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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2017-003252-24
    Trial protocol
    		 BE   ES   SE   PL   BG  
    Global end of trial date
    26 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2021
    First version publication date
    06 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    53718678RSV2004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03379675
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development LLC
    Sponsor organisation address
    920 US, Route 202, P.O. Box 300, Raritan, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, 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
    02 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was 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.
    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 were evaluated throughout the study from signing of the informed consent form (ICF) until the last study-related activity. Safety evaluations included monitoring of adverse events (AEs), clinical laboratory tests, vital signs measurements, physical examinations, electrocardiograms (ECGs), and assessment of specific toxicities.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 7
    Country: Number of subjects enrolled
    Brazil: 5
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Ukraine: 3
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    72
    EEA total number of subjects
    27
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    54
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 79 subjects were screened for this study, but only 72 subjects were randomized and received intervention. Out of the 72, 66 were RSV positive and thus included in the intent-to-treat infected (ITT-i) analysis.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo as an oral solution once daily for 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered matching placebo once daily for 7 days.

    Arm title
    		 JNJ-53718678 80 mg
    Arm description
    		 Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-53718678 80 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered JNJ-53718678 80 mg once daily for 7 days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered JNJ-53718678 80 mg once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding.

    Arm title
    		 JNJ-53718678 500 mg
    Arm description
    		 Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-53718678 500 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered JNJ-53718678 500 mg once daily for 7 days.

    Number of subjects in period 1
    		Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Started
    24
    24
    24
    Completed
    22
    22
    20
    Not completed
    2
    2
    4
         Consent withdrawn by subject
    2
    1
    2
         Adverse event, non-fatal
    -
    -
    2
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo as an oral solution once daily for 7 days.

    Reporting group title
    JNJ-53718678 80 mg
    Reporting group description
    		 Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding.

    Reporting group title
    JNJ-53718678 500 mg
    Reporting group description
    		 Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days.

    Reporting group values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg Total
    Number of subjects
    		 24 24 24 72
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    		 17 22 15 54
        From 65 to 84 years
    		 7 2 9 18
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.9 ( 14.16 ) 48.4 ( 17.39 ) 51.7 ( 17.89 ) -
    Title for Gender
    Units: subjects
        Female
    		 14 11 12 37
        Male
    		 10 13 12 35

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo as an oral solution once daily for 7 days.

    Reporting group title
    JNJ-53718678 80 mg
    Reporting group description
    		 Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding.

    Reporting group title
    JNJ-53718678 500 mg
    Reporting group description
    		 Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days.

    Primary: Area Under the Respiratory Syncytial Virus (RSV) Viral Load-time Curve (AUC) Over Time

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    End point title
    		 Area Under the Respiratory Syncytial Virus (RSV) Viral Load-time Curve (AUC) Over Time [1]
    End point description
    Area under the RSV Viral Load (VL)-time curve 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. The intent-to-treat-infected (ITT-i) population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of subjects who were analyzed at specified timepoints.
    End point type
    Primary
    End point timeframe
    Baseline through Days 3, 5, 8 and 14
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analyses was performed.
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    21
    21
    21
    Units: Log10 copies*hr/mL
    arithmetic mean (standard deviation)
        Day 3 (n=21,21,21)
    203.4 ( 87.63 )
    246.3 ( 67.39 )
    207.3 ( 89.55 )
        Day 5 (n=21,21,20)
    340.4 ( 148.30 )
    424.2 ( 145.73 )
    344.5 ( 189.40 )
        Day 8 (n=21,21,20)
    486.1 ( 254.15 )
    612.3 ( 253.29 )
    470.7 ( 305.38 )
        Day 14 (n=20,19,20)
    619.9 ( 394.15 )
    747.1 ( 352.25 )
    534.4 ( 379.92 )
    No statistical analyses for this end point

