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    Clinical Trial Results:
    A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, administered in Preadolescents and Adolescents (9 to 14 year olds) with a Comparison to Young Women (16 to 26 year olds)

    Summary
    EudraCT number
    2013-001314-15
    Trial protocol
    CZ   NO   DK   ES   Outside EU/EEA  
    Global end of trial date
    15 Sep 2017

    Results information
    Results version number
    v2(current)
    This version publication date
    05 Jul 2018
    First version publication date
    09 Feb 2018
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V503-010
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01984697
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    15 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).
    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
    12 Dec 2013
    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
    Canada: 116
    Country: Number of subjects enrolled
    Chile: 95
    Country: Number of subjects enrolled
    Colombia: 151
    Country: Number of subjects enrolled
    Czech Republic: 116
    Country: Number of subjects enrolled
    Denmark: 132
    Country: Number of subjects enrolled
    Israel: 62
    Country: Number of subjects enrolled
    Korea, Republic of: 46
    Country: Number of subjects enrolled
    Malaysia: 72
    Country: Number of subjects enrolled
    Norway: 106
    Country: Number of subjects enrolled
    South Africa: 107
    Country: Number of subjects enrolled
    Spain: 116
    Country: Number of subjects enrolled
    Taiwan: 42
    Country: Number of subjects enrolled
    Thailand: 76
    Country: Number of subjects enrolled
    Turkey: 22
    Country: Number of subjects enrolled
    United States: 259
    Worldwide total number of subjects
    1518
    EEA total number of subjects
    470
    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)
    606
    Adolescents (12-17 years)
    633
    Adults (18-64 years)
    279
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1536 participants were screened and 1518 were randomized into the study.

    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
    Girls 9 to 14 Years V503 at Months 0 and 6
    Arm description
    Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
    Arm type
    Experimental

    Investigational medicinal product name
    V503
    Investigational medicinal product code
    Other name
    9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection at Months 0 and 6 (initial 2-dose regimen) and Month 36.

    Arm title
    Boys 9 to 14 Years V503 at Months 0 and 6
    Arm description
    Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
    Arm type
    Experimental

    Investigational medicinal product name
    V503
    Investigational medicinal product code
    Other name
    9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection at Months 0 and 6 (initial 2-dose regimen) and Month 36.

    Arm title
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12
    Arm description
    Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
    Arm type
    Experimental

    Investigational medicinal product name
    V503
    Investigational medicinal product code
    Other name
    9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection at Months 0 and 12 (initial 2-dose regimen) and Month 36.

    Arm title
    Girls 9 to 14 Years V503 at Months 0, 2, and 6
    Arm description
    Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
    Arm type
    Experimental

    Investigational medicinal product name
    V503
    Investigational medicinal product code
    Other name
    9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection at Months 0, 2, and 6 (initial 3-dose regimen) and Month 36 (for a subset of participants).

    Arm title
    Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Arm description
    Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
    Arm type
    Active comparator

    Investigational medicinal product name
    V503
    Investigational medicinal product code
    Other name
    9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL IM injection at Months 0, 2, and 6 (initial 3-dose regimen) and Month 36 (for a subset of participants).

    Number of subjects in period 1
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Started
    301
    301
    301
    301
    314
    Vaccination 1
    301
    301
    300
    300
    314
    Vaccination 2
    293
    296
    291
    298
    313
    Vaccination 3
    0 [1]
    0 [2]
    0 [3]
    293
    311
    Month 36 Vaccination
    270
    281
    280
    9 [4]
    31 [5]
    Completed
    258
    270
    272
    280
    279
    Not completed
    43
    31
    29
    21
    35
         Death
    -
    -
    -
    1
    -
         Protocol deviation
    8
    5
    3
    2
    -
         Physician decision
    3
    -
    -
    1
    -
         Missed last follow-up visit
    1
    -
    -
    -
    -
         Pregnancy
    2
    -
    1
    -
    1
         Adverse event, non-fatal
    -
    -
    2
    -
    -
         Consent withdrawn by subject
    15
    21
    13
    11
    13
         Lost to follow-up
    14
    5
    10
    6
    21
    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, participants in this arm were to receive Vaccination 1, Vaccination 2, and the Month 36 vaccination
    [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, participants in this arm were to receive Vaccination 1, Vaccination 2, and the Month 36 vaccination
    [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, participants in this arm were to receive Vaccination 1, Vaccination 2, and the Month 36 vaccination
    [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, only a subset of participants in the arm were to receive the Month 36 vaccination
    [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, only a subset of participants in the arm were to receive the Month 36 vaccination

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Girls 9 to 14 Years V503 at Months 0 and 6
    Reporting group description
    Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.

