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    Clinical Trial Results:
    A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants

    Summary
    EudraCT number
    		 2017-005062-21
    Trial protocol
    		 ES   Outside EU/EEA  
    Global end of trial date
    14 Sep 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Feb 2024
    First version publication date
    05 Aug 2023
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    1654-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03524118
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EudraCT: 2017-005062-21
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002755-PIP01-19
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose. Participants in Dose Panels A, B, C, D1, and E1 will be followed for up to 365 days. After protocol Amendment 4 (AM4), participants in Dose Panels D2 and E2 will be followed for up to 545 days.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 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
    Chile: 22
    Country: Number of subjects enrolled
    Colombia: 36
    Country: Number of subjects enrolled
    South Africa: 49
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United States: 68
    Worldwide total number of subjects
    183
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    10
    Infants and toddlers (28 days-23 months)
    173
    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

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    Recruitment
    Recruitment details
    		 183 participants were randomized and 181 were dosed and included in the All Participants as Treated (APaT) population. Two participants who were randomized to the MK-1654 20 mg dose group actually received MK-1654 50 mg and were included in the MK-1654 50 mg group for safety, pharmacokinetic (PK) and immunogenicity analyses.

    Pre-assignment
    Screening details
    		 Participants enrolled in panels D and E prior to protocol amendment 04 who chose not to participate in the modified schedule followed the D1 and E1 schedule of activities. Participants enrolled in panels D and E prior to protocol amendment 04 who chose to participate in the modified schedule followed the D2 and E2 schedule of activities.

    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
    		 Investigator, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Panel A: Preterm Clesrovimab 20mg
    Arm description
    		 Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clesrovimab
    Investigational medicinal product code
    Other name
    MK-1654
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pre-term infants were administered clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.

    Arm title
    		 Panel B: Pre-term Clesrovimab 50mg
    Arm description
    		 Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clesrovimab
    Investigational medicinal product code
    Other name
    MK-1654
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.

    Arm title
    		 Panel C: Pre-term Clesrovimab 75mg
    Arm description
    		 Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clesrovimab
    Investigational medicinal product code
    Other name
    MK-1654
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.

    Arm title
    		 Panel D1 and D2: Pre-term Clesrovimab 100mg
    Arm description
    		 Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clesrovimab
    Investigational medicinal product code
    Other name
    MK-1654
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Arm title
    		 Panel E1 and E2: Full-term Clesrovimab 100mg
    Arm description
    		 Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clesrovimab
    Investigational medicinal product code
    Other name
    MK-1654
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Arm title
    		 Placebo
    Arm description
    		 Pre-term and Full-term infants received placebo via IM injection.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pre-term and Full-term infants received 0.90% w/v sodium chloride via IM injection.

    Number of subjects in period 1
    		Panel A: Preterm Clesrovimab 20mg Panel B: Pre-term Clesrovimab 50mg Panel C: Pre-term Clesrovimab 75mg Panel D1 and D2: Pre-term Clesrovimab 100mg Panel E1 and E2: Full-term Clesrovimab 100mg Placebo
    Started
    8
    31
    41
    32
    33
    38
    Treated
    8
    31
    40
    32
    32
    38
    Completed
    8
    29
    40
    31
    26
    37
    Not completed
    0
    2
    1
    1
    7
    1
         Physician decision
    -
    -
    -
    -
    1
    -
         Unknown
    -
    1
    -
    -
    1
    1
         Withdrawal by Parent/Guardian
    -
    1
    -
    1
    3
    -
         Lost to follow-up
    -
    -
    -
    -
    1
    -
         Protocol deviation
    -
    -
    1
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Panel A: Preterm Clesrovimab 20mg
    Reporting group description
    		 Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.

    Reporting group title
    Panel B: Pre-term Clesrovimab 50mg
    Reporting group description
    		 Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.

    Reporting group title
    Panel C: Pre-term Clesrovimab 75mg
    Reporting group description
    		 Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.

    Reporting group title
    Panel D1 and D2: Pre-term Clesrovimab 100mg
    Reporting group description
    		 Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Reporting group title
    Panel E1 and E2: Full-term Clesrovimab 100mg
    Reporting group description
    		 Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Reporting group title
    Placebo
    Reporting group description
    		 Pre-term and Full-term infants received placebo via IM injection.