    Primary: Change from Baseline in RSV Viral Load Over Time

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    End point title
    		 Change from Baseline in RSV Viral Load Over Time [2]
    End point description
    Change from baseline in RSV viral load over time was measured as log10 copies per milliliter (Log10 copies/mL) by qRT-PCR assay in the mid-turbinate nasal swab specimens. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of subjects who were analyzed at specified timepoints.
    End point type
    Primary
    End point timeframe
    Baseline up to Day 21
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analyses was performed.
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: Log10 copies/mL
    arithmetic mean (standard deviation)
        Day 2 (n=19,20,22)
    -0.865 ( 1.0917 )
    -0.373 ( 1.2557 )
    -0.862 ( 1.9590 )
        Day 3 (n=20,20,21)
    -2.221 ( 1.7093 )
    -1.436 ( 1.6165 )
    -2.210 ( 1.7185 )
        Day 4 (n=20,21,20)
    -2.325 ( 2.1919 )
    -2.300 ( 1.8980 )
    -2.670 ( 1.8937 )
        Day 5 (n=20,21,20)
    -3.031 ( 1.5010 )
    -2.324 ( 1.6727 )
    -3.156 ( 2.2887 )
        Day 6 (n=20,21,20)
    -3.169 ( 1.3263 )
    -3.149 ( 1.6325 )
    -3.448 ( 2.1068 )
        Day 7 (n=19,21,20)
    -3.312 ( 1.3333 )
    -3.093 ( 1.8236 )
    -3.746 ( 1.9299 )
        Day 8 (n=21,20,18)
    -3.953 ( 1.5674 )
    -3.983 ( 1.3928 )
    -4.960 ( 1.7804 )
        Day 9 (n=12,11,8)
    -4.095 ( 1.8738 )
    -5.236 ( 2.1955 )
    -4.227 ( 3.2780 )
        Day 10 (n=10,10,9)
    -3.861 ( 1.3354 )
    -5.207 ( 1.6821 )
    -5.186 ( 1.9710 )
        Day 11 (n=7,8,7)
    -5.267 ( 1.7261 )
    -5.108 ( 1.8076 )
    -4.824 ( 2.3663 )
        Day 12 (n=7,7,7)
    -5.553 ( 2.2298 )
    -5.248 ( 1.7249 )
    -5.488 ( 2.0944 )
        Day 13 (n=6,6,7)
    -6.629 ( 1.6551 )
    -5.454 ( 1.7934 )
    -5.488 ( 2.0944 )
        Day 14 (n=19,18,19)
    -4.858 ( 1.7419 )
    -5.777 ( 1.6183 )
    -5.135 ( 1.6444 )
        Day 21 (n=20,19,20)
    -5.129 ( 1.6513 )
    -5.898 ( 1.6421 )
    -5.433 ( 2.1416 )
    No statistical analyses for this end point

    Primary: RSV Viral Load Over Time

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    End point title
    		 RSV Viral Load Over Time [3]
    End point description
    RSV viral load over time was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of subjects who were analyzed at specified timepoints.
    End point type
    Primary
    End point timeframe
    Baseline up to Day 21
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analyses was performed.
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: Log10 copies/mL
    arithmetic mean (standard deviation)
        Baseline
    5.285 ( 1.7158 )
    5.851 ( 1.6777 )
    5.523 ( 1.7911 )
        Day 2 (n=19,20,22)
    4.495 ( 2.2524 )
    5.511 ( 1.2844 )
    4.626 ( 2.0161 )
        Day 3 (n=20,20,21)
    3.160 ( 2.2603 )
    4.448 ( 1.9513 )
    3.267 ( 2.5490 )
        Day 4 (n=20,21,20)
    3.057 ( 1.7489 )
    3.551 ( 2.1392 )
    2.870 ( 2.5162 )
        Day 5 (n=20,21,20)
    2.351 ( 2.1302 )
    3.528 ( 1.9824 )
    2.384 ( 2.4214 )
        Day 6 (n=20,21,20)
    2.213 ( 1.7570 )
    2.703 ( 2.1637 )
    2.092 ( 2.3186 )
        Day 7 (n=19,21,20)
    2.152 ( 2.0668 )
    2.758 ( 1.6277 )
    1.795 ( 2.0617 )
        Day 8 (n=21,20,18)
    1.398 ( 1.5958 )
    1.804 ( 1.7888 )
    0.661 ( 1.5572 )
        Day 9 (n=12,11,8)
    1.413 ( 1.6205 )
    0.960 ( 1.7302 )
    1.647 ( 1.9728 )
        Day 10 (n=10,10,9)
    1.569 ( 1.7910 )
    0.818 ( 1.7313 )
    0.619 ( 1.2299 )
        Day 11 (n=7,8,7)
    1.910 ( 1.5213 )
    0.579 ( 1.6379 )
    0.664 ( 1.1385 )
        Day 12 (n=7,7,7)
    0.905 ( 1.5454 )
    0.470 ( 1.2425 )
    0.000 ( 0.0000 )
        Day 13 (n=6,6,7)
    0.000 ( 0.0000 )
    0.000 ( 0.0000 )
    0.000 ( 0.0000 )
        Day 14 (n=19,18,19)
    0.492 ( 0.9910 )
    0.290 ( 0.8579 )
    0.421 ( 1.2601 )
        Day 21 (n=20,19,20)
    0.253 ( 0.7866 )
    0.113 ( 0.4932 )
    0.108 ( 0.4808 )
    No statistical analyses for this end point

