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    Clinical Trial Results:
    A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months

    Summary
    EudraCT number
    		 2024-000122-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2025
    First version publication date
    18 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    mRNA-1345-P101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04528719
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ModernaTX, Inc.
    Sponsor organisation address
    325 Binney Street, Cambridge, United States, 02142
    Public contact
    Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.com
    Scientific contact
    Moderna WeCare Team, ModernaTX, Inc., +1 866-663-3762, WeCareClinicalTrials@modernatx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-003309-PIP01-22
    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
    18 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who were RSV-seropositive.
    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, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, applicable International Organization for Standardization (ISO) 14155 medical device guidelines, and other applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2020
    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: 651
    Worldwide total number of subjects
    651
    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)
    7
    Children (2-11 years)
    39
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    288
    From 65 to 84 years
    317
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included 4 Younger Adult Cohorts, 5 Older Adult Cohorts, 1 Japanese Older Adult Cohort, 2 Pediatric Cohorts, and 3 Women of Child-Bearing Potential (WOCBP) Cohorts.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years)
    Arm description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Arm description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose B of mRNA-1345 per day on Day 1, Day 57, and Day 113.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years)
    Arm description
    		 Participants received a single injection of Dose C of mRNA-1345 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Single Injection Placebo in Younger Adults (18 to 49 Years)
    Arm description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Arm title
    		 Three Injection Placebo in Younger Adults (18 to 49 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Arm title
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose D of mRNA-1345 per day on Day 1, Day 57, and Day 113.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose G of mRNA-1345 per day on Day 1, Day 57, and Day 113.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Three Injection Placebo in Children (12 to 59 Months)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Arm title
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose A of mRNA-1345 on Day 1, a booster injection of Dose A of mRNA-1345 approximately 12 months later and a second booster injection of Dose A of mRNA-1345 approximately 24 months after Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose B of mRNA-1345 on Day 1, a booster injection of Dose B of mRNA-1345 approximately 12 months later and a second booster injection of Dose B of mRNA-1345 approximately 24 months after Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose C of mRNA-1345 on Day 1, a booster injection of Dose C of mRNA-1345 approximately 12 months later and a second booster injection of Dose C of mRNA-1345 approximately 24 months after Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose E of mRNA-1345 on Day 1, a booster injection of Dose E of mRNA-1345 approximately 12 months later and a second booster injection of Dose E of mRNA-1345 approximately 24 months after Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of Dose F of mRNA-1345 on Day 1, a booster injection of Dose F of mRNA-1345 approximately 12 months later and a second booster injection of Dose F of mRNA-1345 approximately 24 months after Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Two Injection Placebo in Older Adults (65 to 79 Years)
    Arm description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1 and approximately 12 months later. Participants received second booster injection of Dose A of mRNA-1345 approximately 24 months after Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Arm title
    		 Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Arm description
    		 Participants received a single injection of Dose F of mRNA-1345 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years)
    Arm description
    		 Participants received a single injection of Dose E of mRNA-1345 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years)
    Arm description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Single Injection Placebo in WOCBP (18 to 40 Years)
    Arm description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Arm title
    		 Cohort 15: mRNA-1345 Dose B in Japanese Older Adults
    Arm description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1345
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1345 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Arm description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matched to mRNA-1345 was administered per schedule specified in the arm description.

    Number of subjects in period 1
    		Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years) Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months) Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years) Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years) Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Started
    20
    20
    20
    20
    15
    5
    16
    15
    15
    48
    48
    48
    48
    48
    60
    50
    50
    50
    30
    20
    5
    Safety Set
    19
    20
    20
    20
    15
    5
    15
    15
    15
    47
    48
    48
    48
    48
    59
    50
    49
    49
    30
    20
    5
    Completed
    18
    19
    15
    19
    14
    3
    11
    11
    9
    36
    31
    30
    40
    40
    44
    45
    44
    42
    26
    20
    5
    Not completed
    2
    1
    5
    1
    1
    2
    5
    4
    6
    12
    17
    18
    8
    8
    16
    5
    6
    8
    4
    0
    0
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    1
    1
    1
    -
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    1
    1
    4
    -
    1
    1
    -
    -
    2
    8
    3
    12
    3
    4
    5
    1
    4
    5
    2
    -
    -
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Other Than Specified
    -
    -
    -
    -
    -
    -
    2
    -
    1
    1
    2
    2
    1
    -
    1
    1
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    1
    -
    1
    1
    -
    1
    3
    4
    2
    2
    10
    3
    3
    1
    10
    3
    2
    3
    2
    -
    -
         Protocol deviation
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose B of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose C of mRNA-1345 on Day 1.

    Reporting group title
    Single Injection Placebo in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Three Injection Placebo in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose D of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose G of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Three Injection Placebo in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose A of mRNA-1345 on Day 1, a booster injection of Dose A of mRNA-1345 approximately 12 months later and a second booster injection of Dose A of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose B of mRNA-1345 on Day 1, a booster injection of Dose B of mRNA-1345 approximately 12 months later and a second booster injection of Dose B of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose C of mRNA-1345 on Day 1, a booster injection of Dose C of mRNA-1345 approximately 12 months later and a second booster injection of Dose C of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose E of mRNA-1345 on Day 1, a booster injection of Dose E of mRNA-1345 approximately 12 months later and a second booster injection of Dose E of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose F of mRNA-1345 on Day 1, a booster injection of Dose F of mRNA-1345 approximately 12 months later and a second booster injection of Dose F of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Two Injection Placebo in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1 and approximately 12 months later. Participants received second booster injection of Dose A of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose F of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose E of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.

    Reporting group title
    Single Injection Placebo in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Cohort 15: mRNA-1345 Dose B in Japanese Older Adults
    Reporting group description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.

    Reporting group title
    Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years) Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months) Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years) Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years) Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years) Total
    Number of subjects
    		 20 20 20 20 15 5 16 15 15 48 48 48 48 48 60 50 50 50 30 20 5 651
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.1 ( 7.50 ) 33.4 ( 7.56 ) 32.0 ( 9.55 ) 31.8 ( 4.81 ) 37.5 ( 6.64 ) 24.8 ( 4.09 ) 3.6 ( 1.08 ) 3.2 ( 1.01 ) 3.2 ( 1.17 ) 70.1 ( 3.81 ) 70.2 ( 3.88 ) 69.9 ( 3.94 ) 70.7 ( 3.71 ) 69.9 ( 3.23 ) 69.9 ( 3.71 ) 29.6 ( 6.64 ) 30.3 ( 5.77 ) 31.3 ( 6.24 ) 29.7 ( 6.29 ) 68.6 ( 6.89 ) 65.4 ( 4.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 11 16 6 12 3 11 7 6 25 25 28 26 29 33 50 50 50 30 10 2 440
        Male
    		 10 9 4 14 3 2 5 8 9 23 23 20 22 19 27 0 0 0 0 10 3 211
    Race
    Units: Subjects
        White
    		 14 16 16 18 11 3 11 10 8 45 42 46 43 44 50 45 37 43 27 0 0 529
        Black or African American
    		 6 4 4 0 4 2 1 3 6 1 6 1 2 4 7 5 8 3 1 0 0 68
        Asian
    		 0 0 0 0 0 0 0 1 0 1 0 0 2 0 1 0 2 4 0 20 5 36
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 2
        Multiple
    		 0 0 0 2 0 0 1 1 1 1 0 0 0 0 0 0 3 0 0 0 0 9
        Other
    		 0 0 0 0 0 0 3 0 0 0 0 0 1 0 1 0 0 0 0 0 0 5
        Not Reported
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 0 1 0 2 0 2 3 0 4 2 2 4 6 1 4 4 0 0 36
        Not Hispanic or Latino
    		 20 19 20 20 14 5 14 15 13 45 48 44 46 44 56 44 49 46 26 20 5 613
        Not Reported
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose B of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose C of mRNA-1345 on Day 1.

    Reporting group title
    Single Injection Placebo in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Three Injection Placebo in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose D of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose G of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Three Injection Placebo in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose A of mRNA-1345 on Day 1, a booster injection of Dose A of mRNA-1345 approximately 12 months later and a second booster injection of Dose A of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose B of mRNA-1345 on Day 1, a booster injection of Dose B of mRNA-1345 approximately 12 months later and a second booster injection of Dose B of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose C of mRNA-1345 on Day 1, a booster injection of Dose C of mRNA-1345 approximately 12 months later and a second booster injection of Dose C of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose E of mRNA-1345 on Day 1, a booster injection of Dose E of mRNA-1345 approximately 12 months later and a second booster injection of Dose E of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of Dose F of mRNA-1345 on Day 1, a booster injection of Dose F of mRNA-1345 approximately 12 months later and a second booster injection of Dose F of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Two Injection Placebo in Older Adults (65 to 79 Years)
    Reporting group description
    		 Participants received a total of 3 injections: 1 injection of mRNA-1345 matching-placebo per day on Day 1 and approximately 12 months later. Participants received second booster injection of Dose A of mRNA-1345 approximately 24 months after Day 1.

    Reporting group title
    Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose F of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose E of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.

    Reporting group title
    Single Injection Placebo in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Cohort 15: mRNA-1345 Dose B in Japanese Older Adults
    Reporting group description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.

    Reporting group title
    Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Subject analysis set title
    Cohort 15: mRNA-1345 Dose B in Japanese Older Adults
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single injection of Dose B of mRNA-1345 on Day 1.

    Subject analysis set title
    Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Subject analysis set title
    Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single injection of Dose F of mRNA-1345 on Day 1.

    Subject analysis set title
    Two Injection Placebo in Older Adults (After 1st Dose)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 1.

    Subject analysis set title
    Cohort 7: mRNA-1345 Dose A in Older Adults (After 1st Dose)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose A of mRNA-1345 on Day 1.

    Subject analysis set title
    Cohort 8: mRNA-1345 Dose B in Older Adults (After 1st Dose)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose B of mRNA-1345 on Day 1.

    Subject analysis set title
    Cohort 9: mRNA-1345 Dose C in Older Adults (After 1st Dose)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose C of mRNA-1345 on Day 1.

    Subject analysis set title
    Cohort 10: mRNA-1345 Dose E in Older Adults (After 1st Dose)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose E of mRNA-1345 on Day 1.

    Subject analysis set title
    Cohort 11: mRNA-1345 Dose F in Older Adults (After 1st Dose)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose F of mRNA-1345 on Day 1.

    Subject analysis set title
    Two Injection Placebo in Older Adults (After Month 12)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo approximately 12 months later.

    Subject analysis set title
    Cohort 7: mRNA-1345 Dose A in Older Adults (After Month 12)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose A of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    Cohort 8: mRNA-1345 Dose B in Older Adults (After Month 12)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose B of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    Cohort 9: mRNA-1345 Dose C in Older Adults (After Month 12)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose C of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    Cohort 10: mRNA-1345 Dose E in Older Adults (After Month 12)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose E of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    Cohort 11: mRNA-1345 Dose F in Older Adults (After Month 12)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose F of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    Older Adult Cohorts: After Month 24: mRNA-1345 Dose A‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Subject analysis set title
    Cohort 3: mRNA-1345 Dose B in Younger Adults (After 1st Dose)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose B of mRNA-1345 on Day 1.

    Subject analysis set title
    Cohort 3: mRNA-1345 Dose B in Young Adults (After 2nd Dose)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose B of mRNA-1345 on Day 57.

    Subject analysis set title
    Cohort 3: mRNA-1345 Dose B in Young Adults (After 3rd Dose)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose B of mRNA-1345 on Day 113.

    Subject analysis set title
    Three Injection Placebo in Young Adults (After 1st Dose)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 1.

    Subject analysis set title
    Three Injection Placebo in Younger Adults (After 2nd Dose)‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 57.

    Subject analysis set title
    Three Injection Placebo in Younger Adults (After 3rd Dose)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 113.

    Subject analysis set title
    mRNA-1345 Dose A in Older Adults (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose A of mRNA-1345 on Day 1.

    Subject analysis set title
    mRNA-1345 Dose B in Older Adults (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose B of mRNA-1345 on Day 1.

    Subject analysis set title
    mRNA-1345 Dose C in Older Adults (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose C of mRNA-1345 on Day 1.

    Subject analysis set title
    mRNA-1345 Dose E in Older Adults (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose E of mRNA-1345 on Day 1.

    Subject analysis set title
    mRNA-1345 Dose F in Older Adults (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose F of mRNA-1345 on Day 1.

    Subject analysis set title
    Two Injection Placebo in Older Adults (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 1.

    Subject analysis set title
    mRNA-1345 Dose A in Older Adults (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose A of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    mRNA-1345 Dose B in Older Adults (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose B of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    mRNA-1345 Dose C in Older Adults (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose C of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    mRNA-1345 Dose E in Older Adults (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose E of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    mRNA-1345 Dose F in Older Adults (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose F of mRNA-1345 approximately 12 months later.

    Subject analysis set title
    Two Injection Placebo in Older Adults (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo approximately 12 months later.

    Subject analysis set title
    mRNA-1345 Dose A/Dose A in Older Adults (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Subject analysis set title
    mRNA-1345 Dose B/Dose A in Older Adults (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Subject analysis set title
    mRNA-1345 Dose C/Dose A in Older Adults (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Subject analysis set title
    mRNA-1345 Dose E/Dose A in Older Adults (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Subject analysis set title
    mRNA-1345 Dose F/Dose A in Older Adults (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Subject analysis set title
    2-Injection Placebo/Dose A in Old Adults (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Subject analysis set title
    mRNA-1345 Dose D in Children (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose D of mRNA-1345 on Day 1.

    Subject analysis set title
    mRNA-1345 Dose G in Children (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose G of mRNA-1345 on Day 1.

    Subject analysis set title
    Three Injection Placebo in Children (After 1st Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 1.

    Subject analysis set title
    mRNA-1345 Dose D in Children (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose D of mRNA-1345 on Day 57.

    Subject analysis set title
    mRNA-1345 Dose G in Children (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose G of mRNA-1345 on Day 57.

    Subject analysis set title
    Three Injection Placebo in Children (After 2nd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 57.

    Subject analysis set title
    mRNA-1345 Dose D in Children (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose D of mRNA-1345 on Day 113.

    Subject analysis set title
    mRNA-1345 Dose G in Children (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of Dose G of mRNA-1345 on Day 113.

    Subject analysis set title
    Three Injection Placebo in Children (After 3rd Injection)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received 1 injection of mRNA-1345 matching-placebo on Day 113.

    Primary: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) in Young Adult Cohorts

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    End point title
    		 Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) in Young Adult Cohorts [1] [2]
    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 included all randomized participants who received any study injection and contributed any solicited AR data (that is, had at least 1 postbaseline solicited safety [eDiary] assessment). Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    7 days after injection
    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: The endpoint is descriptive in nature.
    [2] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (After 1st Dose) Cohort 3: mRNA-1345 Dose B in Young Adults (After 2nd Dose)‌ Cohort 3: mRNA-1345 Dose B in Young Adults (After 3rd Dose)‌ Three Injection Placebo in Young Adults (After 1st Dose) Three Injection Placebo in Younger Adults (After 2nd Dose)‌ Three Injection Placebo in Younger Adults (After 3rd Dose)
    Number of subjects analysed
    19
    20
    20
    15
    20
    16
    14
    5
    3
    3
    Units: participants
    15
    18
    20
    6
    20
    14
    12
    2
    0
    1
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Local and Systemic ARs in WOCBP Cohorts and Japanese Adult Cohorts

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    End point title
    		 Number of Participants with Solicited Local and Systemic ARs in WOCBP Cohorts and Japanese Adult Cohorts [3] [4]
    End point description
    Solicited ARs were collected in an 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 AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. Solicited Safety Set included all randomized participants who received any study injection and contributed any solicited AR data (that is, had at least 1 postbaseline solicited safety [eDiary] assessment). Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    7 days after injection
    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: The endpoint is descriptive in nature.
    [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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years) Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years) Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    48
    30
    21
    4
    51
    Units: participants
    46
    44
    11
    20
    3
    48
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Local and Systemic ARs in Older Adult Cohorts

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    End point title
    		 Number of Participants with Solicited Local and Systemic ARs in Older Adult Cohorts [5]
    End point description
    Solicited ARs were collected in an 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 AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. Solicited Safety Set included all randomized participants who received any study injection and contributed any solicited AR data (that is, had at least 1 postbaseline solicited safety [eDiary] assessment). Participants were included in the treatment arm corresponding to the study drug they actually received. Number analyzed = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after each injection
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The endpoint is descriptive in nature.
    End point values
    		 mRNA-1345 Dose A in Older Adults (After 1st Injection) mRNA-1345 Dose B in Older Adults (After 1st Injection) mRNA-1345 Dose C in Older Adults (After 1st Injection) mRNA-1345 Dose E in Older Adults (After 1st Injection) mRNA-1345 Dose F in Older Adults (After 1st Injection) Two Injection Placebo in Older Adults (After 1st Injection) mRNA-1345 Dose A in Older Adults (After 2nd Injection) mRNA-1345 Dose B in Older Adults (After 2nd Injection) mRNA-1345 Dose C in Older Adults (After 2nd Injection) mRNA-1345 Dose E in Older Adults (After 2nd Injection) mRNA-1345 Dose F in Older Adults (After 2nd Injection) Two Injection Placebo in Older Adults (After 2nd Injection) mRNA-1345 Dose A/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose B/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose C/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose E/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose F/Dose A in Older Adults (After 3rd Injection) 2-Injection Placebo/Dose A in Old Adults (After 3rd Injection)
    Number of subjects analysed
    47
    47
    47
    44
    46
    55
    21
    18
    16
    20
    19
    51
    10
    7
    3
    10
    12
    22
    Units: participants
    34
    42
    42
    35
    31
    25
    7
    8
    3
    10
    7
    14
    8
    7
    2
    9
    11
    15
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Local and Systemic ARs in Children Cohorts

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    End point title
    		 Number of Participants with Solicited Local and Systemic ARs in Children Cohorts [6]
    End point description
    Solicited ARs were collected in an 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 AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. Solicited Safety Set included all randomized participants who received any study injection and contributed any solicited AR data (that is, had at least 1 postbaseline solicited safety [eDiary] assessment). Participants were included in the treatment arm corresponding to the study drug they actually received. Number analyzed = participants evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after each injection
    Notes
    [6] - 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: The endpoint is descriptive in nature.
    End point values
    		 mRNA-1345 Dose D in Children (After 1st Injection) mRNA-1345 Dose G in Children (After 1st Injection) Three Injection Placebo in Children (After 1st Injection) mRNA-1345 Dose D in Children (After 2nd Injection) mRNA-1345 Dose G in Children (After 2nd Injection) Three Injection Placebo in Children (After 2nd Injection) mRNA-1345 Dose D in Children (After 3rd Injection) mRNA-1345 Dose G in Children (After 3rd Injection) Three Injection Placebo in Children (After 3rd Injection)
    Number of subjects analysed
    15
    14
    15
    8
    14
    11
    9
    11
    9
    Units: participants
    8
    7
    7
    5
    9
    7
    6
    5
    5
    No statistical analyses for this end point