    Reporting group values
    		 Panel A: Preterm Clesrovimab 20mg Panel B: Pre-term Clesrovimab 50mg Panel C: Pre-term Clesrovimab 75mg Panel D1 and D2: Pre-term Clesrovimab 100mg Panel E1 and E2: Full-term Clesrovimab 100mg Placebo Total
    Number of subjects
    		 8 31 41 32 33 38 183
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 2 3 3 0 2 10
        Infants and toddlers (28 days-23 months)
    		 8 29 38 29 33 36 173
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: days
        median (full range (min-max))
    		 68.0 (31 to 257) 109.0 (23 to 255) 94.0 (24 to 245) 139.5 (14 to 239) 164.0 (46 to 250) 128.0 (26 to 275) -
    Gender Categorical
    Units: Subjects
        Female
    		 6 15 20 17 13 19 90
        Male
    		 2 16 21 15 20 19 93
    Race (NIH/OMB)
    Units: Subjects
        American Indian Or Alaska Native
    		 0 0 1 1 1 2 5
        Asian
    		 0 1 0 5 0 0 6
        Black Or African American
    		 4 8 9 14 14 11 60
        Multiple
    		 0 1 17 2 7 9 36
        White
    		 4 20 14 8 11 14 71
        Missing
    		 0 1 0 2 0 2 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 12 25 9 14 18 79
        Non Hispanic or Latino
    		 7 19 16 23 19 20 104

    End points

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    End points reporting groups
    Reporting group title
    Panel A: Preterm Clesrovimab 20mg
    Reporting group description
    		 Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.

    Reporting group title
    Panel B: Pre-term Clesrovimab 50mg
    Reporting group description
    		 Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.

    Reporting group title
    Panel C: Pre-term Clesrovimab 75mg
    Reporting group description
    		 Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.

    Reporting group title
    Panel D1 and D2: Pre-term Clesrovimab 100mg
    Reporting group description
    		 Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Reporting group title
    Panel E1 and E2: Full-term Clesrovimab 100mg
    Reporting group description
    		 Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Reporting group title
    Placebo
    Reporting group description
    		 Pre-term and Full-term infants received placebo via IM injection.

    Subject analysis set title
    Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.

    Subject analysis set title
    Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.

    Subject analysis set title
    Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.

    Subject analysis set title
    Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Subject analysis set title
    Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.

    Subject analysis set title
    Placebo: Pre & Full-term Placebo 0.2, 0.5 Single Dose IM Inj
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Pre-term and Full-term infants received placebo via IM injection.

    Primary: Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)

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    End point title
    		 Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE) [1]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5. Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
    End point type
    Primary
    End point timeframe
    Up to Day 5
    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: No statistical analyses were planned for this endpoint.
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj Placebo: Pre & Full-term Placebo 0.2, 0.5 Single Dose IM Inj
    Number of subjects analysed
    6
    33
    40
    32
    32
    38
    Units: Participants
        with solicited injection site adverse events
    3
    3
    3
    2
    2
    2
        without solicited injection site adverse events
    3
    30
    37
    30
    30
    36
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)

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    End point title
    		 Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE) [2]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were monitored from Day 1 to Day 5. Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
    End point type
    Primary
    End point timeframe
    Up to Day 5
    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: No statistical analyses were planned for this endpoint.”
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj Placebo: Pre & Full-term Placebo 0.2, 0.5 Single Dose IM Inj
    Number of subjects analysed
    6
    33
    40
    32
    32
    38
    Units: Participants
        with solicited systemic adverse events
    2
    8
    9
    2
    3
    9
        without solicited systemic adverse events
    4
    25
    31
    30
    29
    29
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)

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    End point title
    		 Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE) [3]
    End point description
    An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event. Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
    End point type
    Primary
    End point timeframe
    Up to Day 545
    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: No statistical analyses were planned for this endpoint.
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj Placebo: Pre & Full-term Placebo 0.2, 0.5 Single Dose IM Inj
    Number of subjects analysed
    6
    33
    40
    32
    32
    38
    Units: Participants
        with serious adverse events (SAE)
    1
    4
    1
    3
    6
    6
        without SAE
    5
    29
    39
    29
    26
    32
    No statistical analyses for this end point

    Secondary: Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)

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    End point title
    		 Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)
    End point description
    AUC0-∞ is a measure of the extrapolated mean concentration in serum from dosing to infinity. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    At designated time points (up to 1 year post-dose)
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: day*μg/mL
        geometric mean (geometric coefficient of variation)
    1560 ± 43.5
    3520 ± 22.8
    5510 ± 22.4
    6790 ± 25.4
    5690 ± 15.9
    No statistical analyses for this end point

