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    Clinical Trial Results:
    A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.

    Summary
    EudraCT number
    		 2020-001170-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2024
    First version publication date
    21 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V503-066
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04772534
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 jRCT: jRCT2031210080
    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
    06 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9vHPV vaccine. No hypothesis will be tested since this study is an estimation-only study.
    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
    17 May 2021
    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
    Japan: 314
    Worldwide total number of subjects
    314
    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)
    158
    Adolescents (12-17 years)
    156
    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 boys aged 9 to 15 years and healthy girls aged 9 to 14 years who had not yet had coitarche and had not previously received an HPV vaccine were enrolled at study sites in Japan.

    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
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys
    Arm description
    		 9 to 15 year old boys received a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    9vHPV Vaccine
    Investigational medicinal product code
    Other name
    V503 SILGARD®9 GARDASIL™9
    Pharmaceutical forms
    Solution 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-mL intramuscular injection

    Arm title
    		 Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys
    Arm description
    		 9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    9vHPV Vaccine
    Investigational medicinal product code
    Other name
    V503 SILGARD®9 GARDASIL™9
    Pharmaceutical forms
    Solution 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-mL intramuscular injection

    Arm title
    		 Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Arm description
    		 9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    9vHPV Vaccine
    Investigational medicinal product code
    Other name
    V503 SILGARD®9 GARDASIL™9
    Pharmaceutical forms
    Solution 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-mL intramuscular injection

    Number of subjects in period 1
    		Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Started
    105
    104
    105
    Completed
    101
    104
    104
    Not completed
    4
    0
    1
         Physician decision
    1
    -
    -
         Consent withdrawn by subject
    3
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys
    Reporting group description
    		 9 to 15 year old boys received a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).

    Reporting group title
    Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys
    Reporting group description
    		 9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

    Reporting group title
    Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Reporting group description
    		 9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

    Reporting group values
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls Total
    Number of subjects
    		 105 104 105 314
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 49 53 56 158
        Adolescents (12-17 years)
    		 56 51 49 156
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    		 12.0 (9 to 15) 11.0 (9 to 14) 11.0 (9 to 14) -
    Gender Categorical
    Units: Subjects
        Female
    		 0 0 105 105
        Male
    		 105 104 0 209
    Race
    Units: Subjects
        Japanese
    		 105 104 105 314

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys
    Reporting group description
    		 9 to 15 year old boys received a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).

    Reporting group title
    Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys
    Reporting group description
    		 9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

    Reporting group title
    Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Reporting group description
    		 9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

    Primary: Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

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    End point title
    		 Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 [1]
    End point description
    The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination. Participants who were seronegative on Day 1, received all vaccinations of 9vHPV within the acceptable day ranges, and provided blood samples are included.
    End point type
    Primary
    End point timeframe
    4 weeks post last vaccination (Month 7)
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Number of subjects analysed
    104
    104
    104
    Units: Percentage of participants
    number (confidence interval 95%)
        Anti-HPV 6
    100.0 (96.0 to 100.0)
    100.0 (96.0 to 100.0)
    100.0 (96.1 to 100.0)
        Anti-HPV 11
    100.0 (96.0 to 100.0)
    100.0 (96.0 to 100.0)
    100.0 (96.1 to 100.0)
        Anti-HPV 16
    100.0 (96.3 to 100.0)
    100.0 (96.3 to 100.0)
    100.0 (96.3 to 100.0)
        Anti-HPV 18
    100.0 (96.2 to 100.0)
    100.0 (96.1 to 100.0)
    100.0 (95.7 to 100.0)
        Anti-HPV 31
    100.0 (96.0 to 100.0)
    100.0 (96.1 to 100.0)
    100.0 (96.0 to 100.0)
        Anti-HPV 33
    100.0 (95.8 to 100.0)
    100.0 (96.0 to 100.0)
    100.0 (96.2 to 100.0)
        Anti-HPV 45
    100.0 (96.2 to 100.0)
    100.0 (96.2 to 100.0)
    100.0 (96.3 to 100.0)
        Anti-HPV 52
    100.0 (96.3 to 100.0)
    100.0 (96.2 to 100.0)
    100.0 (96.3 to 100.0)
        Anti-HPV 58
    100.0 (96.4 to 100.0)
    100.0 (96.4 to 100.0)
    100.0 (96.3 to 100.0)
    No statistical analyses for this end point

    Primary: Percentage of Participants With at Least 1 Serious Adverse Event (SAE)

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    End point title
    		 Percentage of Participants With at Least 1 Serious Adverse Event (SAE) [2]
    End point description
    A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. All participants who received ≥1 study vaccination are included.
    End point type
    Primary
    End point timeframe
    Up to ~Month 30
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Number of subjects analysed
    103
    104
    104
    Units: Percentage of Participants
        number (not applicable)
    0.0
    1.9
    2.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants with at Least 1 Injection-site Adverse Event

