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    The EU Clinical Trials Register currently displays   44298   clinical trials with a EudraCT protocol, of which   7352   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Clinical Trial Results:
    A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

    Summary
    EudraCT number
    2021-000281-15
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    15 Mar 2024

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Sep 2024
    First version publication date
    30 Sep 2024
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    mRNA-1273-P204
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04796896
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ModernaTX, Inc.
    Sponsor organisation address
    325 Binney Street, Cambridge, United States, 02142
    Public contact
    Moderna Clinical Trials Support Center, ModernaTX, Inc., +1 877-777-7187, clinicaltrials@modernatx.com
    Scientific contact
    Moderna Clinical Trials Support Center, ModernaTX, Inc., +1 877-777-7187, clinicaltrials@modernatx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-005791-PIP01-20
    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
    17 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injections in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).
    Protection of trial subjects
    This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and other applicable laws and regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Mar 2021
    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
    United States: 11529
    Country: Number of subjects enrolled
    Canada: 413
    Worldwide total number of subjects
    11942
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    2837
    Children (2-11 years)
    9105
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted in 3 parts: Part 1 (open-label; dose-escalation and age de-escalation), Part 2 (placebo-controlled), and Part 3 (open-label; lower dose regimen). A comparison to the mRNA-1273-P301 (NCT04470427) study's efficacy data was performed on a sub-group of mRNA-1273-P301 study participants aged 18-25 (N=296).

    Period 1
    Period 1 title
    Primary Series (PS)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Part 1 and Part 3 were open label. Part 2 was conducted in an observer-blind manner.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part 1 (6-11 Years): mRNA-1273 50 µg
    Arm description
    Participants received 2 doses of 50 micrograms (µg) mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (6-11 Years): mRNA-1273 100 µg
    Arm description
    Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (2-5 Years): mRNA-1273 25 µg
    Arm description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (2-5 Years): mRNA-1273 50 µg
    Arm description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (6-23 Months): mRNA-1273 25 µg
    Arm description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2 (6-11 Years): Placebo
    Arm description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a coronavirus disease 2019 (COVID-19) vaccine under Emergency Use Authorization (EUA).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate, Sterile concentrate
    Routes of administration
    Intramuscular use, Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1273 was administered per schedule specified in the arm description.

    Arm title
    Part 2 (6-11 Years): mRNA-1273 50 µg
    Arm description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2 (2-5 Years): Placebo
    Arm description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1273 was administered per schedule specified in the arm description.

    Arm title
    Part 2 (2-5 Years): mRNA-1273 25 µg
    Arm description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2 (6-23 Months): Placebo
    Arm description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1273 was administered per schedule specified in the arm description.

    Arm title
    Part 2 (6-23 Months): mRNA-1273 25 µg
    Arm description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
    Arm description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Number of subjects in period 1
    Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
    Started
    380
    371
    75
    149
    150
    1004
    3011
    1008
    3040
    669
    1995
    90
    Received First Injection
    380
    371
    75
    149
    150
    997
    3005
    1007
    3031
    667
    1993
    90
    Received Second Injection
    379
    371
    75
    149
    150
    974
    2995
    984
    3007
    649
    1979
    84
    Received First Injection in Open-label
    0 [1]
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    702
    0 [6]
    640
    0 [7]
    444
    0 [8]
    0 [9]
    Completed
    307
    316
    55
    131
    105
    556
    2329
    515
    2086
    366
    1387
    51
    Not completed
    73
    55
    20
    18
    45
    448
    682
    493
    954
    303
    608
    39
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    36
    31
    11
    8
    16
    162
    299
    149
    303
    94
    192
    16
         Physician decision
    1
    -
    -
    -
    -
    3
    18
    1
    7
    -
    5
    -
         Other Than Specified
    6
    5
    3
    2
    6
    31
    86
    66
    388
    48
    258
    4
         Adverse event, non-fatal
    1
    -
    -
    -
    -
    1
    1
    -
    1
    1
    1
    -
         Protocol Deviation
    -
    -
    -
    1
    1
    2
    2
    2
    2
    1
    -
    -
         Received Emergency Use Authorization (EUA) Vaccine
    5
    4
    -
    3
    1
    194
    37
    222
    29
    115
    9
    1
         Lost to follow-up
    24
    15
    6
    4
    21
    55
    237
    52
    221
    43
    142
    18
         Missing
    -
    -
    -
    -
    -
    -
    2
    1
    2
    1
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of participants in this milestone is consistent with study data.
    Period 2
    Period 2 title
    Booster Dose (BD) Phase
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Part 1 was open label. Part 2 was conducted in an observer-blind manner.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on Booster Dose (BD)-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg
    Arm description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg
    Arm description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg
    Arm description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg
    Arm description
    Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg
    Arm description
    Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Placebo

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate, Sterile concentrate
    Routes of administration
    Intramuscular use, Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.
    Arm type
    Placebo

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg
    Arm description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273.214
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate, Sterile concentrate
    Routes of administration
    Intramuscular use, Intramuscular use
    Dosage and administration details
    mRNA-1273.214 was administered per dose and schedule specified in the arm description.

