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    Clinical Trial Results:
    A Phase 4, Randomized, Observer-blind, Placebo-controlled, Crossover Study to Assess Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age

    Summary
    EudraCT number
    		 2025-000442-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Apr 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    mRNA-1273-P404
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06634797
    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)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Apr 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
    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 on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, and other applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Oct 2024
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1000
    Worldwide total number of subjects
    1000
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    450
    Adults (18-64 years)
    550
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomized in a 1:1 ratio (500 participants in each injection sequence) to receive 2 study injections (mRNA-1273.712 and placebo) in a crossover design.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1: mRNA-1273.712 Then Placebo
    Arm description
    		 Participants received mRNA-1273.712 as an intramuscular (IM) injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study.
    Arm type
    		 Experimental

    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 was administered per schedule specified in the arm description.

    Investigational medicinal product name
    mRNA-1273.712
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.712 was administered per schedule specified in the arm description.

    Arm title
    		 Sequence 2: Placebo Then mRNA-1273.712
    Arm description
    		 Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1273.712
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273.712 was administered per 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 was administered per schedule specified in the arm description.

    Number of subjects in period 1
    		Sequence 1: mRNA-1273.712 Then Placebo Sequence 2: Placebo Then mRNA-1273.712
    Started
    500
    500
    Received Study Vaccination
    500
    497
    Completed
    438
    424
    Not completed
    62
    76
         Consent withdrawn by subject
    12
    21
         Physician decision
    3
    3
         Adverse event, non-fatal
    -
    1
         Other than specified
    1
    1
         Screen failure
    -
    2
         Lost to follow-up
    46
    48

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence 1: mRNA-1273.712 Then Placebo
    Reporting group description
    		 Participants received mRNA-1273.712 as an intramuscular (IM) injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study.

    Reporting group title
    Sequence 2: Placebo Then mRNA-1273.712
    Reporting group description
    		 Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study.

    Reporting group values
    		 Sequence 1: mRNA-1273.712 Then Placebo Sequence 2: Placebo Then mRNA-1273.712 Total
    Number of subjects
    		 500 500 1000
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 235 215 450
        Adults (18-64 years)
    		 265 285 550
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.7 ( 5.73 ) 20.0 ( 5.71 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 266 272 538
        Male
    		 234 228 462
    Race
    Units: Subjects
        White
    		 320 334 654
        Black or African American
    		 132 108 240
        Asian
    		 19 14 33
        American Indian or Alaska Native
    		 1 3 4
        Native Hawaiian or Other Pacific Islander
    		 1 1 2
        Multiple
    		 21 30 51
        Other
    		 3 7 10
        Not Reported
    		 3 3 6
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 68 79 147
        Not Hispanic or Latino
    		 423 417 840
        Not Reported
    		 8 4 12
        Unknown
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Sequence 1: mRNA-1273.712 Then Placebo
    Reporting group description
    		 Participants received mRNA-1273.712 as an intramuscular (IM) injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study.

    Reporting group title
    Sequence 2: Placebo Then mRNA-1273.712
    Reporting group description
    		 Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study.

    Subject analysis set title
    mRNA-1273.712
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received mRNA-1273.712 as an IM injection on either Day 1 in Sequence 1 (mRNA-1273.712 – placebo) or Day 29 in Sequence 2 (placebo - mRNA-1273.712) of the study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants received placebo matched to mRNA-1273.712 as an IM injection on either Day 1 in Sequence 2 (placebo - mRNA-1273.712) or Day 29 in Sequence 1 (mRNA-1273.712 – placebo) of the study.

    Subject analysis set title
    Sequence 1 (mRNA-1273.712 – Placebo): mRNA-1273.712
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received mRNA-1273.712 as an IM injection on Day 1 in Sequence 1 of the study.

    Subject analysis set title
    Sequence 1 (mRNA-1273.712 – Placebo): Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study.

    Subject analysis set title
    Sequence 2 (Placebo – mRNA-1273.712): Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study.

    Subject analysis set title
    Sequence 2 (Placebo – mRNA-1273.712): mRNA-1273.712
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study.

