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    Clinical Trial Results:
    A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Concomitantly in Boys and Girls 9 to 11 Years of Age

    Summary
    EudraCT number
    		 2021-003591-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Feb 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2025
    First version publication date
    17 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V503-076
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05119855
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.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
    12 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9-valent Human Papillomavirus (9vHPV) vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of messenger ribonucleic acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (mRNA-1273) vaccine versus non-concomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Mar 2022
    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: 165
    Worldwide total number of subjects
    165
    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)
    165
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy children 9 to 11 years of age were enrolled in this study; 165 participants were randomly assigned in a 1:1 ratio to the Concomitant Group and the Non-concomitant Group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Concomitant Group
    Arm description
    		 Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    9vHPV Vaccine
    Investigational medicinal product code
    Other name
    V503 GARDASIL®9 SILGARD®9
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    9-valent human papillomavirus (Types 6, 11,16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mLintramuscular (IM) injection

    Investigational medicinal product name
    mRNA-1273 Vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 Vaccine Moderna COVID-19Vaccine
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 50 mcg dose administered as a 0.25-mLIM injection

    Arm title
    		 Non-concomitant Group
    Arm description
    		 Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    mRNA-1273 Vaccine
    Investigational medicinal product code
    Other name
    SARS-CoV-2 Vaccine Moderna COVID-19Vaccine
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    mRNA-1273 50 mcg dose administered as a 0.25-mLIM injection

    Investigational medicinal product name
    9vHPV Vaccine
    Investigational medicinal product code
    Other name
    V503 GARDASIL®9 SILGARD®9
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    9-valent human papillomavirus (Types 6, 11,16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mLintramuscular (IM) injection

    Number of subjects in period 1
    		Concomitant Group Non-concomitant Group
    Started
    82
    83
    Vaccinated: mRNA-1273 Dose 1
    81
    81
    Vaccinated: 9vHPV Dose 1
    81
    72
    Vaccinated: mRNA-1273 Dose 2
    78
    78
    Vaccinated: 9vHPV Dose 2
    67
    66
    Concomitant Dose 1 Day 1 9vHPV
    81
    0 [1]
    Concomitant Dose 1 Day 1 mRNA-1273
    81
    0 [2]
    Concomitant Dose 2 Month 1 mRNA-1273
    78
    0 [3]
    Concomitant Dose 2 Month 6 9vHPV
    67
    0 [4]
    Non-concomitant Dose 1 Day 1 mRNA-1273
    0 [5]
    81
    Non-concomitant Dose 2 Month 1 mRNA-1273
    0 [6]
    78
    Non-concomitant Dose 1 Month 2 9vHPV
    0 [7]
    72
    Non-concomitant Dose 2 Month 8 9vHPV
    0 [8]
    66
    Completed
    66
    64
    Not completed
    16
    19
         Withdrawal By Parent/Guardian
    10
    10
         Lost to follow-up
    6
    8
         Randomized by Mistake Without Study Treatment
    -
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Non-Concomitant Dose 2 Month 1 mRNA-1273 is not applicable to Concomitant Arm.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Non-Concomitant Dose 1 Month 2 9vHPV is not applicable to Concomitant Arm.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Non-Concomitant Dose 2 Month 8 9vHPV is not applicable to Concomitant Arm.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Non-Concomitant Dose 1 Day 1 mRNA-1273 is not applicable to Concomitant Arm.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Concomitant Dose 1 Day 1 9vHPV is not applicable to Non-Concomitant Arm.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Concomitant Dose 1 Day 1 mRNA-1273 is not applicable to Non-Concomitant Arm.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Concomitant Dose 2 Month 1 mRNA-1273 is not applicable to Non-Concomitant Arm.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Per protocol, Concomitant Dose 2 Month 6 9vHPV is not applicable to Non-Concomitant Arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Concomitant Group
    Reporting group description
    		 Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6.

    Reporting group title
    Non-concomitant Group
    Reporting group description
    		 Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8.

    Reporting group values
    		 Concomitant Group Non-concomitant Group Total
    Number of subjects
    		 82 83 165
    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)
    		 82 83 165
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 9.9 ( 0.9 ) 9.9 ( 0.8 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 43 45 88
        Male
    		 39 38 77
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 28 31 59
        White
    		 53 48 101
        More than one race
    		 0 2 2
        Unknown or Not Reported
    		 0 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 50 46 96
        Not Hispanic or Latino
    		 32 37 69
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Concomitant Group
    Reporting group description
    		 Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6.