    Arm title
    Part 3 (6-11 Years): BD mRNA-1273 25 µg
    Arm description
    Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.
    Arm type
    Experimental

    Investigational medicinal product name
    mRNA-1273
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 was administered per dose and schedule specified in the arm description.

    Number of subjects in period 2 [10]
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg Part 3 (6-11 Years): BD mRNA-1273 25 µg
    Started
    229
    247
    122
    31
    59
    9
    38
    5
    37
    505
    2261
    8
    20
    411
    1879
    58
    123
    70
    Received Booster Injection
    229
    247
    122
    31
    59
    9
    38
    5
    37
    505
    2261
    8
    20
    411
    1879
    58
    123
    70
    Completed
    201
    227
    90
    24
    55
    9
    36
    5
    30
    460
    2073
    7
    18
    351
    1626
    55
    115
    50
    Not completed
    28
    20
    32
    7
    4
    0
    2
    0
    7
    45
    188
    1
    2
    60
    253
    3
    8
    20
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    15
    11
    9
    4
    3
    -
    2
    -
    4
    24
    84
    -
    -
    27
    107
    2
    3
    9
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    3
    -
    -
    -
         Other Than Specified
    -
    3
    4
    1
    1
    -
    -
    -
    -
    4
    24
    -
    -
    5
    24
    1
    1
    4
         Received Another COVID-19 Vaccine Under EUA
    2
    1
    1
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    5
    20
    -
    -
    -
         Lost to follow-up
    11
    5
    18
    2
    -
    -
    -
    -
    3
    17
    78
    1
    2
    23
    99
    -
    4
    7
    Notes
    [10] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The number of participants in this period is consistent with study data.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1 (6-11 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 micrograms (µg) mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (6-11 Years): mRNA-1273 100 µg
    Reporting group description
    Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (2-5 Years): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (2-5 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (6-23 Months): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (6-11 Years): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a coronavirus disease 2019 (COVID-19) vaccine under Emergency Use Authorization (EUA).

    Reporting group title
    Part 2 (6-11 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (2-5 Years): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (2-5 Years): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (6-23 Months): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (6-23 Months): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).

    Reporting group values
    Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg Total
    Number of subjects
    380 371 75 149 150 1004 3011 1008 3040 669 1995 90 11942
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days - 23 months)
    0 0 0 0 150 0 0 11 18 669 1989 0 2837
        Children (2 - 11 years)
    380 371 75 149 0 1004 3011 997 3022 0 6 90 9105
        Adults (between 18 and 64 years)
    0 0 0 0 0 0 0 0 0 0 0 0 0
    Gender Categorical
    Units: Subjects
        Female
    185 199 39 69 67 516 1456 498 1490 341 981 34 5875
        Male
    195 172 36 80 83 488 1555 510 1550 328 1014 56 6067
    Race
    Units: Subjects
        White
    266 284 54 128 124 676 1960 793 2307 527 1568 48 8735
        Black or African American
    34 13 3 7 3 94 310 38 142 18 62 37 761
        Asian
    28 25 8 3 7 100 297 51 191 38 94 2 844
        American Indian or Alaska Native
    0 2 0 0 1 3 15 3 11 0 7 2 44
        Native Hawaiian or Other Pacific Islander
    1 0 0 0 0 0 4 3 5 0 0 0 13
        Other
    3 10 7 1 3 22 62 16 43 7 33 0 207
        Multiple
    39 31 3 10 11 98 330 100 324 76 215 0 1237
        Not Reported
    9 4 0 0 0 10 23 4 13 2 11 1 77
        Unknown
    0 2 0 0 1 1 10 0 4 1 5 0 24
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    72 69 24 17 15 183 562 142 429 94 257 29 1893
        Not Hispanic or Latino
    304 296 51 129 133 811 2421 857 2593 568 1719 58 9940
        Not Reported
    3 3 0 3 1 5 21 8 13 6 17 1 81
        Unknown
    1 3 0 0 1 5 7 1 5 1 2 2 28
    Subject analysis sets

    Subject analysis set title
    Part 1 (6-11 Years): mRNA-1273 50 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (6-11 Years): mRNA-1273 100 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (2-5 Years): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (2-5 Years): mRNA-1273 50 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (6-23 Months): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 2 (6-11 Years): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (6-11 Years): mRNA-1273 50 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 2 (2-5 Years): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (2-5 Years): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 2 (6-23 Months): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (6-23 Months): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 3 (6-11 Years): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 3 doses of 25 µg mRNA-1273 by IM injection on Days 1, 29, and 149.

    Subject analysis set title
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

    Subject analysis set title
    Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a placebo in the blinded phase and then crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a placebo in the blinded phase and then crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. Adverse Events were collected from the first cross-over dose until the first booster dose.

    Subject analysis set title
    Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a placebo in the blinded phase and then crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. Adverse Events were collected from the first cross-over dose until the first booster dose.