    Reporting group title
    Boys 9 to 14 Years V503 at Months 0 and 6
    Reporting group description
    Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.

    Reporting group title
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12
    Reporting group description
    Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.

    Reporting group title
    Girls 9 to 14 Years V503 at Months 0, 2, and 6
    Reporting group description
    Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.

    Reporting group title
    Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Reporting group description
    Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.

    Reporting group values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6 Total
    Number of subjects
    301 301 301 301 314 1518
    Age, Customized
    Units: Subjects
        Between 9 and 10 years
    100 98 100 101 0 399
        Between 11 and 12 years
    102 102 106 100 0 410
        Between 13 and 14 years
    99 101 95 100 0 395
        Between 16 and 26 years
    0 0 0 0 314 314
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    11.4 ± 1.7 11.5 ± 1.7 11.4 ± 1.6 11.4 ± 1.7 21.0 ± 2.7 -
    Gender, Male/Female
    Units: Subjects
        Female
    301 0 151 301 314 1067
        Male
    0 301 150 0 0 451

    End points

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    End points reporting groups
    Reporting group title
    Girls 9 to 14 Years V503 at Months 0 and 6
    Reporting group description
    Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.

    Reporting group title
    Boys 9 to 14 Years V503 at Months 0 and 6
    Reporting group description
    Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.

    Reporting group title
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12
    Reporting group description
    Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.

    Reporting group title
    Girls 9 to 14 Years V503 at Months 0, 2, and 6
    Reporting group description
    Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.

    Reporting group title
    Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Reporting group description
    Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.