    Reporting group title
    Non-concomitant Group
    Reporting group description
    		 Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8.

    Primary: Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV)

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    End point title
    		 Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV)
    End point description
    Antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) are reported for both arms for all randomized participants included in the per-protocol immunogenicity (PPI) population. The PPI population is HPV-type specific. HPV-type specific PPI population included all randomized participants who; were seronegative pre 9vHPV vaccination to the relevant HPV type(s); had all protocol planned 9vHPV vaccinations; had evaluable serology results post 9vHPV Dose 2 vaccination; no protocol deviations that may affect evaluation of participant's immune response to 9vHPV vaccination. The number of subjects analyzed is the total number of participants for inclusion in any HPV type specific PPI.
    End point type
    Primary
    End point timeframe
    Up to approximately 4 weeks post vaccination with 9vHPV Dose 2
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    51 [1]
    49 [2]
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=47, 46)
    2198.5 (1806.9 to 2674.8)
    1806.8 (1481.8 to 2202.9)
        Anti-HPV 11 (n=46, 49)
    1517.6 (1247.5 to 1846.2)
    1138.2 (941.4 to 1376.2)
        Anti-HPV 16 (n=47, 46)
    9595.8 (7822.5 to 11771.0)
    7042.3 (5728.2 to 8657.7)
        Anti-HPV 18 (n=48, 46)
    2139.2 (1721.3 to 2658.6)
    1713.2 (1372.1 to 2139.1)
        Anti-HPV 31 (n=46, 47)
    1695.6 (1383.9 to 2077.3)
    1404.7 (1149.0 to 1717.2)
        Anti-HPV 33 (n=48, 47)
    1172.3 (950.8 to 1445.5)
    889.9 (720.2 to 1099.6)
        Anti-HPV 45 (n=50, 47)
    518.0 (413.0 to 649.6)
    370.8 (293.6 to 468.4)
        Anti-HPV 52 (n=49, 48)
    733.6 (614.4 to 875.9)
    504.7 (421.9 to 603.7)
        Anti-HPV 58 (n= 48, 48)
    1095.2 (900.5 to 1332.1)
    912.6 (750.3 to 1110.0)
    Notes
    [1] - Number of subjects analyzed is number of participants included in any HPV type specific PPI.
    [2] - Number of subjects analyzed is number of participants included in any HPV type specific PPI.
    Statistical analysis title
    		 GMT Ratio for Anti-HPV 11
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 11 Concomitant Group n=46; Anti-HPV 11 Non-concomitant Group n=49.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.75
    Statistical analysis title
    		 GMT Ratio for Anti-HPV 6
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 6 Concomitant Group n=47; Anti-HPV 6 Non-concomitant Group n=46.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.61
    Statistical analysis title
    		 GMT Ratio for Anti-HPV 58
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 58 Concomitant Group n=48; Anti-HPV 58 Non-concomitant Group n=48.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.58
    Statistical analysis title
    		 GMT Ratio for Anti-HPV 33
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 33 Concomitant Group n=48; Anti-HPV 33 Non-concomitant Group n=47.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.77
    Statistical analysis title
    		 GMT Ratio Anti-HPV 45
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 45 Concomitant Group n=50; Anti-HPV 45 Non-concomitant Group n=47.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.93
    Statistical analysis title
    		 GMT Ratio for Anti-HPV 52
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 52 Concomitant Group n=49; Anti-HPV 52 Non-concomitant Group n=48.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.87
    Statistical analysis title
    		 GMT Ratio for Anti-HPV 18
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with data available: Anti-HPV 18 Concomitant Group n=48; Anti-HPV 18 Non-concomitant Group n=46.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.7
    Statistical analysis title
    		 GMT Ratio for Anti-HPV 16
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 16 Concomitant Group n=47; Anti-HPV 16 Non-concomitant Group n=46.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.82
    Statistical analysis title
    		 GMT Ratio for Ant-HPV 31
    Statistical analysis description
    Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant. Number of subjects analyzed is type-specific PPI; HPV type n-value denotes PPI population with GMT data available: Anti-HPV 31 Concomitant Group n=46; Anti-HPV 31 Non-concomitant Group n=47.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Titer (GMT) Ratio
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.61