    Subject analysis set title
    BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

    Subject analysis set title
    BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Subject analysis sets values
    Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): mRNA-1273 25 µg Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover) Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover) Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover) BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
    Number of subjects
    380
    371
    69
    155
    150
    995
    3007
    1007
    3031
    666
    1994
    90
    296
    701
    640
    444
    103
    189
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days - 23 months)
    0
        Children (2 - 11 years)
    0
        Adults (between 18 and 64 years)
    296
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender Categorical
    Units: Subjects
        Female
    153
        Male
    143
    Race
    Units: Subjects
        White
    207
        Black or African American
    29
        Asian
    30
        American Indian or Alaska Native
    3
        Native Hawaiian or Other Pacific Islander
    2
        Other
    8
        Multiple
    14
        Not Reported
    3
        Unknown
    0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    78
        Not Hispanic or Latino
    216
        Not Reported
    0
        Unknown
    2

    End points

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    End points reporting groups
    Reporting group title
    Part 1 (6-11 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 micrograms (µg) mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (6-11 Years): mRNA-1273 100 µg
    Reporting group description
    Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (2-5 Years): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (2-5 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (6-23 Months): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (6-11 Years): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a coronavirus disease 2019 (COVID-19) vaccine under Emergency Use Authorization (EUA).

    Reporting group title
    Part 2 (6-11 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (2-5 Years): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (2-5 Years): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (6-23 Months): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (6-23 Months): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).
    Reporting group title
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on Booster Dose (BD)-Day 1.

    Reporting group title
    Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg
    Reporting group description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg
    Reporting group description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg
    Reporting group description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg
    Reporting group description
    Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Reporting group title
    Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg
    Reporting group description
    Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Reporting group title
    Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Reporting group title
    Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Reporting group title
    Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Reporting group title
    Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Reporting group title
    Part 3 (6-11 Years): BD mRNA-1273 25 µg
    Reporting group description
    Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.

    Subject analysis set title
    Part 1 (6-11 Years): mRNA-1273 50 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (6-11 Years): mRNA-1273 100 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (2-5 Years): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (2-5 Years): mRNA-1273 50 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 1 (6-23 Months): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 2 (6-11 Years): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (6-11 Years): mRNA-1273 50 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 2 (2-5 Years): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (2-5 Years): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 2 (6-23 Months): Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (6-23 Months): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Subject analysis set title
    Part 3 (6-11 Years): mRNA-1273 25 µg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received 3 doses of 25 µg mRNA-1273 by IM injection on Days 1, 29, and 149.

    Subject analysis set title
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

    Subject analysis set title
    Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a placebo in the blinded phase and then crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Subject analysis set title
    Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a placebo in the blinded phase and then crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. Adverse Events were collected from the first cross-over dose until the first booster dose.

    Subject analysis set title
    Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants received a placebo in the blinded phase and then crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. Adverse Events were collected from the first cross-over dose until the first booster dose.

    Subject analysis set title
    BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

    Subject analysis set title
    BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Primary: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

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    End point title
    Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [1]
    End point description
    Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. Solicited Safety Set: all participants in Safety Set (Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection) who contributed any solicited AR data, that is, had at least 1 post-baseline solicited safety assessment. Data for this endpoint was not collected for the treatment groups mRNA-1273.214.
    End point type
    Primary
    End point timeframe
    7 days post-vaccination
    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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg Part 3 (6-11 Years): BD mRNA-1273 25 µg Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): mRNA-1273 25 µg
    Number of subjects analysed
    228
    247
    122
    31
    58
    8
    38
    5
    18
    405
    1853
    56
    380
    371
    69
    153
    150
    994
    3005
    998
    3014
    664
    1991
    90
    Units: participants
    216
    221
    93
    24
    46
    7
    36
    4
    12
    358
    1726
    30
    374
    367
    62
    147
    141
    823
    2983
    797
    2800
    596
    1889
    66
    No statistical analyses for this end point

    Primary: Number of Participants With Unsolicited AEs

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    End point title
    Number of Participants With Unsolicited AEs [2]
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately. Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection.
    End point type
    Primary
    End point timeframe
    Up to 28 days post-vaccination
    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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): mRNA-1273 25 µg
    Number of subjects analysed
    229
    247
    122
    31
    59
    9
    38
    5
    37
    505
    2261
    8
    20
    411
    1879
    58
    123
    380
    371
    69
    155
    150
    995
    3007
    1007
    3031
    666
    1994
    90
    Units: participants
    38
    20
    24
    8
    4
    1
    8
    1
    5
    57
    282
    0
    0
    33
    196
    4
    7
    106
    92
    15
    51
    75
    207
    785
    325
    1087
    283
    883
    17
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study