    Primary: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    258
    263
    257
    254
    238
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1657.9 (1479.6 to 1857.6)
    1557.4 (1391.5 to 1743.1)
    2678.8 (2390.2 to 3002.1)
    1496.1 (1334.1 to 1677.8)
    770.9 (684.8 to 867.9)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Young Women 16 to 26 Years V503 at Months 0, 2, and 6 v Girls 9 to 14 Years V503 at Months 0 and 6
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    < 0.001 [2]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    2.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.83
         upper limit
    2.53
    Notes
    [1] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [2] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    501
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    P-value
    < 0.001 [4]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    2.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.73
         upper limit
    2.36
    Notes
    [3] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [4] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    P-value
    < 0.001 [6]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    3.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.93
         upper limit
    4.11
    Notes
    [5] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [6] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 11 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 11 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    258
    264
    257
    254
    238
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1388.9 (1240.4 to 1555.3)
    1423.9 (1273.2 to 1592.3)
    2941.8 (2626.6 to 3294.9)
    1306.3 (1165.5 to 1464.0)
    580.5 (516.0 to 653.0)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    P-value
    < 0.001 [8]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    2.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.03
         upper limit
    2.82
    Notes
    [7] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [8] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    P-value
    < 0.001 [10]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    5.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.32
         upper limit
    5.94
    Notes
    [9] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [10] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    502
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [11]
    P-value
    < 0.001 [12]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    2.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.09
         upper limit
    2.88
    Notes
    [11] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [12] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 16 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 16 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    273
    264
    269
    249
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    8004.9 (7160.5 to 8948.8)
    8474.8 (7582.4 to 9472.3)
    14329.3 (12796.4 to 16045.9)
    6996.0 (6254.1 to 7825.8)
    3154.0 (2807.1 to 3543.7)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [13]
    P-value
    < 0.001 [14]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    2.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.14
         upper limit
    3
    Notes
    [13] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [14] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [15]
    P-value
    < 0.001 [16]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    4.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.84
         upper limit
    5.37
    Notes
    [15] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [16] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    522
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [17]
    P-value
    < 0.001 [18]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    2.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.29
         upper limit
    3.15
    Notes
    [17] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [18] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 18 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 18 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    272
    266
    270
    267
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1872.8 (1651.6 to 2123.6)
    1860.9 (1641.1 to 2110.2)
    2810.4 (2474.9 to 3191.3)
    2049.3 (1806.4 to 2324.8)
    761.5 (670.8 to 864.5)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [19]
    P-value
    < 0.001 [20]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    2.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.04
         upper limit
    2.92
    Notes
    [19] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [20] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [21]
    P-value
    < 0.001 [22]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    2.46
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.05
         upper limit
    2.96
    Notes
    [21] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [22] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [23]
    P-value
    < 0.001 [24]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    3.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.06
         upper limit
    4.45
    Notes
    [23] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [24] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 31 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 31 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    271
    268
    271
    264
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1436.3 (1272.1 to 1621.8)
    1498.2 (1326.5 to 1692.0)
    2117.5 (1873.7 to 2393.1)
    1748.3 (1548.1 to 1974.5)
    572.1 (505.8 to 647.2)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [25]
    P-value
    < 0.001 [26]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    2.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.1
         upper limit
    3
    Notes
    [25] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [26] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    535
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [27]
    P-value
    < 0.001 [28]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    2.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.2
         upper limit
    3.12
    Notes
    [27] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [28] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [29]
    P-value
    < 0.001 [30]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.08
         upper limit
    4.45
    Notes
    [29] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [30] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 33 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 33 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    273
    271
    269
    275
    279
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1030.0 (920.4 to 1152.7)
    1040.0 (928.9 to 1164.3)
    2197.5 (1961.9 to 2461.3)
    796.4 (712.0 to 890.9)
    348.1 (311.5 to 389.1)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    552
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [31]
    P-value
    < 0.001 [32]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    2.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.5
         upper limit
    3.5
    Notes
    [31] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [32] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [33]
    P-value
    < 0.001 [34]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    2.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.55
         upper limit
    3.5
    Notes
    [33] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [34] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    548
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [35]
    P-value
    < 0.001 [36]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    6.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.36
         upper limit
    7.43
    Notes
    [35] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [36] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 45 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 45 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    274
    273
    268
    275
    280
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    357.6 (313.7 to 407.6)
    352.3 (309.0 to 401.7)
    417.7 (365.9 to 476.9)
    661.7 (580.6 to 754.1)
    213.6 (187.7 to 243.2)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    554
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [37]
    P-value
    < 0.001 [38]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    1.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.38
         upper limit
    2.03
    Notes
    [37] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [38] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    553
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [39]
    P-value
    < 0.001 [40]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    1.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.37
         upper limit
    1.99
    Notes
    [39] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [40] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    548
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [41]
    P-value
    < 0.001 [42]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    1.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.61
         upper limit
    2.37
    Notes
    [41] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [42] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 52 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 52 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    273
    268
    275
    271
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    581.1 (521.9 to 647.1)
    640.4 (575.2 to 713.0)
    1123.4 (1008.1 to 1251.9)
    909.9 (817.6 to 1012.5)
    364.2 (327.0 to 405.6)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [43]
    P-value
    < 0.001 [44]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    1.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.51
         upper limit
    2.05
    Notes
    [43] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [44] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [45]
    P-value
    < 0.001 [46]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.36
         upper limit
    1.87
    Notes
    [45] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [46] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [47]
    P-value
    < 0.001 [48]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    3.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.64
         upper limit
    3.61
    Notes
    [47] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [48] - One-sided non-inferiority test at alpha=0.025 level.

