        Cough: Day 21 (n=10,10)
    0.30 ± 0.949
    0.10 ± 0.316
        Feeding Problems: Baseline (n=10,8)
    0.40 ± 0.516
    0.00 ± 0.000
        Feeding Problems: Day 3 (n=11,8)
    0.18 ± 0.405
    0.38 ± 0.518
        Feeding Problems: Day 5 (n=11,9)
    0.45 ± 0.688
    0.22 ± 0.441
        Feeding Problems: Day 8 (n=11,10)
    0.18 ± 0.603
    0.10 ± 0.316
        Feeding Problems: Day 14 (n=11,10)
    0.00 ± 0.000
    0.0 ± 0.000
        Feeding Problems: Day 21 (n=10,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Baseline (n=10,8)
    0.20 ± 0.632
    0.25 ± 0.707
        Dehydration: Day 3 (n=11,8)
    0.18 ± 0.603
    0.00 ± 0.000
        Dehydration: Day 5 (n=11,9)
    0.55 ± 0.934
    0.00 ± 0.000
        Dehydration: Day 8 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Day 14 (n=11,10)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Day 21 (n=10,10)
    0.00 ± 0.000
    0.00 ± 0.000
    No statistical analyses for this end point

    Secondary: Severity of Signs and Symptoms of RSV Infection Assessed by the PRESORS

    Close Top of page
    End point title
    Severity of Signs and Symptoms of RSV Infection Assessed by the PRESORS
    End point description
    The severity of signs and symptoms of RSV infection (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Unit on scale
    arithmetic mean (standard deviation)
        Baseline (n=10,8)
    0.88 ± 0.189
    0.61 ± 0.378
        Day 2 (n=10,8)
    0.95 ± 0.405
    0.81 ± 0.570
        Day 3 (n=11,8)
    0.86 ± 0.350
    0.59 ± 0.505
        Day 4 (n=11,8)
    0.83 ± 0.422
    0.47 ± 0.450
        Day 5 (n=11,9)
    0.61 ± 0.277
    0.37 ± 0.371
        Day 6 (n=11,9)
    0.52 ± 0.305
    0.32 ± 0.444
        Day 7 (n=11,8)
    0.32 ± 0.247
    0.25 ± 0.330
        Day 8 (n=11,10)
    0.43 ± 0.268
    0.21 ± 0.295
        Day 9 (n=11,7)
    0.27 ± 0.258
    0.10 ± 0.089
        Day 10 (n=11,10)
    0.23 ± 0.273
    0.13 ± 0.143
        Day 11 (n=11,9)
    0.19 ± 0.296
    0.09 ± 0.128
        Day 12 (n=11,9)
    0.17 ± 0.281
    0.12 ± 0.196
        Day 13 (n=11,10)
    0.14 ± 0.296
    0.13 ± 0.153
        Day 14 (n=11,9)
    0.13 ± 0.299
    0.06 ± 0.091
        Day 15 (n=11,7)
    0.12 ± 0.301
    0.06 ± 0.125
        Day 16 (n=10,10)
    0.16 ± 0.313
    0.03 ± 0.081
        Day 17 (n=8,9)
    0.16 ± 0.376
    0.06 ± 0.093
        Day 18 (n=9,10)
    0.13 ± 0.328
    0.08 ± 0.159
        Day 19 (n=10,8)
    0.14 ± 0.312
    0.05 ± 0.147
        Day 20 (n=9,10)
    0.16 ± 0.327
    0.05 ± 0.105
        Day 21 (n=9,9)
    0.16 ± 0.327
    0.01 ± 0.028
    No statistical analyses for this end point

    Secondary: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

    Close Top of page
    End point title
    Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores
    End point description
    Change from baseline in parent(s)/caregiver(s) PRESORS scores was reported. PRESORS Score consisted of 5-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Day 3, 5, 8, 14, 21 of interventional phase
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    10
    8
    Units: Units on scale
    arithmetic mean (standard deviation)
        Day 3 (n= 10,7)
    0.01 ± 0.341
    -0.02 ± 0.249
        Day 5 (n= 10,8)
    -0.27 ± 0.309
    -0.26 ± 0.437
        Day 8 (n= 10,8)
    -0.42 ± 0.314
    -0.39 ± 0.508
        Day 14 (n= 10,8)
    -0.73 ± 0.396
    -0.54 ± 0.396
        Day 21 (n= 9,8)
    -0.70 ± 0.408
    -0.60 ± 0.390
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinician PRESORS Score