    Primary: Time to Undetectable RSV Viral Load

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    End point title
    		 Time to Undetectable RSV Viral Load [4]
    End point description
    The time to undetectable nasal RSV RNA viral load was defined as the time to the first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
    End point type
    Primary
    End point timeframe
    Up to Day 21
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analyses was performed.
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: days
        median (confidence interval 90%)
    9.7 (7.03 to 11.74)
    8.0 (6.86 to 12.80)
    7.0 (5.92 to 9.90)
    No statistical analyses for this end point

    Primary: Number of Subjects with Undetectable RSV Viral Load

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    End point title
    		 Number of Subjects with Undetectable RSV Viral Load [5]
    End point description
    The number of subjects with undetectable RSV viral load over time were reported. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, n (subjects analyzed) signifies the number of subjects analyzed at specified timepoints.
    End point type
    Primary
    End point timeframe
    Baseline up to Day 21
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analyses was performed.
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: subjects
        Baseline
    0
    0
    0
        Day 2 (n=19,20,22)
    1
    0
    1
        Day 3 (n=20,20,21)
    4
    1
    6
        Day 4 (n=20,21,20)
    3
    3
    6
        Day 5 (n=20,21,20)
    7
    3
    8
        Day 6 (n=20,21,20)
    6
    7
    9
        Day 7 (n=19,21,20)
    7
    4
    10
        Day 8 (n=21,20,18)
    11
    9
    15
        Day 9 (n=12,11,8)
    6
    8
    4
        Day 10 (n=10,10,9)
    5
    8
    7
        Day 11 (n=7,8,7)
    4
    7
    5
        Day 12 (n=7,7,7)
    5
    6
    7
        Day 13 (n=6,6,7)
    6
    6
    7
        Day 14 (n=19,18,19)
    15
    16
    17
        Day 21 (n=20,19,20)
    18
    18
    19
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse Events (AEs) as a Measure of Safety and Tolerability

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    End point title
    		 Number of subjects with Adverse Events (AEs) as a Measure of Safety and Tolerability
    End point description
    An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. The safety population included randomized subjects who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    24
    24
    24
    Units: subjects
    15
    18
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Laboratory Abnormalities

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    End point title
    		 Number of Subjects with Clinically Significant Laboratory Abnormalities
    End point description
    Number of subjects with clinically significant laboratory (serum chemistry, hematology and urinalyses) abnormalities were reported. The safety population included randomized subjects who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    24
    24
    24
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment Emergent Vital Sign Abnormalities

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    End point title
    		 Number of Subjects with Treatment Emergent Vital Sign Abnormalities
    End point description
    The subjects were analyzed for abnormalities in vital sign parameters like diastolic blood pressure (DBP), oxygen saturation, pulse rate, respiratory rate (RR), systolic blood pressure (SBP) and temperature. The classification was based on division of microbiology and infectious diseases (DMID) scale. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, n (subjects analyzed) signifies the number of subjects analyzed at specified categories.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    24
    24
    24
    Units: subjects
        Abnormally low DBP (n=21,21,22)
    2
    0
    0
        Mild increased DBP (n=21,21,22)
    0
    3
    0
        Moderate increased DBP (n=21,21,22)
    0
    0
    1
        Abnormally low oxygen saturation (n=21,21,22)
    2
    1
    2
        Abnormally high pulse rate (n=21,21,22)
    1
    0
    0
        Mild increased RR (n=21,21,22)
    3
    3
    0
        Moderate increased RR (n=21,21,22)
    2
    1
    1
        Severe increased RR (n=21,21,22)
    0
    1
    0
        Abnormally low SBP (n=21,21,22)
    1
    1
    0
        Mild increased SBP (n=21,21,22)
    3
    4
    1
        Moderate increased SBP (n=21,21,22)
    1
    0
    0
        Severe increased SBP (n=21,21,22)
    0
    0
    1
        Abnormally high temperature (n=22,21,22)
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Worst Treatment Emergent Electrocardiograms (ECGs) Abnormalities