    Primary: Number of Participants with Unsolicited AEs in Younger Adult Cohorts

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    End point title
    		 Number of Participants with Unsolicited AEs in Younger Adult Cohorts [7] [8]
    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. Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to 28 days after each injection
    Notes
    [7] - 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: The endpoint is descriptive in nature.
    [8] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (After 1st Dose) Cohort 3: mRNA-1345 Dose B in Young Adults (After 2nd Dose)‌ Cohort 3: mRNA-1345 Dose B in Young Adults (After 3rd Dose)‌ Three Injection Placebo in Young Adults (After 1st Dose) Three Injection Placebo in Younger Adults (After 2nd Dose)‌ Three Injection Placebo in Younger Adults (After 3rd Dose)
    Number of subjects analysed
    19
    20
    20
    15
    20
    16
    15
    5
    4
    3
    Units: participants
    2
    2
    15
    5
    6
    1
    3
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Unsolicited AE in WOCBP Cohorts and Japanese Adult Cohorts

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    End point title
    		 Number of Participants with Unsolicited AE in WOCBP Cohorts and Japanese Adult Cohorts [9] [10]
    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 PT/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. Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to 28 days after each injection
    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: The endpoint is descriptive in nature.
    [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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years) Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years) Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    48
    30
    21
    4
    51
    Units: participants
    12
    5
    4
    1
    2
    11
    No statistical analyses for this end point

    Primary: Number of Participants with Unsolicited AEs in Older Adult Cohorts

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    End point title
    		 Number of Participants with Unsolicited AEs in Older Adult Cohorts [11] [12]
    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 PT/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. Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to 28 days after each injection
    Notes
    [11] - 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: The endpoint is descriptive in nature.
    [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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years)
    Number of subjects analysed
    47
    48
    48
    48
    48
    59
    Units: participants
    19
    15
    19
    19
    21
    14
    No statistical analyses for this end point

    Primary: Number of Participants with SAEs or Medically Attended AEs (MAAEs) in Younger Adult Cohorts

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    End point title
    		 Number of Participants with SAEs or Medically Attended AEs (MAAEs) in Younger Adult Cohorts [13] [14]
    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. 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. Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to Day 1095 (End of Study)
    Notes
    [13] - 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: The endpoint is descriptive in nature.
    [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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (After 1st Dose) Cohort 3: mRNA-1345 Dose B in Young Adults (After 2nd Dose)‌ Cohort 3: mRNA-1345 Dose B in Young Adults (After 3rd Dose)‌ Three Injection Placebo in Young Adults (After 1st Dose) Three Injection Placebo in Younger Adults (After 2nd Dose)‌ Three Injection Placebo in Younger Adults (After 3rd Dose)
    Number of subjects analysed
    19
    20
    20
    15
    20
    16
    15
    5
    4
    3
    Units: participants
        SAEs
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        MAAEs
    0
    0
    9
    4
    2
    1
    2
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Unsolicited AEs in Children Cohorts

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    End point title
    		 Number of Participants with Unsolicited AEs in Children Cohorts [15] [16]
    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 PT/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. Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to 28 days after each injection
    Notes
    [15] - 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: The endpoint is descriptive in nature.
    [16] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    15
    15
    15
    Units: participants
    4
    6
    7
    No statistical analyses for this end point

    Primary: Number of Participants with SAEs or MAAEs in WOCBP Cohorts and Japanese Adult Cohorts

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    End point title
    		 Number of Participants with SAEs or MAAEs in WOCBP Cohorts and Japanese Adult Cohorts [17] [18]
    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. 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. Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to Day 1095 (End of Study)
    Notes
    [17] - 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: The endpoint is descriptive in nature.
    [18] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years) Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years) Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Number of subjects analysed
    48
    49
    30
    21
    4
    51
    Units: participants
        SAEs
    0
    0
    0
    0
    0
    1
        MAAEs
    11
    17
    10
    1
    1
    15
    No statistical analyses for this end point

    Primary: Number of Participants with SAEs or MAAEs in Older Adult Cohorts

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    End point title
    		 Number of Participants with SAEs or MAAEs in Older Adult Cohorts [19]
    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. 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. Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to Day 1095 (End of Study)
    Notes
    [19] - 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: The endpoint is descriptive in nature.
    End point values
    		 mRNA-1345 Dose A in Older Adults (After 1st Injection) mRNA-1345 Dose B in Older Adults (After 1st Injection) mRNA-1345 Dose C in Older Adults (After 1st Injection) mRNA-1345 Dose E in Older Adults (After 1st Injection) mRNA-1345 Dose F in Older Adults (After 1st Injection) Two Injection Placebo in Older Adults (After 1st Injection) mRNA-1345 Dose A in Older Adults (After 2nd Injection) mRNA-1345 Dose B in Older Adults (After 2nd Injection) mRNA-1345 Dose C in Older Adults (After 2nd Injection) mRNA-1345 Dose E in Older Adults (After 2nd Injection) mRNA-1345 Dose F in Older Adults (After 2nd Injection) Two Injection Placebo in Older Adults (After 2nd Injection) mRNA-1345 Dose A/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose B/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose C/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose E/Dose A in Older Adults (After 3rd Injection) mRNA-1345 Dose F/Dose A in Older Adults (After 3rd Injection) 2-Injection Placebo/Dose A in Old Adults (After 3rd Injection)
    Number of subjects analysed
    47
    48
    48
    48
    48
    59
    21
    18
    17
    20
    20
    52
    10
    7
    3
    10
    12
    22
    Units: participants
        SAEs
    4
    0
    1
    3
    5
    1
    1
    1
    2
    1
    1
    1
    0
    1
    0
    1
    1
    1
        MAAEs
    8
    4
    7
    6
    8
    4
    2
    0
    2
    2
    2
    4
    2
    0
    0
    1
    2
    1
    No statistical analyses for this end point

    Primary: Number of Participants with SAEs or MAAEs in Children Cohorts

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    End point title
    		 Number of Participants with SAEs or MAAEs in Children Cohorts [20] [21]
    End point description
    Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to Day 1095 (End of Study)
    Notes
    [20] - 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: The endpoint is descriptive in nature.
    [21] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    15
    15
    15
    Units: participants
        SAEs
    0
    0
    0
        MAAEs
    5
    11
    8
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibodies (Abs) (RSV-A and RSV-B) for Young Adult Cohorts

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    End point title
    		 Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibodies (Abs) (RSV-A and RSV-B) for Young Adult Cohorts [22]
    End point description
    Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. LLOQ was 11 international units (IU)/milliliter (mL) for RSV-A and 8 IU/mL for RSV-B. Per-protocol (PP) Set: Full Analysis Set (FAS) participants (all randomized participants who received any study injection, had baseline data for analyses that require baseline data, and had at least 1 postinjection assessment for analysis endpoint) who a) complied with injection schedule, b) complied with timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during period corresponding to immunogenicity analysis objective. Participants were included in the arm to which they were randomized. ‘n’ = participants evaluable for specified categories. ‘9999’ represents data not collected for specified cohorts.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, 113, 141, 169, and 281
    Notes
    [22] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years)
    Number of subjects analysed
    18
    19
    19
    19
    15
    4
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A: Day 1 (n=18,19,19,19,15,4)
    981.7 (688.4 to 1399.8)
    750.1 (472.8 to 1190.0)
    811.9 (525.6 to 1254.1)
    1252.6 (767.5 to 2044.3)
    1581.0 (1113.2 to 2245.4)
    2054.7 (1262.7 to 3343.4)
        RSV-A: Day 29 (n=18,19,19,19,15,4)
    20140.7 (13749.6 to 29502.4)
    16687.8 (11984.9 to 23236.2)
    19111.9 (12383.9 to 29495.1)
    22312.3 (15470.8 to 32179.3)
    1461.0 (941.7 to 2266.6)
    1988.9 (930.6 to 4251.1)
        RSV-A: Day 57 (n=18,19,15,17,14,4)
    17184.7 (11128.9 to 26535.8)
    12624.2 (8407.6 to 18955.4)
    11856.0 (5981.3 to 23500.7)
    17390.2 (10457.9 to 28917.8)
    1321.8 (928.2 to 1882.3)
    1564.6 (665.8 to 3676.6)
        RSV-A: Day 85 (n=18,19,13,17,13,3)
    15484.6 (10242.6 to 23409.4)
    8838.7 (6448.5 to 12114.9)
    17802.2 (9821.8 to 32267.0)
    12581.7 (8142.4 to 19441.4)
    1426.1 (926.5 to 2195.2)
    1400.5 (555.1 to 3533.8)
        RSV-A: Day 113 (n=18,17,12,16,13,3)
    13991.8 (9014.2 to 21718.1)
    7034.8 (5109.9 to 9684.7)
    12571.6 (6782.8 to 23300.7)
    14692.4 (9907.9 to 21787.4)
    1230.2 (815.4 to 1856.0)
    1940.4 (297.7 to 12646.6)
        RSV-A: Day 141 (n=18,19,13,16,14,3)
    9561.8 (5982.5 to 15282.5)
    5582.9 (4028.9 to 7736.2)
    10500.2 (6144.7 to 17942.8)
    14375.8 (9374.3 to 22045.8)
    1378.9 (857.8 to 2216.6)
    1909.1 (522.8 to 6970.7)
        RSV-A: Day 169 (n=18,19,13,17,13,3)
    9448.0 (6169.7 to 14468.4)
    5232.8 (3684.1 to 7432.5)
    13287.2 (7992.9 to 22088.2)
    11516.4 (6681.9 to 19848.7)
    1334.8 (902.7 to 1973.7)
    1345.1 (363.4 to 4978.4)
        RSV-A: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    8669.8 (5301.3 to 14178.7)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    1103.5 (776.9 to 1567.4)
        RSV-B: Day 1 (n=18,19,19,19,15,4)
    795.3 (532.8 to 1187.3)
    1091.6 (560.2 to 2127.3)
    842.7 (494.3 to 1436.5)
    1097.4 (533.8 to 2255.8)
    1144.2 (694.9 to 1884.1)
    1373.7 (448.2 to 4210.6)
        RSV-B: Day 29 (n=18,19,19,18,15,4)
    11487.5 (7894.8 to 16715.3)
    12741.6 (9388.1 to 17293.0)
    13496.5 (8379.8 to 21737.4)
    12901.6 (8474.9 to 19640.5)
    1009.5 (612.3 to 1664.5)
    1640.5 (294.4 to 9143.0)
        RSV-B: Day 57 (n=18,19,15,17,14,4)
    12156.5 (7773.0 to 19012.1)
    14221.7 (9366.5 to 21593.6)
    15341.5 (10067.7 to 23378.0)
    9374.5 (5178.1 to 16971.7)
    1053.3 (527.6 to 2102.6)
    2168.5 (411.5 to 11428.7)
        RSV-B: Day 85 (n=18,19,13,17,13,3)
    8380.0 (5212.3 to 13472.9)
    8996.4 (5678.6 to 14252.8)
    13400.3 (8814.8 to 20371.2)
    9007.3 (4360.2 to 18607.0)
    939.1 (513.2 to 1718.6)
    1324.8 (98.6 to 17800.2)
        RSV-B: Day 113 (n=18,17,12,16,13,3)
    8255.0 (5581.9 to 12208.0)
    10657.0 (6790.7 to 16724.4)
    13515.1 (8581.1 to 21286.0)
    8744.3 (4545.8 to 16820.5)
    874.2 (447.1 to 1709.4)
    1459.2 (162.8 to 13081.1)
        RSV-B: Day 141 (n=18,19,13,16,14,3)
    8478.6 (5461.9 to 13161.5)
    8019.8 (5289.7 to 12159.0)
    14408.6 (8599.6 to 24141.7)
    7313.6 (3859.4 to 13859.6)
    963.4 (571.5 to 1624.0)
    1478.9 (79.2 to 27622.2)
        RSV-B: Day 169 (n=18,19,13,17,13,3)
    7078.4 (4563.6 to 10978.8)
    5769.0 (3878.2 to 8581.6)
    11801.7 (7020.9 to 19837.7)
    6276.6 (3418.9 to 11522.9)
    730.6 (394.3 to 1353.8)
    1119.5 (66.8 to 18749.5)
        RSV-B: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    7081.8 (4123.2 to 12163.2)
    819.2 (22.2 to 30249.3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for Older Adults Cohorts

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    End point title
    		 GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for Older Adults Cohorts [23]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 13 IU/mL for RSV-A and 10 IU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, 169, and 365
    Notes
    [23] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years)
    Number of subjects analysed
    47
    46
    47
    46
    46
    58
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A: Day 1 (n=47,46,47,46,46,58)
    1204.7 (918.5 to 1580.0)
    1224.9 (877.7 to 1709.4)
    1879.9 (1403.5 to 2517.9)
    1519.0 (1128.8 to 2044.0)
    1329.8 (969.1 to 1824.8)
    1590.7 (1141.8 to 2215.9)
        RSV-A: Day 29 (n=44,43,47,45,44,56)
    13739.0 (9875.5 to 19113.8)
    17053.4 (12486.8 to 23289.9)
    31341.0 (24366.7 to 40311.4)
    19008.4 (14470.5 to 24969.5)
    13619.5 (9340.7 to 19858.3)
    1827.2 (1306.1 to 2556.2)
        RSV-A: Day 57 (n=46,39,44,42,45,58)
    10967.5 (7762.9 to 15494.9)
    15494.9 (8445.9 to 16648.4)
    24600.2 (18782.3 to 32220.3)
    15121.9 (10705.9 to 21359.5)
    9476.3 (6537.5 to 13736.3)
    1783.9 (1257.5 to 2530.7)
        RSV-A: Day 85 (n=44,42,46,45,43,55)
    9020.8 (6523.6 to 12474.0)
    9947.3 (7262.5 to 13624.5)
    17772.8 (13062.3 to 24182.0)
    11372.8 (8253.5 to 15671.1)
    7192.1 (4987.4 to 10371.4)
    1761.0 (1243.8 to 2493.3)
        RSV-A: Day 169 (n=43,42,44,44,44,55)
    5746.9 (4133.8 to 7989.4)
    4815.2 (3517.0 to 6592.4)
    10674.2 (7754.6 to 14693.1)
    5936.5 (4280.0 to 8234.3)
    4263.2 (3028.4 to 6001.6)
    1652.6 (1186.1 to 2302.6)
        RSV-A: Day 365 (n=38,33,36,41,40,49)
    3399.6 (2279.9 to 5069.2)
    2525.7 (1795.9 to 3551.9)
    6141.1 (4144.2 to 9100.1)
    4592.4 (3343.7 to 6307.5)
    3161.4 (2187.0 to 4570.0)
    2035.5 (1403.1 to 2952.8)
        RSV-B: Day 1 (n=47,46,47,46,46,58)
    1135.3 (833.2 to 1547.0)
    941.0 (681.6 to 1299.1)
    1455.4 (1008.2 to 2100.9)
    1507.7 (1055.3 to 2153.9)
    1437.5 (1015.1 to 2035.4)
    1451.0 (1053.2 to 1998.9)
        RSV-B: Day 29 (n=44,43,47,45,44,56)
    9432.1 (6706.2 to 13266.0)
    9319.9 (6754.5 to 12859.7)
    18187.1 (13207.4 to 25044.4)
    10235.2 (7445.9 to 14069.5)
    8154.9 (5568.3 to 11943.0)
    1580.1 (1102.0 to 2265.5)
        RSV-B: Day 57 (n=46,39,44,42,45,58)
    7905.3 (5765.3 to 10839.5)
    8869.0 (6455.4 to 12185.0)
    15182.3 (11431.9 to 20163.0)
    8004.0 (5684.9 to 11269.1)
    6196.1 (4369.6 to 8786.0)
    1840.8 (1332.2 to 2543.5)
        RSV-B: Day 85 (n=44,42,46,45,43,55)
    6385.1 (4652.7 to 8762.4)
    6931.0 (4873.8 to 9856.6)
    11985.6 (8513.6 to 16873.6)
    6754.9 (4823.0 to 9460.6)
    5065.2 (3432.3 to 7474.8)
    1874.2 (1375.7 to 2553.3)
        RSV-B: Day 169 (n=43,42,44,44,44,55)
    5226.3 (3747.5 to 7288.8)
    4313.9 (3166.9 to 5876.2)
    8171.7 (6023.4 to 11086.3)
    4873.5 (3518.5 to 6750.3)
    4164.0 (2876.3 to 6028.0)
    2034.3 (1484.3 to 2788.2)
        RSV-B: Day 365 (n=38,33,36,41,40,49)
    2586.2 (1849.1 to 3617.2)
    2475.8 (1791.4 to 3421.5)
    4262.6 (3088.9 to 5882.2)
    2321.2 (1657.2 to 3251.1)
    2113.9 (1548.6 to 2885.6)
    1673.2 (1190.9 to 2350.8)
    No statistical analyses for this end point

    Secondary: GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for Japanese Adults Cohorts

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    End point title
    		 GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for Japanese Adults Cohorts [24]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 11 IU/mL for RSV-A and 8 IU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, and 169
    Notes
    [24] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Number of subjects analysed
    20
    4
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A: Day 1 (n=20,4)
    1602.1 (1042.5 to 2462.1)
    1798.9 (1125.1 to 2876.2)
        RSV-A: Day 29 (n=20,4)
    17861.7 (10929.3 to 29191.4)
    1476.5 (918.1 to 2374.5)
        RSV-A: Day 57 (n=20,4)
    15627.7 (9983.1 to 24463.9)
    1508.3 (554.5 to 4102.6)
        RSV-A: Day 85 (n=19,4)
    12447.6 (7781.3 to 19912.1)
    1449.6 (606.4 to 3465.0)
        RSV-A: Day 169 (n=20,4)
    6658.1 (4213.0 to 10522.3)
    1292.8 (810.1 to 2062.9)
        RSV-B: Day 1 (n=20,4)
    1029.4 (732.8 to 1446.1)
    1275.6 (368.5 to 4415.3)
        RSV-B: Day 29 (n=20,4)
    6791.7 (4432.3 to 10406.8)
    1033.4 (293.4 to 3640.0)
        RSV-B: Day 57 (n=20,4)
    4862.2 (3312.9 to 7136.1)
    1086.3 (261.0 to 4521.1)
        RSV-B: Day 85 (n=19,4)
    3818.4 (2655.8 to 5490.0)
    1039.1 (302.4 to 3571.0)
        RSV-B: Day 169 (n=20,4)
    2751.5 (1933.2 to 3916.1)
    879.9 (342.0 to 2263.6)
    No statistical analyses for this end point

    Secondary: GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for WOCBP Cohorts

