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    Clinical Trial Results:
    A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity, Safety and Tolerability of Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years

    Summary
    EudraCT number
    		 2023-001144-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 Mar 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Mar 2025
    First version publication date
    20 Sep 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V501-213
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    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?
    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
    30 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus [qHPV] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The study consisted of Base and Extension Stage. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years. After Base Stage, girls aged 9-19 years old entered Extension Stage to evaluate persistence of immune responses for up to 60 months postvacciantion 1.
    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
    31 Aug 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 60 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 766
    Worldwide total number of subjects
    766
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    102
    Adolescents (12-17 years)
    187
    Adults (18-64 years)
    477
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Chinese girls aged 9 to19 years and young women aged 20 to 26 years were enrolled

    Period 1
    Period 1 title
    Base Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chinese Girls Aged 9 to 19 Years
    Arm description
    		 Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
    Arm type
    		 Experimental

    Investigational medicinal product name
    V501
    Investigational medicinal product code
    Other name
    (Gardasil®) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine qHPV
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6

    Arm title
    		 Chinese Young Women Aged 20 to 26 Years
    Arm description
    		 Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
    Arm type
    		 Active comparator

    Investigational medicinal product name
    V501
    Investigational medicinal product code
    Other name
    (Gardasil®) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine qHPV
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6

    Number of subjects in period 1
    		Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Started
    383
    383
    Vaccination 1
    383
    383
    Vaccination 2
    379 [1]
    378 [2]
    Vaccination 3
    378 [3]
    377 [4]
    Completed
    383
    379
    Not completed
    0
    4
         Consent withdrawn by subject
    -
    4
    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: The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected the number of subjects will be greater than, or equal to the number that completed minus those that left.
    [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: Some participants missed Vaccination visits 2 (month 2) and 3 (month 3) but returned to Month 60 visit.
    [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: Some participants missed Vaccination visits 2 (month 2) and 3 (month 3) but returned to Month 60 visit.
    [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: Some participants missed Vaccination visits 2 (month 2) and 3 (month 3) but returned to Month 60 visit.
    Period 2
    Period 2 title
    Extension Study
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Arm description
    		 In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [5]
    		Extension Study: Chinese Girls Aged 9 to 19 Years
    Started
    365
    Completed
    338
    Not completed
    27
         Consent withdrawal by parent/guardian
    2
         Consent withdrawn by subject
    25
    Notes
    [5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Per protocol, the subject disposition for this extension study included only 1 treatment arm: Chinese Girls Aged 9 to 19 Years.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Chinese Girls Aged 9 to 19 Years
    Reporting group description
    		 Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Reporting group title
    Chinese Young Women Aged 20 to 26 Years
    Reporting group description
    		 Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Reporting group values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years Total
    Number of subjects
    		 383 383 766
    Age categorical
    Units: Subjects
        Chinese Girls Aged 9 to 19 years
    		 383 0 383
        Chinese Young Women Aged 20 to 26 Years
    		 0 383 383
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ( 3.3 ) 23.4 ( 1.8 ) -
    Sex: Female, Male
    Units:
        Female
    		 383 383 766
        Male
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 383 383 766
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 383 383 766
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 0 0 0
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Chinese Girls Aged 9 to 19 Years
    Reporting group description
    		 Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Reporting group title
    Chinese Young Women Aged 20 to 26 Years
    Reporting group description
    		 Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
    Reporting group title
    Extension Study: Chinese Girls Aged 9 to 19 Years
    Reporting group description
    		 In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT).

    Primary: Base Stage: Geometric Mean Titers (GMTs) for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 Assessed by Competitive Luminex Immunoassay (cLIA)

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    End point title
    		 Base Stage: Geometric Mean Titers (GMTs) for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 Assessed by Competitive Luminex Immunoassay (cLIA)
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years and Chinese young women aged 20 to 26 years (base study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 7 (1 month postdose 3)
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n= 343; 315)
    975.2 (905.6 to 1050.2)
    686.6 (635.5 to 741.7)
        Anti-HPV 11 (n= 343; 315)
    807.4 (749.8 to 869.4)
    580.2 (537.0 to 626.8)
        Anti-HPV 16 (n=354; 330)
    4573.7 (4244.5 to 4928.3)
    2989.2 (2766.7 to 3229.6)
        Anti-HPV 18 (n=333; 318)
    1176.5 (1069.0 to 1294.8)
    708.6 (642.4 to 781.6)
    Statistical analysis title
    		 GMT Ratio for HPV 6
    Statistical analysis description
    Anti-HPV 6
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 GMT Ratio
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 1.58
    Notes
    [1] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.
    Statistical analysis title
    		 GMT Ratio for HPV 11
    Statistical analysis description
    Anti-HPV 11
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 GMT Ratio
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.55
    Notes
    [2] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.
    Statistical analysis title
    		 GMT Ratio for HPV 16
    Statistical analysis description
    Anti-HPV 16
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 GMT Ratio
    Point estimate
    1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 1.7
    Notes
    [3] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.
    Statistical analysis title
    		 GMT Ratio for HPV 18
    Statistical analysis description
    Anti-HPV 18
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 GMT Ratio
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.45
         upper limit
    		 1.9
    Notes
    [4] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.