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    End point title
    		 Number of Subjects with Worst Treatment Emergent Electrocardiograms (ECGs) Abnormalities
    End point description
    The number of subjects with ECG abnormalities were reported. The ECG variables that were analyzed are heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. The safety population included randomized subjects who received at least one dose of study drug. Here, 'n' (subjects analyzed) signifies number of subjects analyzed for specified categories.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    24
    24
    24
    Units: subjects
        Abnormally low heart rate (n=23,24,22)
    1
    1
    0
        Abnormally high PR interval (n=21,24,22)
    0
    0
    1
        Abnormally high QRS interval (n=23,24,22)
    0
    0
    1
        QTcB Increase 30 and 60ms (Bazett) (n=23,24,22)
    1
    2
    5
        QTcF Increase 30 and 60ms (Fridericia)(n=23,24,22)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Abnormalities in Physical Examination

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    End point title
    		 Number of Subjects With Abnormalities in Physical Examination
    End point description
    A physical examination (including height [only at screening] and body weight measurements) and skin examination were performed. A skin examination included an examination of the mucous membranes, but not a vaginal or rectal examination. The safety population included randomized subjects who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: subjects
    Notes
    [6] - Clinically relevant treatment emergent abnormalities were reported as adverse events.
    [7] - Clinically relevant treatment emergent abnormalities were reported as adverse events.
    [8] - Clinically relevant treatment emergent abnormalities were reported as adverse events.
    No statistical analyses for this end point

    Secondary: Time to Resolution of Selected RSV Symptoms as Assessed by RI-PRO

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    End point title
    		 Time to Resolution of Selected RSV Symptoms as Assessed by RI-PRO
    End point description
    Resolution of RSV symptoms was defined as a score of ‘Not at all’ (score = 0) or ‘A little bit’ (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. RI-PRO is a 32 items questionnaire computed in six domain scores, representing symptom severity. Selected RSV symptoms include symptoms in the following domains: Nose, Throat, Chest/respiratory and Body/systemic. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: days
        median (confidence interval 90%)
    10.6 (6.40 to 15.90)
    7.4 (5.05 to 9.52)
    7.7 (6.36 to 18.92)
    No statistical analyses for this end point

    Secondary: Time to Return to Usual Activity/Health Based on RI-PRO

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    End point title
    		 Time to Return to Usual Activity/Health Based on RI-PRO
    End point description
    Time from the first dose of study drug until the time of 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. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: days
    median (confidence interval 90%)
        Time to return to usual activity
    5.6 (4.62 to 10.62)
    3.0 (1.39 to 7.88)
    6.0 (2.99 to 8.33)
        Time to return to usual health
    9.1 (5.62 to 10.64)
    8.6 (5.57 to 10.81)
    8.3 (5.51 to 11.87)
    No statistical analyses for this end point

    Secondary: Peripheral Capillary Oxygen Saturation (SpO2) Over Time

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    End point title
    		 Peripheral Capillary Oxygen Saturation (SpO2) Over Time
    End point description
    Oxygen saturation was measured by the investigator over time. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 3, 8, 14 and 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    21
    21
    22
    Units: Percentage of SpO2 (%)
    arithmetic mean (standard deviation)
        Baseline (n=21,21,22)
    95.8 ( 2.74 )
    96.0 ( 2.60 )
    95.6 ( 2.72 )
        Day 3 (n=20,21,21)
    95.7 ( 3.57 )
    96.8 ( 2.17 )
    95.8 ( 2.62 )
        Day 8 (n=21,21,19)
    96.9 ( 2.26 )
    96.5 ( 2.23 )
    97.2 ( 1.69 )
        Day 14 (n=20,19,20)
    96.7 ( 1.81 )
    96.6 ( 2.14 )
    97.4 ( 0.99 )
        Day 21 (n=20,19,20)
    96.6 ( 2.41 )
    97.1 ( 1.47 )
    97.1 ( 1.23 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Peripheral Capillary Oxygen saturation

