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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants

    Summary
    EudraCT number
    2015-001714-96
    Trial protocol
    DK   GB   HU   FI   BG   ES   CZ   NL   DE  
    Global end of trial date
    26 Sep 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Apr 2018
    First version publication date
    11 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R2222-RSV-1332
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02325791
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Rd., Tarrytown, United States, 10591
    Public contact
    Clinical Trial Management, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trial Management, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001747-PIP01-15
    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
    01 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study consisted of 2 parts: Part A and Part B. The objective of Part A is to determine the Pharmacokinetics (PK) of intramuscular (IM) administration of Suptavumab and Part B is to demonstrate the efficacy of Suptavumab in preventing medically attended respiratory syncytial virus (RSV) infections.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Bulgaria: 173
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    Finland: 20
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Hungary: 82
    Country: Number of subjects enrolled
    United States: 432
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    New Zealand: 25
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Chile: 127
    Country: Number of subjects enrolled
    Panama: 5
    Country: Number of subjects enrolled
    South Africa: 8
    Country: Number of subjects enrolled
    Turkey: 107
    Country: Number of subjects enrolled
    Ukraine: 95
    Worldwide total number of subjects
    1177
    EEA total number of subjects
    356
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    1177
    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)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in 2 parts between 22-Jun-2015 and 26-Sep-2017. Part-A of study was conducted at 6 sites in 3 countries and part-B was conducted at 175 sites in 18 countries. Only Part B of the study was conducted in Europe. A total of 23 subjects were enrolled in part-A and a total of 1154 subjects were randomized in part-B.

    Pre-assignment
    Screening details
    In Part A: 27 subjects were screened, of which 23 received first dose of study drug. In Part B: out of 1154, 1150 subjects received first dose of study drug, of those 1052 continued & received second dose 8 weeks later. Subjects were randomized in 1:1:1 ratio in Part B by gestational age category and region (North America, or rest of the world).

    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, Monitor
    Blinding implementation details
    Part-A of study was open label where as in Part-B the parent(s) or guardian(s) of study subjects, the principal investigators, and study site personnel were remain blinded to all subject assignments throughout the study. The sponsor’s study director, medical monitor, study monitor, and any other sponsor and contract research organization personnel who were in regular contact with the study site were remained blinded to all subject assignments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part A: Suptavumab 30 mg/kg
    Arm description
    Subjects received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Suptavumab
    Investigational medicinal product code
    REGN2222
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of suptavumab 30 mg/kg was administered IM via 1 or 2 simultaneous injections according to the total volume of study drug determined by the subject’s body weight. Suptavumab was supplied as a lyophilized powder and was reconstituted with 1.4 milliliter (mL) of sterile water for IM injection, the composition of the drug product was 150 milligram per milliliter (mg/mL) suptavumab.

    Arm title
    Part B: Placebo matched to Suptavumab
    Arm description
    Subjects received 2 IM doses of placebo matched to Suptavumab. Suptavumab; the first dose on Day 1 and the second dose on Day 57.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered two doses of placebo (matched to suptavumab) 8 weeks apart (q8w).

    Arm title
    Part B: Suptavumab 30 mg/kg - 1 Dose
    Arm description
    Subjects received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    Suptavumab
    Investigational medicinal product code
    REGN2222
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of suptavumab 30 mg/kg was administered IM via 1 or 2 simultaneous injections according to the total volume of study drug determined by the subject’s body weight. Suptavumab was supplied as a lyophilized powder and was reconstituted with 1.4 mL of sterile water for IM injection, the composition of the drug product was 150 mg/mL suptavumab.

    Investigational medicinal product name
    Placebo (matched to Suptavumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered one dose of placebo (matched to suptavumab) on Day 57.

    Arm title
    Part B: Suptavumab 30 mg/kg - 2 Doses
    Arm description
    Subjects received 2 doses of suptavumab 30 mg/kg IM, the first dose on Day 1 and the second dose on Day 57.
    Arm type
    Experimental

    Investigational medicinal product name
    Suptavumab
    Investigational medicinal product code
    REGN2222
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Suptavumab 30 mg/kg was administered IM via 1 or 2 simultaneous injections according to the total volume of study drug determined by the subject’s body weight. Suptavumab was supplied as a lyophilized powder and was reconstituted with 1.4 mL of sterile water for IM injection, the composition of the drug product was 150 mg/mL suptavumab.