    Secondary: Maximum Serum Concentration (Cmax) of Clesrovimab

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    End point title
    		 Maximum Serum Concentration (Cmax) of Clesrovimab
    End point description
    Cmax is the highest observed serum drug concentration. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    At designated time points (up to 1 year post-dose)
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    26.3 ± 19.3
    61.7 ± 21.8
    94.5 ± 20.5
    117 ± 23.5
    99.9 ± 13.7
    No statistical analyses for this end point

    Secondary: Time to Maximum Serum Concentration (Tmax) of Clesrovimab

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    End point title
    		 Time to Maximum Serum Concentration (Tmax) of Clesrovimab
    End point description
    Tmax is the amount of time required to reach Cmax. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    At designated time points (up to 1 year post-dose)
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: day
        median (full range (min-max))
    4.0 (3.80 to 4.60)
    4.20 (3.70 to 5.30)
    4.20 (3.00 to 5.80)
    4.10 (3.70 to 6.00)
    4.10 (3.70 to 4.90)
    No statistical analyses for this end point

    Secondary: Apparent Terminal Half-life (t1/2) of Clesrovimab

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    End point title
    		 Apparent Terminal Half-life (t1/2) of Clesrovimab
    End point description
    t1/2 is the time required for 50% of drug to be cleared from serum. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    At designated time points (up to 1 year post-dose)
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: day
        geometric mean (geometric coefficient of variation)
    48.8 ± 34.6
    44.6 ± 10.9
    46.1 ± 15.1
    45.2 ± 13.7
    43.0 ± 9.72
    No statistical analyses for this end point

    Secondary: Serum Concentration of Clesrovimab on Day 7 (C7days)

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    End point title
    		 Serum Concentration of Clesrovimab on Day 7 (C7days)
    End point description
    Serum concentration of clesrovimab was measured on Day 7. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    24.4 ± 20.4
    57.8 ± 21.6
    88.1 ± 20.4
    109 ± 23.0
    92.8 ± 13.3
    No statistical analyses for this end point

    Secondary: Serum Concentration of Clesrovimab on Day 14 (C14days)

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    End point title
    		 Serum Concentration of Clesrovimab on Day 14 (C14days)
    End point description
    Serum concentration of clesrovimab was measured on Day 14. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    19.4 ± 22.1
    46.8 ± 20.6
    71.1 ± 19.7
    88.6 ± 21.8
    75.4 ± 12.9
    No statistical analyses for this end point

    Secondary: Serum Concentration of Clesrovimab on Day 90 (C90days)

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    End point title
    		 Serum Concentration of Clesrovimab on Day 90 (C90days)
    End point description
    Serum concentration of clesrovimab was measured on Day 90. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    5.60 ± 49.5
    13.0 ± 25.4
    20.4 ± 25.8
    25.2 ± 28.6
    21.1 ± 18.8
    No statistical analyses for this end point

    Secondary: Serum Concentration of Clesrovimab on Day 150 (C150days)

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    End point title
    		 Serum Concentration of Clesrovimab on Day 150 (C150days)
    End point description
    Serum concentration of clesrovimab was measured on Day 150. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    Day 150
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    2.24 ± 80.6
    4.98 ± 34.2
    8.05 ± 37.7
    9.70 ± 40.2
    7.96 ± 26.7
    No statistical analyses for this end point

    Secondary: Serum Concentration of Clesrovimab on Day 365 (C365days)

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    End point title
    		 Serum Concentration of Clesrovimab on Day 365 (C365days)
    End point description
    Serum concentration of clesrovimab was measured on Day 365. Population analyzed was all randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
    End point type
    Secondary
    End point timeframe
    Day 365
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    5
    33
    40
    32
    31
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    0.0953 ± 362
    0.177 ± 79.4
    0.313 ± 107
    0.355 ± 104
    0.248 ± 63.1
    No statistical analyses for this end point

    Secondary: Number of participants with positive titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2