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    End point title
    Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study [3]
    End point description
    An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of protocol specified neurologic diseases, anaphylaxis, multisystem inflammatory syndrome in children (MIS-C) and myocarditis and/or pericarditis. An MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. This included visits to a study site for unscheduled assessments and visits to healthcare practitioners external to the study site. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately. Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection.
    End point type
    Primary
    End point timeframe
    Throughout the study period (up to 24 months)
    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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): mRNA-1273 25 µg Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover) Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover) Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)
    Number of subjects analysed
    229
    247
    122
    31
    59
    9
    38
    5
    37
    505
    2261
    8
    20
    411
    1879
    58
    123
    380
    371
    69
    155
    150
    995
    3007
    1007
    3031
    666
    1994
    90
    701
    640
    444
    Units: participants
        SAEs
    1
    1
    1
    0
    0
    0
    0
    1
    0
    7
    16
    0
    0
    3
    7
    0
    0
    5
    3
    0
    0
    3
    1
    22
    3
    32
    6
    45
    1
    3
    8
    4
        AESIs
    1
    0
    2
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    2
    9
    0
    0
    5
    7
    0
    1
    2
    2
    19
    7
    13
    2
    13
    0
    3
    1
    1
        MAAEs
    85
    71
    59
    16
    23
    4
    17
    3
    10
    182
    901
    1
    3
    137
    616
    16
    34
    175
    169
    32
    80
    105
    155
    1095
    411
    1687
    340
    1237
    22
    221
    204
    171
        AEs Leading to Discontinuation
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Trial (Study P301)

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    End point title
    Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Trial (Study P301) [4]
    End point description
    Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ and values greater than upper limit of quantification (ULOQ) were replaced by ULOQ if actual values were not available. LLOQ was 18.5 arbitrary units (AU)/milliliter (mL) and ULOQ was 45118 AU/mL for ID50 titer. Per-Protocol (PP) Immunogenicity Subset: all enrolled participants who received at least 1 injection of study drug, had baseline SARS-CoV-2 status, had baseline and at least 1 post-injection antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving highly active antiretroviral therapy (HAART) for participants with HIV; and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 57 P204/Day 57 P301
    Notes
    [4] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): mRNA-1273 50 µg Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects analysed
    201
    56
    51
    68
    97
    309
    294
    Units: titer
    geometric mean (confidence interval 95%)
        ID50
    1669.1 (1504.5 to 1851.6)
    1890.2 (1603.8 to 2227.7)
    1012.5 (848.2 to 1208.6)
    1845.9 (1600.5 to 2128.9)
    1782.6 (1542.0 to 2060.7)
    1618.3 (1460.0 to 1793.9)
    1321.9 (1196.5 to 1460.5)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Part 2 (6-11 Years): mRNA-1273 50 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects included in analysis
    603
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    GMR
    Point estimate
    1.224
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.061
         upper limit
    1.413

    Primary: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Endpoint Efficacy Trial (Study P301)

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    End point title
    GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Endpoint Efficacy Trial (Study P301) [5]
    End point description
    Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received at least 1 injection of study drug, had baseline severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) status, had baseline and at least 1 post-injection antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 and negative serology test based on binding antibody (bAb) specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with human immunodeficiency virus (HIV); and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 57 P204/Day 57 P301
    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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects analysed
    289
    268
    61
    294
    Units: AU/mL
        geometric mean (confidence interval 95%)
    1394.1 (1267.7 to 1533.1)
    1759.8 (1606.7 to 1927.4)
    4368.6 (3339.6 to 5714.6)
    1400.4 (1272.7 to 1541.0)
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Part 2 (6-23 Months): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects included in analysis
    562
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    GMR
    Point estimate
    1.257
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.101
         upper limit
    1.434
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Part 2 (2-5 Years): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects included in analysis
    583
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    GMR
    Point estimate
    0.995
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.87
         upper limit
    1.139

    Primary: Seroresponse rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Trial (Study P301)

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    End point title
    Seroresponse rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Trial (Study P301) [6]
    End point description
    Percentage of participants with seroresponse for pseudovirus neutralizing antibody ID50 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. PP Immunogenicity Subset: all enrolled participants who received at least 1 injection of study drug, had baseline SARS-CoV-2 status, had baseline and at least 1 post-injection antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed’ = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 57 P204/Day 57 P301
    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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): mRNA-1273 50 µg Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects analysed
    201
    56
    50
    68
    96
    307
    294
    Units: percentage of participants
    number (confidence interval 95%)
        ID50
    99.5 (97.3 to 99.9)
    100 (93.6 to 100.0)
    100 (92.9 to 100)
    100 (94.7 to 100.0)
    100 (96.2 to 100.0)
    99.0 (97.2 to 99.8)
    99.3 (97.6 to 99.9)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Part 2 (6-11 Years): mRNA-1273 50 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects included in analysis
    601
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    1.6

    Primary: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Endpoint Efficacy Trial (Study P301)

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    End point title
    SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in the Clinical Endpoint Efficacy Trial (Study P301) [7]
    End point description
    Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 and ULOQ AU/mL was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received at least 1 injection of study drug, had baseline SARS-CoV-2 status, had baseline and at least 1 post-injection antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed’ = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 57 P204/Day 57 P301
    Notes
    [7] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects analysed
    284
    264
    61
    294
    Units: percentage of participants
        number (confidence interval 95%)
    98.9 (96.9 to 99.8)
    100 (98.6 to 100.0)
    88.5 (77.8 to 95.3)
    99.3 (97.6 to 99.9)
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Part 2 (6-23 Months): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects included in analysis
    558
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    2.4
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Part 2 (2-5 Years): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects included in analysis
    578
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage difference
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    1.5