    Number of subjects in period 1 [1]
    Part A: Suptavumab 30 mg/kg Part B: Placebo matched to Suptavumab Part B: Suptavumab 30 mg/kg - 1 Dose Part B: Suptavumab 30 mg/kg - 2 Doses
    Started
    23
    383
    385
    381
    Completed
    23
    358
    360
    355
    Not completed
    0
    25
    25
    26
         Protocol deviation
    -
    -
    1
    -
         Death
    -
    3
    -
    1
         Physician decision
    -
    1
    1
    -
         Adverse event
    -
    1
    1
    -
         Consent withdrawn by subject
    -
    5
    8
    16
         Lost to follow-up
    -
    15
    14
    9
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 1177 (Worldwide number enrolled), only 1172 subjects who received the study drug were reported.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: Suptavumab 30 mg/kg
    Reporting group description
    Subjects received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

    Reporting group title
    Part B: Placebo matched to Suptavumab
    Reporting group description
    Subjects received 2 IM doses of placebo matched to Suptavumab. Suptavumab; the first dose on Day 1 and the second dose on Day 57.

    Reporting group title
    Part B: Suptavumab 30 mg/kg - 1 Dose
    Reporting group description
    Subjects received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.

    Reporting group title
    Part B: Suptavumab 30 mg/kg - 2 Doses
    Reporting group description
    Subjects received 2 doses of suptavumab 30 mg/kg IM, the first dose on Day 1 and the second dose on Day 57.

    Reporting group values
    Part A: Suptavumab 30 mg/kg Part B: Placebo matched to Suptavumab Part B: Suptavumab 30 mg/kg - 1 Dose Part B: Suptavumab 30 mg/kg - 2 Doses Total
    Number of subjects
    23 383 385 381 1172
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    6.04 ± 8.284 13.00 ± 6.903 12.59 ± 6.897 12.75 ± 6.900 -
    Gender categorical
    Units: Subjects
        Female
    9 186 172 179 546
        Male
    14 197 213 202 626
    Race
    Units: Subjects
        White
    19 338 334 326 1017
        Black or African American
    0 32 34 35 101
        Asian
    0 2 3 3 8
        American Indian or Alaska native
    0 0 2 0 2
        Native hawaiian or other pacific
    2 0 0 2 4
        Other
    2 7 9 11 29
        Not reported
    0 4 3 4 11
    Ethnicity
    Units: Subjects
        Not hispanic or latino
    20 297 300 302 919
        Hispanic or latino
    3 80 81 75 239
        Not reported
    0 6 4 4 14

    End points

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    End points reporting groups
    Reporting group title
    Part A: Suptavumab 30 mg/kg
    Reporting group description
    Subjects received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

    Reporting group title
    Part B: Placebo matched to Suptavumab
    Reporting group description
    Subjects received 2 IM doses of placebo matched to Suptavumab. Suptavumab; the first dose on Day 1 and the second dose on Day 57.

    Reporting group title
    Part B: Suptavumab 30 mg/kg - 1 Dose
    Reporting group description
    Subjects received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.

    Reporting group title
    Part B: Suptavumab 30 mg/kg - 2 Doses
    Reporting group description
    Subjects received 2 doses of suptavumab 30 mg/kg IM, the first dose on Day 1 and the second dose on Day 57.