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    End point title
    		 Change from Baseline in Peripheral Capillary Oxygen saturation
    End point description
    Change from baseline in oxygen saturation levels was calculated by the investigator. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Days 3, 8, 14 and 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: % of SpO2
    arithmetic mean (standard deviation)
        Day 3 (n=19,21,20)
    0.2 ( 2.44 )
    0.9 ( 1.73 )
    0.5 ( 2.21 )
        Day 8 (n=20,21,18)
    1.1 ( 2.07 )
    0.5 ( 1.29 )
    1.3 ( 2.72 )
        Day 14 (n=19,19,19)
    1.2 ( 2.09 )
    0.7 ( 1.73 )
    1.2 ( 2.10 )
        Day 21 (n=19,19,19)
    1.1 ( 2.21 )
    1.2 ( 2.22 )
    1.3 ( 3.11 )
    No statistical analyses for this end point

    Secondary: Pulse Rate Over Time

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    End point title
    		 Pulse Rate Over Time
    End point description
    Pulse rate was measured by the investigator over time. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 3, 8, 14 and 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: beats/min
    arithmetic mean (standard deviation)
        Baseline (n=22,21,23)
    77.8 ( 13.05 )
    78.0 ( 12.16 )
    76.9 ( 10.86 )
        Day 3 (n=20,21,21)
    78.7 ( 15.64 )
    76.6 ( 13.20 )
    76.4 ( 11.88 )
        Day 8 (n=21,21,19)
    71.8 ( 10.58 )
    74.5 ( 12.74 )
    70.7 ( 8.22 )
        Day 14 (n=20,19,20)
    73.3 ( 6.27 )
    71.4 ( 13.09 )
    73.0 ( 12.62 )
        Day 21 (n=20,19,20)
    71.7 ( 10.00 )
    71.9 ( 9.76 )
    69.4 ( 7.13 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pulse Rate

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    End point title
    		 Change from Baseline in Pulse Rate
    End point description
    Change from baseline in pulse rate was calculated by the investigator. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Days 3, 8, 14 and 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: beats/min
    arithmetic mean (standard deviation)
        Day 3 (n=20,21,21)
    0.2 ( 11.80 )
    -1.4 ( 10.17 )
    0.0 ( 10.27 )
        Day 8 (n=21,21,19)
    -6.4 ( 11.61 )
    -3.5 ( 14.03 )
    -5.4 ( 13.17 )
        Day 14 (n=20,19,20)
    -5.3 ( 10.29 )
    -7.4 ( 13.76 )
    -4.3 ( 13.16 )
        Day 21 (n=20,19,20)
    -6.9 ( 12.85 )
    -6.8 ( 12.11 )
    -6.9 ( 9.11 )
    No statistical analyses for this end point

    Secondary: Respiratory Rate Over Time

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    End point title
    		 Respiratory Rate Over Time
    End point description
    Respiratory rate was measured by the investigator over time. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 3, 8, 14 and 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    21
    21
    23
    Units: breaths/min
    arithmetic mean (standard deviation)
        Baseline (n=21,21,23)
    19.2 ( 3.52 )
    18.0 ( 3.08 )
    18.2 ( 3.55 )
        Day 3 (n=19,21,21)
    18.3 ( 3.06 )
    16.7 ( 3.02 )
    17.1 ( 2.64 )
        Day 8 (n=21,21,19)
    18.0 ( 2.48 )
    17.4 ( 4.15 )
    16.9 ( 1.82 )
        Day 14 (n=20,19,20)
    18.1 ( 2.44 )
    16.4 ( 3.10 )
    16.6 ( 2.11 )
        Day 21 (n=20,19,20)
    17.6 ( 2.82 )
    15.7 ( 3.41 )
    16.6 ( 2.23 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Respiratory Rate