    Close Top of page
    End point title
    Change from Baseline in Clinician PRESORS Score
    End point description
    Change from baseline in clinician (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) PRESORS scores was reported. PRESORS Score consisted of 5-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 3, 5, 8, 14, 21 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    9
    7
    Units: Units on scale
    arithmetic mean (standard deviation)
        Activity Level: Day 3 (8,7)
    -0.25 ± 0.707
    0.00 ± 0.000
        Activity Level: Day 5 (9,6)
    -0.44 ± 0.527
    0.00 ± 0.000
        Activity Level: Day 8 (9,6)
    -0.44 ± 0.527
    -0.17 ± 0.408
        Activity Level: Day 14 (9,4)
    -0.44 ± 0.527
    0.00 ± 0.000
        Activity Level: Day 21 (9,6)
    -0.44 ± 0.527
    -0.17 ± 0.408
        Sleep Disturbance: Day 3 (n=8,7)
    0.00 ± 0.756
    -0.29 ± 0.756
        Sleep Disturbance: Day 5 (n=9,7)
    -0.56 ± 0.527
    -0.29 ± 0.488
        Sleep Disturbance: Day 8 (n=9,7)
    -0.56 ± 0.572
    -0.43 ± 0.535
        Sleep Disturbance: Day 14 (n=9,6)
    -0.56 ± 0.572
    -0.33 ± 0.516
        Sleep Disturbance: Day 21 (n=9,7)
    -0.56 ± 0.572
    -0.57 ± 0.0535
        Breathing Problems: Day 3 (n=8,7)
    -0.13 ± 0.353
    0.00 ± 1.155
        Breathing Problems: Day 5 (n=9,7)
    -0.44 ± 1.333
    0.00 ± 1.155
        Breathing Problems: Day 8 (n=9,7)
    -0.44 ± 1.333
    -0.57 ± 0.976
        Breathing Problems: Day 14 (n=9,6)
    -0.89 ± 1.054
    -0.67 ± 1.033
        Breathing Problems: Day 21 (n=9,7)
    -0.89 ± 1.054
    -0.67 ± 1.033
        Retractions: Day 3 (n=8,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Retractions: Day 5 (n=9,7)
    -0.44 ± 0.882
    0.00 ± 0.000
        Retractions: Day 8 (n=9,7)
    -0.44 ± 0.882
    0.00 ± 0.000
        Retractions: Day 14 (n=9,6)
    -0.44 ± 0.882
    0.00 ± 0.000
        Retractions: Day 21 (n=9,7)
    -0.44 ± 0.882
    -0.29 ± 0.756
        Tachypnea: Day 3 (n=8,7)
    0.25 ± 0.707
    0.00 ± 0.000
        Tachypnea: Day 5 (n=9,7)
    0.00 ± 0.000
    -0.29 ± 0.756
        Tachypnea: Day 8 (n=9,7)
    0.00 ± 0.000
    -0.29 ± 0.756
        Tachypnea: Day 14 (n=9,6)
    0.00 ± 0.000
    0.00 ± 0.000
        Tachypnea: Day 21 (n=9,7)
    0.00 ± 0.000
    -0.29 ± 0756
        Feeding Problems: Day 3 (n=8,7)
    0.00 ± 1.069
    0.29 ± 0.756
        Feeding Problems: Day 5 (n=9,7)
    0.00 ± 1.000
    0.00 ± 0.000
        Feeding Problems: Day 8 (n=9,7)
    -0.22 ± 0.667
    0.00 ± 0.000
        Feeding Problems: Day 14 (n=9,6)
    -0.22 ± 0.667
    0.00 ± 0.000
        Feeding Problems: Day 21 (n=9,7)
    -0.22 ± 0.667
    0.00 ± 0.000
        Cough: Day 3 (n=8,7)
    -0.25 ± 1.488
    0.29 ± 0.488
        Cough: Day 5 (n=9,7)
    -1.11 ± 1.269
    0.43 ± 0.535
        Cough: Day 8 (n=9,7)
    -1.22 ± 1.093
    0.14 ± 0.378
        Cough: Day 14 (n=9,6)
    -1.33 ± 1.000
    0.33 ± 0.516
        Cough: Day 21 (n=9,7)
    -1.33 ± 1.000
    0.00 ± 0.000
        Nasal Secretions: Day 3 (n=8,7)
    0.25 ± 0.707
    -0.29 ± 0.488
        Nasal Secretions: Day 5 (n=9,7)
    -0.22 ± 0.667
    -0.29 ± 0.488
        Nasal Secretions: Day 8 (n=9,7)
    -0.22 ± 0.667
    -0.29 ± 0.488
        Nasal Secretions: Day 14 (n=9,6)
    -0.33 ± 0.500
    -0.33 ± 0.516
        Nasal Secretions: Day 21 (n=9,7)
    -0.33 ± 0.500
    -0.29 ± 0.488
        Wheezing: Day 3 (n=8,7)
    0.38 ± 0.744
    0.14 ± 0.378
        Wheezing: Day 5 (n=9,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Wheezing: Day 8 (n=9,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Wheezing: Day 14 (n=9,6)
    0.00 ± 0.000
    0.00 ± 0.000
        Wheezing: Day 21 (n=9,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Day 3 (n=8,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Day 5 (n=9,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Day 8 (n=9,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Day 14 (n=9,6)
    0.00 ± 0.000
    0.00 ± 0.000
        Dehydration: Day 21 (n=9,7)
    0.00 ± 0.000
    0.00 ± 0.000
    No statistical analyses for this end point