    Primary: Geometric Mean Titers to HPV Type 58 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Geometric Mean Titers to HPV Type 58 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Primary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    270
    270
    265
    273
    261
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1251.2 (1119.6 to 1398.4)
    1325.7 (1186.2 to 1481.6)
    2444.6 (2185.2 to 2734.9)
    1229.3 (1100.7 to 1373.0)
    491.1 (438.6 to 549.8)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [49]
    P-value
    < 0.001 [50]
    Method
    ANOVA
    Parameter type
    GMT ratio
    Point estimate
    2.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.15
         upper limit
    3.01
    Notes
    [49] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [50] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [51]
    P-value
    < 0.001 [52]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    2.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.3
         upper limit
    3.16
    Notes
    [51] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [52] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [53]
    P-value
    < 0.001 [54]
    Method
    ANOVA
    Parameter type
    GMT Ratio
    Point estimate
    4.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.23
         upper limit
    5.86
    Notes
    [53] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
    [54] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 6 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 6 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    258
    263
    257
    254
    238
    Units: Percentage of participants
        number (confidence interval 95%)
    99.6 (97.9 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    99.2 (97.2 to 99.9)
    99.6 (97.7 to 100)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    501
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [55]
    P-value
    < 0.001 [56]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.3
    Notes
    [55] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [56] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [57]
    P-value
    < 0.001 [58]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.8
         upper limit
    2
    Notes
    [57] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [58] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [59]
    P-value
    < 0.001 [60]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    2.3
    Notes
    [59] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [60] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 11 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 11 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    258
    264
    257
    254
    238
    Units: Percentage of participants
        number (confidence interval 95%)
    100 (98.6 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    99.6 (97.8 to 100)
    99.6 (97.7 to 100)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    502
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [61]
    P-value
    < 0.001 [62]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.3
    Notes
    [61] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [62] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [63]
    P-value
    < 0.001 [64]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    2.3
    Notes
    [63] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [64] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [65]
    P-value
    < 0.001 [66]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    2.3
    Notes
    [65] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [66] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 16 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 16 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    273
    264
    269
    249
    Units: Percentage of participants
        number (confidence interval 95%)
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    99.6 (97.8 to 100)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [67]
    P-value
    < 0.001 [68]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.2
    Notes
    [67] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [68] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [69]
    P-value
    < 0.001 [70]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.2
    Notes
    [69] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [70] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    522
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [71]
    P-value
    < 0.001 [72]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.2
    Notes
    [71] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [72] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 18 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 18 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    272
    266
    270
    267
    Units: Percentage of participants
        number (confidence interval 95%)
    100 (98.7 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
    99.6 (98.0 to 100)
    98.5 (96.2 to 99.6)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [73]
    P-value
    < 0.001 [74]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    3.8
    Notes
    [73] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [74] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [75]
    P-value
    < 0.001 [76]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    3.8
    Notes
    [75] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [76] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [77]
    P-value
    < 0.001 [78]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    3.8
    Notes
    [77] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [78] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 31 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 31 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    271
    268
    271
    264
    Units: Percentage of participants
        number (confidence interval 95%)
    99.6 (98.0 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    99.6 (97.9 to 100)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    536
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [79]
    P-value
    < 0.001 [80]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    1.8
    Notes
    [79] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [80] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [81]
    P-value
    < 0.001 [82]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.1
    Notes
    [81] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [82] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    535
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [83]
    P-value
    < 0.001 [84]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.1
    Notes
    [83] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [84] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 33 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 33 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    273
    271
    269
    275
    279
    Units: Percentage of participants
        number (confidence interval 95%)
    99.6 (98.0 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    100 (98.7 to 100)
    99.6 (98.0 to 100)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    552
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [85]
    P-value
    < 0.001 [86]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    1.7
    Notes
    [85] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [86] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    548
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [87]
    P-value
    < 0.001 [88]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    2
    Notes
    [87] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [88] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [89]
    P-value
    < 0.001 [90]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2
    Notes
    [89] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [90] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 45 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 45 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    274
    273
    268
    275
    280
    Units: Percentage of participants
        number (confidence interval 95%)
    99.3 (97.4 to 99.9)
    99.3 (97.4 to 99.9)
    100 (98.6 to 100)
    99.3 (97.4 to 99.9)
    97.9 (95.4 to 99.2)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    553
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [91]
    P-value
    < 0.001 [92]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    4
    Notes
    [91] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [92] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    554
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [93]
    P-value
    < 0.001 [94]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    4
    Notes
    [93] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [94] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    548
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [95]
    P-value
    < 0.001 [96]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    4.6
    Notes
    [95] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [96] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 52 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 52 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    272
    273
    268
    275
    271
    Units: Percentage of participants
        number (confidence interval 95%)
    99.6 (98.0 to 100)
    100 (98.7 to 100)
    100 (98.6 to 100)
    99.6 (98.0 to 100)
    99.6 (98.0 to 100)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [97]
    P-value
    < 0.001 [98]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.1
    Notes
    [97] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [98] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    543
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [99]
    P-value
    < 0.001 [100]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    1.7
    Notes
    [99] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [100] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    539
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [101]
    P-value
    < 0.001 [102]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.1
    Notes
    [101] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [102] - One-sided non-inferiority test at alpha=0.025 level.