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    End point title
    		 Change from Baseline in Respiratory Rate
    End point description
    Change from baseline in respiratory rate was calculated by the investigator. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Days 3, 8, 14 and 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: breaths/min
    arithmetic mean (standard deviation)
        Day 3 (n=19,21,21)
    -0.8 ( 2.25 )
    -1.3 ( 3.52 )
    -0.9 ( 2.10 )
        Day 8 (n=21,21,19)
    -1.1 ( 3.51 )
    0.6 ( 4.17 )
    -1.4 ( 2.34 )
        Day 14 (n=20,19,20)
    -1.3 ( 3.33 )
    -1.7 ( 3.59 )
    -1.8 ( 2.83 )
        Day 21 (n=20,19,20)
    -1.8 ( 3.33 )
    -2.4 ( 4.34 )
    -1.8 ( 2.73 )
    No statistical analyses for this end point

    Secondary: Body Temperature Over Time

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    End point title
    		 Body Temperature Over Time
    End point description
    Body temperature was measured over time. Subjects were provided a thermometer and asked to record body temperature in the electronic device on the non-visit days. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: degree celsius
    arithmetic mean (standard deviation)
        Baseline (n=22,21,23)
    36.75 ( 0.561 )
    36.73 ( 0.601 )
    36.83 ( 0.622 )
        Day 2 (n=19,20,17)
    36.60 ( 0.593 )
    36.62 ( 0.733 )
    36.57 ( 0.585 )
        Day 3 (n=21,20,21)
    36.69 ( 0.446 )
    36.65 ( 0.574 )
    36.57 ( 0.572 )
        Day 4 (n=19,21,19)
    36.58 ( 0.430 )
    36.35 ( 0.647 )
    36.05 ( 0.939 )
        Day 5 (n=19,21,19)
    36.55 ( 0.485 )
    36.32 ( 0.543 )
    36.24 ( 0.665 )
        Day 6 (n=18,21,19)
    36.33 ( 0.659 )
    36.29 ( 0.389 )
    36.39 ( 0.735 )
        Day 7 (n=17,20,20)
    36.40 ( 0.571 )
    36.33 ( 0.495 )
    36.28 ( 0.656 )
        Day 8 (n=20,21,18)
    36.55 ( 0.404 )
    36.44 ( 0.527 )
    36.26 ( 0.396 )
        Day 9 (n=1,0,1)
    36.60 ( 0.00 )
    0.00 ( 0.00 )
    36.30 ( 0.00 )
        Day 10 (n=0,0,2)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    36.20 ( 0.424 )
        Day 11 (n=0,0,1)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    36.30 ( 0.00 )
        Day 12 (n=0,0,1)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    36.30 ( 0.00 )
        Day 14 (n=20,19,20)
    36.50 ( 0.291 )
    36.38 ( 0.346 )
    36.37 ( 0.389 )
        Day 21 (n=20,19,20)
    36.46 ( 0.299 )
    36.40 ( 0.380 )
    36.32 ( 0.380 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Temperature

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    End point title
    		 Change from Baseline in Body Temperature
    End point description
    Change from baseline in body temperature was calculated. Subjects were provided a thermometer and asked to record body temperature in the electronic device on the non-visit days. The ITT-i population consisted of all randomized subjects who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Day 2 up to Day 21
    End point values
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    22
    21
    23
    Units: degree celcius
    arithmetic mean (standard deviation)
        Day 2 (n=19,20,17)
    -0.19 ( 0.573 )
    -0.14 ( 0.720 )
    -0.34 ( 0.433 )
        Day 3 (n=21,20,21)
    -0.01 ( 0.595 )
    -0.11 ( 0.621 )
    -0.27 ( 0.390 )
        Day 4 (n=19,21,19)
    -0.15 ( 0.485 )
    -0.38 ( 0.589 )
    -0.82 ( 0.808 )
        Day 5 (n=19,21,19)
    -0.17 ( 0.650 )
    -0.41 ( 0.645 )
    -0.63 ( 0.667 )
        Day 6 (n=18,21,19)
    -0.42 ( 0.866 )
    -0.45 ( 0.530 )
    -0.48 ( 0.785 )
        Day 7 (n=17,20,20)
    -0.39 ( 0.799 )
    -0.42 ( 0.653 )
    -0.57 ( 0.715 )
        Day 8 (n=20,21,18)
    -0.11 ( 0.477 )
    -0.29 ( 0.652 )
    -0.55 ( 0.465 )
        Day 9 (n=1,0,1)
    -0.80 ( 0.00 )
    0.00 ( 0.00 )
    -0.10 ( 0.00 )
        Day 10 (n=0,0,2)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    -0.25 ( 0.354 )
        Day 11 (n=0,0,1)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    -0.10 ( 0.00 )
        Day 12 (n=0,0,1)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    -0.10 ( 0.00 )
        Day 14 (n=20,19,20)
    -0.20 ( 0.411 )
    -0.40 ( 0.624 )
    -0.48 ( 0.402 )
        Day 21 (n=20,19,20)
    -0.24 ( 0.503 )
    -0.37 ( 0.615 )
    -0.52 ( 0.537 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post dose