    Primary: Part B: Percentage of Subjects With Medically Attended RSV Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150

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    End point title
    Part B: Percentage of Subjects With Medically Attended RSV Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150 [1]
    End point description
    A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room [ER], urgent care [UC], or pediatric clinic visits [for either a sick or well visit]) with RSV LRTI. An RSV LRTI in an infant: RSV-proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, & with 1 of following signs of LRTI, as assessed by healthcare provider: -lower chest wall indrawing -hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) –Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit. Full analysis set (FAS): all randomized subjects who received any study drug, & is analyzed according to treatment allocated by IVRS/IWRS at randomization (as randomized.
    End point type
    Primary
    End point timeframe
    From first study drug administration up to Day 150
    Notes
    [1] - 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: Only arms applicable for this end point are reported.
    End point values
    Part B: Placebo matched to Suptavumab Part B: Suptavumab 30 mg/kg - 1 Dose Part B: Suptavumab 30 mg/kg - 2 Doses
    Number of subjects analysed
    383
    385
    381
    Units: percentage of subjects
        number (not applicable)
    8.1
    7.7
    9.3
    Statistical analysis title
    Placebo vs suptavumab 30 mg/kg-1 Dose
    Statistical analysis description
    A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to Kaplan-Meier (KM) estimate from the placebo group. Randomization strata adjusted in Cochran-Mantel-Haenszel (CMH) test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.
    Comparison groups
    Part B: Placebo matched to Suptavumab v Part B: Suptavumab 30 mg/kg - 1 Dose
    Number of subjects included in analysis
    768
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8239 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    percentage treatment difference
    Point estimate
    -0.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.318
         upper limit
    3.438
    Notes
    [2] - Analysis performed using CMH statistics with randomization stratum adjusted using Mantel-Haenzel (MH) method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.
    Statistical analysis title
    Placebo vs suptavumab 30 mg/kg-2 Doses
    Statistical analysis description
    A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.
    Comparison groups
    Part B: Suptavumab 30 mg/kg - 2 Doses v Part B: Placebo matched to Suptavumab
    Number of subjects included in analysis
    764
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.5773 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    percentage treatment difference
    Point estimate
    1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.898
         upper limit
    5.201
    Notes
    [3] - Analysis performed using CMH statistics with randomization stratum adjusted using MH method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.
    [4] - Threshold for significance at 0.05 level.

    Secondary: Part A: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Part A: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) [5]
    End point description
    Any untoward medical occurrence in subject who received investigational medicinal product (IMP) was considered an adverse event (AE)without regard to possibility of causal relationship with this treatment. TEAEs:AEs that developed/worsened/became serious during on-treatment period (defined as time between the date of first study drug administration & date of end of study/last visit).Serious AE:Any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening,required initial or prolonged in-patient hospitalization,persistent/significant disability/incapacity,congenital anomaly/birth defect, or considered as medically important event. Any TEAE included subjects with both serious & non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03(Grade 3 [severe] & Grade 4[life-threatening]) was used in this study to grade clinical AEs. Safety analysis set (SAS)included enrolled subjects who received any dose of suptavumab.
    End point type
    Secondary
    End point timeframe
    From baseline until Day 150
    Notes
    [5] - 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: Only arm applicable for this end point is reported.
    End point values
    Part A: Suptavumab 30 mg/kg
    Number of subjects analysed
    23
    Units: percentage of subjects
    number (not applicable)
        Any TEAE
    69.6
        Any Grade 3/Serious TEAE
    4.3
    No statistical analyses for this end point

    Secondary: Part B: Percentage of Subjects Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150

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    End point title
    Part B: Percentage of Subjects Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150 [6]
    End point description
    A medically attended RSV infection was defined as an infant with a positive RSV test by RT-PCR with any of the following events: -Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection - or Outpatient visit (ER, UC), or pediatric clinic visits [for either a sick or well visit]) with RSV LRTI. An RSV LRTI in an infant: RSV-proven respiratory infection (i.e, positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider: -Lower chest wall indrawing -Hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) -Wheezing or crackles. The 150-day efficacy assessment period:first study drug intake through the Day 150 visit. Analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    From the first study drug administration up to Day 150
    Notes
    [6] - 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: Only arms applicable for this end point are reported.
    End point values
    Part B: Placebo matched to Suptavumab Part B: Suptavumab 30 mg/kg - 1 Dose Part B: Suptavumab 30 mg/kg - 2 Doses
    Number of subjects analysed
    383
    385
    381
    Units: percentage of subjects
        number (not applicable)
    12.5
    11.9
    14.5
    Statistical analysis title
    Placebo vs suptavumab 30 mg/kg- 1 Dose
    Statistical analysis description
    A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.
    Comparison groups
    Part B: Placebo matched to Suptavumab v Part B: Suptavumab 30 mg/kg - 1 Dose
    Number of subjects included in analysis
    768
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7778 [7]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    percentage treatment difference
    Point estimate
    -0.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.291
         upper limit
    3.959
    Notes
    [7] - Analysis performed using CMH statistics with randomization stratum adjusted using MH method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.
    Statistical analysis title
    Placebo vs suptavumab 30 mg/kg- 2 Doses
    Statistical analysis description
    A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.
    Comparison groups
    Part B: Placebo matched to Suptavumab v Part B: Suptavumab 30 mg/kg - 2 Doses
    Number of subjects included in analysis
    764
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4154 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    percentage treatment difference
    Point estimate
    2.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.836
         upper limit
    6.867
    Notes
    [8] - Analysis performed using CMH statistics with randomization stratum adjusted using MH method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are TEAEs that developed/worsened during the ‘on treatment period’. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 & for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Subject data was summarized according to treatment group.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Part A: Suptavumab 30 mg/kg
    Reporting group description
    Subjects received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