    Primary: Percentage of Participants with ≥1 Solicited Injection-site Adverse Event (AE)

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    End point title
    		 Percentage of Participants with ≥1 Solicited Injection-site Adverse Event (AE) [3]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. Solicited AEs are predefined AEs at injection site. Participants used vaccination report card (VRC) to note injection site AEs based on questions asked. Per protocol, percentage of participants with ≥1 solicited injection site AE is reported by injection site for participants in Concomitant (Day 1 mRNA-1273 [right arm] Dose 1; Day 1 9vHPV [left arm] Dose 1; Month 1 mRNA-1273 Dose 2; Month 6 9vHPV Dose 2) and Non-Concomitant (Day 1 mRNA-1273 Dose 1; Month 1 mRNA-1273 Dose 2; Month 2 9vHPV Dose 1; Month 8 9vHPV Dose 2). Per protocol, reporting by injection site for Concomitant Day 1 Dose 1 is specific to this safety endpoint. Per protocol, safety analyses population included all randomized participants who had ≥1 dose of any study vaccine and included by study vaccine given. 9999 indicates data not available.
    End point type
    Primary
    End point timeframe
    Up to approximately Day 7 post vaccination with any study vaccine
    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: Per protocol, only descriptive statistics were planned and are presented for this endpoint.
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    81 [4]
    81 [5]
    Units: Percentage of Participants
    number (not applicable)
        Concomitant Day 1 mRNA-1273 Dose 1 (n=81,0)
    49.4
    9999
        Concomitant Day 1 9vHPV Dose 1 (n=81,0)
    39.5
    9999
        Concomitant Month 1 mRNA-1273 Dose 2 (n=78,0)
    35.9
    9999
        Concomitant Month 6 9vHPV Dose 2 (n=67,0)
    26.9
    9999
        Non-concomitant Day 1 mRNA-1273 Dose 1 (n=0,81)
    9999
    55.6
        Non-concomitant Month 1 mRNA-1273 Dose 2 (n=0,78)
    9999
    44.9
        Non-Concomitant Month 2 9vHPV Dose 1 (n=0,72)
    9999
    29.2
        Non-concomitant Month 8 9vHPV Dose 2 (n=0,66)
    9999
    43.9
    Notes
    [4] - Number of subjects analyzed is safety analyses population.
    [5] - Number of subjects analyzed is safety analyses population.
    No statistical analyses for this end point

    Primary: Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies

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    End point title
    		 Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies
    End point description
    The geometric mean concentration (GMC) of serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. GMCs are reported for both arms for all randomized participants included in the mRNA-1273 per-protocol (mRNA-1273-PP) population. The analysis mRNA-1273-PP population included all randomized participants who; had all protocol planned mRNA-1273 vaccinations; had evaluable serology results post mRNA-1273 Dose 2 vaccination; no protocol deviations that may affect evaluation of participant's immune response to mRNA-1273 vaccination.
    End point type
    Primary
    End point timeframe
    Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    56 [6]
    60 [7]
    Units: μg/mL
        geometric mean (confidence interval 95%)
    763084.3 (673224.4 to 864938.4)
    650527.9 (576365.9 to 734232.5)
    Notes
    [6] - Number of subjects analyzed is mRNA-1273-PP population.
    [7] - Number of subjects analyzed is mRNA-1273-PP population.
    Statistical analysis title
    		 GMC Ratio of SARS-CoV-2 Spike Protein
    Statistical analysis description
    Geometric Mean Concentration (GMC) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-SARS-CoV-2 concentrations and a fixed effect for the vaccination groups, Concomitant versus Non-Concomitant.
    Comparison groups
    Concomitant Group v Non-concomitant Group
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Concentration (GMC) Ratio
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.4