    Primary: Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA

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    End point title
    		 Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA [5]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 12 post-vaccination 1
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=328)
    259.1 (237.6 to 282.4)
        Anti-HPV 11 (n=328)
    206.7 (190.5 to 224.3)
        Anti-HPV 16 (n=338)
    1149.8 (1054.6 to 1253.7)
        Anti-HPV 18 (n=320)
    284.2 (257.3 to 313.8)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA

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    End point title
    		 Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA [6]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 24 post-vaccination 1
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=322)
    137.9 (125.5 to 151.4)
        Anti-HPV 11 (n=322)
    110.3 (101.0 to 120.6)
        Anti-HPV 16 (n=333)
    522.6 (472.1 to 578.5)
        Anti-HPV 18 (n=316)
    157.2 (142.7 to 173.3)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA

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    End point title
    		 Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA [7]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 36 post-vaccination 1
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=318)
    110.6 (101.3 to 120.7)
        Anti-HPV 11 (n=318)
    87.0 (79.6 to 95.2)
        Anti-HPV 16 (n=329)
    400.8 (359.5 to 446.8)
        Anti-HPV 18 (n=312)
    131.9 (120.2 to 144.8)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA

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    End point title
    		 Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA [8]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 48 post-vaccination 1
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=311)
    103.0 (94.4 to 112.4)
        Anti-HPV 11 (n=311)
    81.8 (74.8 to 89.3)
        Anti-HPV 16 (n=321)
    347.5 (310.0 to 389.6)
        Anti-HPV 18 (n=305)
    130.3 (118.9 to 142.7)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA

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    End point title
    		 Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA [9]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 60 post-vaccination 1
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=307)
    87.6 (80.4 to 95.4)
        Anti-HPV 11 (n=307)
    67.3 (61.6 to 73.5)
        Anti-HPV 16 (n=317)
    283.2 (250.8 to 319.8)
        Anti-HPV 18 (n=302)
    113.6 (103.7 to 124.5)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA [10]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 12 post-vaccination 1
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=328)
    99.1 (97.4 to 99.8)
        Anti-HPV 11 (n=328)
    99.7 (98.3 to 100.0)
        Anti-HPV 16 (n=338)
    100.0 (98.9 to 100.0)
        Anti-HPV 18 (n=320)
    96.9 (94.3 to 98.5)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA [11]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 24 post-vaccination 1
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=322)
    88.8 (84.9 to 92.0)
        Anti-HPV 11 (n=322)
    95.3 (92.4 to 97.4)
        Anti-HPV 16 (n=333)
    99.7 (98.3 to 100.0)
        Anti-HPV 18 (n=316)
    87.7 (83.5 to 91.1)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA [12]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 36 post-vaccination 1
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=318)
    83.6 (79.1 to 87.5)
        Anti-HPV 11 (n=318)
    92.1 (88.6 to 94.8)
        Anti-HPV 16 (n=329)
    98.8 (96.9 to 99.7)
        Anti-HPV 18 (n=312)
    84.0 (79.4 to 87.9)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA [13]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 48 post-vaccination 1
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=311)
    68.5 (63.0 to 73.6)
        Anti-HPV 11 (n=311)
    85.2 (80.8 to 89.0)
        Anti-HPV 16 (n=321)
    91.9 (88.4 to 94.6)
        Anti-HPV 18 (n=305)
    64.6 (58.9 to 70.0)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA [14]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 60 post-vaccination 1
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=307)
    61.9 (56.2 to 67.3)
        Anti-HPV 11 (n=307)
    74.9 (69.7 to 79.7)
        Anti-HPV 16 (n=317)
    87.1 (82.9 to 90.6)
        Anti-HPV 18 (n=302)
    58.3 (52.5 to 63.9)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