    Reporting group title
    Part B: Placebo (matched to suptavumab)
    Reporting group description
    Subjects received 2 doses of placebo matched to suptavumab IM on Day 1 and Day 57.

    Reporting group title
    Part B: Suptavumab 30 mg/kg- 1 Dose
    Reporting group description
    Subjects received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57. Subject data was summarized according to the as treated study treatment group. The impact of this analysis rule was that subjects who were randomized to Suptavumab 2 doses group (Part B: Suptavumab 30 mg/kg) were analyzed for safety in the suptavumab single dose group (Part B: Placebo + Suptavumab 30 mg/kg) if they did not receive the second dose in Part B: Suptavumab 30 mg/kg arm.

    Reporting group title
    Part B: Suptavumab 30 mg/kg -2 Doses
    Reporting group description
    Subjects received 2 doses of REGN2222 30 mg/kg IM on Day 1 and Day 57. Subject data was summarized according to the as treated study treatment group. The impact of this analysis rule was that subjects who were randomized to REGN2222 2 doses group were analyzed for safety in the suptavumab single dose group (Suptavumab 30 mg/kg + Placebo) if they did not receive the second dose in this arm.

    Serious adverse events
    Part A: Suptavumab 30 mg/kg Part B: Placebo (matched to suptavumab) Part B: Suptavumab 30 mg/kg- 1 Dose Part B: Suptavumab 30 mg/kg -2 Doses
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    44 / 384 (11.46%)
    54 / 418 (12.92%)
    29 / 348 (8.33%)
         number of deaths (all causes)
    0
    2
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Eye haemangioma
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-Abdominal haemangioma
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Child abuse
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    3 / 418 (0.72%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Respirovirus test positive
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-Respiratory arrest
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cyanosis
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 384 (0.52%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Amniotic band syndrome
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital inguinal hernia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macrocephaly
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 384 (0.52%)
    2 / 418 (0.48%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apnoea neonatal
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotonic-Hyporesponsive episode
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    1 / 418 (0.24%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 384 (0.52%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    1 / 418 (0.24%)
    3 / 348 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sandifer's syndrome
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    2 / 418 (0.48%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    1 / 418 (0.24%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 23 (0.00%)
    9 / 384 (2.34%)
    10 / 418 (2.39%)
    7 / 348 (2.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 9
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 23 (0.00%)
    4 / 384 (1.04%)
    2 / 418 (0.48%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    2 / 418 (0.48%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 384 (0.52%)
    2 / 418 (0.48%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    2 / 418 (0.48%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudocroup
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 23 (0.00%)
    5 / 384 (1.30%)
    13 / 418 (3.11%)
    2 / 348 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 13