    Secondary: Time to Resolution of RSV Symptoms

    Close Top of page
    End point title
    Time to Resolution of RSV Symptoms
    End point description
    Time to resolution (that is, to none or mild) of RSV symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration) was recorded. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline.
    End point type
    Secondary
    End point timeframe
    Up to 21 days of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Hours
        median (confidence interval 90%)
    194.00 (164.20 to 238.00)
    118.60 (17.00 to 238.00)
    No statistical analyses for this end point

    Secondary: Time to Improvement on Overall Health

    Close Top of page
    End point title
    Time to Improvement on Overall Health
    End point description
    Time to improvement based on general questions on overall health was reported. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized.
    End point type
    Secondary
    End point timeframe
    Up to 21 days of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Hours
        median (confidence interval 90%)
    188.3 (183.60 to 238.00)
    199.7 (183.70 to 238.00)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Worsening or Improvement of RSV Disease

    Close Top of page
    End point title
    Percentage of Subjects with Worsening or Improvement of RSV Disease
    End point description
    Percentage of subjects with worsening or improvement of RSV disease based on general questions on overall health was reported. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    On Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 of interventional phase
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Percentage of Subjects
    number (not applicable)
        Day 2 : Very Much Improved (n=3,1)
    0
    0
        Day 2: Very Much Worse (n=3,1)
    0
    0
        Day 3: Very Much Improved (n=3,1)
    0
    0
        Day 3: Very Much Worse (n=3,1)
    0
    0
        Day 4: Very Much Improved (n=3,1)
    0
    0
        Day 4: Very Much Worse (n=3,1)
    0
    0
        Day 5: Very Much Improved (n=3,1)
    0
    0
        Day 5: Very Much Worse (n=3,1)
    0
    0
        Day 6: Very Much Improved (n=3,1)
    2
    0
        Day 6: Very Much Worse (n=3,1)
    0
    0
        Day 7: Very Much Improved (n=3,1)
    2
    0
        Day 7: Very Much Worse (n=3,1)
    0
    0
        Day 8: Very Much Improved (n=3,2)
    1
    1
        Day 8: Very Much Worse (n=3,2)
    0
    0
        Day 9: Very Much Improved (n=10,7)
    6
    3
        Day 9: Very Much Worse (n=10,7)
    0
    0
        Day 10: Very Much Improved (n=11,10)
    4
    5
        Day 10 Very Much Worse (n=11,10)
    0
    0
        Day 11 Very Much Improved (n=11,8)
    6
    3
        Day 11: Very Much Worse (n=11,8)
    0
    0
        Day 12 Very Much Improved (n=11,8)
    6
    5
        Day 12: Very Much Worse (n=11,8)
    0
    0
        Day 13 Very Much Improved (n=11,10)
    10
    5
        Day 13: Very Much Worse (n=11,10)
    0
    0
        Day 14: Very Much Improved (n=11,9)
    10
    5
        Day 14: Very Much Worse (n=11,9)
    0
    0
        Day 15: Very Much Improved (n=11,7)
    10
    4
        Day 15: Very Much Worse (n=11,7)
    0
    0
        Day 16: Very Much Improved (n=9,10)
    7
    8
        Day 16: Very Much Worse (n=9,10)
    0
    0
        Day 17: Very Much Improved (n=8,9)
    7
    8
        Day 17: Very Much Worse (n=8,9)
    0
    0
        Day 18: Very Much Improved (n=9,10)
    8
    8
        Day 18: Very Much Worse (n=9,10)
    0
    0
        Day 19: Very Much Improved (n=10,8)
    9
    6
        Day 19: Very Much Worse (n=10,8)
    0
    0
        Day 20: Very Much Improved (n=9,10)
    8
    7
        Day 20: Very Much Worse (n=9,10)
    0
    0
        Day 21: Very Much Improved (n=9,9)
    8
    7
        Day 21: Very Much Worse (n=9,9)
    0
    0
    No statistical analyses for this end point