    Secondary: Percentage of Participants with Seroconversion to HPV Type 58 After the Last Dose of V503 in the Planned Regimen

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    End point title
    Percentage of Participants with Seroconversion to HPV Type 58 After the Last Dose of V503 in the Planned Regimen
    End point description
    Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    270
    270
    265
    273
    261
    Units: Percentage of participants
        number (confidence interval 95%)
    100 (98.6 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    99.6 (98.0 to 100)
    99.6 (97.9 to 100)
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [103]
    P-value
    < 0.001 [104]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.1
    Notes
    [103] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [104] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [105]
    P-value
    < 0.001 [106]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    2.1
    Notes
    [105] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [106] - One-sided non-inferiority test at alpha=0.025 level.
    Statistical analysis title
    Non-inferiority
    Comparison groups
    Boys 9 to 14 Years V503 at Months 0 and 6 v Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [107]
    P-value
    < 0.001 [108]
    Method
    Miettinen and Nurminen
    Parameter type
    Seroconversion percentage difference
    Point estimate
    0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    2.1
    Notes
    [107] - Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
    [108] - One-sided non-inferiority test at alpha=0.025 level.

    Other pre-specified: Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24

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    End point title
    Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
    End point description
    Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Other pre-specified
    End point timeframe
    Month 24
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    301
    301
    300
    300
    314
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV Type 6 (n=253, 259, 252, 249, 232)
    260.7 (231.5 to 293.6)
    209.1 (185.9 to 235.1)
    574.0 (509.6 to 646.5)
    300.7 (266.8 to 339.0)
    153.2 (135.4 to 173.5)
        Anti-HPV Type 11 (n=253, 260, 252, 249, 232)
    169.8 (150.5 to 191.7)
    150.6 (133.6 to 169.7)
    443.7 (392.9 to 501.0)
    201.9 (178.7 to 228.1)
    98.3 (86.6 to 111.6)
        Anti-HPV Type 16 (n=266, 269, 259, 264, 241)
    900.5 (788.0 to 1028.9)
    801.0 (701.5 to 914.6)
    2316.2 (2023.5 to 2651.4)
    1041.3 (910.8 to 1190.4)
    461.6 (401.2 to 531.0)
        Anti-HPV Type 18 (n=266, 268, 261, 265, 259)
    196.8 (174.9 to 221.6)
    169.6 (150.7 to 190.8)
    380.8 (337.9 to 429.1)
    255.8 (227.2 to 288.0)
    122.2 (108.4 to 137.7)
        Anti-HPV Type 31 (n=266, 267, 263, 266, 258)
    160.6 (140.8 to 183.3)
    139.1 (122.0 to 158.7)
    312.8 (273.9 to 357.1)
    260.6 (228.4 to 297.3)
    89.6 (78.4 to 102.5)
        Anti-HPV Type 33 (n=267, 267, 264, 270, 269)
    131.2 (116.9 to 147.2)
    121.5 (108.3 to 136.4)
    341.7 (304.3 to 383.6)
    120.8 (107.7 to 135.4)
    61.3 (54.6 to 68.7)
        Anti-HPV Type 45 (n=268, 269, 263, 270, 271)
    37.8 (33.2 to 43.0)
    31.9 (28.0 to 36.3)
    62.3 (54.7 to 71.1)
    86.9 (76.4 to 98.9)
    30.7 (27.0 to 34.9)
        Anti-HPV Type 52 (n=266, 269, 263, 270, 261)
    85.1 (76.4 to 94.7)
    80.9 (72.7 to 90.0)
    199.4 (179.0 to 222.2)
    150.4 (135.2 to 167.4)
    73.7 (66.1 to 82.1)
        Anti-HPV Type 58 (n=264, 266, 260, 268, 253)
    155.4 (138.0 to 175.1)
    149.8 (133.1 to 168.6)
    380.2 (337.3 to 428.6)
    183.7 (163.3 to 206.7)
    76.8 (68.0 to 86.7)
    No statistical analyses for this end point