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    2 / 418 (0.48%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    5 / 418 (1.20%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    0 / 418 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    2 / 418 (0.48%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 384 (0.26%)
    0 / 418 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Part A: Suptavumab 30 mg/kg Part B: Placebo (matched to suptavumab) Part B: Suptavumab 30 mg/kg- 1 Dose Part B: Suptavumab 30 mg/kg -2 Doses
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 23 (56.52%)
    218 / 384 (56.77%)
    219 / 418 (52.39%)
    198 / 348 (56.90%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 384 (0.00%)
    1 / 418 (0.24%)
    1 / 348 (0.29%)
         occurrences all number
    2
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 23 (4.35%)
    14 / 384 (3.65%)
    24 / 418 (5.74%)
    23 / 348 (6.61%)
         occurrences all number
    1
    20
    27
    24
    Nasal congestion
         subjects affected / exposed
    0 / 23 (0.00%)
    25 / 384 (6.51%)
    24 / 418 (5.74%)
    27 / 348 (7.76%)
         occurrences all number
    0
    35
    27
    33
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 23 (8.70%)
    13 / 384 (3.39%)
    16 / 418 (3.83%)
    11 / 348 (3.16%)
         occurrences all number
    2
    13
    16
    11
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 23 (0.00%)
    31 / 384 (8.07%)
    32 / 418 (7.66%)
    22 / 348 (6.32%)
         occurrences all number
    0
    40
    37
    24
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 23 (0.00%)
    20 / 384 (5.21%)
    11 / 418 (2.63%)
    14 / 348 (4.02%)
         occurrences all number
    0
    20
    13
    14
    Diarrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    15 / 384 (3.91%)
    24 / 418 (5.74%)
    12 / 348 (3.45%)
         occurrences all number
    0
    16
    25
    13
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 23 (4.35%)
    31 / 384 (8.07%)
    25 / 418 (5.98%)
    24 / 348 (6.90%)
         occurrences all number
    1
    32
    25
    26
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 23 (8.70%)
    12 / 384 (3.13%)
    8 / 418 (1.91%)
    8 / 348 (2.30%)
         occurrences all number
    2
    13
    8
    8
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    2 / 23 (8.70%)
    16 / 384 (4.17%)
    19 / 418 (4.55%)
    27 / 348 (7.76%)
         occurrences all number
    2
    19
    27
    33
    Bronchitis
         subjects affected / exposed
    0 / 23 (0.00%)
    24 / 384 (6.25%)
    24 / 418 (5.74%)
    13 / 348 (3.74%)
         occurrences all number
    0
    32
    30
    20
    Conjunctivitis
         subjects affected / exposed
    1 / 23 (4.35%)
    18 / 384 (4.69%)
    25 / 418 (5.98%)
    18 / 348 (5.17%)
         occurrences all number
    1
    20
    28
    20
    Nasopharyngitis
         subjects affected / exposed
    0 / 23 (0.00%)
    53 / 384 (13.80%)
    30 / 418 (7.18%)
    35 / 348 (10.06%)
         occurrences all number
    0
    73
    35
    45
    Otitis media
         subjects affected / exposed
    0 / 23 (0.00%)
    29 / 384 (7.55%)
    49 / 418 (11.72%)
    26 / 348 (7.47%)
         occurrences all number
    0
    41
    84
    37
    Rhinitis
         subjects affected / exposed
    1 / 23 (4.35%)
    14 / 384 (3.65%)
    17 / 418 (4.07%)
    18 / 348 (5.17%)
         occurrences all number
    1
    15
    18
    19
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 23 (13.04%)
    74 / 384 (19.27%)
    92 / 418 (22.01%)
    75 / 348 (21.55%)
         occurrences all number
    3
    102
    127
    119
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 23 (13.04%)
    20 / 384 (5.21%)
    19 / 418 (4.55%)
    21 / 348 (6.03%)
         occurrences all number
    3
    26
    26
    24