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    End point title
    		 GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for WOCBP Cohorts [25]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 13 IU/mL for RSV-A and 10 IU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, 113, 141, and 169
    Notes
    [25] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    48
    44
    29
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A: Day 1 (n=49,48,44,29)
    902.8 (688.4 to 1184.1)
    1111.6 (858.6 to 1439.3)
    1135.1 (844.5 to 1525.8)
    1358.4 (879.1 to 2099.0)
        RSV-A: Day 29 (n=49,46,41,28)
    8497.2 (6631.2 to 10888.3)
    12362.2 (8923.0 to 17127.0)
    12635.8 (9143.8 to 17461.5)
    1348.6 (855.1 to 2127.1)
        RSV-A: Day 57 (n=45,45,42,28)
    8250.2 (6278.4 to 10841.3)
    11270.7 (8269.0 to 15362.1)
    12722.4 (9594.7 to 16869.7)
    1940.5 (1200.9 to 3135.7)
        RSV-A: Day 85 (n=43,41,37,24)
    6364.7 (4855.0 to 8343.8)
    10169.9 (7272.4 to 14221.8)
    10568.9 (7406.5 to 15081.5)
    1683.1 (996.9 to 2841.7)
        RSV-A: Day 113 (n=44,43,37,25)
    5231.9 (3797.5 to 7207.9)
    7675.4 (5725.6 to 10289.2)
    8439.8 (5882.5 to 12109.0)
    1885.9 (1118.6 to 3179.5)
        RSV-A: Day 141 (n=40,42,36,25)
    4518.2 (3263.9 to 6254.7)
    6315.6 (4534.8 to 8795.8)
    7059.2 (4777.3 to 10431.2)
    1519.5 (943.7 to 2446.5)
        RSV-A: Day 169 (n=41,43,34,23)
    3731.9 (2736.9 to 5088.7)
    5476.8 (3924.4 to 7643.2)
    5387.8 (3720.1 to 7803.1)
    1620.7 (988.3 to 2657.9)
        RSV-B: Day 1 (n=49,48,44,29)
    958.4 (724.4 to 1267.8)
    1676.1 (1197.0 to 2346.8)
    1148.9 (789.9 to 1670.9)
    930.8 (597.4 to 1450.2)
        RSV-B: Day 29 (n=49,46,41,28)
    7236.5 (5573.6 to 9395.4)
    11368.3 (8304.0 to 15563.4)
    10591.9 (7302.2 to 15363.5)
    903.0 (554.2 to 1471.3)
        RSV-B: Day 57 (n=45,45,42,28)
    5129.7 (3937.6 to 6682.7)
    7873.5 (5922.9 to 10466.6)
    8072.7 (6072.3 to 10732.0)
    1333.1 (832.2 to 2135.7)
        RSV-B: Day 85 (n=43,41,37,24)
    4592.4 (3542.9 to 5952.6)
    7877.3 (5767.7 to 10758.6)
    6470.1 (4836.7 to 8655.1)
    1536.9 (952.1 to 2481.0)
        RSV-B: Day 113 (n=44,43,37,25)
    3453.3 (2743.4 to 4346.9)
    6448.3 (4858.8 to 8557.7)
    5348.4 (3996.3 to 7158.0)
    1319.7 (833.5 to 2089.6)
        RSV-B: Day 141 (n=40,42,36,25)
    3470.7 (2626.8 to 4585.9)
    5421.0 (3977.3 to 7388.7)
    4670.8 (3375.0 to 6464.2)
    1317.5 (848.1 to 2046.7)
        RSV-B: Day 169 (n=41,43,34,23)
    3112.6 (2372.6 to 4083.4)
    4959.7 (3637.6 to 6762.3)
    3879.0 (2771.7 to 5428.7)
    1151.9 (704.6 to 1883.3)
    No statistical analyses for this end point

    Secondary: GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for Children Cohorts

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    End point title
    		 GMT of Serum RSV Neutralizing Abs (RSV-A and RSV-B) for Children Cohorts [26]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 13 IU/mL for RSV-A and 10 IU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 85, and 141
    Notes
    [26] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    14
    13
    11
    Units: IU/mL
    geometric mean (confidence interval 95%)
        RSV-A: Day 1 (n=14,13,11)
    240.1 (96.4 to 597.8)
    602.1 (185.8 to 1951.4)
    447.2 (152.3 to 1312.9)
        RSV-A: Day 29 (n=14,12,11)
    8376.1 (3354.9 to 20912.2)
    11440.4 (6477.0 to 20207.1)
    642.6 (236.9 to 1743.4)
        RSV-A: Day 85 (n=5,9,4)
    5114.0 (1255.2 to 20835.8)
    4820.1 (1823.9 to 12737.9)
    145.2 (23.5 to 896.3)
        RSV-A: Day 141 (n=4,5,5)
    4660.8 (1141.8 to 19025.7)
    13233.4 (3136.2 to 55840.1)
    735.9 (199.3 to 2716.9)
        RSV-B: Day 1 (n=14,13,11)
    345.7 (152.1 to 785.9)
    832.9 (312.6 to 2219.5)
    394.4 (138.3 to 1124.5)
        RSV-B: Day 29 (n=14,12,11)
    4931.9 (2080.0 to 11693.7)
    5940.3 (3446.4 to 10238.9)
    490.2 (178.2 to 1348.1)
        RSV-B: Day 85 (n=5,9,4)
    2534.8 (1213.6 to 5294.1)
    2622.2 (1453.8 to 4729.7)
    107.2 (25.2 to 455.3)
        RSV-B: Day 141 (n=4,5,5)
    2899.9 (419.8 to 20031.0)
    5038.4 (2241.8 to 11323.7)
    957.0 (192.0 to 4770.9)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) of Serum Binding Abs (PreF and PostF) for Young Adult Cohorts

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    End point title
    		 Geometric Mean Concentration (GMC) of Serum Binding Abs (PreF and PostF) for Young Adult Cohorts [27]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 19 arbitrary unit (AU)/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories. ‘9999’ represents data not collected for specified cohorts.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, 113, 141, 169, and 281
    Notes
    [27] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years)
    Number of subjects analysed
    18
    19
    15
    19
    14
    4
    Units: AU/mL
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 1 (n=18,19,15,19,14,4)
    7467.2 (5552.0 to 10043.2)
    5812.9 (4162.1 to 8118.4)
    6215.6 (4738.9 to 8152.4)
    7722.4 (5034.0 to 11846.5)
    7272.6 (5784.0 to 9144.5)
    9290.5 (6403.5 to 13479.2)
        PreF-bAb: Day 29 (n=18,19,15,18,14,4)
    120491.6 (92412.4 to 157102.6)
    125952.6 (103884.6 to 152708.3)
    135260.0 (95356.2 to 191862.2)
    116742.7 (89152.0 to 152872.1)
    7226.1 (5489.8 to 9511.7)
    10307.3 (7281.3 to 14590.9)
        PreF-bAb: Day 57 (n=18,19,14,17,14,4)
    98849.5 (75545.8 to 129341.8)
    89896.9 (70717.8 to 114277.4)
    98889.3 (65188.1 to 150013.4)
    90612.8 (65451.1 to 125447.6)
    7659.7 (5931.1 to 9892.2)
    9097.5 (7091.1 to 11671.6)
        PreF-bAb: Day 85 (n=18,19,12,17,13,3)
    69574.6 (50071.5 to 96674.2)
    67912.3 (51691.0 to 89224.0)
    112481.0 (76987.5 to 164337.9)
    70057.9 (49495.6 to 99162.5)
    7154.4 (5232.9 to 9781.4)
    10664.3 (8260.2 to 13768.0)
        PreF-bAb: Day 113 (n=18,17,12,16,13,3)
    61182.6 (43795.1 to 85473.2)
    58058.4 (43549.8 to 77400.6)
    103093.5 (66326.3 to 160241.9)
    61171.5 (44176.0 to 84705.6)
    6877.3 (5199.8 to 9096.0)
    10317.7 (9299.1 to 11447.8)
        PreF-bAb: Day 141 (n=18,19,13,16,14,3)
    57291.0 (40876.2 to 80297.6)
    48121.1 (37794.8 to 61268.8)
    99738.7 (70499.4 to 141104.8)
    59941.7 (46326.6 to 77558.0)
    7077.7 (5307.6 to 9438.1)
    10026.5 (6884.4 to 14602.7)
        PreF-bAb: Day 169 (n=18,19,13,17,13,3)
    48392.9 (34510.9 to 67858.8)
    40948.1 (31357.1 to 53472.6)
    83648.6 (56870.6 to 123035.3)
    49499.8 (35508.9 to 69003.3)
    6953.1 (5161.5 to 9366.6)
    9958.8 (9347.1 to 10610.6)
        PreF-bAb: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    54418.7 (36137.6 to 81947.8)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    8330.4 (3649.2 to 19016.7)
        PostF-bAb: Day 1 (n=18,19,15,19,14,4)
    7781.5 (5367.0 to 11282.3)
    6372.2 (4670.2 to 8694.6)
    8569.1 (5972.0 to 12295.8)
    9605.3 (5951.6 to 15502.0)
    7788.2 (5463.6 to 11101.9)
    7759.1 (996.6 to 60412.1)
        PostF-bAb: Day 29 (n=18,19,15,18,14,4)
    108811.5 (72461.7 to 163395.8)
    112799.6 (82736.5 to 153786.4)
    132127.9 (84337.9 to 206998.2)
    130974.4 (97851.3 to 175309.8)
    8011.2 (5514.7 to 11637.9)
    8495.6 (1077.7 to 66969.9)
        PostF-bAb: Day 57 (n=18,19,14,17,14,4)
    85196.0 (58250.0 to 124606.9)
    75628.1 (51928.5 to 110143.8)
    94125.8 (56861.6 to 155811.0)
    81923.9 (56585.6 to 118608.3)
    7984.5 (5469.2 to 11656.5)
    7997.4 (909.5 to 70318.9)
        PostF-bAb: Day 85 (n=18,19,12,17,13,3)
    60967.0 (39795.8 to 93401.0)
    59128.0 (40040.4 to 87314.9)
    89605.4 (50873.4 to 157825.7)
    61176.8 (42975.5 to 87086.9)
    7318.3 (5049.8 to 10605.9)
    7683.9 (166.3 to 354981.2)
        PostF-bAb: Day 113 (n=18,17,12,16,13,3)
    53258.8 (35653.9 to 79556.5)
    51435.0 (33669.1 to 78575.2)
    85589.8 (48631.9 to 150634.0)
    53606.8 (36326.1 to 79108.0)
    8374.5 (5784.3 to 12124.5)
    7441.6 (150.4 to 368224.0)
        PostF-bAb: Day 141 (n=18,19,13,16,14,3)
    48311.1 (32332.8 to 72185.7)
    41981.1 (27984.5 to 62977.9)
    71562.6 (43250.9 to 118406.8)
    52803.7 (35845.3 to 77785.3)
    8019.4 (5567.2 to 11551.7)
    7352.4 (177.1 to 305240.2)
        PostF-bAb: Day 169 (n=18,19,13,17,13,3)
    41471.6 (27763.8 to 61947.1)
    34074.2 (23529.9 to 49343.5)
    63113.6 (37586.8 to 105976.6)
    44688.8 (30203.3 to 66121.4)
    8438.3 (5792.5 to 12292.6)
    7024.3 (110.4 to 446737.5)
        PostF-bAb: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    43784.2 (24668.6 to 77712.5)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    5859.6 (134.3 to 255601.8)
    No statistical analyses for this end point

    Secondary: GMC of Serum Binding Abs (PreF and PostF) for Older Adults Cohorts

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    End point title
    		 GMC of Serum Binding Abs (PreF and PostF) for Older Adults Cohorts [28]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, 169, and 365
    Notes
    [28] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years)
    Number of subjects analysed
    47
    46
    47
    46
    46
    58
    Units: AU/mL
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 1 (n=47,46,47,46,46,58)
    7184.6 (5872.3 to 8790.1)
    6960.5 (5456.3 to 8879.3)
    9173.2 (7267.6 to 11578.5)
    9134.1 (7414.4 to 11252.7)
    8077.0 (6430.5 to 10145.0)
    7871.3 (6388.4 to 9698.5)
        PreF-bAb: Day 29 (n=44,43,47,45,44,56)
    58206.6 (46911.4 to 72221.3)
    80760.1 (67929.5 to 96014.0)
    111145.6 (87974.7 to 140419.4)
    77569.9 (62867.0 to 95711.4)
    59833.7 (45903.3 to 77991.6)
    8119.5 (6379.3 to 10334.4)
        PreF-bAb: Day 57 (n=46,39,44,42,45,58)
    50630.1 (41214.3 to 62197.1)
    56860.8 (47987.0 to 67375.5)
    85785.4 (70699.4 to 104090.5)
    56901.4 (44316.0 to 73060.9)
    41427.1 (31766.9 to 54025.1)
    8164.6 (6555.1 to 10169.3)
        PreF-bAb: Day 85 (n=44,42,46,45,43,55)
    39390.5 (31889.7 to 48655.6)
    47141.3 (40078.1 to 55449.3)
    64628.3 (52007.5 to 80311.8)
    48550.6 (38678.9 to 60941.8)
    35150.3 (26811.4 to 46082.7)
    8157.9 (6427.1 to 10354.9)
        PreF-bAb: Day 169 (n=43,42,44,44,44,55)
    27977.0 (22479.6 to 34818.8)
    27948.6 (22579.4 to 34594.4)
    41137.0 (33523.9 to 50479.0)
    29704.2 (23626.6 to 37345.1)
    23376.4 (18019.0 to 30326.6)
    8338.6 (6717.2 to 10351.4)
        PreF-bAb: Day 365 (n=38,33,36,41,40,49)
    19409.7 (15017.6 to 25086.3)
    19632.9 (15902.1 to 24238.9)
    31346.1 (24301.8 to 40432.2)
    21454.1 (17263.3 to 26662.3)
    16715.1 (12878.1 to 21695.2)
    9660.9 (7556.6 to 12351.2)
        PostF-bAb: Day 1 (n=47,46,47,46,46,58)
    12066.0 (9323.5 to 15615.2)
    10638.2 (8135.1 to 13911.5)
    10424.6 (8167.5 to 13305.5)
    14206.6 (10853.0 to 18596.5)
    10454.3 (7820.9 to 13974.4)
    11806.0 (9501.6 to 14669.2)
        PostF-bAb: Day 29 (n=44,43,47,45,44,56)
    69105.0 (52552.2 to 90871.5)
    85033.1 (66619.6 to 108535.9)
    95879.2 (71829.4 to 127981.4)
    84909.7 (64905.4 to 111079.5)
    47736.3 (35493.9 to 64201.5)
    12067.1 (9309.9 to 15640.8)
        PostF-bAb: Day 57 (n=46,39,44,42,45,58)
    57804.6 (45307.2 to 73749.2)
    51619.0 (40747.4 to 65391.2)
    78968.1 (61971.7 to 100626.0)
    59943.4 (43861.2 to 81922.2)
    35785.6 (26916.4 to 47577.3)
    12029.2 (9463.0 to 15291.4)
        PostF-bAb: Day 85 (n=44,42,46,45,43,55)
    45084.0 (34300.5 to 59257.6)
    48819.9 (39107.1 to 60945.1)
    59983.2 (45895.2 to 78395.6)
    54054.5 (40304.3 to 72495.8)
    30765.7 (22703.4 to 41691.1)
    12343.8 (9609.4 to 15856.1)
        PostF-bAb: Day 169 (n=43,42,44,44,44,55)
    35691.0 (27328.8 to 46611.8)
    29608.9 (22904.2 to 38276.1)
    39154.9 (30112.5 to 50912.6)
    37080.4 (27865.2 to 49343.2)
    20712.5 (15371.7 to 27908.9)
    12392.0 (9900.6 to 15510.5)
        PostF-bAb: Day 365 (n=38,33,36,41,40,49)
    25144.5 (18758.7 to 33704.2)
    21589.3 (16517.4 to 28218.6)
    27730.5 (20151.4 to 38160.1)
    26193.9 (19873.3 to 34524.7)
    16381.1 (11727.9 to 22880.5)
    13768.8 (10464.4 to 18116.6)
    No statistical analyses for this end point

    Secondary: GMC of Serum Binding Abs (PreF and PostF) for Japanese Adults Cohorts

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    End point title
    		 GMC of Serum Binding Abs (PreF and PostF) for Japanese Adults Cohorts [29]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, and 169
    Notes
    [29] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Number of subjects analysed
    20
    4
    Units: AU/mL
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 1 (n=20,4)
    7545.4 (5542.0 to 10273.0)
    6680.8 (1973.6 to 22614.3)
        PreF-bAb: Day 29 (n=20,4)
    68684.0 (53080.2 to 88874.6)
    7135.5 (2085.4 to 24414.7)
        PreF-bAb: Day 57 (n=20,4)
    54618.2 (41547.3 to 71801.3)
    7424.1 (1926.2 to 28614.2)
        PreF-bAb: Day 85 (n=19,4)
    44979.3 (33718.5 to 60000.7)
    7024.4 (1766.1 to 27939.0)
        PreF-bAb: Day 169 (n=20,4)
    29334.8 (22147.5 to 38854.6)
    6674.7 (1804.1 to 24694.1)
        PostF-bAb: Day 1 (n=20,4)
    9925.8 (6459.4 to 15252.6)
    8374.0 (1665.8 to 42096.2)
        PostF-bAb: Day 29 (n=20,4)
    75173.8 (55351.4 to 102095.1)
    7936.5 (1775.1 to 35483.8)
        PostF-bAb: Day 57 (n=20,4)
    57428.6 (42049.2 to 78433.0)
    8492.2 (1601.8 to 45021.9)
        PostF-bAb: Day 85 (n=19,4)
    47821.3 (33458.4 to 68349.9)
    8387.1 (1575.0 to 44663.5)
        PostF-bAb: Day 169 (n=20,4)
    32673.4 (23417.0 to 45588.9)
    8090.6 (1394.2 to 46950.5)
    No statistical analyses for this end point