    Primary: Percentage of Participants with ≥1 Solicited Systemic AE

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    End point title
    		 Percentage of Participants with ≥1 Solicited Systemic AE [8]
    End point description
    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. Solicited AEs are predefined systemic events. Participants used VRC to note solicited AEs based on questions asked. Per protocol the percentage of participants who experienced ≥1 solicited systemic AE are reported for participants in Concomitant (Day 1 mRNA-1273 [right arm] Dose 1; Day 1 9vHPV [left arm] Dose 1; Month 1 mRNA-1273 Dose 2; Month 6 9vHPV Dose 2) and Non-Concomitant (Day 1 mRNA-1273 Dose 1; Month 1 mRNA-1273 Dose 2; Month 2 9vHPV Dose 1; Month 8 9vHPV Dose 2) Groups. Per protocol, reporting based on injection time; 9vHPV and mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group and are combined below. Per protocol, safety analyses population included all randomized participants who had ≥1 dose of any study vaccine and included by study vaccine given. 9999 indicates data not available.
    End point type
    Primary
    End point timeframe
    Up to approximately Day 7 post vaccination with any study vaccine
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were planned and are presented for this endpoint.
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    81 [9]
    81 [10]
    Units: Percentage of Participants
    number (not applicable)
        Concomitant Day 1 mRNA-1273+9vHPV Dose 1 (n=81,0)
    33.3
    9999
        Concomitant Month 1 mRNA-1273 Dose 2 (n=78,0)
    33.3
    9999
        Concomitant Month 6 9vHPV Dose 2 (n=67,0)
    17.9
    9999
        Non-concomitant Day 1 mRNA-1273 Dose 1 (n=0,81)
    9999
    55.6
        Non-concomitant Month 1 mRNA-1273 Dose 2 (n=0,78)
    9999
    44.9
        Non-Concomitant Month 2 9vHPV Dose 1 (n=0,72)
    9999
    29.2
        Non-concomitant Month 8 9vHPV Dose 2 (n=0,66)
    9999
    43.9
    Notes
    [9] - Number of subjects analyzed is safety analyses population.
    [10] - Number of subjects analyzed is safety analyses population.
    No statistical analyses for this end point

    Primary: Percentage of Participants with ≥1 Serious Adverse Event (SAE)

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    End point title
    		 Percentage of Participants with ≥1 Serious Adverse Event (SAE) [11]
    End point description
    A SAE was defined as; one that results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other important medical event that may require medical intervention. Per protocol the percentage of participants who experienced ≥1 SAE are reported here for participants in Concomitant (Day 1 mRNA-1273 [right arm] Dose 1; Day 1 9vHPV [left arm] Dose 1; Month 1 mRNA-1273 Dose 2; Month 6 9vHPV Dose 2) and Non-Concomitant (Day 1 mRNA-1273 Dose 1; Month 1 mRNA-1273 Dose 2; Month 2 9vHPV Dose 1; Month 8 9vHPV Dose 2) Groups. Per protocol, reporting is based on injection time; 9vHPV and mRNA-1273 Dose 1 were given on Day 1 of the Concomitant Group and are combined below. Per protocol, safety analyses population included all randomized participants who had ≥1 dose of any study vaccine and included by study vaccine given. 9999 indicates data not available.
    End point type
    Primary
    End point timeframe
    Up to approximately Day 28 post vaccination with any study vaccine
    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: Per protocol, only descriptive statistics were planned and are presented for this endpoint.
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    81 [12]
    81 [13]
    Units: Percentage of Participants
    number (not applicable)
        Concomitant Day 1 mRNA-1273+9vHPV Dose 1 (n=81,0)
    0.0
    9999
        Concomitant Month 1 mRNA-1273 Dose 2 (n=78,0)
    0.0
    9999
        Concomitant Month 6 9vHPV Dose 2 (n=67,0)
    0.0
    9999
        Non-concomitant Day 1 mRNA-1273 Dose 1 (n=0,81)
    9999
    0.0
        Non-concomitant Month 1 mRNA-1273 Dose 2 (n=0,78)
    9999
    0.0
        Non-Concomitant Month 2 9vHPV Dose 1 (n=0,72)
    9999
    0.0
        Non-concomitant Month 8 9vHPV Dose 2 (n=0,66)
    9999
    0.0
    Notes
    [12] - Number of subjects analyzed is safety analyses population.
    [13] - Number of subjects analyzed is safety analyses population.
    No statistical analyses for this end point