    Primary: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Clinical Endpoint Efficacy Trial (Study P301)

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    End point title
    GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Clinical Endpoint Efficacy Trial (Study P301)
    End point description
    Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = Pre-booster SARS-CoV-2 negative participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    BD-Day 29 P204/Day 57 P301
    End point values
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
    Number of subjects analysed
    294
    76
    137
    Units: AU/mL
        geometric mean (confidence interval 95%)
    1400.4 (1272.7 to 1541.0)
    5457.2 (4525.7 to 6580.3)
    5575.9 (5026.8 to 6184.9)
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
    Number of subjects included in analysis
    431
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    GMR
    Point estimate
    3.982
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.459
         upper limit
    4.583
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    GMR
    Point estimate
    3.897
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.158
         upper limit
    4.808

    Primary: GM Concentration of Post-third Dose (Part 3) Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Clinical Endpoint Efficacy Trial (Study P301)

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    End point title
    GM Concentration of Post-third Dose (Part 3) Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Clinical Endpoint Efficacy Trial (Study P301) [8]
    End point description
    Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Third Dose-Day 29 P204/Day 57 P301
    Notes
    [8] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 3 (6-11 Years): BD mRNA-1273 25 µg Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects analysed
    52
    294
    Units: AU/mL
        geometric mean (confidence interval 95%)
    4616.6 (3669.4 to 5808.3)
    1400.4 (1272.7 to 1541.0)
    No statistical analyses for this end point

    Primary: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Clinical Trial (Study P301)

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    End point title
    SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Clinical Trial (Study P301)
    End point description
    Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = Pre-booster SARS-CoV-2 negative participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    BD-Day 29 P204/Day 57 P301
    End point values
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
    Number of subjects analysed
    294
    72
    129
    Units: percentage of participants
        number (confidence interval 95%)
    99.3 (97.6 to 99.9)
    100 (95.0 to 100.0)
    100 (97.2 to 100.0)
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
    Number of subjects included in analysis
    423
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    2.4
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    percentage difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.4
         upper limit
    2.4

    Primary: SRR for Post-third Dose (Part 3) Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

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    End point title
    SRR for Post-third Dose (Part 3) Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 [9]
    End point description
    Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Third Dose-Day 29 P204/Day 57 P301
    Notes
    [9] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 3 (6-11 Years): BD mRNA-1273 25 µg Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
    Number of subjects analysed
    50
    294
    Units: percentage of participants
        number (confidence interval 95%)
    90.0 (78.2 to 96.7)
    99.3 (97.6 to 99.9)
    No statistical analyses for this end point

    Secondary: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57

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    End point title
    GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 [10]
    End point description
    GM level of SARSCOV2S2P immunoglobulin G (IgG) antibody VAC123/VAC72, as measured by ECL multiplex assay specific to SARS-CoV-2 spike protein is reported. Antibody values reported as <LLOQ were replaced by 0.5*LLOQ and values >ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 23 AU/mL and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 AU/mL and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset: all enrolled participants who received at least 1 dose of IP, had baseline SARS-CoV-2 status, had baseline and at least 1 post-injection antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations. Overall number of participants analyzed= participants evaluable for this endpoint. n = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 57 (1 month after Dose 2)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): mRNA-1273 25 µg
    Number of subjects analysed
    200
    56
    50
    68
    96
    308
    304
    285
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline (Day 1) (n=200,56,50,68,96,294,304,285)
    35.6 (31.0 to 40.8)
    49.1 (33.9 to 71.1)
    15.8 (13.5 to 18.5)
    33.7 (26.2 to 43.4)
    14.6 (12.8 to 16.7)
    32.6 (28.5 to 37.3)
    24.5 (21.7 to 27.5)
    22.0 (19.1 to 25.3)
        Day 57 (n=200,56,50, 61,95,308,301,280)
    325784.0 (302917.7 to 350376.4)
    457349.2 (402424.0 to 519770.8)
    261952.0 (227935.8 to 301044.7)
    417419.8 (359399.2 to 484807.0)
    297561.7 (234740.9 to 377194.3)
    293118.9 (261748.3 to 328249.4)
    235059.2 (198610.2 to 278197.3)
    293955.4 (256077.7 to 337435.8)
    No statistical analyses for this end point

    Secondary: Part 1 and Part 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29