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    End point title
    		 Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) [15]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 12 post-vaccination 1
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=328)
    217.0 (198.1 to 237.6)
        Anti-HPV 11 (n=328)
    172.1 (158.3 to 187.1)
        Anti-HPV 16 (n=338)
    1025.8 (945.5 to 1113.0)
        Anti-HPV 18 (n=320)
    228.0 (204.4 to 254.4)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

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    End point title
    		 Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) [16]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 24 post-vaccination 1
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=322)
    85.5 (76.4 to 95.6)
        Anti-HPV 11 (n=322)
    68.6 (61.6 to 76.4)
        Anti-HPV 16 (n=333)
    394.9 (354.6 to 439.9)
        Anti-HPV 18 (n=316)
    76.9 (67.0 to 88.3)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

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    End point title
    		 Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) [17]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 36 post-vaccination 1
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=318)
    66.5 (59.6 to 74.1)
        Anti-HPV 11 (n=318)
    52.7 (47.2 to 58.8)
        Anti-HPV 16 (n=329)
    304.0 (272.2 to 339.5)
        Anti-HPV 18 (n=312)
    57.5 (50.0 to 66.1)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

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    End point title
    		 Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) [18]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 48 post-vaccination 1
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=311)
    63.4 (56.8 to 70.8)
        Anti-HPV 11 (n=311)
    51.1 (45.9 to 56.9)
        Anti-HPV 16 (n=321)
    289.6 (258.7 to 324.2)
        Anti-HPV 18 (n=305)
    55.3 (47.8 to 63.9)
    No statistical analyses for this end point

    Primary: Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)

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    End point title
    		 Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) [19]
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 60 post-vaccination 1
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=307)
    58.6 (52.5 to 65.4)
        Anti-HPV 11 (n=307)
    47.2 (42.4 to 52.5)
        Anti-HPV 16 (n=317)
    264.3 (235.8 to 296.3)
        Anti-HPV 18 (n=302)
    51.0 (44.0 to 59.1)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA [20]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 12 post-vaccination 1
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=328)
    100.0 (98.9 to 100.0)
        Anti-HPV 11 (n=328)
    100.0 (98.9 to 100.0)
        Anti-HPV 16 (n=338)
    100.0 (98.9 to 100.0)
        Anti-HPV 18 (n=320)
    100.0 (98.9 to 100.0)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA [21]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 24 post-vaccination 1
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=322)
    98.4 (96.4 to 99.5)
        Anti-HPV 11 (n=322)
    98.4 (96.4 to 99.5)
        Anti-HPV 16 (n=333)
    100.0 (98.9 to 100.0)
        Anti-HPV 18 (n=316)
    98.1 (95.9 to 99.3)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA [22]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 36 post-vaccination 1
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=318)
    98.1 (95.9 to 99.3)
        Anti-HPV 11 (n=318)
    99.4 (97.7 to 99.9)
        Anti-HPV 16 (n=329)
    100.0 (98.9 to 100.0)
        Anti-HPV 18 (n=312)
    96.2 (93.4 to 98.0)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA [23]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 48 post-vaccination 1
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n =311)
    97.4 (95.0 to 98.9)
        Anti-HPV 11 (n =311)
    98.4 (96.3 to 99.5)
        Anti-HPV 16 (n =321)
    100.0 (98.9 to 100.0)
        Anti-HPV 18 (n =305)
    95.1 (92.0 to 97.2)
    No statistical analyses for this end point

    Primary: Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA

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    End point title
    		 Extension Stage: Percentage of Participants with Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA [24]
    End point description
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. Per protocol, the analysis population included Chinese girls aged 9 to 19 years (in extension study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Primary
    End point timeframe
    Month 60 post-vaccination 1
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this outcome measure.
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=307)
    96.7 (94.1 to 98.4)
        Anti-HPV 11 (n=307)
    98.4 (96.2 to 99.5)
        Anti-HPV 16 (n=317)
    100.0 (98.8 to 100.0)
        Anti-HPV 18 (n=302)
    95.4 (92.3 to 97.4)
    No statistical analyses for this end point

    Secondary: Base Stage: Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: cLIA