    Primary: Number of Participants with Elevated cTnI at Day 4 or Day 32 (3 days After Injection 1 or Injection 2)

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    End point title
    		 Number of Participants with Elevated cTnI at Day 4 or Day 32 (3 days After Injection 1 or Injection 2) [1]
    End point description
    Elevated cTnI was defined as >53.53 picograms per milliliter (pg/mL) in males and >38.64 pg/mL in females. Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of subjects analysed' includes the number of participants with normal cTnI at pre-injection at either Day 1 or Day 29 and non-missing cTnI at both pre-injection and 3 days after any injection. One participant who was included in the analysis, had an elevation of cTnI pre-injection of study intervention on Day 1 and had a normal value of cTnI pre-injection of study intervention on Day 29. Note that other factors such as physical activity can affect cTnI.
    End point type
    Primary
    End point timeframe
    Day 4 and Day 32
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparative statistical analyses were planned for this endpoint.
    End point values
    		 mRNA-1273.712 Placebo
    Number of subjects analysed
    890
    910
    Units: participants
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2)

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    End point title
    		 Number of Participants with Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2)
    End point description
    Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females. Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of subjects analysed' includes the number of participants with normal cTnI at pre-injection and non-missing cTnI at both pre-injection and 28 days after any injection.
    End point type
    Secondary
    End point timeframe
    Day 29 and Day 57
    End point values
    		 mRNA-1273.712 Placebo
    Number of subjects analysed
    858
    853
    Units: participants
    4
    8
    No statistical analyses for this end point

    Secondary: Number of Participants with Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Adverse Events Leading to Withdrawal

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    End point title
    		 Number of Participants with Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Adverse Events Leading to Withdrawal
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in birth defects or was an important medical event. A MAAE was defined as an AE that led to an unscheduled visit to a healthcare practitioner. Investigators reported AEs as AESIs based on pre-defined criteria. All suspected cases of cardiomyopathy and non-infectious myocarditis, pericarditis, and myopericarditis were reported as AESIs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. Safety Set: All randomized participants who received at least 1 study injection.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 57
    End point values
    		 Sequence 1 (mRNA-1273.712 – Placebo): mRNA-1273.712 Sequence 1 (mRNA-1273.712 – Placebo): Placebo Sequence 2 (Placebo – mRNA-1273.712): Placebo Sequence 2 (Placebo – mRNA-1273.712): mRNA-1273.712
    Number of subjects analysed
    500
    460
    497
    454
    Units: participants
        SAEs
    0
    0
    0
    1
        MAAEs
    6
    5
    9
    10
        AESIs
    1
    1
    0
    0
        AEs Leading to Study Discontinuation
    0
    0
    1
    0
        AEs Leading to Discontinuation of Study Injection
    1
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Elevated cTnI Level at Day 1 (Baseline)

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    End point title
    		 Number of Participants with Elevated cTnI Level at Day 1 (Baseline)
    End point description
    Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females. Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of subjects analysed' includes the number of participants with non-missing cTnI at Day 1.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Sequence 1: mRNA-1273.712 Then Placebo Sequence 2: Placebo Then mRNA-1273.712
    Number of subjects analysed
    491
    489
    Units: participants
    2
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 up to Day 57
    Adverse event reporting additional description
    Safety Set: All randomized participants who received at least 1 dose of study injection. Data are presented by study intervention sequence, and treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    mRNA-1273.712 – Placebo Sequence: mRNA-1273.712
    Reporting group description
    		 Participants received mRNA-1273.712 as an intramuscular injection on Day 1 of the study.

    Reporting group title
    mRNA-1273.712 – Placebo Sequence: Placebo
    Reporting group description
    		 Participants received placebo matching mRNA-1273.712 as an intramuscular injection on Day 29 of the study.

    Reporting group title
    Placebo – mRNA-1273.712 Sequence: Placebo
    Reporting group description
    		 Participants received placebo matching mRNA-1273.712 as an intramuscular injection on Day 1 of the study.

    Reporting group title
    Placebo – mRNA-1273.712: mRNA-1273.712
    Reporting group description
    		 Participants received mRNA-1273.712 as an intramuscular injection on Day 29 of the study.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events reported above the 5% threshold.
    Serious adverse events
    		 mRNA-1273.712 – Placebo Sequence: mRNA-1273.712 mRNA-1273.712 – Placebo Sequence: Placebo Placebo – mRNA-1273.712 Sequence: Placebo Placebo – mRNA-1273.712: mRNA-1273.712
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 500 (0.00%)
    0 / 460 (0.00%)
    0 / 497 (0.00%)
    1 / 454 (0.22%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Psychiatric disorders
    Suicidal Ideation
         subjects affected / exposed
    0 / 500 (0.00%)
    0 / 460 (0.00%)
    0 / 497 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 mRNA-1273.712 – Placebo Sequence: mRNA-1273.712 mRNA-1273.712 – Placebo Sequence: Placebo Placebo – mRNA-1273.712 Sequence: Placebo Placebo – mRNA-1273.712: mRNA-1273.712
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 500 (0.00%)
    0 / 460 (0.00%)
    0 / 497 (0.00%)
    0 / 454 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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