    Secondary: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

    Close Top of page
    End point title
    Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)
    End point description
    Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) was evaluated. It is the time from first dose of study drug until the time to return to pre-RSV disease level. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline.
    End point type
    Secondary
    End point timeframe
    Up to 21 days of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    10
    Units: Hours
        median (confidence interval 90%)
    194.0 (164.20 to 238.00)
    118.6 (17.00 to 238.00)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Require (re)Hospitalization During Treatment and Follow-up

    Close Top of page
    End point title
    Percentage of Subjects who Require (re)Hospitalization During Treatment and Follow-up
    End point description
    Percentage of subjects who require (re)hospitalization during treatment and follow-up were reported. ITT-i analysis set included all randomized subjects who received at least one dose of study drug and who had a centrally confirmed RSV viral load of >=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized.
    End point type
    Secondary
    End point timeframe
    Up to 28 days of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    11
    Units: Percentage of subjects
        number (not applicable)
    9.1
    18.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Adverse Events as a Measure of Safety and Tolerability

    Close Top of page
    End point title
    Percentage of Subjects with Adverse Events as a Measure of Safety and Tolerability
    End point description
    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. The Safety set (SAF) included all subjects who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where ‘analyzed as treated’ is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
    End point type
    Secondary
    End point timeframe
    From screening up to maximum of Day 31 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    11
    Units: Percentage of subjects
        number (not applicable)
    27.3
    27.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormal Chemistry Laboratory Findings

    Close Top of page
    End point title
    Percentage of Subjects with Abnormal Chemistry Laboratory Findings
    End point description
    Percentage of subject with abnormal chemistry laboratory findings were reported. It included alanine aminotransferase (Grade 1 and 4), aspartate aminotransferase (Grade 1). Hyperkalemia (Grade 1 and 2). The safety set (SAF) included all subjects who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where ‘analyzed as treated’ is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all subjects who were analyzed at specified categories.
    End point type
    Secondary
    End point timeframe
    From screening up to Day 28 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    11
    Units: Percentage of Subject
    number (not applicable)
        Alanine Aminotransferase Increase-Grade1 (n=11,11)
    9.1
    0
        Alanine Aminotransferase Increase-Grade4 (n=11,11)
    9.1
    0
        Aspartate Aminotransferase- Grade 1 (n=11,11)
    9.1
    18.2
        Hyperkalemia-Grade 1 (n=10,11)
    30.0
    0
        Hyperkalemia-Grade 2 (n=10,11)
    10.0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormal Urinalysis Laboratory Findings

    Close Top of page
    End point title
    Percentage of Subjects with Abnormal Urinalysis Laboratory Findings
    End point description
    Percentage of subject with abnormal urinalysis (Hematuria- Grade 1) laboratory finding was reported. The Safety set (SAF) included all subjects who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where ‘analyzed as treated’ is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of subjects analyzed), included all subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From screening up to Day 28 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    4
    4
    Units: Percentage of Subject
        number (not applicable)
    0
    25.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormal Electrocardiograms (ECGs) Findings