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    End point title
    		 Base Stage: Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: cLIA
    End point description
    Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 1 month post dose 3. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years and Chinese young women aged 20 to 26 years (base study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month postdose 3)
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: Percentage of Participants
    number (not applicable)
        Anti-HPV 6 (n=343; 315)
    100.0
    100.0
        Anti-HPV 11 (n=343; 315)
    100.0
    100.0
        Anti-HPV 16 (n=354; 330)
    100.0
    100.0
        Anti-HPV 18 (n=333; 318)
    100.0
    100.0
    Statistical analysis title
    		 Difference of Seroconversion percentage HPV 6
    Statistical analysis description
    Anti-HPV 6
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [25]
    P-value
    		 < 0.0001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentages (%)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.2
    Notes
    [25] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.
    Statistical analysis title
    		 Difference of Seroconversion percentage HPV 16
    Statistical analysis description
    Anti-HPV 16
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [26]
    P-value
    		 < 0.0001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in %
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.2
    Notes
    [26] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.
    Statistical analysis title
    		 Difference of Seroconversion percentage HPV 18
    Statistical analysis description
    Anti-HPV 18
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [27]
    P-value
    		 < 0.0001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in %
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.2
    Notes
    [27] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.
    Statistical analysis title
    		 Difference of Seroconversion percentage HPV 11
    Statistical analysis description
    Anti-HPV 11
    Comparison groups
    Chinese Girls Aged 9 to 19 Years v Chinese Young Women Aged 20 to 26 Years
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    		 [28]
    P-value
    		 < 0.0001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in %
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.2
    Notes
    [28] - The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.

    Secondary: Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA

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    End point title
    		 Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA
    End point description
    Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years and Chinese young women aged 20 to 26 years (base study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month postdose 3)
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 6 (n=343; 315)
    902.7 (831.2 to 980.3)
    604.5 (554.7 to 658.8)
        Anti-HPV 11 (n=343; 315)
    756.2 (695.7 to 821.9)
    518.7 (475.5 to 565.9)
        Anti-HPV 16 (n=354; 330)
    4170.0 (3849.3 to 4517.4)
    2659.3 (2447.8 to 2889.0)
        Anti-HPV 18 (n=333; 318)
    1012.8 (918.7 to 1116.5)
    612.0 (553.9 to 676.1)
    No statistical analyses for this end point

    Secondary: Base Stage: Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA

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    End point title
    		 Base Stage: Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA
    End point description
    Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 1 month post dose 3. Antibodies were measured using a IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). Per protocol, the analysis population included Chinese girls aged 9 to 19 years and Chinese young women aged 20 to 26 years (base study) with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month postdose 3)
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: Percentage of Participants
    number (not applicable)
        Anti-HPV 6 (n=343; 315)
    100.0
    100.0
        Anti-HPV 11 (n=343; 315)
    100.0
    100.0
        Anti-HPV 16 (n=354; 330)
    100.0
    100.0
        Anti-HPV 18 (n=333; 318)
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Base Stage: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

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    End point title
    		 Base Stage: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus. The analysis population concisted of participants who recieved at least one dose of study vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 15 days after any vaccination
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: Percentage of Participants
        number (not applicable)
    36.6
    40.7
    No statistical analyses for this end point

    Secondary: Base Stage: Percentage of Participants With a Solicited Systemic AE

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    End point title
    		 Base Stage: Percentage of Participants With a Solicited Systemic AE
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough. The analysis population concisted of participants who recieved at least one dose of study vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 15 days after any vaccination
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: Percentage of Participants
        number (not applicable)
    39.9
    42.0
    No statistical analyses for this end point

    Secondary: Base Stage: Percentage of Participants Who Have a Serious Adverse Event (SAE)

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    End point title
    		 Base Stage: Percentage of Participants Who Have a Serious Adverse Event (SAE)
    End point description
    An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition. The analysis population concisted of participants who recieved at least one dose of study vaccination.
    End point type
    Secondary
    End point timeframe
    Up to Month 7 (1 month postdose 3)
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: Percentage of Participants
        number (not applicable)
    1.6
    2.87
    No statistical analyses for this end point

    Secondary: Base Stage: Percentage of Participants With Any AE

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    End point title
    		 Base Stage: Percentage of Participants With Any AE
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The analysis population concisted of participants who recieved at least one dose of study vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 31 days after any vaccination
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: Percentage of Participants
        number (not applicable)
    61.6
    68.9
    No statistical analyses for this end point