    Secondary: GMC of Serum Binding Abs (PreF and PostF) for WOCBP Cohorts

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    End point title
    		 GMC of Serum Binding Abs (PreF and PostF) for WOCBP Cohorts [30]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 57, 85, 113, 141, and 169
    Notes
    [30] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    48
    44
    29
    Units: AU/mL
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 1 (n=49,48,44,29)
    5928.0 (4863.4 to 7225.7)
    7202.1 (6057.1 to 8563.7)
    7343.9 (5928.6 to 9097.1)
    7304.7 (5506.0 to 9691.1)
        PreF-bAb: Day 29 (n=49,46,41,28)
    49988.1 (42696.9 to 58524.3)
    67953.4 (57275.4 to 80622.1)
    73032.9 (57716.9 to 92413.0)
    7096.0 (5310.3 to 9482.3)
        PreF-bAb: Day 57 (n=45,45,42,28)
    38705.6 (31796.3 to 47116.3)
    53448.8 (45016.1 to 63461.1)
    60971.6 (49956.9 to 74414.9)
    7249.7 (5279.3 to 9955.6)
        PreF-bAb: Day 85 (n=43,41,37,24)
    32336.5 (26872.1 to 38912.0)
    44024.8 (36651.3 to 52881.8)
    47681.9 (37818.8 to 60117.3)
    7439.4 (5228.9 to 10584.4)
        PreF-bAb: Day 113 (n=44,43,37,25)
    27226.3 (22498.5 to 32947.5)
    37691.8 (31871.8 to 44574.5)
    39558.4 (30970.3 to 50528.0)
    8630.9 (6060.7 to 12290.8)
        PreF-bAb: Day 141 (n=40,42,36,24)
    24463.1 (19820.3 to 30193.3)
    33916.5 (28517.4 to 40337.9)
    34388.8 (27339.6 to 43255.6)
    8582.2 (6206.3 to 11867.8)
        PreF-bAb: Day 169 (n=41,43,34,23)
    22511.6 (18527.1 to 27353.0)
    30274.0 (25749.3 to 35593.8)
    33390.0 (26145.5 to 42641.8)
    8374.0 (6075.5 to 11542.1)
        PostF-bAb: Day 1 (n=49,48,44,29)
    7337.1 (5793.8 to 9291.5)
    8284.3 (6672.7 to 10285.2)
    10108.1 (8068.3 to 12663.7)
    9374.8 (6909.2 to 12720.3)
        PostF-bAb: Day 29 (n=49,46,41,28)
    56083.1 (44704.7 to 70357.5)
    58023.9 (44840.2 to 75083.8)
    79654.7 (60853.5 to 104264.7)
    8807.1 (6531.0 to 11876.5)
        PostF-bAb: Day 57 (n=45,45,42,28)
    43453.5 (34303.0 to 55045.0)
    43215.3 (33324.0 to 56042.6)
    60988.0 (46949.1 to 79225.0)
    9300.0 (6784.0 to 12749.0)
        PostF-bAb: Day 85 (n=43,41,37,24)
    34371.5 (26637.2 to 44351.6)
    32642.4 (24808.7 to 42949.7)
    49095.5 (36720.7 to 65640.7)
    9031.4 (6213.4 to 13127.4)
        PostF-bAb: Day 113 (n=44,43,37,25)
    29414.6 (23233.3 to 37240.6)
    31019.5 (23547.8 to 40862.1)
    43359.9 (32563.0 to 57736.6)
    10585.1 (7253.6 to 15446.6)
        PostF-bAb: Day 141 (n=40,42,36,24)
    26740.9 (20593.7 to 34722.9)
    26633.4 (20241.6 to 35043.6)
    37108.7 (27752.6 to 49618.8)
    10775.7 (7529.3 to 15421.8)
        PostF-bAb: Day 169 (n=41,43,34,23)
    23089.1 (18052.3 to 29531.4)
    24488.3 (18865.9 to 31786.3)
    36499.6 (27296.8 to 48804.9)
    9459.4 (6424.5 to 13927.9)
    No statistical analyses for this end point

    Secondary: GMC of Serum Binding Abs (PreF and PostF) for Children Cohorts

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    End point title
    		 GMC of Serum Binding Abs (PreF and PostF) for Children Cohorts [31]
    End point description
    Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 85, and 141
    Notes
    [31] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    14
    13
    11
    Units: AU/mL
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 1 (n=14,13,11)
    2917.4 (1032.3 to 8244.7)
    8082.8 (3651.1 to 17893.8)
    3049.5 (646.4 to 14387.0)
        PreF-bAb: Day 29 (n=14,11,11)
    77346.4 (40482.2 to 147780.1)
    85262.9 (58818.3 to 123596.7)
    5607.0 (2180.6 to 14417.8)
        PreF-bAb: Day 85 (n=5,9,4)
    52637.4 (24725.1 to 112059.9)
    47425.7 (29293.9 to 76780.5)
    1340.6 (188.5 to 9535.5)
        PreF-bAb: Day 141 (n=4,5,5)
    56838.9 (27535.9 to 117325.1)
    85960.5 (53327.1 to 138564.0)
    9477.9 (2516.4 to 35699.0)
        PostF-bAb: Day 1 (n=14,13,11)
    4452.1 (2103.2 to 9424.4)
    14341.2 (7611.3 to 27021.9)
    5101.7 (991.9 to 26240.5)
        PostF-bAb: Day 29 (n=14,11,11)
    71426.3 (34951.2 to 145966.8)
    121809.4 (69071.8 to 214813.1)
    9566.1 (3803.8 to 24057.8)
        PostF-bAb: Day 85 (n=5,9,4)
    36288.6 (12278.4 to 107250.9)
    57293.0 (31394.4 to 104556.5)
    1906.1 (647.6 to 5610.0)
        PostF-bAb: Day 141 (n=4,5,5)
    42645.7 (8769.3 to 207389.1)
    87523.8 (36792.6 to 208205.3)
    7012.1 (1396.5 to 35207.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Young Adults Cohorts

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    End point title
    		 Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Young Adults Cohorts [32]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 11 AU/mL for RSV-A and 8 AU/mL for RSV-B. PP Set included FAS participants (all randomized participants who received any study injection, had baseline data for analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories. ‘9999’ represents data not collected for specified cohorts.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, 169, and 281
    Notes
    [32] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years)
    Number of subjects analysed
    18
    19
    19
    19
    15
    4
    Units: ratio
    geometric mean (confidence interval 95%)
        RSV-A: Day 29 (n=18,19,19,18,15,4)
    20.52 (13.62 to 30.91)
    22.25 (14.77 to 33.51)
    23.54 (16.14 to 34.33)
    19.96 (13.95 to 28.58)
    0.92 (0.79 to 1.08)
    0.97 (0.69 to 1.35)
        RSV-A: Day 57 (n=18,19,15,17,14,4)
    17.51 (10.98 to 27.91)
    16.83 (10.09 to 28.08)
    15.33 (9.24 to 25.44)
    13.93 (9.80 to 19.81)
    0.91 (0.73 to 1.14)
    0.76 (0.31 to 1.90)
        RSV-A: Day 85 (n=18,19,13,17,13,3)
    15.77 (10.67 to 23.33)
    11.78 (7.76 to 17.90)
    21.19 (11.53 to 38.93)
    9.34 (5.99 to 14.56)
    0.95 (0.77 to 1.17)
    0.73 (0.35 to 1.54)
        RSV-A: Day 113 (n=18,17,12,16,13,3)
    14.25 (9.09 to 22.34)
    8.70 (5.30 to 14.27)
    17.22 (10.58 to 28.02)
    9.58 (6.65 to 13.82)
    0.87 (0.70 to 1.08)
    1.02 (0.20 to 5.28)
        RSV-A: Day 141 (n=18,19,13,16,14,3)
    9.74 (6.07 to 15.63)
    7.44 (4.94 to 11.20)
    15.56 (9.54 to 25.38)
    9.22 (6.82 to 12.47)
    0.95 (0.70 to 1.31)
    1.00 (0.13 to 7.46)
        RSV-A: Day 169 (n=18,19,13,17,13,3)
    9.62 (6.27 to 14.77)
    6.98 (4.64 to 10.49)
    19.69 (12.79 to 30.30)
    8.42 (5.91 to 12.01)
    0.95 (0.76 to 1.18)
    0.71 (0.15 to 3.36)
        RSV-A: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    12.55 (7.96 to 19.78)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.58 (0.35 to 0.95)
        RSV-B: Day 29 (n=18,19,19,18,15,4)
    14.44 (9.57 to 21.80)
    11.67 (6.72 to 20.28)
    16.02 (9.92 to 25.87)
    13.88 (8.06 to 23.92)
    0.88 (0.69 to 1.13)
    1.19 (0.60 to 2.38)
        RSV-B: Day 57 (n=18,19,15,17,14,4)
    15.28 (9.61 to 24.32)
    13.03 (8.11 to 20.94)
    19.28 (12.29 to 30.23)
    8.68 (5.18 to 14.56)
    0.94 (0.67 to 1.33)
    1.58 (0.54 to 4.61)
        RSV-B: Day 85 (n=18,19,13,17,13,3)
    10.54 (6.78 to 16.36)
    8.24 (5.23 to 12.97)
    14.87 (8.66 to 25.54)
    7.34 (4.36 to 12.36)
    0.92 (0.63 to 1.35)
    1.21 (0.37 to 3.90)
        RSV-B: Day 113 (n=18,17,12,16,13,3)
    10.38 (6.51 to 16.55)
    8.52 (5.36 to 13.54)
    16.54 (8.49 to 32.23)
    6.38 (3.71 to 10.97)
    0.80 (0.59 to 1.08)
    1.33 (0.71 to 2.48)
        RSV-B: Day 141 (n=18,19,13,16,14,3)
    10.66 (6.45 to 17.62)
    7.35 (4.52 to 11.95)
    20.19 (12.20 to 33.40)
    5.23 (3.34 to 8.18)
    0.86 (0.65 to 1.13)
    1.35 (0.35 to 5.23)
        RSV-B: Day 169 (n=18,19,13,17,13,3)
    8.90 (5.69 to 13.93)
    5.28 (3.54 to 7.90)
    16.54 (9.40 to 29.08)
    5.01 (3.17 to 7.93)
    0.67 (0.49 to 0.92)
    1.02 (0.26 to 3.97)
        RSV-B: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    10.66 (5.82 to 19.54)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.75 (0.09 to 5.90)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Older Adults Cohorts

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    End point title
    		 GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Older Adults Cohorts [33]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 11 AU/mL for RSV-A and 8 AU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 169, and 365
    Notes
    [33] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years)
    Number of subjects analysed
    46
    43
    47
    45
    45
    58
    Units: ratio
    geometric mean (confidence interval 95%)
        RSV-A: Day 29 (n=44,43,47,45,44,56)
    12.03 (8.78 to 16.47)
    14.14 (10.23 to 19.54)
    16.67 (12.34 to 22.53)
    12.17 (8.90 to 16.64)
    10.19 (7.17 to 14.48)
    1.15 (0.99 to 1.34)
        RSV-A: Day 57 (n=46,39,44,42,45,58)
    9.16 (6.73 to 12.47)
    9.31 (6.65 to 13.04)
    12.86 (9.62 to 17.19)
    10.03 (7.18 to 14.03)
    7.05 (5.14 to 9.69)
    1.12 (0.95 to 1.33)
        RSV-A: Day 85 (n=44,42,46,45,43,55)
    7.53 (5.54 to 10.24)
    7.73 (5.95 to 10.05)
    9.43 (6.80 to 13.06)
    7.54 (5.57 to 10.22)
    5.27 (3.82 to 7.29)
    1.11 (0.98 to 1.26)
        RSV-A: Day 169 (n=43,42,44,44,44,55)
    5.05 (3.77 to 6.67)
    4.05 (2.96 to 5.54)
    5.79 (4.56 to 7.35)
    4.10 (3.04 to 5.54)
    3.08 (2.33 to 4.08)
    0.99 (0.86 to 1.15)
        RSV-A: Day 365 (n=38,33,36,41,40,49)
    3.06 (2.20 to 4.24)
    2.66 (1.94 to 3.66)
    3.19 (2.37 to 4.30)
    2.96 (2.22 to 3.94)
    2.39 (1.84 to 3.10)
    1.15 (0.96 to 3.38)
        RSV-B: Day 29 (n=44,43,47,45,44,56)
    8.96 (6.79 to 11.84)
    9.60 (7.31 to 12.61)
    12.50 (9.10 to 17.16)
    6.65 (4.86 to 8.87)
    5.30 (3.74 to 7.49)
    1.12 (0.98 to 1.29)
        RSV-B: Day 57 (n=46,39,44,42,45,58)
    7.08 (5.40 to 9.28)
    8.87 (6.71 to 11.73)
    9.77 (7.34 to 13.00)
    5.66 (4.35 to 7.36)
    4.28 (3.21 to 5.72)
    1.27 (1.12 to 1.44)
        RSV-B: Day 85 (n=44,42,46,45,43,55)
    5.62 (4.24 to 7.45)
    7.02 (5.35 to 9.20)
    7.99 (6.00 to 10.64)
    4.57 (3.54 to 5.90)
    3.51 (2.58 to 4.78)
    1.27 (1.12 to 1.44)
        RSV-B: Day 169 (n=43,42,44,44,44,55)
    4.38 (3.37 to 5.70)
    4.60 (3.69 to 5.73)
    5.50 (4.39 to 6.89)
    3.20 (2.36 to 4.34)
    2.87 (2.24 to 3.70)
    1.33 (1.14 to 1.55)
        RSV-B: Day 365 (n=38,33,36,41,40,49)
    2.37 (1.87 to 3.01)
    2.78 (2.10 to 3.69)
    2.89 (2.28 to 3.66)
    1.61 (1.25 to 2.06)
    1.52 (1.23 to 1.88)
    1.07 (0.89 to 1.29)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Japanese Adults Cohorts ‌

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    End point title
    		 GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Japanese Adults Cohorts ‌ [34]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 11 AU/mL for RSV-A and 8 AU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, and 169
    Notes
    [34] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Number of subjects analysed
    20
    4
    Units: ratio
    geometric mean (confidence interval 95%)
        RSV-A: Day 29 (n=20,4)
    11.15 (7.76 to 16.01)
    0.82 (0.42 to 1.60)
        RSV-A: Day 57 (n=20,4)
    9.75 (7.17 to 13.27)
    0.84 (0.32 to 2.19)
        RSV-A: Day 85 (n=19,4)
    7.77 (5.61 to 10.76)
    0.81 (0.28 to 2.29)
        RSV-A: Day 169 (n=20,4)
    4.16 (2.96 to 5.43)
    0.72 (0.33 to 1.55)
        RSV-B: Day 29 (n=20,4)
    6.60 (4.90 to 8.88)
    0.81 (0.47 to 1.41)
        RSV-B: Day 57 (n=20,4)
    4.72 (3.60 to 6.19)
    0.85 (0.60 to 1.20)
        RSV-B: Day 85 (n=19,4)
    3.82 (2.97 to 4.91)
    0.81 (0.49 to 1.36)
        RSV-B: Day 169 (n=20,4)
    2.67 (2.04 to 3.50)
    0.69 (0.47 to 1.01)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for WOCBP Cohorts ‌

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    End point title
    		 GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for WOCBP Cohorts ‌ [35]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 11 AU/mL for RSV-A and 8 AU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, and 169
    Notes
    [35] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    46
    41
    28
    Units: ratio
    geometric mean (confidence interval 95%)
        RSV-A: Day 29 (n=49,46,41,28)
    9.41 (7.29 to 12.15)
    11.22 (8.43 to 14.94)
    11.60 (8.71 to 15.46)
    1.05 (0.88 to 1.26)
        RSV-A: Day 57 (n=45,45,42,28)
    9.30 (6.99 to 12.36)
    10.19 (7.80 to 13.31)
    10.79 (8.53 to 13.64)
    1.41 (1.11 to 1.78)
        RSV-A: Day 85 (n=43,41,37,24)
    7.50 (5.60 to 10.05)
    10.15 (7.60 to 13.57)
    8.75 (6.59 to 11.61)
    1.21 (0.94 to 1.56)
        RSV-A: Day 113 (n=44,43,37,25)
    6.07 (4.48 to 8.22)
    7.07 (5.39 to 9.27)
    6.88 (5.30 to 8.94)
    1.32 (0.99 to 1.75)
        RSV-A: Day 141 (n=40,42,36,25)
    4.75 (3.49 to 6.46)
    5.84 (4.58 to 7.43)
    5.70 (4.30 to 7.56)
    1.02 (0.79 to 1.33)
        RSV-A: Day 169 (n=41,43,34,23)
    3.94 (2.94 to 5.29)
    5.11 (3.86 to 6.77)
    4.42 (3.60 to 5.43)
    0.99 (0.81 to 1.21)
        RSV-B: Day 29 (n=49,46,41,28)
    7.55 (5.36 to 10.64)
    6.45 (4.68 to 8.89)
    9.09 (6.04 to 13.68)
    0.95 (0.75 to 1.21)
        RSV-B: Day 57 (n=45,45,42,28)
    5.45 (3.90 to 7.62)
    4.76 (3.49 to 6.49)
    6.63 (4.71 to 9.34)
    1.46 (1.19 to 1.80)
        RSV-B: Day 85 (n=43,41,37,24)
    5.65 (4.14 to 7.72)
    4.56 (3.29 to 6.31)
    5.88 (4.27 to 8.10)
    1.47 (1.11 to 1.97)
        RSV-B: Day 113 (n=44,43,37,25)
    3.91 (2.83 to 5.41)
    3.79 (2.78 to 5.16)
    5.02 (3.80 to 6.64)
    1.73 (1.20 to 2.49)
        RSV-B: Day 141 (n=40,42,36,25)
    3.52 (2.55 to 4.87)
    3.15 (2.39 to 4.16)
    3.79 (2.69 to 5.33)
    1.44 (1.09 to 1.92)
        RSV-B: Day 169 (n=41,43,34,23)
    3.15 (2.27 to 4.36)
    2.98 (2.21 to 4.02)
    3.06 (2.24 to 4.17)
    1.21 (0.96 to 1.52)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Children Cohorts ‌

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    End point title
    		 GMFR of Postbaseline/Baseline RSV Neutralizing Abs (RSV-A and RSV-B) Titers for Children Cohorts ‌ [36]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 11 AU/mL for RSV-A and 8 AU/mL for RSV-B. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 85, and 141
    Notes
    [36] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    14
    12
    11
    Units: ratio
    geometric mean (confidence interval 95%)
        RSV-A: Day 29 (n=14,12,11)
    34.88 (13.79 to 88.22)
    18.94 (5.54 to 64.71)
    1.44 (0.66 to 3.15)
        RSV-A: Day 85 (n=5,9,4)
    40.25 (15.23 to 106.35)
    7.26 (1.75 to 30.14)
    0.65 (0.21 to 2.02)
        RSV-A: Day 141 (n=4,5,5)
    49.96 (9.01 to 276.88)
    17.71 (1.69 to 185.65)
    1.41 (0.32 to 6.12)
        RSV-B: Day 29 (n=14,12,11)
    14.26 (7.05 to 28.87)
    7.21 (2.36 to 22.02)
    1.24 (0.55 to 2.82)
        RSV-B: Day 85 (n=5,9,4)
    17.56 (5.59 to 55.13)
    3.20 (0.94 to 10.89)
    0.64 (0.27 to 1.52)
        RSV-B: Day 141 (n=4,5,5)
    13.28 (3.35 to 52.64)
    6.32 (3.30 to 12.08)
    1.93 (0.35 to 52.64)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Young Adults Cohorts