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    End point title
    		 Percentage of Participants with at Least 1 Injection-site Adverse Event
    End point description
    An adverse event (AE) is 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 AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. All participants who received ≥1 study vaccination are included.
    End point type
    Secondary
    End point timeframe
    Up to 15 days after each vaccination
    End point values
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Number of subjects analysed
    103
    104
    104
    Units: Percentage of Participants
        number (not applicable)
    84.5
    81.7
    88.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With at Least 1 Systemic Adverse Even

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    End point title
    		 Percentage of Participants With at Least 1 Systemic Adverse Even
    End point description
    An AE is 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 AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. All participants who received ≥1 study vaccination are included.
    End point type
    Secondary
    End point timeframe
    Up to 15 days after each vaccination
    End point values
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Number of subjects analysed
    103
    104
    104
    Units: Percentage of Participants
        number (not applicable)
    53.4
    39.4
    31.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event

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    End point title
    		 Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event
    End point description
    A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE. All participants who received ≥1 study vaccination are included.
    End point type
    Secondary
    End point timeframe
    Up to ~Month 30
    End point values
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Number of subjects analysed
    103
    104
    104
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

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    End point title
    		 Geometric Mean Titers of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
    End point description
    Serum antibodies to HPV types 6, 11, 16, 18 31, 33, 45, 52, and 58 will be measured with a cLIA. Titers are reported in milli Merck Units/mL. Participants who were seronegative on Day 1, received all vaccinations of 9vHPV within the acceptable day ranges, and provided blood samples are included.
    End point type
    Secondary
    End point timeframe
    4 weeks post last vaccination (Month 7)
    End point values
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Number of subjects analysed
    104
    104
    105
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-HPV 6
    1759.8 (1481.2 to 2090.8)
    2417.0 (2057.3 to 2839.6)
    2343.2 (2036.1 to 2696.5)
        Anti-HPV 11
    1341.8 (1136.1 to 1584.9)
    1510.1 (1310.3 to 1740.4)
    1508.5 (1340.8 to 1697.0)
        Anti-HPV 16
    7020.8 (5955.3 to 8277.1)
    9808.5 (8437.7 to 11402.0)
    9800.0 (8440.1 to 11379.1)
        Anti-HPV 18
    2629.6 (2154.7 to 3209.1)
    2464.6 (2095.6 to 2898.5)
    2999.8 (2509.3 to 3586.3)
        Anti-HPV 31
    2095.0 (1717.2 to 2555.9)
    1908.5 (1619.3 to 2249.4)
    1838.7 (1571.8 to 2151.0)
        Anti-HPV 33
    894.9 (753.1 to 1063.4)
    1272.1 (1085.2 to 1491.2)
    1283.1 (1132.4 to 1453.8)
        Anti-HPV 45
    848.9 (701.1 to 1027.8)
    508.4 (431.7 to 598.8)
    599.6 (520.6 to 690.4)
        Anti-HPV 52
    925.3 (774.9 to 1105.0)
    587.4 (503.3 to 685.5)
    582.7 (517.3 to 656.4)
        Anti-HPV 58
    1401.7 (1177.4 to 1668.8)
    1350.6 (1155.1 to 1579.1)
    1379.8 (1216.4 to 1565.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to ~30 months
    Adverse event reporting additional description
    All participants who received ≥1 dose of study treatment are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys
    Reporting group description
    		 9 to 15 year old boys received a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).

    Reporting group title
    Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls
    Reporting group description
    		 9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

    Reporting group title
    Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys
    Reporting group description
    		 9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

    Serious adverse events
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
    3 / 104 (2.88%)
    2 / 104 (1.92%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Strabismus
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis acute
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 1: 3-Dose Regimen in 9 to 15 Year Old Boys Arm 3: 2-Dose Regimen in 9 to 14 Year Old Girls Arm 2: 2-Dose Regimen in 9 to 14 Year Old Boys
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 103 (33.01%)
    18 / 104 (17.31%)
    24 / 104 (23.08%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 103 (9.71%)
    6 / 104 (5.77%)
    9 / 104 (8.65%)
         occurrences all number
    10
    6
    9
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    18 / 103 (17.48%)
    8 / 104 (7.69%)
    12 / 104 (11.54%)
         occurrences all number
    18
    8
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 103 (5.83%)
    4 / 104 (3.85%)
    3 / 104 (2.88%)
         occurrences all number
    6
    4
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2021
    AM1: The primary purpose of the amendment was to initiate enrollment of girls earlier than boys.
    19 Sep 2022
    AM2: The primary purpose of the amendment was to update Sponsor name and address.

    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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