    Other pre-specified: Antibody Persistence: Percentage of Participants with Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24

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    End point title
    Antibody Persistence: Percentage of Participants with Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
    End point description
    Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Other pre-specified
    End point timeframe
    Month 24
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    301
    301
    300
    300
    314
    Units: Percentage of participants
    number (confidence interval 95%)
        Anti-HPV Type 6 (n=253, 259, 252, 249, 232)
    98.4 (96.0 to 99.6)
    96.9 (94.0 to 98.7)
    99.2 (97.2 to 99.9)
    99.6 (97.8 to 100)
    94.0 (90.1 to 96.7)
        Anti-HPV Type 11 (n=253, 260, 252, 249, 232)
    98.0 (95.4 to 99.4)
    95.8 (92.6 to 97.9)
    99.6 (97.8 to 100)
    98.8 (96.5 to 99.8)
    94.8 (91.1 to 97.3)
        Anti-HPV Type 16 (n=266, 269, 259, 264, 241)
    98.9 (96.7 to 99.8)
    99.6 (97.9 to 100)
    100 (98.6 to 100)
    99.6 (97.9 to 100)
    99.6 (97.7 to 100)
        Anti-HPV Type 18 (n=266, 268, 261, 265, 259)
    98.5 (96.2 to 99.6)
    95.9 (92.8 to 97.9)
    98.9 (96.7 to 99.8)
    99.2 (97.3 to 99.9)
    95.0 (91.6 to 97.3)
        Anti-HPV Type 31 (n=266, 267, 263, 266, 258)
    97.0 (94.2 to 98.7)
    94.8 (91.4 to 97.1)
    98.5 (96.2 to 99.6)
    97.7 (95.2 to 99.2)
    91.5 (87.4 to 94.6)
        Anti-HPV Type 33 (n=267, 267, 264, 270, 269)
    97.8 (95.2 to 99.2)
    96.6 (93.7 to 98.4)
    99.2 (97.3 to 99.9)
    98.9 (96.8 to 99.8)
    94.8 (91.4 to 97.1)
        Anti-HPV Type 45 (n=268, 269, 263, 270, 271)
    88.4 (84.0 to 92.0)
    85.9 (81.1 to 89.8)
    93.9 (90.3 to 96.5)
    96.7 (93.8 to 98.5)
    82.7 (77.6 to 87.0)
        Anti-HPV Type 52 (n=266, 269, 263, 270, 261)
    96.6 (93.7 to 98.4)
    95.2 (91.9 to 97.4)
    99.2 (97.3 to 99.9)
    99.3 (97.3 to 99.9)
    97.3 (94.6 to 98.9)
        Anti-HPV Type 58 (n=264, 266, 260, 268, 253)
    98.9 (96.7 to 99.8)
    99.6 (97.9 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
    96.0 (92.9 to 98.1)
    No statistical analyses for this end point