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    End point title
    		 GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Young Adults Cohorts [37]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included FAS participants (all randomized participants who received any study injection, had baseline data for analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with injection schedule, b) complied with timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories. ‘9999’ represents data not collected for specified cohorts.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, 169, and 281
    Notes
    [37] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years)
    Number of subjects analysed
    18
    19
    15
    18
    14
    4
    Units: ratio
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 29 (n=18,19,15,18,14,4)
    16.14 (11.44 to 22.76)
    21.67 (15.42 to 30.45)
    21.76 (16.73 to 28.30)
    16.87 (12.41 to 22.94)
    0.99 (0.88 to 1.12)
    1.11 (0.86 to 1.43)
        PreF-bAb: Day 57 (n=18,19,14,17,14,4)
    13.24 (9.71 to 18.05)
    15.47 (10.80 to 22.15)
    16.02 (11.60 to 22.12)
    11.89 (8.46 to 16.72)
    1.05 (0.97 to 1.14)
    0.98 (0.83 to 1.16)
        PreF-bAb: Day 85 (n=18,19,12,17,13,3)
    9.32 (6.40 to 13.57)
    11.68 (7.93 to 17.22)
    17.08 (13.05 to 22.37)
    9.27 (6.85 to 12.54)
    0.99 (0.89 to 1.11)
    1.02 (0.80 to 1.31)
        PreF-bAb: Day 113 (n=18,17,12,16,13,3)
    8.19 (5.94 to 11.30)
    9.67 (6.52 to 14.35)
    15.27 (10.79 to 21.61)
    7.46 (5.27 to 10.57)
    0.96 (0.85 to 1.08)
    0.99 (0.85 to 1.15)
        PreF-bAb: Day 141 (n=18,19,13,16,14,3)
    7.67 (5.47 to 10.75)
    8.28 (6.02 to 11.38)
    16.07 (12.12 to 21.30)
    6.50 (4.73 to 8.95)
    0.97 (0.86 to 1.10)
    0.96 (0.63 to 1.47)
        PreF-bAb: Day 169 (n=18,19,13,17,13,3)
    6.48 (4.72 to 8.89)
    7.04 (5.14 to 9.65)
    13.48 (10.07 to 18.04)
    5.87 (4.44 to 7.75)
    0.97 (0.85 to 1.11)
    0.96 (0.89 to 1.03)
        PreF-bAb: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    8.42 (5.87 to 12.08)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.80 (0.34 to 1.90)
        PostF-bAb: Day 29 (n=18,19,15,18,14,4)
    13.98 (8.69 to 22.49)
    17.70 (11.75 to 26.66)
    15.42 (10.99 to 21.64)
    14.64 (10.81 to 19.83)
    1.03 (0.94 to 1.12)
    1.09 (0.96 to 1.25)
        PostF-bAb: Day 57 (n=18,19,14,17,14,4)
    10.95 (7.07 to 16.95)
    11.87 (7.70 to 18.30)
    10.85 (7.39 to 15.94)
    9.08 (6.65 to 12.41)
    1.03 (0.97 to 1.09)
    1.03 (0.86 to 1.24)
        PostF-bAb: Day 85 (n=18,19,12,17,13,3)
    7.83 (4.79 to 12.81)
    9.28 (5.93 to 14.52)
    9.87 (6.48 to 15.02)
    6.90 (5.08 to 9.38)
    1.02 (0.95 to 1.10)
    1.12 (0.94 to 1.33)
        PostF-bAb: Day 113 (n=18,17,12,16,13,3)
    6.84 (4.46 to 10.49)
    7.56 (4.72 to 12.10)
    8.96 (5.79 to 13.88)
    5.60 (4.01 to 7.82)
    1.05 (0.98 to 1.13)
    1.09 (0.98 to 1.20)
        PostF-bAb: Day 141 (n=18,19,13,16,14,3)
    6.21 (4.06 to 9.49)
    6.59 (4.23 to 10.26)
    7.98 (5.47 to 11.63)
    4.54 (3.38 to 6.11)
    1.03 (0.95 to 1.12)
    1.07 (0.90 to 1.27)
        PostF-bAb: Day 169 (n=18,19,13,17,13,3)
    5.33 (3.53 to 8.04)
    5.35 (3.58 to 7.98)
    7.04 (4.87 to 10.17)
    4.20 (3.14 to 5.62)
    1.06 (0.97 to 1.16)
    1.02 (0.72 to 1.46)
        PostF-bAb: Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    4.78 (3.25 to 7.04)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.85 (0.40 to 1.84)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Older Adults Cohorts

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    End point title
    		 GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Older Adults Cohorts [38]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 169, and 365
    Notes
    [38] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years)
    Number of subjects analysed
    44
    43
    47
    45
    44
    56
    Units: ratio
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 29 (n=44,43,47,45,44,56)
    8.46 (6.79 to 10.55)
    11.61 (9.24 to 14.58)
    12.12 (9.17 to 16.01)
    8.40 (6.77 to 10.41)
    7.21 (5.61 to 9.26)
    1.04 (0.92 to 1.17)
        PreF-bAb: Day 57 (n=46,39,44,42,45,58)
    7.03 (5.75 to 8.59)
    7.83 (6.32 to 9.69)
    9.25 (7.20 to 11.87)
    6.57 (5.26 to 8.22)
    5.11 (4.03 to 6.48)
    1.04 (0.92 to 1.16)
        PreF-bAb: Day 85 (n=44,42,46,45,43,55)
    5.44 (4.27 to 6.92)
    6.54 (5.26 to 8.11)
    6.96 (5.43 to 8.93)
    5.40 (4.40 to 6.63)
    4.32 (3.42 to 5.46)
    1.02 (0.91 to 1.14)
        PreF-bAb: Day 169 (n=43,42,44,44,44,55)
    4.05 (3.34 to 4.90)
    4.08 (3.25 to 5.14)
    4.72 (3.83 to 5.81)
    3.31 (2.71 to 4.06)
    2.82 (2.28 to 3.48)
    1.02 (0.89 to 1.16)
        PreF-bAb: Day 365 (n=38,33,36,41,40,49)
    2.90 (2.38 to 3.53)
    3.37 (2.62 to 4.33)
    3.22 (2.55 to 4.07)
    2.42 (1.98 to 2.95)
    2.10 (1.73 to 2.55)
    1.16 (0.96 to 1.39)
        PostF-bAb: Day 29 (n=44,43,47,45,44,56)
    5.91 (4.63 to 7.54)
    7.89 (6.20 to 10.04)
    9.20 (7.08 to 11.94)
    5.86 (4.54 to 7.56)
    4.35 (3.60 to 5.25)
    1.03 (0.92 to 1.17)
        PostF-bAb: Day 57 (n=46,39,44,42,45,58)
    4.85 (3.92 to 6.01)
    4.99 (4.00 to 6.22)
    7.40 (5.89 to 9.30)
    4.12 (3.08 to 5.51)
    3.42 (2.85 to 4.09)
    1.02 (0.92 to 1.13)
        PostF-bAb: Day 85 (n=44,42,46,45,43,55)
    3.75 (2.83 to 4.97)
    4.30 (3.41 to 5.41)
    5.66 (4.51 to 7.12)
    3.82 (3.00 to 4.87)
    2.86 (2.41 to 3.40)
    1.02 (0.91 to 1.14)
        PostF-bAb: Day 169 (n=43,42,44,44,44,55)
    3.00 (2.47 to 3.64)
    2.69 (2.15 to 3.37)
    3.75 (3.05 to 4.62)
    2.58 (2.03 to 3.27)
    1.93 (1.66 to 2.25)
    1.00 (0.89 to 1.13)
        PostF-bAb: Day 365 (n=38,33,36,41,40,49)
    2.27 (1.86 to 2.77)
    2.34 (1.87 to 2.93)
    2.62 (2.17 to 3.15)
    1.87 (1.47 to 2.37)
    1.56 (1.35 to 1.81)
    1.16 (0.97 to 1.39)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Japanese Adults Cohorts

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    End point title
    		 GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Japanese Adults Cohorts [39]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, and 169
    Notes
    [39] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Number of subjects analysed
    20
    4
    Units: ratio
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 29 (n=20,4)
    9.10 (6.46 to 12.83)
    1.07 (0.94 to 1.21)
        PreF-bAb: Day 57 (n=20,4)
    7.24 (5.26 to 9.97)
    1.11 (0.96 to 1.29)
        PreF-bAb: Day 85 (n=19,4)
    6.04 (4.34 to 8.41)
    1.05 (0.85 to 1.30)
        PreF-bAb: Day 169 (n=20,4)
    3.89 (2.87 to 5.26)
    1.00 (0.85 to 1.17)
        PostF-bAb: Day 29 (n=20,4)
    7.57 (4.70 to 12.21)
    0.95 (0.79 to 1.14)
        PostF-bAb: Day 57 (n=20,4)
    5.79 (3.80 to 8.82)
    1.01 (0.88 to 1.17)
        PostF-bAb: Day 85 (n=19,4)
    4.60 (3.11 to 6.80)
    1.00 (0.90 to 1.11)
        PostF-bAb: Day 169 (n=20,4)
    3.29 (2.36 to 4.60)
    0.97 (0.78 to 1.20)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for WOCBP Cohorts

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    End point title
    		 GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for WOCBP Cohorts [40]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, and 169
    Notes
    [40] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    46
    42
    28
    Units: ratio
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 29 (n=49,46,41,28)
    8.43 (6.86 to 10.37)
    9.58 (7.74 to 11.86)
    10.22 (7.80 to 13.39)
    1.00 (0.88 to 1.13)
        PreF-bAb: Day 57 (n=45,45,42,28)
    6.65 (5.26 to 8.39)
    7.45 (6.10 to 9.10)
    8.09 (6.54 to 10.01)
    0.99 (0.87 to 1.14)
        PreF-bAb: Day 85 (n=43,41,37,24)
    5.65 (4.44 to 7.18)
    6.54 (5.30 to 8.08)
    6.17 (4.84 to 7.87)
    0.99 (0.85 to 1.16)
        PreF-bAb: Day 113 (n=44,43,37,25)
    4.81 (3.82 to 6.06)
    5.43 (4.41 to 6.69)
    5.10 (3.96 to 6.56)
    1.17 (0.94 to 1.47)
        PreF-bAb: Day 141 (n=40,42,36,24)
    4.08 (3.23 to 5.14)
    4.95 (4.17 to 5.88)
    4.32 (3.53 to 5.29)
    1.14 (0.92 to 1.41)
        PreF-bAb: Day 169 (n=41,43,34,23)
    3.83 (3.04 to 4.82)
    4.43 (3.64 to 5.40)
    4.05 (3.30 to 4.98)
    1.02 (0.91 to 1.16)
        PostF-bAb: Day 29 (n=49,46,41,28)
    7.64 (6.00 to 9.74)
    7.22 (5.74 to 9.09)
    8.11 (6.39 to 10.29)
    0.97 (0.89 to 1.07)
        PostF-bAb: Day 57 (n=45,45,42,28)
    5.90 (4.66 to 7.48)
    5.16 (4.13 to 6.43)
    5.86 (4.85 to 7.08)
    0.99 (0.89 to 1.10)
        PostF-bAb: Day 85 (n=43,41,37,24)
    4.76 (3.74 to 6.05)
    4.39 (3.46 to 5.58)
    4.40 (3.52 to 5.50)
    0.96 (0.85 to 1.10)
        PostF-bAb: Day 113 (n=44,43,37,25)
    4.19 (3.37 to 5.21)
    3.94 (3.15 to 4.93)
    3.93 (3.18 to 4.86)
    1.13 (0.95 to 1.35)
        PostF-bAb: Day 141 (n=40,42,36,24)
    3.58 (2.83 to 4.53)
    3.41 (2.80 to 4.15)
    3.35 (2.76 to 4.08)
    1.10 (0.92 to 1.32)
        PostF-bAb: Day 169 (n=41,43,34,23)
    3.27 (2.62 to 4.08)
    3.19 (2.60 to 3.92)
    3.12 (2.54 to 3.83)
    1.00 (0.87 to 1.15)
    No statistical analyses for this end point

    Secondary: GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Children Cohorts