    Secondary: Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria

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    End point title
    		 Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
    End point description
    In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range. The analysis population concisted of participants who recieved at least one dose of study vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after any vaccination
    End point values
    		 Chinese Girls Aged 9 to 19 Years Chinese Young Women Aged 20 to 26 Years
    Number of subjects analysed
    383
    383
    Units: Percentage of Participants
    number (not applicable)
        < 37.2 °C (99.0 °F)
    87.2
    84.9
        ≥37.2 °C (99.0 °F) and < 38.3 °C (100.9 °F)
    12.3
    14.9
        ≥ 38.3 °C (100.9 °F) and < 39.3 °C (102.7 °F)
    0.3
    0.3
        ≥ 39.3 °C (102.7 °F) and < 40.3 °C (104.5 °F)
    0.3
    0.0
        ≥ 40.3 °C (104.5 °F)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Extension Stage: Percentage of Participants Who Have a Serious Adverse Event

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    End point title
    		 Extension Stage: Percentage of Participants Who Have a Serious Adverse Event
    End point description
    The percentage of participants with an SAE were assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition. The analysis population consisted of all participants who received at least 1 dose of study vaccination and had clinical follow-up for safety.
    End point type
    Secondary
    End point timeframe
    Month 7 up to Month 60
    End point values
    		 Extension Study: Chinese Girls Aged 9 to 19 Years
    Number of subjects analysed
    365
    Units: Percentage of Participants
        number (not applicable)
    2.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Chinese Girls Aged 9 to 19 Years (Base Study)
    Reporting group description
    		 -

    Reporting group title
    Chinese Girls Aged 9 to 19 Years (Extension Study)
    Reporting group description
    		 -

    Reporting group title
    Chinese Young Women Aged 20 to 26 Years (Base Study)
    Reporting group description
    		 -

    Serious adverse events
    		 Chinese Girls Aged 9 to 19 Years (Base Study) Chinese Girls Aged 9 to 19 Years (Extension Study) Chinese Young Women Aged 20 to 26 Years (Base Study)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 383 (1.57%)
    8 / 365 (2.19%)
    11 / 383 (2.87%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ependymoma
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Peroneal nerve injury
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatic nerve injury
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abortion missed
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oligohydramnios
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperemesis gravidarum
         subjects affected / exposed
    0 / 383 (0.00%)
    2 / 365 (0.55%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abortion threatened
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foetal distress syndrome
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertrophic anal papilla
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic adhesions
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mammary duct ectasia
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrosalpinx
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulval eczema
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urethral
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Gastrointestinal somatic symptom disorder
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Helicobacter infection
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    1 / 383 (0.26%)
    0 / 365 (0.00%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial vulvovaginitis
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 383 (0.00%)
    0 / 365 (0.00%)
    1 / 383 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 383 (0.00%)
    1 / 365 (0.27%)
    0 / 383 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Chinese Girls Aged 9 to 19 Years (Base Study) Chinese Girls Aged 9 to 19 Years (Extension Study) Chinese Young Women Aged 20 to 26 Years (Base Study)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    216 / 383 (56.40%)
    0 / 365 (0.00%)
    238 / 383 (62.14%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    32 / 383 (8.36%)
    0 / 365 (0.00%)
    42 / 383 (10.97%)
         occurrences all number
    47
    0
    51
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    122 / 383 (31.85%)
    0 / 365 (0.00%)
    152 / 383 (39.69%)
         occurrences all number
    189
    0
    233
    Injection site pruritus
         subjects affected / exposed
    32 / 383 (8.36%)
    0 / 365 (0.00%)
    16 / 383 (4.18%)
         occurrences all number
    33
    0
    20
    Pyrexia
         subjects affected / exposed
    104 / 383 (27.15%)
    0 / 365 (0.00%)
    108 / 383 (28.20%)
         occurrences all number
    196
    0
    194
    Fatigue
         subjects affected / exposed
    41 / 383 (10.70%)
    0 / 365 (0.00%)
    42 / 383 (10.97%)
         occurrences all number
    59
    0
    57
    Injection site swelling
         subjects affected / exposed
    22 / 383 (5.74%)
    0 / 365 (0.00%)
    11 / 383 (2.87%)
         occurrences all number
    25
    0
    14
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    15 / 383 (3.92%)
    0 / 365 (0.00%)
    31 / 383 (8.09%)
         occurrences all number
    18
    0
    33
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    16 / 383 (4.18%)
    0 / 365 (0.00%)
    29 / 383 (7.57%)
         occurrences all number
    16
    0
    30
    Cough
         subjects affected / exposed
    37 / 383 (9.66%)
    0 / 365 (0.00%)
    41 / 383 (10.70%)
         occurrences all number
    40
    0
    47

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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