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    End point title
    Part 1 and Part 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29
    End point description
    GM level of SARSCOV2S2P IgG antibody VAC123/VAC72 is reported. Antibody values reported as <LLOQ were replaced by 0.5*LLOQ and values >ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 23 and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, , not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline, had BD-Day 29 antibody assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. Number analyzed = participants evaluable for this endpoint. n= participants evaluable at specified timepoint. ‘0.99 and 99999’ signifies data not available.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1 (Pre-booster), BD-Day 29 (1 month after booster dose)
    End point values
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg
    Number of subjects analysed
    75
    84
    19
    114
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline (n=72,80,13,91)
    50.0 (42.7 to 58.6)
    37.5 (34.3 to 40.9)
    34.5 (0.99 to 99999)
    51.9 (44.6 to 60.3)
        Day 57 (n=55,56,12,16)
    302128.3 (266991.2 to 341889.7)
    279427.6 (242953.8 to 321377.2)
    241874.9 (180565.7 to 324001.0)
    336189.6 (257789.9 to 438432.5)
        Day 209 (n=45,69,19,111)
    74516.9 (63553.5 to 87371.5)
    66516.5 (59365.2 to 74529.2)
    71427.5 (50801.5 to 100427.9)
    85360.1 (71680.4 to 101650.5)
        BD-Day 1 (n=75,77,19,114)
    66677.7 (52382.4 to 84874.2)
    68322.4 (53860.8 to 86667.0)
    50621.5 (34112.1 to 75121.2)
    86416.4 (72836.0 to 102528.9)
        BD-Day 29 (n=75,84,19,113)
    633999.7 (561311.4 to 716101.0)
    675348.1 (584405.3 to 780443.0)
    536478.9 (403508.2 to 713268.2)
    520973.0 (469812.4 to 577704.8)
    No statistical analyses for this end point

    Secondary: Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

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    End point title
    Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181
    End point description
    GM level of SARSCOV2S2P IgG antibody against B.1.1.529 strain is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 102 and ULOQ was 1180000 AU/mL for VAC123. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impact key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181
    End point values
    Part 3 (6-11 Years): BD mRNA-1273 25 µg
    Number of subjects analysed
    52
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline (Pre-dose 1) (n = 50)
    4659.5 (2918.7 to 7438.5)
        Day 57 (n = 50)
    141758.0 (118762.4 to 169206.2)
        Third Dose-Day 1 (n = 49)
    48176.2 (38955.2 to 59580.0)
        Third Dose-Day 29 (n = 52)
    93436.4 (77735.5 to 112308.5)
        Third Dose-Day 181 (n = 46)
    40271.7 (32950.9 to 49219.2)
    No statistical analyses for this end point

    Secondary: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57

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    End point title
    GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 [11]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ and values greater than ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. PP Immunogenicity Subset: all enrolled participants who received at least 1 injection of study drug, had baseline SARS-CoV-2 status, had baseline and at least 1 post-injection antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable at specified timepoint. 0.999 and 99999 signifies data not evaluable due to below limit of quantification.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 57 (1 month after Dose 2)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): mRNA-1273 50 µg
    Number of subjects analysed
    201
    56
    51
    68
    97
    309
    Units: titer
    geometric mean (confidence interval 95%)
        Day 1 (n=201,56,50,68,97,308)
    9.3 (9.2 to 9.5)
    9.6 (8.9 to 10.3)
    9.3 (0.999 to 99999)
    9.3 (0.999 to 99999)
    9.6 (9.3 to 9.9)
    9.3 (0.999 to 99999)
        Day 57 (n=201,56,51,68,97,309)
    1669.1 (1504.5 to 1851.6)
    1890.2 (1603.8 to 2227.7)
    1012.5 (848.2 to 1208.6)
    1845.9 (1600.5 to 2128.9)
    1782.6 (1542.0 to 2060.7)
    1618.3 (1460.0 to 1793.9)
    No statistical analyses for this end point

    Secondary: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57

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    End point title
    GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 [12]
    End point description
    Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. Data are reported per Baseline SARS-CoV-2 status: Negative and Positive. PP Immunogenicity Subset: all enrolled participants who received at least 1 injection of study drug, had baseline SARS-CoV-2 status, had baseline and at least 1 post-injection antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 57 (1 month after Dose 2)
    Notes
    [12] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): mRNA-1273 25 µg Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
    Number of subjects analysed
    315
    311
    57
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline SARS-CoV-2 (Negative): Day 1(n=315,311,4)
    7.9 (7.5 to 8.4)
    8.0 (7.5 to 8.5)
    21.5 (2.6 to 175.1)
        Baseline SARS-CoV-2 (Positive): Day 1 (n=28,19,57)
    175.3 (130.4 to 235.6)
    199.9 (109.2 to 365.9)
    177.5 (111.2 to 283.3)
        Baseline SARS-CoV-2(Negative): Day 57(n=298,278,4)
    1398.1 (1271.9 to 1536.8)
    1760.8 (1609.7 to 1926.0)
    2140.6 (728.7 to 6288.7)
        Baseline SARS-CoV-2 (Positive): Day 57(n=23,15,57)
    7430.0 (5188.4 to 10640.1)
    10411.6 (6712.1 to 16150.1)
    4592.9 (3470.7 to 6077.9)
    No statistical analyses for this end point