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    End point title
    		 GMFR of Postbaseline/Baseline Serum Binding Abs (PreF and PostF) Titers for Children Cohorts [41]
    End point description
    Antibody values reported as below LLOQ at baseline were replaced by LLOQ for GMFR comparing post-baseline to baseline titer values. LLOQ was 19 AU/mL for PreF-bAb and 16 AU/mL for PostF-bAb. PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 85, and 141
    Notes
    [41] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    14
    11
    11
    Units: ratio
    geometric mean (confidence interval 95%)
        PreF-bAb: Day 29 (n=14,11,11)
    26.51 (13.37 to 52.59)
    13.92 (6.90 to 28.10)
    1.73 (0.56 to 5.31)
        PreF-bAb: Day 85 (n=5,9,4)
    51.02 (5.41 to 481.44)
    6.48 (3.02 to 13.87)
    0.67 (0.48 to 0.93)
        PreF-bAb: Day 141 (n=4,5,5)
    62.82 (1.54 to 2556.22)
    8.32 (5.75 to 12.03)
    1.74 (0.35 to 8.61)
        PostF-bAb: Day 29 (n=14,11,11)
    16.04 (9.19 to 28.00)
    9.28 (4.42 to 19.48)
    1.76 (0.47 to 6.61)
        PostF-bAb: Day 85 (n=5,9,4)
    12.13 (2.21 to 66.49)
    4.68 (2.01 to 10.92)
    0.68 (0.39 to 1.18)
        PostF-bAb: Day 141 (n=4,5,5)
    10.62 (0.95 to 118.19)
    4.47 (1.37 to 14.62)
    1.01 (0.57 to 1.81)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Young Adult Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Young Adult Cohorts [42]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories. ‘9999’ represents data not collected for specified cohorts.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, 169, and 281
    Notes
    [42] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years)
    Number of subjects analysed
    18
    19
    19
    18
    15
    4
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: ≥2-fold Rise- Day 29 (n=18,19,19,18,15,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (81.5 to 100.0)
    0.0 (0.0 to 21.8)
    0.0 (0.0 to 60.2)
        RSV-A: ≥4-fold Rise- Day 29 (n=18,19,19,18,15,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (81.5 to 100.0)
    0.0 (0.0 to 21.8)
    0.0 (0.0 to 60.2)
        RSV-A: ≥2-fold Rise- Day 57 (n=18,19,15,17,14,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        RSV-A: ≥4-fold Rise- Day 57 (n=18,19,15,17,14,4)
    94.4 (72.7 to 99.9)
    94.7 (74.0 to 99.9)
    86.7 (59.5 to 98.3)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        RSV-A: ≥2-fold Rise- Day 85 (n=18,19,13,17,13,3)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (75.3 to 100.0)
    94.1 (71.3 to 99.9)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-A: ≥4-fold Rise- Day 85 (n=18,19,13,17,13,3)
    94.4 (72.7 to 99.9)
    94.7 (74.0 to 99.9)
    84.6 (54.6 to 98.1)
    94.1 (71.3 to 99.9)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-A: ≥2-fold Rise- Day 113 (n=18,17,12,16,13,3)
    100.0 (81.5 to 100.0)
    100.0 (80.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (79.4 to 100.0)
    0.0 (0.0 to 24.7)
    33.3 (0.8 to 90.6)
        RSV-A: ≥4-fold Rise- Day 113 (n=18,17,12,16,13,3)
    94.4 (72.7 to 99.9)
    70.6 (44.0 to 89.7)
    91.7 (61.5 to 99.8)
    93.8 (69.8 to 99.8)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-A: ≥2-fold Rise- Day 141 (n=18,19,13,16,14,3)
    94.4 (72.7 to 99.9)
    94.7 (74.0 to 99.9)
    100.0 (75.3 to 100.0)
    100.0 (79.4 to 100.0)
    7.1 (0.2 to 33.9)
    0.0 (0.0 to 70.8)
        RSV-A: ≥4-fold Rise- Day 141 (n=18,19,13,16,14,3)
    77.8 (52.4 to 93.6)
    73.7 (48.8 to 90.9)
    92.3 (64.0 to 99.8)
    93.8 (69.8 to 99.8)
    7.1 (0.2 to 33.9)
    0.0 (0.0 to 70.8)
        RSV-A: ≥2-fold Rise- Day 169 (n=18,19,13,17,13,3)
    100.0 (81.5 to 100.0)
    94.7 (74.0 to 99.9)
    100.0 (75.3 to 100.0)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-A: ≥4-fold Rise- Day 169 (n=18,19,13,17,13,3)
    83.3 (58.6 to 96.4)
    73.7 (48.8 to 90.9)
    100.0 (75.3 to 100.0)
    82.4 (56.6 to 96.2)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-A: ≥2-fold Rise- Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100.0 (73.5 to 100.0)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
        RSV-A: ≥4-fold Rise- Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    91.7 (61.5 to 99.8)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
        RSV-B: ≥2-fold Rise- Day 29 (n=18,19,19,18,15,4)
    100.0 (81.5 to 100.0)
    94.7 (74.0 to 99.9)
    100.0 (82.4 to 100.0)
    100.0 (81.5 to 100.0)
    0.0 (0.0 to 21.8)
    25.0 (0.6 to 80.6)
        RSV-B: ≥4-fold Rise- Day 29 (n=18,19,19,18,15,4)
    94.4 (72.7 to 99.9)
    89.5 (66.9 to 98.7)
    89.5 (66.9 to 98.7)
    94.4 (72.7 to 99.9)
    0.0 (0.0 to 21.8)
    0.0 (0.0 to 60.2)
        RSV-B: ≥2-fold Rise- Day 57 (n=18,19,15,17,14,4)
    100.0 (81.5 to 100.0)
    94.7 (74.0 to 99.9)
    100.0 (78.2 to 100.0)
    94.1 (71.3 to 99.9)
    7.1 (0.2 to 33.9)
    50.0 (6.8 to 93.2)
        RSV-B: ≥4-fold Rise- Day 57 (n=18,19,15,17,14,4)
    94.4 (72.7 to 99.9)
    89.5 (72.7 to 99.9)
    100.0 (78.2 to 100.0)
    76.5 (50.1 to 93.2)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        RSV-B: ≥2-fold Rise- Day 85 (n=18,19,13,17,13,3)
    100.0 (81.5 to 100.0)
    94.7 (74.0 to 99.9)
    100.0 (75.3 to 100.0)
    94.1 (71.3 to 99.9)
    15.4 (1.9 to 45.4)
    0.0 (0.0 to 70.8)
        RSV-B: ≥4-fold Rise- Day 85 (n=18,19,13,17,13,3)
    88.9 (65.3 to 98.6)
    78.9 (54.4 to 93.9)
    92.3 (64.0 to 99.8)
    76.5 (50.1 to 93.2)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-B: ≥2-fold Rise- Day 113 (n=18,17,12,16,13,3)
    94.4 (72.7 to 99.9)
    94.1 (71.3 to 99.9)
    100.0 (73.5 to 100.0)
    93.8 (69.8 to 99.8)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-B: ≥4-fold Rise- Day 113 (n=18,17,12,16,13,3)
    88.9 (65.3 to 98.6)
    76.5 (50.1 to 93.2)
    83.3 (51.6 to 97.9)
    62.5 (35.4 to 84.8)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-B: ≥2-fold Rise- Day 141 (n=18,19,13,16,14,3)
    94.4 (72.7 to 99.9)
    89.5 (66.9 to 98.7)
    100.0 (75.3 to 100.0)
    81.3 (54.4 to 96.0)
    0.0 (0.0 to 23.2)
    33.3 (0.8 to 90.6)
        RSV-B: ≥4-fold Rise- Day 141 (n=18,19,13,16,14,3)
    83.3 (58.6 to 96.4)
    68.4 (43.4 to 87.4)
    100.0 (75.3 to 100.0)
    62.5 (35.4 to 84.8)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 70.8)
        RSV-B: ≥2-fold Rise- Day 169 (n=18,19,13,17,13,3)
    94.4 (72.7 to 99.9)
    84.2 (60.4 to 96.6)
    100.0 (75.3 to 100.0)
    88.2 (63.6 to 98.5)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-B: ≥4-fold Rise- Day 169 (n=18,19,13,17,13,3)
    88.9 (65.3 to 98.6)
    73.7 (48.8 to 90.9)
    92.3 (64.0 to 99.8)
    52.9 (27.8 to 77.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        RSV-B: ≥2-fold Rise- Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    91.7 (61.5 to 99.8)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
        RSV-B: ≥4-fold Rise- Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    91.7 (61.5 to 99.8)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Older Adults Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Older Adults Cohorts [43]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 169, and 365
    Notes
    [43] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years)
    Number of subjects analysed
    47
    46
    47
    46
    46
    58
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: ≥2-fold Rise- Day 29 (n=44,43,47,45,44,56)
    100.0 (92.0 to 100.0)
    97.7 (87.7 to 99.9)
    97.9 (87.7 to 99.9)
    97.8 (88.2 to 99.9)
    93.2 (81.3 to 98.6)
    7.1 (2.0 to 17.3)
        RSV-A: ≥4-fold Rise- Day 29 (n=44,43,47,45,44,56)
    84.1 (69.9 to 93.4)
    93.0 (80.9 to 98.5)
    93.6 (82.5 to 98.7)
    88.9 (75.9 to 96.3)
    75.0 (59.7 to 86.8)
    5.4 (1.1 to 14.9)
        RSV-A: ≥2-fold Rise-Day 57 (n=46,39,44,42,45,58)
    93.5 (82.1 to 98.6)
    94.9 (82.7 to 99.4)
    95.5 (84.5 to 99.4)
    92.9 (80.5 to 98.5)
    93.3 (81.7 to 98.6)
    6.9 (1.9 to 16.7)
        RSV-A: ≥4-fold Rise-Day 57 (n=46,39,44,42,45,58)
    78.3 (63.6 to 89.1)
    74.4 (57.9 to 87.0)
    90.9 (78.3 to 97.5)
    85.7 (71.5 to 94.6)
    68.9 (53.4 to 81.8)
    1.7 (0.0 to 9.2)
        RSV-A: ≥2-fold Rise-Day 85 (n=44,42,46,45,43,55)
    90.9 (78.3 to 97.5)
    97.6 (97.4 to 99.9)
    95.7 (85.2 to 99.5)
    95.6 (84.9 to 99.5)
    83.7 (69.3 to 93.2)
    3.6 (0.4 to 12.5)
        RSV-A: ≥4-fold Rise-Day 85 (n=44,42,46,45,43,55)
    75.0 (59.7 to 86.8)
    83.3 (68.6 to 93.0)
    82.6 (68.6 to 92.2)
    73.3 (58.1 to 85.4)
    51.2 (35.5 to 66.7)
    1.8 (0.0 to 9.7)
        RSV-A: ≥2-fold Rise-Day 169 (n=43,42,44,44,44,55)
    83.7 (69.3 to 93.2)
    85.7 (71.5 to 94.6)
    93.2 (81.3 to 98.6)
    77.3 (62.2 to 88.5)
    59.1 (43.2 to 73.7)
    3.6 (0.4 to 12.5)
        RSV-A: ≥4-fold Rise-Day 169 (n=43,42,44,44,44,55)
    51.2 (35.5 to 66.7)
    47.6 (32.0 to 63.6)
    65.9 (50.1 to 79.5)
    45.5 (30.4 to 61.2)
    34.1 (20.5 to 49.9)
    3.6 (0.4 to 12.5)
        RSV-A: ≥2-fold Rise-Day 365 (n=38,33,36,41,40,49)
    60.5 (43.4 to 76.0)
    63.6 (45.1 to 79.6)
    66.7 (49.0 to 81.4)
    65.9 (49.4 to 79.9)
    47.5 (31.5 to 63.9)
    16.3 (7.3 to 29.7)
        RSV-A: ≥4-fold Rise-Day 365 (n=38,33,36,41,40,49)
    42.1 (26.3 to 59.2)
    24.2 (11.1 to 42.3)
    41.7 (25.5 to 59.2)
    36.6 (22.1 to 53.1)
    27.5 (14.6 to 43.9)
    6.1 (1.3 to 16.9)
        RSV-B: ≥2-fold Rise- Day 29 (n=44,43,47,45,44,56)
    97.7 (88.0 to 99.9)
    97.7 (87.7 to 99.9)
    100.0 (92.5 to 100.0)
    91.1 (78.8 to 97.5)
    77.3 (62.2 to 88.5)
    7.1 (2.0 to 17.3)
        RSV-B: ≥4-fold Rise- Day 29 (n=44,43,47,45,44,56)
    79.5 (64.7 to 90.2)
    79.1 (64.0 to 90.0)
    80.9 (66.7 to 90.9)
    66.7 (51.0 to 80.0)
    54.5 (38.8 to 69.6)
    1.8 (0.0 to 9.6)
        RSV-B: ≥2-fold Rise-Day 57 (n=46,39,44,42,45,58)
    89.1 (76.4 to 96.4)
    100.0 (91.0 to 100.0)
    95.5 (84.5 to 99.4)
    90.5 (77.4 to 97.3)
    73.3 (58.1 to 85.4)
    13.8 (6.1 to 25.4)
        RSV-B: ≥4-fold Rise-Day 57 (n=46,39,44,42,45,58)
    73.9 (58.9 to 85.7)
    92.3 (79.1 to 98.4)
    81.8 (67.3 to 91.8)
    71.4 (55.4 to 84.3)
    51.1 (35.8 to 66.3)
    1.7 (.0 to 9.2)
        RSV-B: ≥2-fold Rise-Day 85 (n=44,42,46,45,43,55)
    86.4 (72.6 to 94.8)
    97.6 (87.4 to 99.9)
    91.3 (79.2 to 97.6)
    84.4 (70.5 to 93.5)
    72.1 (56.3 to 84.7)
    9.1 (3.0 to 20.0)
        RSV-B: ≥4-fold Rise-Day 85 (n=44,42,46,45,43,55)
    65.9 (50.1 to 79.5)
    78.6 (63.2 to 89.7)
    73.9 (58.9 to 85.7)
    55.6 (40.0 to 70.4)
    41.9 (27.0 to 57.9)
    1.8 (0.0 to 9.7)
        RSV-B: ≥2-fold Rise-Day 169 (n=43,42,44,44,44,55)
    83.7 (69.3 to 93.2)
    95.2 (83.8 to 99.4)
    90.9 (78.3 to 97.5)
    68.2 (52.4 to 81.4)
    63.6 (47.8 to 77.6)
    16.4 (7.8 to 28.8)
        RSV-B: ≥4-fold Rise-Day 169 (n=43,42,44,44,44,55)
    46.5 (31.2 to 62.3)
    45.2 (29.8 to 61.3)
    65.9 (50.1 to 79.5)
    36.4 (22.4 to 52.2)
    27.3 (15.0 to 42.8)
    7.3 (2.0 to 17.6)
        RSV-B: ≥2-fold Rise-Day 365 (n=38,33,36,41,40,49)
    52.6 (35.8 to 69.0)
    60.6 (42.1 to 77.1)
    77.8 (60.8 to 89.9)
    29.3 (16.1 to 45.5)
    25.0 (12.7 to 41.2)
    10.2 (3.4 to 22.2)
        RSV-B: ≥4-fold Rise-Day 365 (n=38,33,36,41,40,49)
    15.8 (6.0 to 31.3)
    30.3 (15.6 to 48.7)
    16.7 (6.4 to 32.8)
    14.6 (5.6 to 29.2)
    12.5 (4.2 to 26.8)
    6.1 (1.3 to 16.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Japanese Adult Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Japanese Adult Cohorts [44]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, and 169
    Notes
    [44] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Number of subjects analysed
    20
    4
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: ≥2-fold Rise- Day 29 (n=20,4)
    100.0 (83.2 to 100.0)
    0.0 (0.0 to 60.2)
        RSV-A: ≥4-fold Rise- Day 29 (n=20,4)
    90.0 (68.3 to 98.8)
    0.0 (0.0 to 60.2)
        RSV-A: ≥2-fold Rise- Day 57 (n=20,4)
    100.0 (83.2 to 100.0)
    0.0 (0.0 to 60.2)
        RSV-A: ≥4-fold Rise- Day 57 (n=20,4)
    85.0 (62.1 to 96.8)
    0.0 (0.0 to 60.2)
        RSV-A: ≥2-fold Rise- Day 85 (n=19,4)
    94.7 (74.0 to 99.9)
    0.0 (0.0 to 60.2)
        RSV-A: ≥4-fold Rise- Day 85 (n=19,4)
    89.5 (66.9 to 98.7)
    0.0 (0.0 to 60.2)
        RSV-A: ≥2-fold Rise- Day 169 (n=20,4)
    90.0 (68.3 to 98.8)
    0.0 (0.0 to 60.2)
        RSV-A: ≥4-fold Rise- Day 169 (n=20,4)
    45.0 (23.1 to 68.5)
    0.0 (0.0 to 60.2)
        RSV-B: ≥2-fold Rise- Day 29 (n=20,4)
    100.0 (83.2 to 100.0)
    0.0 (0.0 to 60.2)
        RSV-B: ≥4-fold Rise- Day 29 (n=20,4)
    75.0 (50.9 to 91.3)
    0.0 (0.0 to 60.2)
        RSV-B: ≥2-fold Rise- Day 57 (n=20,4)
    85.0 (62.1 to 96.8)
    0.0 (0.0 to 60.2)
        RSV-B: ≥4-fold Rise- Day 57 (n=20,4)
    65.0 (40.8 to 84.6)
    0.0 (0.0 to 60.2)
        RSV-B: ≥2-fold Rise- Day 85 (n=19,4)
    94.7 (74.0 to 99.9)
    0.0 (0.0 to 60.2)
        RSV-B: ≥4-fold Rise- Day 85 (n=19,4)
    47.4 (24.4 to 71.1)
    0.0 (0.0 to 60.2)
        RSV-B: ≥2-fold Rise- Day 169 (n=20,4)
    65.0 (40.8 to 84.6)
    0.0 (0.0 to 60.2)
        RSV-B: ≥4-fold Rise- Day 169 (n=20,4)
    30.0 (11.9 to 54.3)
    0.0 (0.0 to 60.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in WOCBP Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in WOCBP Cohorts [45]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, and 169
    Notes
    [45] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    48
    44
    29
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: ≥2-fold Rise-Day 29 (n=49,46,41,28)
    95.9 (86.0 to 99.5)
    97.8 (88.5 to 99.9)
    95.1 (83.5 to 99.4)
    7.1 (0.9 to 23.5)
        RSV-A: ≥4-fold Rise-Day 29 (n=49,46,41,28)
    83.7 (70.3 to 92.7)
    84.8 (71.1 to 93.7)
    92.7 (80.1 to 98.5)
    3.6 (0.1 to 18.3)
        RSV-A: ≥2-fold Rise-Day 57 (n=45,45,42,28)
    95.6 (84.9 to 99.5)
    95.6 (84.9 to 99.5)
    97.6 (87.4 to 99.9)
    21.4 (8.3 to 41.0)
        RSV-A: ≥4-fold Rise-Day 57 (n=45,45,42,28)
    82.2 (67.9 to 92.0)
    80.0 (65.4 to 90.4)
    88.1 (74.4 to 96.0)
    10.7 (2.3 to 28.2)
        RSV-A: ≥2-fold Rise-Day 85 (n=43,41,37,24)
    90.7 (77.9 to 97.4)
    95.1 (83.5 to 99.4)
    97.3 (85.8 to 99.9)
    25.0 (9.8 to 46.7)
        RSV-A: ≥4-fold Rise-Day 85 (n=43,41,37,24)
    67.4 (51.5 to 80.9)
    85.4 (70.8 to 94.4)
    83.8 (68.0 to 93.8)
    4.2 (0.1 to 21.1)
        RSV-A: ≥2-fold Rise-Day 113 (n=44,43,37,25)
    86.4 (72.6 to 94.8)
    90.7 (77.9 to 97.4)
    97.3 (77.9 to 97.4)
    20.0 (6.8 to 40.7)
        RSV-A: ≥4-fold Rise-Day 113 (n=44,43,37,25)
    61.4 (45.5 to 75.6)
    76.7 (61.4 to 88.2)
    75.7 (58.8 to 88.2)
    8.0 (1.0 to 26.0)
        RSV-A: ≥2-fold Rise-Day 141 (n=40,42,36,25)
    80.0 (64.4 to 90.9)
    90.5 (77.4 to 97.3)
    94.4 (81.3 to 99.3)
    16.0 (4.5 to 36.1)
        RSV-A: ≥4-fold Rise-Day 141 (n=40,42,36,25)
    47.5 (31.5 to 63.9)
    69.0 (52.9 to 82.4)
    66.7 (49.0 to 81.4)
    4.0 (0.1 to 20.4)
        RSV-A: ≥2-fold Rise-Day 169 (n=41,43,34,23)
    75.6 (59.7 to 87.6)
    79.1 (64.0 to 90.0)
    91.2 (76.3 to 98.1)
    13.0 (2.8 to 33.6)
        RSV-A: ≥4-fold Rise-Day 169 (n=41,43,34,23)
    43.9 (28.5 to 60.3)
    67.4 (51.5 to 80.9)
    61.8 (43.6 to 77.8)
    0.0 (0.0 to 14.8)
        RSV-B: ≥2-fold Rise-Day 29 (n=49,46,41,28)
    87.8 (75.2 to 95.4)
    87.0 (73.7 to 95.1)
    85.4 (70.8 to 94.4)
    10.7 (2.3 to 28.2)
        RSV-B: ≥4-fold Rise-Day 29 (n=49,46,41,28)
    73.5 (58.9 to 85.1)
    63.0 (47.5 to 76.8)
    73.2 (57.1 to 85.8)
    3.6 (0.1 to 18.3)
        RSV-B: ≥2-fold Rise-Day 57 (n=45,45,42,28)
    84.4 (70.5 to 93.5)
    82.2 (67.9 to 92.0)
    88.1 (74.4 to 96.0)
    14.3 (4.0 to 32.7)
        RSV-B: ≥4-fold Rise-Day 57 (n=45,45,42,28)
    55.6 (40.0 to 70.4)
    57.8 (42.2 to 72.3)
    66.7 (50.5 to 80.4)
    7.1 (0.9 to 23.5)
        RSV-B: ≥2-fold Rise-Day 85 (n=43,41,37,24)
    86.0 (72.1 to 94.7)
    78.0 (62.4 to 89.4)
    89.2 (74.6 to 97.0)
    20.8 (7.1 to 42.2)
        RSV-B: ≥4-fold Rise-Day 85 (n=43,41,37,24)
    67.4 (51.5 to 80.9)
    53.7 (37.4 to 69.3)
    62.2 (44.8 to 77.5)
    8.3 (1.0 to 27.0)
        RSV-B: ≥2-fold Rise-Day 113 (n=44,43,37,25)
    75.0 (59.7 to 86.8)
    74.4 (58.8 to 86.5)
    89.2 (74.6 to 97.0)
    24.0 (9.4 to 45.1)
        RSV-B: ≥4-fold Rise-Day 113 (n=44,43,37,25)
    47.7 (32.5 to 63.3)
    48.8 (33.3 to 64.5)
    56.8 (39.5 to 72.9)
    16.0 (4.5 to 36.1)
        RSV-B: ≥2-fold Rise-Day 141 (n=40,42,36,25)
    72.5 (56.1 to 85.4)
    66.7 (50.5 to 80.4)
    83.3 (67.2 to 93.6)
    28.0 (12.1 to 49.4)
        RSV-B: ≥4-fold Rise-Day 141 (n=40,42,36,25)
    32.5 (18.6 to 49.1)
    45.2 (29.8 to 61.3)
    44.4 (27.9 to 61.9)
    8.0 (1.0 to 26.0)
        RSV-B: ≥2-fold Rise-Day 169 (n=41,43,34,23)
    65.9 (49.4 to 79.9)
    67.4 (51.5 to 80.9)
    76.5 (58.8 to 89.3)
    8.7 (1.1 to 28.0)
        RSV-B: ≥4-fold Rise-Day 169 (n=41,43,34,23)
    41.5 (26.3 to 57.9)
    39.5 (25.0 to 55.6)
    38.2 (22.2 to 56.4)
    0.0 (0.0 to 14.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Children Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in RSV Neutralizing Abs (RSV-A and RSV-B) Titers from Baseline in Children Cohorts [46]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 85, and 141
    Notes
    [46] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    14
    13
    11
    Units: percentage of participants
    number (confidence interval 95%)
        RSV-A: ≥2-fold Rise- Day 29 (n=14,12,11)
    100.0 (76.8 to 100.0)
    75.0 (42.8 to 94.5)
    27.3 (6.0 to 61.0)
        RSV-A: ≥4-fold Rise- Day 29 (n=14,12,11)
    92.9 (66.1 to 99.8)
    75.0 (42.8 to 94.5)
    18.2 (2.3 to 51.8)
        RSV-A: ≥2-fold Rise- Day 85 (n=5,9,4)
    100.0 (47.8 to 100.0)
    77.8 (40.0 to 97.5)
    0.0 (0.0 to 60.2)
        RSV-A: ≥4-fold Rise- Day 85 (n=5,9,4)
    100.0 (47.8 to 100.0)
    77.8 (40.0 to 97.5)
    0.0 (0.0 to 60.2)
        RSV-A: ≥2-fold Rise- Day 141 (n=4,5,5)
    100.0 (39.8 to 100)
    80.0 (28.4 to 99.5)
    40.0 (5.3 to 85.3)
        RSV-A: ≥4-fold Rise- Day 141 (n=4,5,5)
    100 (39.8 to 100.0)
    80.0 (28.4 to 99.5)
    20.0 (0.5 to 71.6)
        RSV-B: ≥2-fold Rise- Day 29 (n=14,12,11)
    100.0 (76.8 to 100.0)
    83.3 (51.6 to 97.9)
    18.2 (2.3 to 51.8)
        RSV-B: ≥4-fold Rise- Day 29 (n=14,12,11)
    71.4 (41.9 to 91.6)
    83.3 (51.6 to 97.9)
    18.2 (2.3 to 51.8)
        RSV-B: ≥2-fold Rise- Day 85 (n=5,9,4)
    100.0 (47.8 to 100.0)
    88.9 (51.8 to 99.7)
    0.0 (0.0 to 60.2)
        RSV-B: ≥4-fold Rise- Day 85 (n=5,9,4)
    100.0 (47.8 to 100.0)
    44.4 (13.7 to 78.8)
    0.0 (0.0 to 60.2)
        RSV-B: ≥2-fold Rise- Day 141 (n=4,5,5)
    100.0 (39.8 to 100.0)
    100.0 (47.8 to 100.0)
    40.0 (5.3 to 85.3)
        RSV-B: ≥4-fold Rise- Day 141 (n=4,5,5)
    100.0 (39.8 to 100.0)
    60.0 (14.7 to 94.7)
    40.0 (5.3 to 85.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Young Adults Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Young Adults Cohorts [47]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories. ‘9999’ represents data not collected for specified cohorts.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, 169, and 281
    Notes
    [47] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Three Injection Placebo in Younger Adults (18 to 49 Years)
    Number of subjects analysed
    18
    19
    15
    18
    14
    4
    Units: percentage of participants
    number (confidence interval 95%)
        PreF-bAb: ≥2-fold Rise-Day 29 (n=18,19,15,18,14,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (81.5 to 100.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥4-fold Rise-Day 29 (n=18,19,15,18,14,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (81.5 to 100.0)
    0.0 (0.0 to 23.0)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥2-fold Rise-Day 57 (n=18,19,14,17,14,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (76.8 to 100.0)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 23.0)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥4-fold Rise-Day 57 (n=18,19,14,17,14,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (76.8 to 100.0)
    94.1 (71.3 to 99.9)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥2-fold Rise-Day 85 (n=18,19,12,17,13,3)
    94.4 (72.7 to 99.9)
    100.0 (82.4 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥4-fold Rise-Day 85 (n=18,19,12,17,13,3)
    88.9 (65.3 to 98.6)
    94.7 (74.0 to 99.9)
    100.0 (73.5 to 100.0)
    94.1 (71.3 to 99.9)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥2-fold Rise-Day 113(n=18,17,12,16,13,3)
    100.0 (81.5 to 100.0)
    100.0 (80.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (79.4 to 100.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥4-fold Rise-Day 113(n=18,17,12,16,13,3)
    88.9 (65.3 to 98.6)
    88.2 (63.6 to 98.5)
    100.0 (73.5 to 100.0)
    87.5 (61.7 to 98.4)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥2-fold Rise-Day 141(n=18,19,13,16,14,3)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (75.3 to 100.0)
    100.0 (79.4 to 100.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥4-fold Rise-Day 141(n=18,19,13,16,14,3)
    83.3 (58.6 to 96.4)
    84.2 (60.4 to 96.6)
    100.0 (75.3 to 100.0)
    87.5 (61.7 to 98.4)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥2-fold Rise-Day 169(n=18,19,13,17,13,3)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (75.3 to 100.0)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥4-fold Rise-Day 169(n=18,19,13,17,13,3)
    66.7 (41.0 to 86.7)
    68.4 (43.4 to 87.4)
    100.0 (75.3 to 100.0)
    82.4 (56.6 to 96.2)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥2-fold Rise-Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    100.0 (73.5 to 100.0)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
        PreF-bAb: ≥4-fold Rise-Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    91.7 (61.5 to 99.8)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
        PostF-bAb: ≥2-fold Rise-Day 29(n=18,19,15,18,14,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    100.0 (78.2 to 100.0)
    100.0 (81.5 to 100.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥4-fold Rise-Day 29(n=18,19,15,18,14,4)
    88.9 (65.3 to 98.6)
    100.0 (82.4 to 100.0)
    93.3 (68.1 to 99.8)
    100.0 (81.5 to 100.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥2-fold Rise-Day 57(n=18,19,14,17,14,4)
    100.0 (81.5 to 100.0)
    100.0 (82.4 to 100.0)
    92.9 (66.1 to 99.8)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥4-fold Rise-Day 57(n=18,19,14,17,14,4)
    83.3 (58.6 to 96.4)
    94.7 (74.0 to 99.9)
    92.9 (66.1 to 99.8)
    94.1 (71.3 to 99.9)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥2-fold Rise-Day 85(n=18,19,12,17,13,3)
    94.4 (72.7 to 99.9)
    100.0 (82.4 to 100.0)
    91.7 (61.5 to 99.8)
    100.0 (80.5 to 100.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PostF-bAb: ≥4-fold Rise-Day 85(n=18,19,12,17,13,3)
    83.3 (58.6 to 96.4)
    78.9 (54.4 to 93.9)
    91.7 (61.5 to 99.8)
    76.5 (66.5 to 89.4)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PostF-bAb:≥2-fold Rise-Day 113(n=18,17,12,16,13,3)
    94.4 (72.7 to 99.9)
    100.0 (80.5 to 100.0)
    91.7 (61.5 to 99.8)
    100.0 (79.4 to 100.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PostF-bAb:≥4-fold Rise-Day 113(n=18,17,12,16,13,3)
    72.2 (46.5 to 90.3)
    64.7 (38.3 to 85.8)
    91.7 (61.5 to 99.8)
    68.8 (41.3 to 89.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PostF-bAb:≥2-fold Rise-Day 141(n=18,19,13,16,14,3)
    94.4 (72.7 to 99.9)
    94.7 (74.0 to 99.9)
    92.3 (64.0 to 99.8)
    93.8 (69.8 to 99.8)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 70.8)
        PostF-bAb:≥4-fold Rise-Day 141(n=18,19,13,16,14,3)
    72.2 (46.5 to 90.3)
    57.9 (33.5 to 79.7)
    92.3 (64.0 to 99.8)
    62.5 (35.4 to 84.8)
    0.0 (0.0 to 23.2)
    0.0 (0.0 to 70.8)
        PostF-bAb:≥2-fold Rise-Day 169(n=18,19,13,17,13,3)
    94.4 (72.7 to 99.9)
    94.7 (74.0 to 99.9)
    92.3 (64.0 to 99.8)
    88.2 (63.6 to 98.5)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PostF-bAb:≥4-fold Rise-Day 169(n=18,19,13,17,13,3)
    55.6 (30.8 to 78.5)
    52.6 (28.9 to 75.6)
    92.3 (64.0 to 99.8)
    52.9 (27.8 to 77.0)
    0.0 (0.0 to 24.7)
    0.0 (0.0 to 70.8)
        PostF-bAb: ≥2-fold Rise-Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    91.7 (61.5 to 99.8)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
        PostF-bAb: ≥4-fold Rise-Day 281 (n=0,0,12,0,0,3)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    66.7 (34.9 to 90.1)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    0.0 (0.0 to 70.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Older Adult Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Older Adult Cohorts [48]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 169, and 365
    Notes
    [48] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 7: mRNA-1345 Dose A in Older Adults (65 to 79 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (65 to 79 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (65 to 79 Years) Cohort 10: mRNA-1345 Dose E in Older Adults (65 to 79 Years) Cohort 11: mRNA-1345 Dose F in Older Adults (65 to 79 Years) Two Injection Placebo in Older Adults (65 to 79 Years)
    Number of subjects analysed
    46
    43
    47
    45
    45
    58
    Units: percentage of participants
    number (confidence interval 95%)
        PreF-bAb: ≥2-fold Rise-Day 29(n=44,43,47,45,44,56)
    100.0 (92.0 to 100.0)
    100.0 (91.8 to 100.0)
    100.0 (92.5 to 100.0)
    97.8 (88.2 to 99.9)
    93.2 (81.3 to 98.6)
    1.8 (0.0 to 9.6)
        PreF-bAb: ≥4-fold Rise-Day 29(n=44,43,47,45,44,56)
    86.4 (72.6 to 94.8)
    88.4 (74.9 to 96.1)
    80.9 (66.7 to 90.9)
    88.9 (75.9 to 96.3)
    75.0 (59.7 to 86.8)
    1.8 (0.0 to 9.6)
        PreF-bAb: ≥2-fold Rise-Day 57(n=46,39,44,42,45,58)
    97.8 (88.5 to 99.9)
    100.0 (91.0 to 100.0)
    100.0 (92.0 to 100.0)
    95.2 (83.8 to 99.4)
    84.4 (70.5 to 93.5)
    1.7 (0.0 to 9.2)
        PreF-bAb: ≥4-fold Rise-Day 57(n=46,39,44,42,45,58)
    76.1 (61.2 to 87.4)
    84.6 (69.5 to 94.1)
    81.8 (67.3 to 91.8)
    78.6 (63.2 to 89.7)
    57.8 (42.2 to 72.3)
    1.7 (0.0 to 9.2)
        PreF-bAb: ≥2-fold Rise-Day 85(n=44,42,46,45,43,55)
    90.9 (78.3 to 97.5)
    95.2 (83.8 to 99.4)
    95.7 (85.2 to 99.5)
    97.8 (88.2 to 99.9)
    86.0 (72.1 to 94.7)
    1.8 (0.0 to 9.7)
        PreF-bAb: ≥4-fold Rise-Day 85(n=44,42,46,45,43,55)
    65.9 (50.1 to 79.5)
    73.8 (58.0 to 86.1)
    76.1 (61.2 to 87.4)
    64.4 (48.8 to 78.1)
    58.1 (42.1 to 73.0)
    1.8 (0.0 to 9.7)
        PreF-bAb:≥2-fold Rise-Day 169(n=43,42,44,44,44,55)
    90.7 (77.9 to 97.4)
    85.7 (71.5 to 94.6)
    88.6 (75.4 to 96.2)
    77.3 (62.2 to 88.5)
    63.6 (47.8 to 77.6)
    3.6 (0.4 to 12.5)
        PreF-bAb:≥4-fold Rise-Day 169(n=43,42,44,44,44,55)
    46.5 (31.2 to 62.3)
    50.0 (34.2 to 65.8)
    56.8 (41.0 to 71.7)
    43.2 (28.3 to 59.0)
    29.5 (16.8 to 45.2)
    3.6 (0.4 to 12.5)
        PreF-bAb:≥2-fold Rise-Day 365(n=38,33,36,41,40,49)
    68.4 (51.3 to 82.5)
    81.8 (64.5 to 93.0)
    69.4 (51.9 to 83.7)
    58.5 (42.1 to 73.7)
    55.0 (38.5 to 70.7)
    14.3 (5.9 to 27.2)
        PreF-bAb:≥4-fold Rise-Day 365(n=38,33,36,41,40,49)
    28.9 (15.4 to 45.9)
    30.3 (15.6 to 48.7)
    33.3 (18.6 to 51.0)
    17.1 (7.2 to 32.1)
    17.5 (7.3 to 32.8)
    10.2 (3.4 to 22.2)
        PostF-bAb:≥2-fold Rise-Day 29(n=44,43,47,45,44,56)
    95.5 (84.5 to 99.4)
    100.0 (91.8 to 100.0)
    95.7 (85.5 to 99.5)
    93.3 (81.7 to 98.6)
    93.2 (81.3 to 98.6)
    1.8 (0.0 to 9.6)
        PostF-bAb:≥4-fold Rise-Day 29(n=44,43,47,45,44,56)
    65.9 (50.1 to 79.5)
    79.1 (64.0 to 90.0)
    83.0 (69.2 to 92.4)
    66.7 (51.0 to 80.0)
    54.5 (38.8 to 69.6)
    1.8 (0.0 to 9.6)
        PostF-bAb:≥2-fold Rise-Day 57(n=46,39,44,42,45,58)
    93.5 (82.1 to 98.6)
    92.3 (79.1 to 98.4)
    95.5 (84.5 to 99.4)
    78.6 (63.2 to 89.7)
    82.2 (67.9 to 92.0)
    1.7 (0.0 to 9.2)
        PostF-bAb:≥4-fold Rise-Day 57(n=46,39,44,42,45,58)
    52.2 (36.9 to 67.1)
    61.5 (44.6 to 76.6)
    81.8 (67.3 to 91.8)
    57.1 (41.0 to 72.3)
    40.0 (25.7 to 55.7)
    1.7 (0.0 to 9.2)
        PostF-bAb:≥2-fold Rise-Day 85(n=44,42,46,45,43,55)
    79.5 (64.7 to 90.2)
    88.1 (74.4 to 96.0)
    87.0 (73.7 to 95.1)
    80.0 (65.4 to 90.4)
    74.4 (58.8 to 86.5)
    1.8 (0.0 to 9.7)
        PostF-bAb:≥4-fold Rise-Day 85(n=44,42,46,45,43,55)
    54.5 (38.8 to 69.6)
    54.8 (38.7 to 70.2)
    71.7 (56.5 to 84.0)
    51.1 (35.8 to 66.3)
    25.6 (13.5 to 41.2)
    1.8 (0.0 to 9.7)
        PostF-bAb:≥2-fold Rise-Day 169(n=43,42,44,44,44,55
    67.4 (51.5 to 80.9)
    61.9 (45.6 to 76.4)
    84.1 (69.9 to 93.4)
    63.6 (47.8 to 77.6)
    45.5 (30.4 to 61.2)
    3.6 (0.4 to 12.5)
        PostF-bAb:≥4-fold Rise-Day 169(n=43,42,44,44,44,55
    37.2 (23.0 to 53.3)
    26.2 (13.9 to 42.0)
    50.0 (34.6 to 65.4)
    29.5 (16.8 to 45.2)
    9.1 (2.5 to 21.7)
    1.8 (0.0 to 9.7)
        PostF-bAb:≥2-fold Rise-Day 365(n=38,33,36,41,40,49
    50.0 (33.4 to 66.6)
    51.5 (33.5 to 69.2)
    66.7 (49.0 to 81.4)
    43.9 (28.5 to 60.3)
    22.5 (10.8 to 38.5)
    14.3 (5.9 to 27.2)
        PostF-bAb:≥4-fold Rise-Day 365(n=38,33,36,41,40,49
    13.2 (4.4 to 28.1)
    18.2 (7.0 to 35.5)
    19.4 (8.2 to 36.0)
    9.8 (2.7 to 23.1)
    5.0 (0.6 to 16.9)
    6.1 (1.3 to 16.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Japanese Adults Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Japanese Adults Cohorts [49]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, and 169
    Notes
    [49] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Number of subjects analysed
    20
    4
    Units: percentage of participants
    number (confidence interval 95%)
        PreF-bAb: ≥2-fold Rise- Day 29 (n=20,4)
    100.0 (83.2 to 100.0)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥4-fold Rise- Day 29 (n=20,4)
    90.0 (68.3 to 98.8)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥2-fold Rise- Day 57 (n=20,4)
    100.0 (83.2 to 100.0)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥4-fold Rise- Day 57 (n=20,4)
    85.0 (62.1 to 96.8)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥2-fold Rise- Day 85 (n=19,4)
    94.7 (74.0 to 99.9)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥4-fold Rise- Day 85 (n=19,4)
    68.4 (43.4 to 87.4)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥2-fold Rise- Day 169 (n=20,4)
    85.0 (62.1 to 96.8)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥4-fold Rise- Day 169 (n=20,4)
    40.0 (19.1 to 63.9)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥2-fold Rise- Day 29 (n=20,4)
    95.0 (75.1 to 99.9)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥4-fold Rise- Day 29 (n=20,4)
    80.0 (56.3 to 94.3)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥2-fold Rise- Day 57 (n=20,4)
    95.0 (75.1 to 99.9)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥4-fold Rise- Day 57 (n=20,4)
    70.0 (45.7 to 88.1)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥2-fold Rise- Day 85 (n=19,4)
    89.5 (66.9 to 98.7)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥4-fold Rise- Day 85 (n=19,4)
    42.1 (20.3 to 66.5)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥2-fold Rise- Day 169 (n=20,4)
    75.0 (50.9 to 91.3)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥4-fold Rise- Day 169 (n=20,4)
    30.0 (11.9 to 54.3)
    0.0 (0.0 to 60.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for WOCBP Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for WOCBP Cohorts [50]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85, 113, 141, and 169
    Notes
    [50] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Single Injection Placebo in WOCBP (18 to 40 Years)
    Number of subjects analysed
    49
    46
    42
    28
    Units: percentage of participants
    number (confidence interval 95%)
        PreF-bAb: ≥2-fold Rise-Day 29 (n=49,46,41,28)
    98.0 (89.1 to 99.9)
    97.8 (88.5 to 99.9)
    97.6 (87.1 to 99.9)
    3.6 (0.1 to 18.3)
        PreF-bAb: ≥4-fold Rise-Day 29 (n=49,46,41,28)
    83.7 (70.3 to 92.7)
    89.1 (76.4 to 96.4)
    85.4 (70.8 to 94.4)
    0.0 (0.0 to 12.3)
        PreF-bAb: ≥2-fold Rise-Day 57 (n=45,45,42,28)
    93.3 (81.7 to 98.6)
    97.8 (88.2 to 99.9)
    100.0 (91.6 to 100.0)
    3.6 (0.1 to 18.3)
        PreF-bAb: ≥4-fold Rise-Day 57 (n=45,45,42,28)
    80.0 (65.4 to 90.4)
    82.2 (67.9 to 92.0)
    85.7 (71.5 to 94.6)
    0.0 (0.0 to 12.3)
        PreF-bAb: ≥2-fold Rise-Day 85 (n=43,41,37,24)
    88.4 (74.9 to 96.1)
    97.6 (87.1 to 99.9)
    97.3 (85.8 to 99.9)
    8.3 (1.0 to 27.0)
        PreF-bAb: ≥4-fold Rise-Day 85 (n=43,41,37,24)
    65.1 (49.1 to 79.0)
    82.9 (67.9 to 92.8)
    73.0 (55.9 to 86.2)
    0.0 (0.0 to 14.2)
        PreF-bAb: ≥2-fold Rise-Day 113 (n=44,43,37,25)
    90.9 (78.3 to 97.5)
    93.0 (80.9 to 98.5)
    91.9 (78.1 to 98.3)
    8.0 (1.0 to 26.0)
        PreF-bAb: ≥4-fold Rise-Day 113 (n=44,43,37,25)
    52.3 (36.7 to 67.5)
    69.8 (53.9 to 82.8)
    62.2 (44.8 to 77.5)
    4.0 (0.1 to 20.4)
        PreF-bAb: ≥2-fold Rise-Day 141 (n=40,42,36,24)
    82.5 (67.2 to 92.7)
    97.6 (87.4 to 99.9)
    94.4 (81.3 to 99.3)
    8.3 (1.0 to 27.0)
        PreF-bAb: ≥4-fold Rise-Day 141 (n=40,42,36,24)
    45.0 (29.3 to 61.5)
    66.7 (50.5 to 80.4)
    55.6 (38.1 to 72.1)
    4.2 (0.1 to 21.1)
        PreF-bAb: ≥2-fold Rise-Day 169 (n=41,43,34,23)
    78.0 (62.4 to 89.4)
    93.0 (80.9 to 98.5)
    91.2 (76.3 to 98.1)
    4.3 (0.1 to 21.9)
        PreF-bAb: ≥4-fold Rise-Day 169 (n=41,43,34,23)
    41.5 (26.3 to 57.9)
    55.8 (39.9 to 70.9)
    55.9 (37.9 to 72.8)
    0.0 (0.0 to 14.8)
        PostF-bAb: ≥2-fold Rise-Day 29 (n=49,46,41,28)
    98.0 (89.1 to 99.9)
    95.7 (85.2 to 99.5)
    95.1 (83.5 to 99.4)
    0.0 (0.0 to 12.3)
        PostF-bAb: ≥4-fold Rise-Day 29 (n=49,46,41,28)
    73.5 (58.9 to 85.1)
    82.6 (68.6 to 92.2)
    82.9 (67.9 to 92.8)
    0.0 (0.0 to 12.3)
        PostF-bAb: ≥2-fold Rise-Day 57 (n=45,45,42,28)
    93.3 (81.7 to 98.6)
    88.9 (75.9 to 96.3)
    95.2 (83.8 to 99.4)
    3.6 (0.1 to 18.3)
        PostF-bAb: ≥4-fold Rise-Day 57 (n=45,45,42,28)
    66.7 (51.0 to 80.0)
    66.7 (51.0 to 80.0)
    76.2 (60.5 to 87.9)
    0.0 (0.0 to 12.3)
        PostF-bAb: ≥2-fold Rise-Day 85 (n=43,41,37,24)
    86.0 (72.1 to 94.7)
    87.8 (73.8 to 95.9)
    91.9 (78.1 to 98.3)
    0.0 (0.0 to 14.2)
        PostF-bAb: ≥4-fold Rise-Day 85 (n=43,41,37,24)
    51.2 (35.5 to 66.7)
    53.7 (37.4 to 69.3)
    54.1 (36.9 to 70.5)
    0.0 (0.0 to 14.2)
        PostF-bAb: ≥2-fold Rise-Day 113 (n=44,43,37,25)
    90.9 (78.3 to 97.5)
    83.7 (69.3 to 93.2)
    86.5 (71.2 to 95.5)
    8.0 (1.0 to 26.0)
        PostF-bAb: ≥4-fold Rise-Day 113 (n=44,43,37,25)
    43.2 (28.3 to 59.0)
    55.8 (39.9 to 70.9)
    48.6 (31.9 to 65.6)
    4.0 (0.1 to 20.4)
        PostF-bAb: ≥2-fold Rise-Day 141 (n=40,42,36,24)
    80.0 (64.4 to 90.9)
    85.7 (71.5 to 94.6)
    80.6 (64.0 to 91.8)
    4.2 (0.1 to 21.1)
        PostF-bAb: ≥4-fold Rise-Day 141 (n=40,42,36,24)
    32.5 (18.6 to 49.1)
    38.1 (23.6 to 54.4)
    36.1 (20.8 to 53.8)
    0.0 (0.0 to 14.2)
        PostF-bAb: ≥2-fold Rise-Day 169 (n=41,43,34,23)
    73.2 (57.1 to 85.2)
    79.1 (64.0 to 90.0)
    79.4 (62.1 to 91.3)
    0.0 (0.0 to 14.8)
        PostF-bAb: ≥4-fold Rise-Day 169 (n=41,43,34,23)
    31.7 (18.1 to 48.1)
    27.9 (15.3 to 43.7)
    26.5 (12.9 to 44.4)
    0.0 (0.0 to 14.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Children Cohorts