    Other pre-specified: Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36

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    End point title
    Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
    End point description
    Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Other pre-specified
    End point timeframe
    Month 36
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    301
    301
    300
    300
    314
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV Type 6 (n=236, 254, 246, 240, 214)
    209.6 (184.9 to 237.6)
    160.1 (141.9 to 180.7)
    401.2 (354.8 to 453.7)
    232.2 (205.1 to 263.0)
    133.8 (117.3 to 152.7)
        Anti-HPV Type 11 (n=236, 255, 246, 240, 214)
    133.7 (117.6 to 152.1)
    115.2 (101.8 to 130.3)
    308.2 (271.8 to 349.6)
    159.1 (140.0 to 180.7)
    82.9 (72.4 to 94.9)
        Anti-HPV Type 16 (n=248, 263, 253, 255, 222)
    673.8 (582.8 to 779.1)
    592.6 (514.7 to 682.4)
    1534.3 (1328.8 to 1771.5)
    792.4 (686.7 to 914.4)
    368.9 (316.4 to 430.0)
        Anti-HPV Type 18 (n=248, 262, 255, 256, 239)
    158.9 (140.8 to 179.4)
    141.7 (125.9 to 159.4)
    276.4 (245.3 to 311.6)
    206.5 (183.3 to 232.7)
    104.1 (92.0 to 117.8)
        Anti-HPV Type 31 (n=248, 261, 257, 258, 235)
    127.8 (111.4 to 146.5)
    106.9 (93.5 to 122.1)
    218.0 (190.6 to 249.4)
    205.9 (180.0 to 235.5)
    74.6 (64.8 to 85.9)
        Anti-HPV Type 33 (n=249, 261, 258, 261, 246)
    106.0 (94.1 to 119.5)
    95.7 (85.1 to 107.5)
    240.4 (213.8 to 270.3)
    95.5 (85.0 to 107.3)
    52.2 (46.3 to 58.9)
        Anti-HPV Type 45 (n=250, 263, 257, 261, 248)
    30.6 (26.9 to 35.0)
    26.8 (23.6 to 30.4)
    43.6 (38.3 to 49.7)
    66.1 (58.1 to 75.2)
    27.3 (23.9 to 31.1)
        Anti-HPV Type 52 (n=248, 263, 257, 261, 239)
    66.2 (59.1 to 74.0)
    63.4 (56.8 to 70.7)
    143.2 (128.3 to 159.9)
    115.9 (103.9 to 129.3)
    61.5 (54.8 to 68.9)
        Anti-HPV Type 58 (n=246, 261, 255, 259, 231)
    125.8 (111.1 to 142.5)
    119.2 (105.6 to 134.5)
    265.3 (234.8 to 299.8)
    143.0 (126.7 to 161.5)
    64.7 (56.9 to 73.6)
    No statistical analyses for this end point

    Other pre-specified: Antibody Persistence: Percentage of Participants with Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36