    Secondary: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29

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    End point title
    GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29
    End point description
    Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Day 209 (6 months after Dose 2), BD-Day 1 (Pre-booster), and BD-Day 29 (1 month after booster dose or third dose)
    End point values
    Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg
    Number of subjects analysed
    75
    84
    19
    114
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline (n=81,16,111,70)
    9.3 (8.5 to 10.3)
    9.0 (8.2 to 9.9)
    12.8 (10.0 to 16.3)
    7.8 (7.1 to 8.6)
        Day 57 (n=56,18,18,55)
    1503.3 (1292.3 to 1748.7)
    1557.1 (1294.2 to 1873.5)
    1275.0 (983.0 to 1653.8)
    1718.7 (1316.5 to 2243.7)
        Day 209 (n=68,18,110,45)
    530.3 (432.5 to 650.2)
    448.6 (376.9 to 533.8)
    544.5 (343.1 to 864.0)
    790.7 (633.8 to 986.4)
        BD-Day 1 (n=75,18,113,75)
    627.9 (467.8 to 842.8)
    558.0 (408.5 to 762.2)
    447.2 (270.0 to 740.7)
    795.5 (640.8 to 987.5)
        BD-Day 29 (n=84,19,114,75)
    6991.6 (6091.2 to 8025.0)
    6474.7 (5406.0 to 7754.8)
    5778.7 (4039.7 to 8266.4)
    5805.4 (5122.4 to 6579.4)
    No statistical analyses for this end point

    Secondary: GM Concentration of Post-third Dose (Part 3) SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181

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    End point title
    GM Concentration of Post-third Dose (Part 3) SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181
    End point description
    Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Third Dose-Day 1 (at least 3 months or 6 months after Dose 2), Third Dose-Day 29 (1 month after third dose), and Third Dose-Day 181 (6 months after third dose)
    End point values
    Part 3 (6-11 Years): BD mRNA-1273 25 µg
    Number of subjects analysed
    52
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Baseline (n=50)
    120.0 (71.9 to 200.3)
        Day 57 (n=50)
    3775.0 (2767.5 to 5149.3)
        Third Dose-Day 1 (n=49)
    1839.1 (1279.8 to 2643.0)
        Third Dose-Day 29 (n=52)
    4616.6 (3669.4 to 5808.3)
        Third Dose-Day 181 (n=46)
    1432.5 (1038.6 to 1975.8)
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants With SARS-CoV-2 infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR)

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    End point title
    Part 2: Number of Participants With SARS-CoV-2 infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) [13]
    End point description
    SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive (as measured by Roche Elecsys) postbaseline; OR positive RT-PCR postbaseline. A summary of SAEs and all nonserious AEs ("Other") regardless of causality, is located in the Reported "Adverse Events" section. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    14 days after second injection
    Notes
    [13] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg
    Number of subjects analysed
    849
    2606
    854
    2592
    563
    1686
    Units: participants
    14
    13
    178
    330
    94
    198
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants With Asymptomatic SARS-CoV-2 infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys)

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    End point title
    Part 2: Number of Participants With Asymptomatic SARS-CoV-2 infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) [14]
    End point description
    Asymptomatic SARS-CoV-2 infection was identified by absence of symptoms and infections as detected by RT-PCR or serology tests: Absence of COVID-19 symptoms AND at least 1 from following: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1 that became positive post-baseline, OR positive RT-PCR test post-baseline. A summary of SAEs and all nonserious AEs ("Other") regardless of causality, is located in the Reported "Adverse Events" section. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    14 days after second injection
    Notes
    [14] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg
    Number of subjects analysed
    849
    2606
    854
    2592
    563
    1686
    Units: participants
    10
    10
    55
    124
    21
    70
    No statistical analyses for this end point

    Secondary: Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19)

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    End point title
    Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) [15]
    End point description
    A COVID-19 case was identified as a positive post-baseline RT-PCR test result together with at least 1 of following systemic symptoms: fever (≥ 38 degrees Celsius [°C]/≥ 100.4 degree Fahrenheit [°F]) or chills, fatigue, headache, myalgia, nasal congestion or rhinorrhea, new loss of taste or smell, sore throat, abdominal pain, diarrhoea, nausea/vomiting, poor appetite/poor feeding; or at least 1 of following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing. A summary of SAEs and all nonserious AEs ("Other") regardless of causality, is located in the Reported "Adverse Events" section. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline.
    End point type
    Secondary
    End point timeframe
    14 days after second injection
    Notes
    [15] - 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: Data for this endpoint was reported for the specified arms only.
    End point values
    Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): Placebo Part 2 (6-23 Months): mRNA-1273 25 µg
    Number of subjects analysed
    849
    2606
    854
    2592
    563
    1686
    Units: participants
    4
    3
    125
    207
    73
    130
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period (up to 24 months)
    Adverse event reporting additional description
    Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Part 1 (6-11 Years): mRNA-1273 100 µg
    Reporting group description
    Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (6-11 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (2-5 Years): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (2-5 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 1 (6-23 Months): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (6-11 Years): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (6-11 Years): mRNA-1273 50 µg
    Reporting group description
    Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (2-5 Years): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (6-23 Months): Placebo
    Reporting group description
    Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (2-5 Years): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    Part 2 (6-23 Months): mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

    Reporting group title
    6-11 Yrs: BD mRNA-1273.214 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Reporting group title
    6-11 Years: BD mRNA-1273 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    Part 3 (6-11 Years): BD mRNA-1273 25 µg
    Reporting group description
    Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.