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    End point title
    		 Percentage of Participants with ≥2-fold and ≥4-fold Increases in Serum Binding Abs (PreF and PostF) Titers from Baseline for Children Cohorts [51]
    End point description
    PP Set included all FAS participants (all randomized participants who received any study injection, had baseline data for those analyses that require baseline data, and had at least 1 postinjection assessment for the analysis endpoint) who a) complied with the injection schedule, b) complied with the timing of immunogenicity blood sampling in order to have baseline and postinjection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and c) had no major protocol violations that impacted immune response during the period corresponding to the immunogenicity analysis objective. Participants were included in the treatment arm to which they were randomized. ‘n’ = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Days 29, 85, and 141
    Notes
    [51] - 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: The endpoint is descriptive in nature.
    End point values
    		 Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Three Injection Placebo in Children (12 to 59 Months)
    Number of subjects analysed
    14
    11
    11
    Units: percentage of participants
    number (confidence interval 95%)
        PreF-bAb: ≥2-fold Rise-Day 29 (n=14,11,11)
    100.0 (76.8 to 100.0)
    90.9 (58.7 to 99.8)
    27.3 (6.0 to 61.0)
        PreF-bAb: ≥4-fold Rise-Day 29 (n=14,11,11)
    92.9 (66.1 to 99.8)
    90.9 (58.7 to 99.8)
    18.2 (2.3 to 51.8)
        PreF-bAb: ≥2-fold Rise-Day 85 (n=5,9,4)
    100.0 (47.8 to 100.0)
    88.9 (51.8 to 99.7)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥4-fold Rise-Day 85 (n=5,9,4)
    100.0 (47.8 to 100.0)
    77.8 (40.0 to 97.2)
    0.0 (0.0 to 60.2)
        PreF-bAb: ≥2-fold Rise-Day 141 (n=4,5,5)
    100.0 (39.8 to 100.0)
    100.0 (47.8 to 100.0)
    40.0 (5.3 to 85.3)
        PreF-bAb: ≥4-fold Rise-Day 141 (n=4,5,5)
    100.0 (39.8 to 100.0)
    100.0 (47.8 to 100.0)
    40.0 (5.3 to 85.3)
        PostF-bAb: ≥2-fold Rise-Day 29 (n=14,11,11)
    100.0 (76.8 to 100.0)
    90.9 (58.7 to 99.8)
    27.3 (6.0 to 61.0)
        PostF-bAb: ≥4-fold Rise-Day 29 (n=14,11,11)
    92.9 (66.1 to 99.8)
    72.7 (39.0 to 94.0)
    18.2 (2.3 to 51.8)
        PostF-bAb: ≥2-fold Rise-Day 85 (n=5,9,4)
    100.0 (47.8 to 100.0)
    88.9 (51.8 to 99.7)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥4-fold Rise-Day 85 (n=5,9,4)
    80.0 (28.4 to 99.5)
    66.7 (29.9 to 92.5)
    0.0 (0.0 to 60.2)
        PostF-bAb: ≥2-fold Rise-Day 141 (n=4,5,5)
    100.0 (39.8 to 100.0)
    80.0 (28.4 to 99.5)
    20.0 (0.5 to 71.6)
        PostF-bAb: ≥4-fold Rise-Day 141 (n=4,5,5)
    75.0 (19.4 to 99.4)
    40.0 (5.3 to 85.3)
    0.0 (0.0 to 52.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Day 1095 (end of study)
    Adverse event reporting additional description
    Safety Set included all randomized participants who received any study injection. Participants were included in the treatment arm corresponding to the study drug they actually received. Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were not considered AEs unless they were serious.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Single Injection Placebo in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Cohort 15: mRNA-1345 Dose B in Japanese Older Adults
    Reporting group description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose B of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose C of mRNA-1345 on Day 1.