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Apr 2015
    Following changes are made: • The status of the FIH study was updated by removing “ongoing” • Clarified the primary objective for Part B • Clarified collection of days on supplemental oxygen • Clarified, in Part B, that the permitted windows for prophylaxis will be based on geographical area • Removed references to the study manual • Clarified, in Part A, the process of dosing for the 24 subjects • Clarified physical examination assessment time points, including the addition, in Part A and Part B, of a physical examination postdose • Clarified, in Part A, whether Visit 4 through Visit 6 will be at the clinic (if a blood draw is required) or will be conducted by telephone (if no blood draw is required) • Clarified IDMC review and recommendation to begin enrollment in Part B • Clarified Regeneron PK data review to confirm Part B dose and the addition of PK dosing adjustment rules • In Part B, stratification from country to region was changed • The gestational age categories as ≤31 weeks, 6 days GA or from 32 weeks, 0 days to 35 weeks, 6 days GA was clarified • The Part B treatment arms were clarified • In Part B, monitoring of the subject to 1 hour after dosing was clarified • In Part B, the duration of subject participation was changed • Changed the frequency of site contacts to weekly Clarified information concerning the Medical Information Packet by changing the name, by updating the contents of the Medical Information Packet (including removal of swab samples), and by defining the time to the associated follow-up visit • Added the description of the Safety Monitoring Team • Described the unscheduled visit for potential respiratory illness, including assessments • In Part B, the statement regarding availability of study staff by telephone 7 days a week was removed • study stopping rules were added • The countries and regions where study sites may be located were clarified • the study population age was clarified.
    08 Jul 2015
    •Extended the Part B Post-Dose Follow-up Period from 93 days to 180 days • Added a section describing the benefit/risk assessment • Updated assessments to be performed at unscheduled visits • Updated the study stopping rules • Clarified that some standard of care treatments are permitted • Included axillary temperature equivalents to rectal temperature • Added a section describing the sponsor’s reporting responsibilities • Made minor clarifications to the text
    04 Aug 2015
    The following changes were requested by the Pediatric Committee of the European Medicines Agency (PDC) as part of the Pediatric Investigation Plan (PIP) negotiations: • Added 2 secondary endpoints to Part B − Rationale: The addition of secondary endpoints for PK and Antidrug antibody (ADA) titers were to align with agreed PIP. • Added RSV LRTI Analysis and Alternative LRTI Definition Analysis as sensitivity analyses to the primary endpoint − Rationale: To align with the EU protocol and requested by Pediatric Committee (PDCO), respectively The following changes were requested by the Argentinian regulatory authority (ANMAT): • Clarified language in Exclusion Criteria for the Mother − Rationale: To add that infants of mothers who are either 16 years or younger or of an age where they cannot legally provide informed consent in their state/country are excluded. The following additional changes were made: • updated the scientific/medical monitor • clarified the window in Part B during which assessment of primary and secondary clinical endpoints will occur − Rationale: Although no change of the actual window in which primary and secondary endpoint acquisition was made, the change was to clarify that the windows end at different times during the study period. Clarify that subjects who completed Day 150 may be eligible to enroll in a subsequent extension study • Changed the screening period in Part B from 14 to 28 days − Rationale: Based on feedback from study PIs that a longer period from screening to enrollment is required if infants are enrolled in the hospital or neonatal intensive care unit but were enrolled in the study clinic. Removed throat swab collection − Rationale: Based on feedback that because of high sensitivity of RT-PCR for diagnosis of RSV, a throat swab in addition to nose swab is not necessary and could be challenging to collect in some preterm infants.
    11 Apr 2017
    Revised the approach of handling of missing data in the primary efficacy analysis as discussed with the United States Food and Drug Administration (US FDA). Specifically, the new statistical approach was directly imputed missing data at Day 150 visit. For those subjects who died prior to Day 150 and the deaths were adjudicated to be RSV related, their missing primary endpoint was imputed as “event occurred”. Remaining early termination subjects (including non-RSV deaths) across all treatment groups, was imputed to the average placebo score (estimated placebo event rate). The approach to estimating the placebo event rate was the Kaplan-Meier estimate at Day 150. • Added power calculation for anticipated smaller sample size - Rationale: To understand the impact of the reduced study enrollment on the primary efficacy analysis. • Revised statistical approach to controlling the overall type I error for the primary efficacy analysis. Rationale: To retain sufficient study power for the primary efficacy endpoint given the reduced sample size. To clarify timing of statistical analyses. Specifically, the efficacy analysis was conducted following completion of the 150-day efficacy assessment period by all subjects. This represented the final analysis of all efficacy endpoints. Rationale: Due to the time sensitivity of future study initiation, this supported timely initiation of such studies and avoid long delays waiting for the start of a RSV season.

    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.
    None reported
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