    Close Top of page
    End point title
    Percentage of Subjects with Abnormal Electrocardiograms (ECGs) Findings
    End point description
    Percentage of subjects with abnormal ECGs findings were reported. Parameters for abnormal ECG finding were QTcB Interval ([450 millisecond [ms], 480 ms], [480 ms, 500 ms], and [more than 500 ms]), QTcF Interval ([450 ms, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), change from baseline for QTcB Interval (less than or equal [<=] 30 ms, [30; 60] ms, and greater than [>] 60 ms), and for QTcF Interval (<=30 ms, [30; 60] ms, and >60 ms). The Safety set (SAF) included all subjects who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where ‘analyzed as treated’ is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of subjects analyzed), included all subjects who were evaluable for this endpoint. Here 'n' (number analyzed) included all subjects who were analyzed for specified categories.
    End point type
    Secondary
    End point timeframe
    From screening up to Day 28 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    10
    11
    Units: Percentage of subjects
    number (not applicable)
        QTcB Interval [450 ms, 480 ms] (n=10,11)
    20.0
    9.1
        QTcB Interval [480 ms, 500 ms] (n=10,11)
    0
    0
        QTcB Interval (More than 500 ms) (n=10,11)
    0
    0
        QTcF Interval [450 ms, 480 ms] (n=10,11)
    0
    0
        QTcF Interval [480 ms, 500 ms] (n=10,11)
    0
    0
        QTcF Interval (More than 500 ms) (n=10,11)
    0
    0
        QTcB Interval (<=30 ms) (n=10,11)
    100.0
    90.9
        QTcB Interval [30; 60] ms (n=10,11)
    0
    9.1
        QTcB Interval (>60 ms) (n=10,11)
    0
    0
        QTcF Interval (<=30 ms) (n=10,11)
    100.0
    90.9
        QTcF Interval [30; 60] ms (n=10,11)
    0
    9.1
        QTcF Interval (>60 ms) (n=10,11)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Vital Sign Abnormalities

    Close Top of page
    End point title
    Percentage of Subjects with Vital Sign Abnormalities
    End point description
    Percentage of subjects with vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities (abnormally low [ABL] and abnormally high [ABH]) were reported. The Safety set (SAF) included all subjects who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where ‘analyzed as treated’ is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all subjects who were analyzed for specified categories.
    End point type
    Secondary
    End point timeframe
    From screening up to Day 28 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    11
    11
    Units: Percentage of subjects
    number (not applicable)
        SBP- ABL (n=11,10)
    9.1
    0
        SBP- ABH (n=11,10)
    0
    0
        DBP- ABL (n=11,10)
    9.1
    0
        DBP- ABH (n=11,10)
    0
    0
        Pulse rate- ABL (n=11,11)
    0
    0
        Pulse rate- ABH (n=11,11)
    9.1
    18.2
        Respiratory Rate-ABL (n=11,11)
    9.1
    0
        Respiratory Rate-ABH (n=11,11)
    0
    0
        Temperature-ABL (n=11,11)
    0
    0
        Temperature-ABH (n=11,11)
    27.3
    45.5
        Oxygen Saturation- ABL (n=10,6)
    0
    0
        Oxygen Saturation- ABH (n=10,6)
    0
    0
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of JNJ-53718678

    Close Top of page
    End point title
    Plasma Concentrations of JNJ-53718678
    End point description
    Pharmacokinetic (PK) analysis were not performed as the amount of data available was not sufficient for PK analysis.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 3 of interventional stage
    End point values
    Placebo JNJ-53718678
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: Nanograms per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [1] - PK analysis not performed due to insufficient data. Hence, 'N' (number of subjects analysed) is 0.
    [2] - PK analysis not performed due to insufficient data. Hence, 'N' (number of subjects analysed) is 0.
    No statistical analyses for this end point

    Secondary: Part 1: RSV Symptom Score

    Close Top of page
    End point title
    Part 1: RSV Symptom Score
    End point description
    RSV Symptom Score was captured by RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV positive subjects who do not enter in the interventional stage. Respiratory symptom severity score: breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, and nasal secretions. RSV positive (+) Analysis Set- Observational Stage: included all the subjects with a positive RSV diagnostic test who did not enter the interventional stage. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 2, 3, 4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 of observational stage
    End point values
    Observational Stage
    Number of subjects analysed
    13
    Units: Units on scale
    arithmetic mean (standard deviation)
        Baseline (n=13)
    0.71 ± 0.456
        Day 2 (n=11)
    0.51 ± 0.199
        Day 3 (n=12)
    0.58 ± 0.452
        Day 4 (n=12)
    0.51 ± 0.290
        Day 5 (n=9)
    0.36 ± 0.228
        Day 6 (n=9)
    0.47 ± 0.325
        Day 7 (n=8)
    0.30 ± 0.227
        Day 8 (n=8)
    0.44 ± 0.456
        Day 9 (n=11)
    0.30 ± 0.267
        Day 10 (n=7)
    0.30 ± 0.438
        Day 11 (n=9)
    0.28 ± 0.339
        Day 12 (n=9)
    0.17 ± 0.167
        Day 13 (n=10)
    0.26 ± 0.337
        Day 14 (n=8)
    0.08 ± 0.118
        Day 15 (n=8)
    0.26 ± 0.346
        Day 16 (n=8)
    0.31 ± 0.415
        Day 17 (n=11)
    0.17 ± 0.209
        Day 18 (n=6)
    0.18 ± 0.214
        Day 19 (n=8)
    0.18 ± 0.250
        Day 20 (n=8)
    0.23 ± 0.317
        Day 21 (n=6)
    0.24 ± 0.374
    No statistical analyses for this end point