    Reporting group title
    Two Injection Placebo in Older Adults (After 1st Dose)
    Reporting group description
    		 Participants received 1 injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Single Injection Placebo in Japanese Older Adults (≥ 60 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Single Injection Placebo in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of mRNA-1345 matching-placebo on Day 1.

    Reporting group title
    Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 8: mRNA-1345 Dose B in Older Adults (After 1st Dose)
    Reporting group description
    		 Participants received 1 injection of Dose B of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 9: mRNA-1345 Dose C in Older Adults (After 1st Dose)
    Reporting group description
    		 Participants received 1 injection of Dose C of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 11: mRNA-1345 Dose F in Older Adults (After 1st Dose)
    Reporting group description
    		 Participants received 1 injection of Dose F of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 7: mRNA-1345 Dose A in Older Adults (After 1st Dose)
    Reporting group description
    		 Participants received 1 injection of Dose A of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 10: mRNA-1345 Dose E in Older Adults (After 1st Dose)
    Reporting group description
    		 Participants received 1 injection of Dose E of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose F of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 9: mRNA-1345 Dose C in Older Adults (After Month 12)
    Reporting group description
    		 Participants received 1 injection of Dose C of mRNA-1345 approximately 12 months later.

    Reporting group title
    Cohort 8: mRNA-1345 Dose B in Older Adults (After Month 12)
    Reporting group description
    		 Participants received 1 injection of Dose B of mRNA-1345 approximately 12 months later.

    Reporting group title
    Cohort 7: mRNA-1345 Dose A in Older Adults (After Month 12)
    Reporting group description
    		 Participants received 1 injection of Dose A of mRNA-1345 approximately 12 months later.

    Reporting group title
    Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose E of mRNA-1345 on Day 1.

    Reporting group title
    Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years)
    Reporting group description
    		 Participants received a single injection of Dose A of mRNA-1345 on Day 1.

    Reporting group title
    Three Injection Placebo in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a total of 3 injections, 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years)
    Reporting group description
    		 Participants received a total of 3 injections, 1 injection of Dose B of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Three Injection Placebo in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections, 1 injection of mRNA-1345 matching-placebo per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections, 1 injection of Dose G of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months)
    Reporting group description
    		 Participants received a total of 3 injections, 1 injection of Dose D of mRNA-1345 per day on Day 1, Day 57, and Day 113.

    Reporting group title
    Cohort 11: mRNA-1345 Dose F in Older Adults (After Month 12)
    Reporting group description
    		 Participants received 1 injection of Dose F of mRNA-1345 approximately 12 months later.

    Reporting group title
    Two Injection Placebo in Older Adults (After Month 12)
    Reporting group description
    		 Participants received 1 injection of mRNA-1345 matching-placebo approximately 12 months later.

    Reporting group title
    Cohort 10: mRNA-1345 Dose E in Older Adults (After Month 12)
    Reporting group description
    		 Participants received 1 injection of Dose E of mRNA-1345 approximately 12 months later.

    Reporting group title
    Older Adult Cohorts: After Month 24: mRNA-1345 Dose A
    Reporting group description
    		 Participants received second booster injection of Dose A of mRNA-1345 at Month 24.

    Serious adverse events
    		 Single Injection Placebo in WOCBP (18 to 40 Years) Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Two Injection Placebo in Older Adults (After 1st Dose) Single Injection Placebo in Japanese Older Adults (≥ 60 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (After 1st Dose) Cohort 9: mRNA-1345 Dose C in Older Adults (After 1st Dose) Cohort 11: mRNA-1345 Dose F in Older Adults (After 1st Dose) Cohort 7: mRNA-1345 Dose A in Older Adults (After 1st Dose) Cohort 10: mRNA-1345 Dose E in Older Adults (After 1st Dose) Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (After Month 12) Cohort 8: mRNA-1345 Dose B in Older Adults (After Month 12) Cohort 7: mRNA-1345 Dose A in Older Adults (After Month 12) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Three Injection Placebo in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Three Injection Placebo in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 11: mRNA-1345 Dose F in Older Adults (After Month 12) Two Injection Placebo in Older Adults (After Month 12) Cohort 10: mRNA-1345 Dose E in Older Adults (After Month 12) Older Adult Cohorts: After Month 24: mRNA-1345 Dose A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    5 / 48 (10.42%)
    4 / 47 (8.51%)
    3 / 48 (6.25%)
    1 / 51 (1.96%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    7 / 148 (4.73%)
    2 / 22 (9.09%)
    5 / 109 (4.59%)
         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
    0
    0
    0
    0
    0
    3
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone sarcoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Concussion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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 / 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
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Tibia fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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 / 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
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    1 / 22 (4.55%)
    0 / 109 (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 / 1
    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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Sinus bradycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    1 / 22 (4.55%)
    0 / 109 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    1 / 22 (4.55%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    1 / 22 (4.55%)
    0 / 109 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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 / 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
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral artery occlusion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic organ prolapse
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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 / 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
         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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Single Injection Placebo in WOCBP (18 to 40 Years) Cohort 15: mRNA-1345 Dose B in Japanese Older Adults Cohort 2: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Cohort 4: mRNA-1345 Dose C in Younger Adults (18 to 49 Years) Two Injection Placebo in Older Adults (After 1st Dose) Single Injection Placebo in Japanese Older Adults (≥ 60 Years) Single Injection Placebo in Younger Adults (18 to 49 Years) Cohort 1: mRNA-1345 Dose A in Younger Adults (18 to 49 Years) Cohort 8: mRNA-1345 Dose B in Older Adults (After 1st Dose) Cohort 9: mRNA-1345 Dose C in Older Adults (After 1st Dose) Cohort 11: mRNA-1345 Dose F in Older Adults (After 1st Dose) Cohort 7: mRNA-1345 Dose A in Older Adults (After 1st Dose) Cohort 10: mRNA-1345 Dose E in Older Adults (After 1st Dose) Cohort 12: mRNA-1345 Dose F in WOCBP (18 to 40 Years) Cohort 9: mRNA-1345 Dose C in Older Adults (After Month 12) Cohort 8: mRNA-1345 Dose B in Older Adults (After Month 12) Cohort 7: mRNA-1345 Dose A in Older Adults (After Month 12) Cohort 13: mRNA-1345 Dose E in WOCBP (18 to 40 Years) Cohort 14: mRNA-1345 Dose A in WOCBP (18 to 40 Years) Three Injection Placebo in Younger Adults (18 to 49 Years) Cohort 3: mRNA-1345 Dose B in Younger Adults (18 to 49 Years) Three Injection Placebo in Children (12 to 59 Months) Cohort 6: mRNA-1345 Dose G in Children (12 to 59 Months) Cohort 5: mRNA-1345 Dose D in Children (12 to 59 Months) Cohort 11: mRNA-1345 Dose F in Older Adults (After Month 12) Two Injection Placebo in Older Adults (After Month 12) Cohort 10: mRNA-1345 Dose E in Older Adults (After Month 12) Older Adult Cohorts: After Month 24: mRNA-1345 Dose A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 30 (23.33%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    13 / 20 (65.00%)
    14 / 59 (23.73%)
    2 / 4 (50.00%)
    5 / 15 (33.33%)
    2 / 19 (10.53%)
    15 / 48 (31.25%)
    23 / 48 (47.92%)
    19 / 48 (39.58%)
    17 / 47 (36.17%)
    15 / 48 (31.25%)
    8 / 51 (15.69%)
    10 / 19 (52.63%)
    8 / 18 (44.44%)
    7 / 18 (38.89%)
    13 / 49 (26.53%)
    7 / 48 (14.58%)
    0 / 5 (0.00%)
    5 / 20 (25.00%)
    9 / 15 (60.00%)
    11 / 15 (73.33%)
    7 / 15 (46.67%)
    8 / 22 (36.36%)
    43 / 148 (29.05%)
    8 / 22 (36.36%)
    23 / 109 (21.10%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    4 / 48 (8.33%)
    2 / 48 (4.17%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    3 / 148 (2.03%)
    1 / 22 (4.55%)
    3 / 109 (2.75%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    0
    0
    4
    2
    2
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    3
    1
    3
    Injection site erythema
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 19 (10.53%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    2
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    2
    0
    0
    0
    0
    0
    Bronchospasm
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Cough
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    3
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Rhinorrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    1 / 22 (4.55%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    1
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    1 / 48 (2.08%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Oppositional defiant disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Meniscus injury
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    1 / 22 (4.55%)
    0 / 109 (0.00%)
         occurrences all number
    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
    1
    0
    Radial head dislocation
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Skin abrasion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    Upper limb fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    2 / 20 (10.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    2 / 148 (1.35%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 59 (0.00%)
    1 / 4 (25.00%)
    4 / 15 (26.67%)
    0 / 19 (0.00%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    3 / 20 (15.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    3 / 148 (2.03%)
    1 / 22 (4.55%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    1
    6
    0
    3
    0
    2
    0
    1
    0
    0
    0
    0
    1
    0
    0
    3
    0
    1
    0
    0
    3
    1
    0
    Migraine
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    1
    0
    0
    Morton's neuralgia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Sensory disturbance
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Vertigo
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    2 / 148 (1.35%)
    0 / 22 (0.00%)
    2 / 109 (1.83%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Nausea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    2 / 20 (10.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    1 / 22 (4.55%)
    1 / 109 (0.92%)
         occurrences all number
    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
    1
    1
    Teething
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Tooth disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Toothache
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    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
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    2 / 109 (1.83%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Angioedema
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Dermatitis atopic
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Dermatitis contact
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Nail dystrophy
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Rash
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Solar lentigo
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Splinter haemorrhages
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Urticaria
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Urticaria papular
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Endocrine disorders
    Basedow's disease
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Hyperthyroidism
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Hypothyroidism
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    3 / 59 (5.08%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    4 / 48 (8.33%)
    3 / 48 (6.25%)
    2 / 47 (4.26%)
    3 / 48 (6.25%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    5 / 148 (3.38%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    0
    0
    1
    4
    4
    2
    3
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    5
    0
    1
    Arthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    3 / 48 (6.25%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 49 (4.08%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    2 / 148 (1.35%)
    1 / 22 (4.55%)
    1 / 109 (0.92%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    4
    1
    0
    2
    2
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    2
    1
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 59 (3.39%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    2 / 48 (4.17%)
    2 / 48 (4.17%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
    1 / 148 (0.68%)
    1 / 22 (4.55%)
    1 / 109 (0.92%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    0
    0
    2
    2
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    1
    1
    Osteoporosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Trigger finger
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Adenovirus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Appendicitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Asymptomatic COVID-19
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
    4 / 148 (2.70%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    4
    0
    0
    Bordetella infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Bronchiolitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    COVID-19
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 59 (3.39%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    3 / 48 (6.25%)
    2 / 51 (3.92%)
    1 / 19 (5.26%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    4 / 49 (8.16%)
    4 / 48 (8.33%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 22 (4.55%)
    10 / 148 (6.76%)
    2 / 22 (9.09%)
    2 / 109 (1.83%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    0
    0
    1
    3
    0
    1
    3
    2
    1
    1
    2
    4
    4
    0
    0
    1
    1
    1
    1
    10
    2
    2
    Ear infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Croup infectious
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Eye infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Folliculitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    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
    1
    Impetigo
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    HCoV-OC43 infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Influenza
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    1 / 22 (4.55%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Nasopharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    3
    1
    0
    0
    0
    1
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Oral fungal infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Oral herpes
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    2 / 15 (13.33%)
    3 / 15 (20.00%)
    2 / 15 (13.33%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    3
    2
    0
    0
    0
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Otitis media acute
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Pharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    2 / 15 (13.33%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    2
    2
    0
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Rhinovirus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    3 / 15 (20.00%)
    1 / 15 (6.67%)
    3 / 15 (20.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    1
    3
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    2 / 51 (3.92%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 49 (4.08%)
    1 / 48 (2.08%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    2
    2
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    3 / 15 (20.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    2 / 148 (1.35%)
    0 / 22 (0.00%)
    2 / 109 (1.83%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    3
    1
    0
    2
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 59 (1.69%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    3 / 148 (2.03%)
    2 / 22 (9.09%)
    4 / 109 (3.67%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    2
    2
    0
    1
    1
    0
    1
    2
    0
    1
    0
    0
    0
    0
    1
    1
    0
    3
    2
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    4 / 15 (26.67%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    9
    13
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 148 (0.68%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    2 / 148 (1.35%)
    0 / 22 (0.00%)
    2 / 109 (1.83%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    3 / 148 (2.03%)
    0 / 22 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 59 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 19 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 5 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 148 (0.00%)
    0 / 22 (0.00%)
    0 / 109 (0.00%)
         occurrences all number
    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

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2020
    This amendment was issued to add 3 cohorts (mRNA-1345 or placebo [Cohort 7 to 9]) of healthy adults of 65 to 79 years of age in order to establish the dose in this population. Additionally, the age range of participants in the pediatric cohorts was increased to 12 to 59 months in order to increase the potential pool of seropositive children in the study.
    21 Apr 2021
    This amendment was issued to add 2 cohorts of adults aged 65 to 79 to receive mRNA-1345 or placebo (Cohort 10 and 11) and to include a WOCBP population to enable future studies to address RSV disease in neonates (Cohort 12, Cohort 13, and Cohort 14).
    27 Aug 2021
    This amendment was issued to include adults of Japanese descent aged 60 years or older (Cohort 15) in order to expand the population and to enable subsequent late-stage clinical studies in Japan.
    06 Dec 2021
    This amendment updated dosing in Cohort 6 and participant numbers in Cohorts 5 and 6.
    22 Feb 2023
    This amendment was issued to add a second booster injection of mRNA-1345 for Cohorts 7 to 11, 24 months after receiving the primary injection, which allowed for an evaluation of the benefit of a second booster in the older adult population and assessed its impact on waning antibody titers and the durability of conferred immune protection.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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