    Reporting group title
    Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
    Reporting group description
    Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).

    Reporting group title
    Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)
    Reporting group description
    Participants received a placebo in the blinded phase and then crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

    Reporting group title
    Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)
    Reporting group description
    Participants received a placebo in the blinded phase and then crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. Adverse Events were collected from the first cross-over dose until the first booster dose.

    Reporting group title
    Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)
    Reporting group description
    Participants received a placebo in the blinded phase and then crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. Adverse Events were collected from the first cross-over dose until the first booster dose.

    Reporting group title
    6 Months-5 Yrs: BD mRNA-1273 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    6 Months-5 Yrs: BD mRNA-1273 10 μg
    Reporting group description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    6 Months-5 Yrs: BD mRNA-1273.214 10 μg
    Reporting group description
    Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

    Reporting group title
    6 Months-5 Yrs: BD mRNA-1273.214 25 μg
    Reporting group description
    Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

    Serious adverse events
    Part 1 (6-11 Years): mRNA-1273 100 µg Part 1 (6-11 Years): mRNA-1273 50 µg Part 1 (2-5 Years): mRNA-1273 25 µg Part 1 (2-5 Years): mRNA-1273 50 µg Part 1 (6-23 Months): mRNA-1273 25 µg Part 2 (6-11 Years): Placebo Part 2 (6-11 Years): mRNA-1273 50 µg Part 2 (2-5 Years): Placebo Part 2 (6-23 Months): Placebo Part 2 (2-5 Years): mRNA-1273 25 µg Part 2 (6-23 Months): mRNA-1273 25 µg 6-11 Yrs: BD mRNA-1273.214 25 μg 6-11 Years: BD mRNA-1273 25 μg Part 3 (6-11 Years): BD mRNA-1273 25 µg Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover) Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover) Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover) 6 Months-5 Yrs: BD mRNA-1273 25 μg 6 Months-5 Yrs: BD mRNA-1273 10 μg 6 Months-5 Yrs: BD mRNA-1273.214 10 μg 6 Months-5 Yrs: BD mRNA-1273.214 25 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 371 (0.81%)
    5 / 380 (1.32%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    3 / 150 (2.00%)
    1 / 995 (0.10%)
    22 / 3007 (0.73%)
    3 / 1007 (0.30%)
    7 / 666 (1.05%)
    32 / 3031 (1.06%)
    45 / 1994 (2.26%)
    0 / 184 (0.00%)
    12 / 2766 (0.43%)
    0 / 70 (0.00%)
    1 / 90 (1.11%)
    3 / 701 (0.43%)
    8 / 640 (1.25%)
    4 / 444 (0.90%)
    1 / 89 (1.12%)
    1 / 212 (0.47%)
    23 / 2771 (0.83%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    1 / 1007 (0.10%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    1 / 150 (0.67%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adnexal torsion
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    2 / 3031 (0.07%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    2 / 666 (0.30%)
    0 / 3031 (0.00%)
    2 / 1994 (0.10%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    1 / 444 (0.23%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    2 / 3031 (0.07%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    1 / 1007 (0.10%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    3 / 1994 (0.15%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    1 / 90 (1.11%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    1 / 666 (0.15%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    2 / 1994 (0.10%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    1 / 640 (0.16%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory symptom
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Disruptive mood dysregulation disorder
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oppositional defiant disorder
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    1 / 701 (0.14%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foreign body ingestion
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 380 (0.26%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiphyseal fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body in respiratory tract
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Greenstick fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Torus fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    1 / 640 (0.16%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    1 / 640 (0.16%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal haematoma
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital hydronephrosis
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 380 (0.26%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    1 / 150 (0.67%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    3 / 1994 (0.15%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    1 / 640 (0.16%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    1 / 3031 (0.03%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign rolandic epilepsy
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    1 / 2771 (0.04%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    1 / 2766 (0.04%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    0 / 3007 (0.00%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    1 / 1994 (0.05%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 371 (0.00%)
    0 / 380 (0.00%)
    0 / 69 (0.00%)
    0 / 155 (0.00%)
    0 / 150 (0.00%)
    0 / 995 (0.00%)
    1 / 3007 (0.03%)
    0 / 1007 (0.00%)
    0 / 666 (0.00%)
    0 / 3031 (0.00%)
    0 / 1994 (0.00%)
    0 / 184 (0.00%)
    0 / 2766 (0.00%)
    0 / 70 (0.00%)
    0 / 90 (0.00%)
    0 / 701 (0.00%)
    0 / 640 (0.00%)
    0 / 444 (0.00%)
    0 / 89 (0.00%)
    0 / 212 (0.00%)
    0 / 2771 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0