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    End point title
    		 Number of participants with positive titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
    End point description
    ADA assessed at 2 or 3 of the following timepoints for each participant: Days 14, 90, 150, 365 and 545. 1.ADA Negative: participants whose ADA results were negative at all timepoints measured; 2.Non-treatment emergent Positive : participants with positive ADA result only at baseline or increase in postdose titer by < 2-fold relative to the baseline titer; 3.Positive response to MK-1654: participants with negative ADA result at baseline and positive at one or more postdose timepoints or with positive ADA result at baseline and increase in postdose titer by >= 2-fold relative to the baseline titer. Population analyzed was all randomized participants who received at least one dose of study treatment and were evaluable with at least one ADA result after treatment with MK-1654. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group received MK-1654 Panel B 50 mg and included in the MK-1654 50 mg group for the protocol specified immunogenicity analysis population.
    End point type
    Secondary
    End point timeframe
    Days 14, 90, 150, 365 and 545.
    End point values
    		 Panel A: Pre-term Clesrovimab 20mg Single Dose IM Injection Panel B: Pre-term Clesrovimab 50mg Single Dose IM Injection Panel C: Pre-term Clesrovimab 75mg Single Dose IM Injection Panel D1 & D2: Pre-term Clesrovimab 100mg Single Dose IM Inj Panel E1 & E2: Full-term Clesrovimab 100mg Single Dose IM Inj
    Number of subjects analysed
    6
    33
    40
    32
    32
    Units: Participants
        ADA Negative status
    4
    23
    35
    15
    9
        Non-treatment emergent positive
    0
    0
    0
    1
    1
        ADA Positive response to MK-1654
    2
    9
    4
    16
    20
        Maximum Postdose Titer of 20 to < 189 of ADA
    0
    6
    2
    4
    2
        Maximum Postdose Titer of 189 to < 1077.5 of ADA
    0
    1
    1
    3
    7
        Maximum Postdose Titer of 1077.5 to < 9285 of ADA
    0
    0
    1
    4
    7
        Maximum Postdose Titer of 9285 to 160000 of ADA
    2
    2
    0
    4
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 545
    Adverse event reporting additional description
    All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Two participants randomized to the MK-1654 Panel A 20 mg dose group received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for protocol specified safety analysis population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    MK-1654 20 mg in Pre-term Infants
    Reporting group description
    		 -

    Reporting group title
    MK-1654 50 mg in Pre-term Infants
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    MK-1654 100 mg Pre-Term Infants
    Reporting group description
    		 -

    Reporting group title
    MK-1654 100 mg Full-Term Infants
    Reporting group description
    		 -

    Reporting group title
    MK-1654 75 mg in Pre-term Infants
    Reporting group description
    		 -