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    End point title
    Antibody Persistence: Percentage of Participants with Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
    End point description
    Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay. The per-protocol population included all participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
    End point type
    Other pre-specified
    End point timeframe
    Month 36
    End point values
    Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Number of subjects analysed
    301
    301
    300
    300
    314
    Units: Percentage of participants
    geometric mean (confidence interval 95%)
        Anti-HPV Type 6 (n=236, 254, 246, 240, 214)
    95.3 (91.8 to 97.7)
    91.3 (87.2 to 94.5)
    99.2 (97.1 to 99.9)
    97.9 (95.2 to 99.3)
    92.1 (87.6 to 95.3)
        Anti-HPV Type 11 (n=236, 255, 246, 240, 214)
    94.1 (90.2 to 96.7)
    92.9 (89.1 to 95.8)
    99.2 (97.1 to 99.9)
    98.8 (96.4 to 99.7)
    92.1 (87.6 to 95.3)
        Anti-HPV Type 16 (n=248, 263, 253, 255, 222)
    97.2 (94.3 to 98.9)
    98.5 (96.2 to 99.6)
    100 (98.6 to 100)
    99.2 (97.2 to 99.9)
    98.2 (95.5 to 99.5)
        Anti-HPV Type 18 (n=248, 262, 255, 256, 239)
    95.6 (92.2 to 97.8)
    94.3 (90.7 to 96.8)
    97.6 (94.9 to 99.1)
    97.3 (94.4 to 98.9)
    90.8 (86.4 to 94.1)
        Anti-HPV Type 31 (n=248, 261, 257, 258, 235)
    94.0 (90.2 to 96.6)
    91.2 (87.1 to 94.3)
    96.5 (93.5 to 98.4)
    97.7 (95.0 to 99.1)
    86.0 (80.8 to 90.1)
        Anti-HPV Type 33 (n=249, 261, 258, 261, 246)
    94.0 (90.3 to 96.6)
    96.9 (94.1 to 98.7)
    99.2 (97.2 to 99.9)
    98.1 (95.6 to 99.4)
    91.9 (87.7 to 95.0)
        Anti-HPV Type 45 (n=250, 263, 257, 261, 248)
    83.6 (78.4 to 88.0)
    81.4 (76.1 to 85.9)
    87.9 (83.3 to 91.7)
    91.2 (87.1 to 94.3)
    77.8 (72.1 to 82.8)
        Anti-HPV Type 52 (n=248, 263, 257, 261, 239)
    93.5 (89.7 to 96.3)
    93.9 (90.3 to 96.5)
    98.8 (96.6 to 99.8)
    97.7 (95.1 to 99.2)
    95.0 (91.4 to 97.4)
        Anti-HPV Type 58 (n=246, 261, 255, 259, 231)
    98.0 (95.3 to 99.3)
    99.2 (97.3 to 99.9)
    100 (98.6 to 100)
    98.8 (96.7 to 99.8)
    94.8 (91.1 to 97.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination
    Adverse event reporting additional description
    Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Girls 9 to 14 Years V503 at Months 0 and 6
    Reporting group description
    Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. A challenge dose of V503 0.5 mL IM injection was administered at Month 36.

    Reporting group title
    Young Women 16 to 26 Years V503 at Months 0, 2, and 6
    Reporting group description
    Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. A challenge dose of V503 0.5 mL IM injection was administered at Month 36 for a subset of participants.

    Reporting group title
    Girls 9 to 14 Years V503 at Months 0, 2, and 6
    Reporting group description
    Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. A challenge dose of V503 0.5 mL IM injection was administered at Month 36 for a subset of participants.

    Reporting group title
    Boys 9 to 14 Years V503 at Months 0 and 6
    Reporting group description
    Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. A challenge dose of V503 0.5 mL IM injection was administered at Month 36.

    Reporting group title
    Girls and Boys 9 to 14 Years V503 at Months 0 and 12
    Reporting group description
    Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. A challenge dose of V503 0.5 mL IM injection was administered at Month 36.

    Serious adverse events
    Girls 9 to 14 Years V503 at Months 0 and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 294 (2.04%)
    11 / 313 (3.51%)
    6 / 300 (2.00%)
    9 / 296 (3.04%)
    6 / 293 (2.05%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 313 (0.32%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 294 (0.00%)
    4 / 313 (1.28%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Premature delivery
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 313 (0.32%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 313 (0.32%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalitis autoimmune
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 313 (0.32%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 313 (0.32%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 313 (0.32%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    1 / 296 (0.34%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 313 (0.32%)
    0 / 300 (0.00%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    0 / 300 (0.00%)
    1 / 296 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 294 (0.00%)
    0 / 313 (0.00%)
    1 / 300 (0.33%)
    0 / 296 (0.00%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Girls 9 to 14 Years V503 at Months 0 and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 294 (18.03%)
    90 / 313 (28.75%)
    55 / 300 (18.33%)
    32 / 296 (10.81%)
    46 / 293 (15.70%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 294 (2.72%)
    16 / 313 (5.11%)
    7 / 300 (2.33%)
    9 / 296 (3.04%)
    7 / 293 (2.39%)
         occurrences all number
    9
    19
    8
    9
    8
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    49 / 294 (16.67%)
    80 / 313 (25.56%)
    53 / 300 (17.67%)
    28 / 296 (9.46%)
    41 / 293 (13.99%)
         occurrences all number
    65
    148
    81
    31
    52

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2015
    Amendment 1: Added peripheral blood mononuclear cell (PBMC) collection and testing at Month 24; added U.S. sites and IND number; added participants for PBMC testing.

    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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