    Secondary: Part 1: PRESORS Scores by the Clinician (Clinician PRESORS) on the Day of RSV Diagnosis

    Close Top of page
    End point title
    Part 1: PRESORS Scores by the Clinician (Clinician PRESORS) on the Day of RSV Diagnosis
    End point description
    Clinician PRESORS scores will be reported for hospitalized RSV positive participants. Clinician PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician. RSV (+) Analysis Set- Observational Stage: included all the subjects with a positive RSV diagnostic test who did not enter the interventional stage. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    On the day of RSV diagnosis (Baseline) up to Discharge post-diagnosis (21 Days) of observational stage
    End point values
    Observational Stage
    Number of subjects analysed
    13
    Units: units on scale
    arithmetic mean (standard deviation)
        Activity Level (n=11)
    0.18 ± 0.405
        Sleep Disturbance (n=13)
    0.38 ± 0.506
        Breathing Problems (n=13)
    0.38 ± 0.961
        Retractions (n=13)
    0.31 ± 0.751
        Tachypnea (n=13)
    0.15 ± 0.555
        Feeding Problems (n=13)
    0.69 ± 1.109
        Cough (n=13)
    0.54 ± 0.519
        Nasal Secretions (n=13)
    0.85 ± 0.689
        Wheezing (n=13)
    0.00 ± 0.000
        Dehydration (n=13)
    0.00 ± 0.000
    No statistical analyses for this end point

    Secondary: Part 1: RSV Viral Load During Pre-Diagnostic Phase

    Close Top of page
    End point title
    Part 1: RSV Viral Load During Pre-Diagnostic Phase
    End point description
    RSV Viral load during pre-diagnostic phase was determined based on measurements of RSV viral load in nasal secretions by a qRT-PCR assay in mid-turbinate nasal swab specimens. All Enrolled Analysis Set- Observational Stage included all subjects who signed the ICF of the observational stage and were classified as eligible. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Pre-diagnostic phase: Within 24hrs of Observation Day 1
    End point values
    Observational Stage
    Number of subjects analysed
    12
    Units: Log10 copies/mL
        arithmetic mean (standard deviation)
    7.529 ± 1.1371
    No statistical analyses for this end point

    Secondary: Part 1: RSV Viral Load Kinetics from Day 1 to Day 8

    Close Top of page
    End point title
    Part 1: RSV Viral Load Kinetics from Day 1 to Day 8
    End point description
    RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage) was measured by real-time qRT-PCR assay in the mid-turbinate nasal swab specimens. RSV (+) Analysis Set- Observational Stage: included all the subjects with a positive RSV diagnostic test who did not enter the interventional stage. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    From Baseline Day 2, 3, 4, 5, 6, 7, 8 of observational stage
    End point values
    Observational Stage
    Number of subjects analysed
    12
    Units: Log10 copies/mL
    arithmetic mean (standard deviation)
        Baseline (n=12)
    7.194 ± 0.9462
        Day 2 (n=7)
    6.495 ± 1.8904
        Day 3 (n=7)
    5.937 ± 1.7768
        Day 4 (n=7)
    4.947 ± 1.4159
        Day 5 (n=6)
    3.274 ± 1.9774
        Day 6 (n=6)
    3.068 ± 1.9636
        Day 7 (n=4)
    2.595 ± 1.8282
        Day 8 (n=6)
    2.675 ± 1.4538
    No statistical analyses for this end point