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post dose [9]
    End point description
    AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose. Pharmacokinetic analysis set included all subjects who received JNJ-53718678 and for whom at least one pharmacokinetic (PK) concentration was reported. Here 'N' (number of subjects analyzed) signifies number of subjects analyzed for this endpoint and 'n' (number analyzed) signifies number of subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Days 1 and 7 up to 24 hours post dose
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    20
    17
    Units: nanogram hours per milliliter (ng*h/mL)
    arithmetic mean (standard deviation)
        Day 1 (n=17,15)
    4530 ( 1560 )
    29800 ( 9180 )
        Day 7 (n=18,16)
    5470 ( 1620 )
    41200 ( 15300 )
    No statistical analyses for this end point

    Secondary: Predose Plasma Concentration (Ctrough) of JNJ-53718678

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    End point title
    		 Predose Plasma Concentration (Ctrough) of JNJ-53718678 [10]
    End point description
    Ctrough is the trough observed plasma concentration of JNJ-53718678. Pharmacokinetic analysis set included all subjects who received JNJ-53718678 and for whom at least one pharmacokinetic (PK) concentration was reported. Here 'N' (number of subjects analyzed) signifies number of subjects analyzed for this endpoint and 'n' (number analyzed) signifies number of subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Days 1 and 7
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    20
    17
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Day 1 (n=17,15)
    68.2 ( 36.2 )
    514 ( 249 )
        Day 7 (n=18,16)
    84.4 ( 39.4 )
    774 ( 451 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 [11]
    End point description
    Cmax is the maximum observed plasma concentration of JNJ-53718678. Pharmacokinetic analysis set included all subjects who received JNJ-53718678 and for whom at least one pharmacokinetic (PK) concentration was reported. Here 'N' (number of subjects analyzed) signifies number of subjects analyzed for this endpoint and 'n' (number analyzed) signifies number of subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Days 1 and 7
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 JNJ-53718678 80 mg JNJ-53718678 500 mg
    Number of subjects analysed
    20
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1 (n=20,17)
    490 ( 150 )
    2870 ( 802 )
        Day 7 (n=18,16)
    552 ( 131 )
    3540 ( 1050 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 29 days
    Adverse event reporting additional description
    Safety analysis set included all randomized subjects who received at least one dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo as an oral solution once daily for 7 days.

    Reporting group title
    JNJ-53718678 80 mg
    Reporting group description
    		 Subjects received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, subjects received matching placebo to maintain the blinding.

    Reporting group title
    JNJ-53718678 500 mg
    Reporting group description
    		 Subjects received JNJ-53718678 500 mg as an oral solution once daily for 7 days.

    Serious adverse events
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo JNJ-53718678 80 mg JNJ-53718678 500 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 24 (45.83%)
    13 / 24 (54.17%)
    6 / 24 (25.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    Headache
         subjects affected / exposed
    3 / 24 (12.50%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
         occurrences all number
    3
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 24 (37.50%)
    9 / 24 (37.50%)
    5 / 24 (20.83%)
         occurrences all number
    10
    14
    5
    Vomiting
         subjects affected / exposed
    1 / 24 (4.17%)
    3 / 24 (12.50%)
    0 / 24 (0.00%)
         occurrences all number
    1
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 24 (12.50%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    3
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    3
    1
    0
    Rash
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2019
    The amendment 1 included the following changes: some other minor editorial changes, corrections, and clarifications: replaced the RI-PRO questionnaire by the RiiQ questionnaire for the assessment of the duration and severity of signs and symptoms of RSV infection as reported by the subject, for all newly enrolled subjects after approval of the amendment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The RiiQ Scale that replaced RI-PRO questionnaire was only evaluated in the 5 subjects who were enrolled after implementation of protocol amendment 1. This sample size was too small to draw conclusions on comparison between RiiQ and RI-PRO results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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