    Serious adverse events
    		 MK-1654 20 mg in Pre-term Infants MK-1654 50 mg in Pre-term Infants Placebo MK-1654 100 mg Pre-Term Infants MK-1654 100 mg Full-Term Infants MK-1654 75 mg in Pre-term Infants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 33 (12.12%)
    6 / 38 (15.79%)
    3 / 32 (9.38%)
    6 / 32 (18.75%)
    1 / 40 (2.50%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Toxicity to various agents
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    1 / 38 (2.63%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary cyst
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Irregular breathing
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    2 / 38 (5.26%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    3 / 38 (7.89%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-1654 20 mg in Pre-term Infants MK-1654 50 mg in Pre-term Infants Placebo MK-1654 100 mg Pre-Term Infants MK-1654 100 mg Full-Term Infants MK-1654 75 mg in Pre-term Infants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    29 / 33 (87.88%)
    33 / 38 (86.84%)
    26 / 32 (81.25%)
    29 / 32 (90.63%)
    29 / 40 (72.50%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Accidental overdose
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 33 (6.06%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 33 (6.06%)
    4 / 38 (10.53%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    5 / 40 (12.50%)
         occurrences all number
    1
    2
    4
    1
    1
    5
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 33 (6.06%)
    1 / 38 (2.63%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 40 (2.50%)
         occurrences all number
    1
    2
    1
    1
    1
    1
    Injection site pain
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 33 (0.00%)
    1 / 38 (2.63%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    0
    2
    2
    0
    3
    Injection site swelling
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 33 (3.03%)
    1 / 38 (2.63%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    1
    0
    2
    0
    Pyrexia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    1 / 38 (2.63%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    1
    2
    2
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    5 / 33 (15.15%)
    5 / 38 (13.16%)
    2 / 32 (6.25%)
    4 / 32 (12.50%)
    2 / 40 (5.00%)
         occurrences all number
    0
    5
    5
    2
    4
    2
    Flatulence
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    Teething
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    3 / 32 (9.38%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 33 (9.09%)
    2 / 38 (5.26%)
    2 / 32 (6.25%)
    3 / 32 (9.38%)
    1 / 40 (2.50%)
         occurrences all number
    1
    3
    2
    3
    8
    1
    Nasal congestion
         subjects affected / exposed
    2 / 6 (33.33%)
    5 / 33 (15.15%)
    5 / 38 (13.16%)
    6 / 32 (18.75%)
    8 / 32 (25.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    6
    5
    6
    11
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 33 (6.06%)
    1 / 38 (2.63%)
    4 / 32 (12.50%)
    3 / 32 (9.38%)
    1 / 40 (2.50%)
         occurrences all number
    1
    2
    1
    6
    11
    1
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 33 (6.06%)
    1 / 38 (2.63%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    1
    2
    1
    2
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    2 / 38 (5.26%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    0
    2
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Miliaria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    1 / 38 (2.63%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    2
    1
    0
    Rash papular
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    0 / 32 (0.00%)
    4 / 32 (12.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    4
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    2 / 6 (33.33%)
    7 / 33 (21.21%)
    9 / 38 (23.68%)
    2 / 32 (6.25%)
    2 / 32 (6.25%)
    5 / 40 (12.50%)
         occurrences all number
    2
    7
    10
    2
    2
    6
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    Croup infectious
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    2 / 38 (5.26%)
    0 / 32 (0.00%)
    3 / 32 (9.38%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    2
    0
    5
    1
    Ear infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    0 / 38 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    1 / 32 (3.13%)
    6 / 32 (18.75%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    1
    8
    0
    COVID-19
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    3 / 38 (7.89%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    2 / 40 (5.00%)
         occurrences all number
    0
    0
    3
    0
    2
    2
    Bronchitis
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 33 (9.09%)
    1 / 38 (2.63%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    3 / 40 (7.50%)
         occurrences all number
    0
    7
    1
    1
    1
    4
    Bronchiolitis
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 33 (6.06%)
    5 / 38 (13.16%)
    7 / 32 (21.88%)
    5 / 32 (15.63%)
    4 / 40 (10.00%)
         occurrences all number
    3
    3
    9
    8
    6
    6
    Respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    0 / 38 (0.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    1
    2
    0
    Otitis media acute
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    2 / 38 (5.26%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    3 / 38 (7.89%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    3
    1
    5
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 33 (6.06%)
    7 / 38 (18.42%)
    10 / 32 (31.25%)
    10 / 32 (31.25%)
    11 / 40 (27.50%)
         occurrences all number
    1
    7
    19
    20
    22
    19
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 33 (3.03%)
    1 / 38 (2.63%)
    2 / 32 (6.25%)
    2 / 32 (6.25%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    1
    2
    2
    0
    Rhinitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    2 / 38 (5.26%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 33 (6.06%)
    5 / 38 (13.16%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    7
    1
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 6 (33.33%)
    17 / 33 (51.52%)
    12 / 38 (31.58%)
    12 / 32 (37.50%)
    18 / 32 (56.25%)
    7 / 40 (17.50%)
         occurrences all number
    2
    22
    22
    19
    52
    8
    Viral pharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 33 (0.00%)
    1 / 38 (2.63%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 33 (3.03%)
    1 / 38 (2.63%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Sep 2018
    The primary reason for amendment 1 was was to extend the scope and duration of post-dose safety monitoring to support the safety evaluation of MK-1654.
    07 Feb 2019
    The primary reason for amendment 2 was to ensure that all instances of hives or welts are evaluated to ensure consistent follow-up of potential allergic reactions.
    28 Feb 2020
    The primary reason for amendment 3 was to remove the restrictions for the administration of rotavirus vaccine.
    05 Oct 2020
    The primary reason for amendment 4 was to modify the blood collection schedule for Panels D and E adding Day 545 postdose blood draw for ADA and SNA collection for participants enrolled in Panels D and E prior to Amendment 04 who chose to participate in the modified blood collection schedule and Panel D and E participants enrolled under Amendment 04. The SAE follow-up period for these participants was extended to Day 545 accordingly; to discontinue the collection of microsample blood for ADA for all Panels; to discontinue the collection of microsample blood for PK for Panels D and E; document 100 mg as the selected dose for Panels D and E; to allow the oral polio vaccine to be administered concomitantly with MK- 1654

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Apr 2019
    An out of specification (OOS) pause on enrollment and dosing was initiated by MSD as a precautionary measure on 1-APR-2019 due to small number of visible particles per vial on stability testing on the original MK-1654 lot used for P002 supply. Further investigations revealed the visible particles were MK-1654 aggregates. The original lot was replaced with a new one, meeting all criteria, resuming dosing in the study on 31-Aug-2019 with agreement from FDA.
    31 Aug 2019

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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