    Secondary: Part 1: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Over Time

    Close Top of page
    End point title
    Part 1: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Over Time
    End point description
    Change from baseline in Parent(s)/Caregiver(s) (for concepts: sleep disturbance, crying, illness behavior, breathing problems, retractions, tachypnea, tachycardia, breathing sounds, feeding problem, cough, nasal secretions, dehydration) PRESORS scores was reported. PRESORS Score consisted of 5-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. RSV (+) Analysis Set- Observational Stage: included all the subjects with a positive RSV diagnostic test who did not enter the interventional stage. Here 'N' (number of subjects analysed), included all subjects who were evaluable for this endpoint. Here 'n' (number analysed) included all subjects who were analysed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    From baseline to Day 3, 5, 8, 14, 21 of the observational stage
    End point values
    Observational Stage
    Number of subjects analysed
    13
    Units: Units on scale
    arithmetic mean (standard deviation)
        Sleep Disturbance: Baseline (n=13)
    0.54 ± 0.660
        Sleep Disturbance: Day 3 (n=12)
    0.58 ± 0.669
        Sleep Disturbance: Day 5 (n=12)
    0.25 ± 0.452
        Sleep Disturbance: Day 8 (n=12)
    0.50 ± 0.798
        Sleep Disturbance: Day 14 (n=11)
    0.18 ± 0.405
        Sleep Disturbance: Day 21 (n=10)
    0.30 ± 0.675
        Crying: Baseline (n=13)
    0.77 ± 1.013
        Crying: Day 3 (n=12)
    0.25 ± 0.452
        Crying: Day 5 (n=12)
    0.08 ± 0.289
        Crying: Day 8 (n=12)
    0.08 ± 0.289
        Crying: Day 14 (n=11)
    0.09 ± 0.302
        Crying: Day 21 (n=10)
    0.10 ± 0.316
        Illness Behavior: Baseline (n=13)
    1.15 ± 0.899
        Illness Behavior: Day 3 (n=12)
    0.58 ± 0.793
        Illness Behavior: Day 5 (n=12)
    0.58 ± 0.793
        Illness Behavior: Day 8 (n=12)
    0.83 ± 1.030
        Illness Behavior: Day 14 (n=11)
    0.45 ± 0.820
        Illness Behavior: Day 21 (n=10)
    0.40 ± 0.843
        Breathing Problems: Baseline (n=13)
    0.31 ± 0.751
        Breathing Problems: Day 3 (n=12)
    0.42 ± 0.996
        Breathing Problems: Day 5 (n=12)
    0.17 ± 0.577
        Breathing Problems: Day 8 (n=12)
    0.50 ± 1.168
        Breathing Problems: Day 14 (n=11)
    0.27 ± 0.905
        Breathing Problems: Day 21 (n=10)
    0.30 ± 0.949
        Nasal Secretions: Baseline (n=13)
    1.23 ± 0.725
        Nasal Secretions: Day 3 (n=12)
    1.25 ± 0.754
        Nasal Secretions: Day 5 (n=12)
    0.92 ± 0.793
        Nasal Secretions: Day 8 (n=12)
    0.83 ± 0.835
        Nasal Secretions: Day 14 (n=11)
    0.45 ± 0.820
        Nasal Secretions: Day 21 (n=10)
    0.70 ± 0.949
        Tachypnea: Baseline (n=13)
    0.31 ± 0.751
        Tachypnea: Day 3 (n=12)
    0.17 ± 0.577
        Tachypnea: Day 5 (n=12)
    0.17 ± 0.577
        Tachypnea: Day 8 (n=12)
    0.17 ± 0.577
        Tachypnea: Day 14 (n=11)
    0.00 ± 0.000
        Tachypnea: Day 21 (n=10)
    0.00 ± 0.000
        Tachycardia: Baseline (n=13)
    0.31 ± 0.751
        Tachycardia: Day 3 (n=12)
    0.17 ± 0.577
        Tachycardia: Day 5 (n=12)
    0.00 ± 0.000
        Tachycardia: Day 8 (n=12)
    0.00 ± 0.000
        Tachycardia: Day 14 (n=11)
    0.00 ± 0.000
        Tachycardia: Day 21 (n=10)
    0.00 ± 0.000
        Retractions: Baseline (n=13)
    0.31 ± 0.751
        Retractions: Day 3 (n=12)
    0.17 ± 0.577
        Retractions: Day 5 (n=12)
    0.25 ± 0.866
        Retractions: Day 8 (n=12)
    0.00 ± 0.000
        Retractions: Day 14 (n=11)
    0.00 ± 0.000
        Retractions: Day 21 (n=10)
    0.00 ± 0.000
        Breathing Sounds: Baseline (n=13)
    1.08 ± 1.441
        Breathing Sounds: Day 3 (n=12)
    1.33 ± 1.435
        Breathing Sounds: Day 5 (n=12)
    1.42 ± 1.505
        Breathing Sounds: Day 8 (n=12)
    0.50 ± 1.168
        Breathing Sounds: Day 14 (n=11)
    0.55 ± 1.214
        Breathing Sounds: Day 21 (n=10)
    0.90 ± 1.197
        Cough: Baseline (n=13)
    2.08 ± 0.954
        Cough: Day 3 (n=12)
    1.50 ± 0.674
        Cough: Day 5 (n=12)
    1.25 ± 0.754
        Cough: Day 8 (n=12)
    1.08 ± 0.793
        Cough: Day 14 (n=11)
    0.45 ± 0.688
        Cough: Day 21 (n=10)
    0.40 ± 0.516
        Feeding Problems: Baseline (n=13)
    0.46 ± 0.877
        Feeding Problems: Day 3 (n=12)
    0.25 ± 0.452
        Feeding Problems: Day 5 (n=12)
    0.33 ± 0.651
        Feeding Problems: Day 8 (n=12)
    0.17 ± 0.389
        Feeding Problems: Day 14 (n=11)
    0.00 ± 0.000
        Feeding Problems: Day 21 (n=10)
    0.00 ± 0.000
        Dehydration: Baseline (n=13)
    0.00 ± 0.000
        Dehydration: Day 3 (n=12)
    0.25 ± 0.866
        Dehydration: Day 5 (n=12)
    0.00 ± 0.000
        Dehydration: Day 8 (n=12)
    0.00 ± 0.000
        Dehydration: Day 14 (n=11)
    0.18 ± 0.603
        Dehydration: Day 21 (n=10)
    0.00 ± 0.000
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 1 year 7 months
    Adverse event reporting additional description
    The Safety set (SAF) included all subjects who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where ‘analysed as treated’ is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Interventional Phase: JNJ-53718678
    Reporting group description
    As per original dosing, subjects were randomized to receive JNJ-53718678 (for Age Group 1 greater than or equal to [>=] 28 days and less than [<] 3 months: 5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 6 mg/kg and for Age Group 3 (>=6 months): 9 mg/kg) once daily for 7 days. After Protocol amendment 2, subjects were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) twice daily for 7 days.