    Primary: Percentage of Participants with ≥1 Vaccine-Related SAE

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    End point title
    		 Percentage of Participants with ≥1 Vaccine-Related SAE [14]
    End point description
    A vaccine related SAE defined as; results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, congenital anomaly/birth defect, or event that may require medical intervention; AND related to study vaccine as judged by investigator. Percentage of participants with ≥1 vaccine related SAE are reported here for participants in Concomitant (Day 1 mRNA-1273 [right arm] Dose 1; Day 1 9vHPV [left arm] Dose 1; Month 1 mRNA-1273 Dose 2; Month 6 9vHPV Dose 2) and Non-Concomitant (Day 1 mRNA-1273 Dose 1; Month 1 mRNA-1273 Dose 2; Month 2 9vHPV Dose 1; Month 8 9vHPV Dose 2) Group. Per protocol, reporting is based on injection time; 9vHPV and mRNA-1273 Dose 1 given on Day 1 of Concomitant Group are combined below. Per protocol, safety analyses population included all randomized participants who had ≥1 dose of any study vaccine and included by study vaccine given. 9999 indicates data not available.
    End point type
    Primary
    End point timeframe
    Up to approximately 9 Months
    Notes
    [14] - 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: Per protocol, only descriptive statistics were planned and are presented for this endpoint.
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    81 [15]
    81 [16]
    Units: Percentage of Participants
    number (not applicable)
        Concomitant Day 1 mRNA-1273+9vHPV Dose 1 (n=81,0)
    0.0
    9999
        Concomitant Month 1 mRNA-1273 Dose 2 (n=78,0)
    0.0
    9999
        Concomitant Month 6 9vHPV Dose 2 (n=67,0)
    0.0
    9999
        Non-concomitant Day 1 mRNA-1273 Dose 1 (n=0,81)
    9999
    0.0
        Non-concomitant Month 1 mRNA-1273 Dose 2 (n=0,78)
    9999
    0.0
        Non-Concomitant Month 2 9vHPV Dose 1 (n=0,72)
    9999
    0.0
        Non-concomitant Month 8 9vHPV Dose 2 (n=0,66)
    9999
    0.0
    Notes
    [15] - Number of subjects analyzed is safety analyses population.
    [16] - Number of subjects analyzed is safety analyses population.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine

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    End point title
    		 Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine
    End point description
    Serum derived antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 measured with cLIA. Seroconversion defined as shift from anti HPV seronegative at pre vaccination to seropositive 4 weeks post 9vHPV Dose 2. Anti HPV titers ≥serostatus cutoffs were seropositive per HPV type. Serostatus cutoffs milli Merck units/milliliter (mMU/mL) per HPV Type: Type 6: ≥34, Type 11: ≥25, Type 16: ≥32, Type 18: ≥26, Type 31: ≥15, Type 33: ≥10, Type 45: ≥10, Type 52: ≥14, Type 58: ≥10. Percentage of participants who seroconverted are reported for both arms included in the PPI population. PPI is HPV-specific and included all randomized participants who; seronegative by HPV-9 cLIA to HPV type pre 9vHPV vaccination; had all protocol planned 9vHPV vaccines; evaluable serology results collected post 9vHPV Dose 2; no protocol deviations may alter evaluation of participant's immune response to 9vHPV. Number of subjects analyzed is total number of participants included in any HPV type specific PPI.
    End point type
    Secondary
    End point timeframe
    Up to approximately 4 weeks post vaccination with 9vHPV Dose 2
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    51 [17]
    49 [18]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 cLIA ≥34 mMU/​mL (n=47, 46)
    100.0 (92.5 to 100.0)
    100.0 (92.3 to 100)
        Anti-HPV 11 cLIA ≥25 mMU/​mL (n=46, 49)
    100.0 (92.3 to 100.0)
    100.0 (92.7 to 100.0)
        Anti-HPV 16 cLIA ≥32 mMU/​mL (n=47, 46)
    100.0 (92.5 to 100.0)
    100.0 (92.3 to 100.0)
        Anti-HPV 18 cLIA ≥26 mMU/​mL (n=48, 46)
    100.0 (92.6 to 100.0)
    100.0 (92.3 to 100.0)
        Anti-HPV 31 cLIA ≥15 mMU/​mL (n=46, 47)
    100.0 (92.3 to 100.0)
    100.0 (92.5 to 100.0)
        Anti-HPV 33 cLIA ≥10 mMU/​mL (n=48, 47)
    100.0 (92.6 to 100.0)
    100.0 (92.5 to 100.0)
        Anti-HPV 45 cLIA ≥10 mMU/​mL (n=50, 47)
    100.0 (92.9 to 100.0)
    100.0 (92.5 to 100.0)
        Anti-HPV 52 cLIA ≥14 mMU/​mL (n=49, 48)
    100.0 (92.7 to 100.0)
    100.0 (92.6 to 100.0)
        Anti-HPV 58 cLIA ≥10 mMU/​mL (n=48, 48)
    100.0 (92.6 to 100.0)
    100.0 (92.6 to 100.0)
    Notes
    [17] - Number of subjects analyzed is number of participants included in any HPV type specific PPI.
    [18] - Number of subjects analyzed is number of participants included in any HPV type specific PPI.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine

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    End point title
    		 Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine
    End point description
    Serum derived antibodies to SARS-CoV-2 spike protein measured with ECL. Seroresponse is defined as a ≥4-fold rise in SARS-CoV-2 spike protein-specific binding antibody concentration from baseline to 4 weeks post vaccination with mRNA-1273 Dose 2. Percentage of participants who experience seroresponse is reported for both Concomitant Group and Non-concomitant Groups for all randomized participants included in the mRNA-1273 mRNA-1273-PP. The mRNA-1273-PP population included all randomized participants who; had all protocol planned mRNA-1273 vaccinations; had evaluable serology results from samples collected post mRNA-1273 Dose 2 vaccination; no protocol deviations that may affect evaluation of participant's immune response to mRNA-1273 vaccination.
    End point type
    Secondary
    End point timeframe
    Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2
    End point values
    		 Concomitant Group Non-concomitant Group
    Number of subjects analysed
    56 [19]
    60 [20]
    Units: Percentage of Participants
        number (confidence interval 95%)
    96.4 (87.7 to 99.6)
    95.0 (86.1 to 99.0)
    Notes
    [19] - Number of subjects analyzed is mRNA-1273-PP population.
    [20] - Number of subjects analyzed is mRNA-1273-PP population.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 9 Months
    Adverse event reporting additional description
    All-Cause Mortality included all randomized participants. The safety analysis population (total subjects exposed) included all randomized participants who were vaccinated with at least 1 dose of any study vaccine; participants were included to the treatment group according to the vaccination they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Non-concomitant Group
    Reporting group description
    		 Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8.

    Reporting group title
    Concomitant Group
    Reporting group description
    		 Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6.

    Serious adverse events
    		 Non-concomitant Group Concomitant Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 81 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Non-concomitant Group Concomitant Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 81 (72.84%)
    55 / 81 (67.90%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    30 / 81 (37.04%)
    26 / 81 (32.10%)
         occurrences all number
    46
    33
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    20 / 81 (24.69%)
    6 / 81 (7.41%)
         occurrences all number
    25
    6
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    11 / 81 (13.58%)
    13 / 81 (16.05%)
         occurrences all number
    11
    16
    Fatigue
         subjects affected / exposed
    23 / 81 (28.40%)
    23 / 81 (28.40%)
         occurrences all number
    38
    32
    Injection site erythema
         subjects affected / exposed
    12 / 81 (14.81%)
    6 / 81 (7.41%)
         occurrences all number
    18
    7
    Injection site pain
         subjects affected / exposed
    52 / 81 (64.20%)
    46 / 81 (56.79%)
         occurrences all number
    122
    113
    Pyrexia
         subjects affected / exposed
    10 / 81 (12.35%)
    11 / 81 (13.58%)
         occurrences all number
    14
    15
    Injection site swelling
         subjects affected / exposed
    18 / 81 (22.22%)
    14 / 81 (17.28%)
         occurrences all number
    27
    22
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 81 (6.17%)
    9 / 81 (11.11%)
         occurrences all number
    7
    10
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    16 / 81 (19.75%)
    9 / 81 (11.11%)
         occurrences all number
    19
    12
    Arthralgia
         subjects affected / exposed
    10 / 81 (12.35%)
    7 / 81 (8.64%)
         occurrences all number
    11
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jan 2022
    Amendment 01: The primary reasons for this amendment are to change the age range for study participants to 9 to 11 years of age and to change the dose (volume) of the mRNA-1273 vaccine to 50 μg (0.25 mL) to reflect emerging clinical data for the mRNA-1273 vaccine.
    28 Jul 2022
    Amendment 02: The primary reason for this amendment is to allow enrollment of participants with SARS-CoV-2 infection >90 days prior to enrollment.
    24 Feb 2023
    Amendment 03: The primary purpose of this amendment is to change from a hypothesis testing study to an estimation study design due to early closure of enrollment.

    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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