    Reporting group title
    Interventional Phase: Placebo
    Reporting group description
    As per original dosing, subjects were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 greater than or equal to [>=] 28 days and less than [<] 3 months: 5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 6 mg/kg and for Age Group 3 (>=6 months): 9 mg/kg) qd for 7 days. After Protocol amendment 2, subjects were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) bid for 7 days.

    Serious adverse events
    Interventional Phase: JNJ-53718678 Interventional Phase: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Interventional Phase: JNJ-53718678 Interventional Phase: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 11 (27.27%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Atopic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Dermatitis Diaper
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2019
    The overall reason is to update the protocol to add the missing part of the Visit Schedule for Rash Management in Pediatric Subjects.
    05 Jun 2020
    The overall reason for the amendment is to implement a risk mitigation plan for the newly recruited subjects in the interventional stage following identification of an exposure (Cmax)-related important potential risk of QT interval prolongation identified in the thorough QT (TQT) Study 53718678RSV1009 in healthy adult subjects.
    13 Jul 2020
    The overall reason is to implement recommendations from Health Authorities (HA).

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Oct 2020
    The core eResearchTechnology (ERT), clinical servers were disconnected from the internet, but they were not powered off, thereby eliminating the risk of potential data loss during a system re-start. During the service interruption, data could be collected locally on an ECG or eCOA device as normal. No new sites could be initiated while the servers were offline, however, existing sites could enroll new subjects. Application reminders, notifications, or alerts continued to trigger. For ECG services, sites were reminded about storage capacity and the need to request new storage cards, if capacity were reached. In addition, a process was available for sites to submit urgent ECGs for a preliminary ERT cardiology review during the outage. Internet connectivity to ERT’s servers was fully restored in a phased approach that started on 01 October 2020 and completed on 29 October 2020. By this time, all data on local devices could be transmitted to ERT’s servers.
    29 Oct 2020

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The required number of subjects in the interventional phase was not reached, and hence, limiting the interpretability of the data.
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA