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    Clinical Trial Results:
    A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL™ (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study)

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2014-005717-23
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    01 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Feb 2016
    First version publication date
    06 Feb 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    V501-018
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00092547
    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., +1 1-800-672-6371, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., +1 1-800-672-6371, 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
    01 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2005
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).
    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. The following additional measure defined for this study was in place for the protection of trial participants: Participants who received placebo vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen in the extension study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Oct 2003
    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
    Colombia: 171
    Country: Number of subjects enrolled
    Denmark: 161
    Country: Number of subjects enrolled
    United States: 740
    Country: Number of subjects enrolled
    Mexico: 146
    Country: Number of subjects enrolled
    Norway: 34
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Spain: 90
    Country: Number of subjects enrolled
    Taiwan: 52
    Country: Number of subjects enrolled
    Thailand: 160
    Country: Number of subjects enrolled
    United Kingdom: 218
    Worldwide total number of subjects
    1781
    EEA total number of subjects
    512
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    1781
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    1781 participants were randomized to receive qHPV or Placebo in the Base Study. At Month 30, participants who received Placebo in the Base Study were eligible to receive qHPV, and formed the Extension Group. Participants were to be followed for safety and efficacy for up to 10 years. Abbreviations: D=Day; M=Month.

    Pre-assignment
    Screening details
    The study enrolled healthy preadolescents and adolescents aged 9 to 15 years of age.

    Period 1
    Period 1 title
    Base Study Vaccine Phase (D1 to M7)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    Placebo in Base Study
    Arm description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Number of subjects in period 1
    qHPV Vaccine in Base Study Placebo in Base Study
    Started
    1184
    597
    Vaccinated in Base Study
    1179
    596
    Completed
    1121
    561
    Not completed
    63
    36
         Not Vaccinated
             5
             1
         Moved
             3
             1
         per sponsor request: (noncompliant)
             -
             1
         Adverse event, non-fatal
             4
             1
         Refused Vaccination
             5
             3
         Consent withdrawn by subject
             28
             21
         Did not meet local regulations
             -
             1
         Lost to follow-up
             18
             7
    Period 2
    Period 2 title
    Base Study Follow-up Phase (M7 to M18)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered between Month 7 and 18.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    Placebo in Base Study
    Arm description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6. No study treatment was administered between Month 7 and 18.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Number of subjects in period 2
    qHPV Vaccine in Base Study Placebo in Base Study
    Started
    1121
    561
    Completed
    1108
    551
    Not completed
    20
    14
         Protocol deviation
             1
             -
         Subject moved
             1
             5
         Physician decision
             1
             -
         Consent withdrawn by subject
             4
             2
         Lost to follow-up
             13
             7
    Joined
    7
    4
         Previously discontinued and re-entered study
             7
             4
    Period 3
    Period 3 title
    Base Study Follow-up Phase (M18 to M30)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered between Month 18 and 30.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    Placebo in Base Study
    Arm description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6. No study treatment was administered between Month 18 and 30.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Number of subjects in period 3 [1]
    qHPV Vaccine in Base Study Placebo in Base Study
    Started
    964
    490
    Completed
    956
    485
    Not completed
    8
    5
         Protocol deviation
             1
             -
         Subject moved
             4
             2
         Consent withdrawn by subject
             1
             3
         Lost to follow-up
             2
             -
    Notes
    [1] - 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: Includes participants who re-entered the study
    Period 4
    Period 4 title
    Ext Study Vaccine Phase (M30 to M37)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered between Month 30 and 37.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    qHPV Vaccine in Extension Study
    Arm description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Month 30, 32, and 36

    Number of subjects in period 4
    qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
    Started
    956
    485
    Vaccinated in Extension Study
    0 [2]
    482
    Completed
    933
    469
    Not completed
    23
    16
         Subject moved
             3
             -
         Consent withdrawn by subject
             6
             9
         Lost to follow-up
             14
             7
    Notes
    [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: Includes participants who re-entered the study
    Period 5
    Period 5 title
    Long-term Follow-up (M42 visit)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 42 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    qHPV Vaccine in Extension Study
    Arm description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 42 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Month 30, 32, and 36

    Number of subjects in period 5 [3]
    qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
    Started
    612
    308
    Completed
    611
    308
    Not completed
    1
    0
         Adverse event, non-fatal
             1
             -
    Notes
    [3] - 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: Includes participants who re-entered the study
    Period 6
    Period 6 title
    Long-term Follow-up (M72 visit)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 72 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    qHPV Vaccine in Extension Study
    Arm description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 72 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Month 30, 32, and 36

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Number of subjects in period 6 [4]
    qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
    Started
    550
    276
    Completed
    550
    276
    Notes
    [4] - 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: Includes participants who re-entered the study
    Period 7
    Period 7 title
    Long-term Follow-up (M96 visit)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 96 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    qHPV Vaccine in Extension Study
    Arm description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 96 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Month 30, 32, and 36

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Number of subjects in period 7 [5]
    qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
    Started
    508
    267
    Completed
    508
    267
    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: Includes participants who re-entered the study
    Period 8
    Period 8 title
    Long-term Follow-up (M126 visit)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    qHPV Vaccine in Base Study
    Arm description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 126 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Arm title
    qHPV Vaccine in Extension Study
    Arm description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 126 visit.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection at Month 30, 32, and 36

    Number of subjects in period 8 [6]
    qHPV Vaccine in Base Study qHPV Vaccine in Extension Study
    Started
    454
    211
    Completed
    454
    211
    Notes
    [6] - 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: Includes participants who re-entered the study

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.

    Reporting group title
    Placebo in Base Study
    Reporting group description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.

    Reporting group values
    qHPV Vaccine in Base Study Placebo in Base Study Total
    Number of subjects
    1184 597 1781
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.9 ± 1.9 11.8 ± 1.9 -
    Gender categorical
    Units: Subjects
        Female
    616 322 938
        Male
    568 275 843
    Race / Ethnicity
    Units: Subjects
        Asian
    149 70 219
        Black
    50 21 71
        Hispanic American
    260 130 390
        Native American
    0 1 1
        White
    716 369 1085
        Other
    9 6 15

    End points

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    End points reporting groups
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.

    Reporting group title
    Placebo in Base Study
    Reporting group description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered between Month 7 and 18.

    Reporting group title
    Placebo in Base Study
    Reporting group description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6. No study treatment was administered between Month 7 and 18.
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered between Month 18 and 30.

    Reporting group title
    Placebo in Base Study
    Reporting group description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6. No study treatment was administered between Month 18 and 30.
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered between Month 30 and 37.

    Reporting group title
    qHPV Vaccine in Extension Study
    Reporting group description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 42 visit.

    Reporting group title
    qHPV Vaccine in Extension Study
    Reporting group description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 42 visit.
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 72 visit.

    Reporting group title
    qHPV Vaccine in Extension Study
    Reporting group description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 72 visit.
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 96 visit.

    Reporting group title
    qHPV Vaccine in Extension Study
    Reporting group description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 96 visit.
    Reporting group title
    qHPV Vaccine in Base Study
    Reporting group description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6. No study treatment was administered at the Month 126 visit.

    Reporting group title
    qHPV Vaccine in Extension Study
    Reporting group description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. No study treatment was administered at the Month 126 visit.

    Subject analysis set title
    qHPV Vaccine in Base Study: Safety Analysis
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6

    Subject analysis set title
    Placebo Vaccine in Base Study: Safety Analysis
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1,Month 2, and Month 6

    Subject analysis set title
    qHPV Vaccine in Extension Study: Safety Analysis
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.

    Subject analysis set title
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6 and had immunogenicity follow-up.

    Subject analysis set title
    qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 and had immunogenicity follow-up.

    Subject analysis set title
    qHPV in Base Study: Effectiveness Analysis
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6 and had effectiveness follow-up.

    Subject analysis set title
    qHPV Vaccine in Extension Study: Effectiveness Analysis
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 and had effectiveness follow-up.

    Primary: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18

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    End point title
    Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 [1]
    End point description
    Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. The analysis population was all participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up during the time frame.
    End point type
    Primary
    End point timeframe
    Up to Month 18
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical hypothesis was planned for: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
    End point values
    qHPV Vaccine in Base Study: Safety Analysis Placebo Vaccine in Base Study: Safety Analysis
    Number of subjects analysed
    1165
    584
    Units: Participants
    6
    0
    No statistical analyses for this end point

    Primary: Number of Participants Reporting SAEs from Month 18 through Month 37

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    End point title
    Number of Participants Reporting SAEs from Month 18 through Month 37 [2]
    End point description
    Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37. The analysis population was all participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up during the time frame.
    End point type
    Primary
    End point timeframe
    Month 18 to Month 37
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical hypothesis was planned for: Number of Participants Reporting SAEs from Month 18 through Month 37
    End point values
    qHPV Vaccine in Base Study: Safety Analysis qHPV Vaccine in Extension Study: Safety Analysis
    Number of subjects analysed
    923
    477
    Units: Participants
    0
    3
    No statistical analyses for this end point

    Primary: Number of Participants Reporting Other (non-serious) AEs Through Month 18

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    End point title
    Number of Participants Reporting Other (non-serious) AEs Through Month 18 [3]
    End point description
    Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. The analysis population was all participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up during the time frame.
    End point type
    Primary
    End point timeframe
    Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical hypothesis was planned for: Number of Participants Reporting Other (non-serious) AEs Through Month 18
    End point values
    qHPV Vaccine in Base Study: Safety Analysis Placebo Vaccine in Base Study: Safety Analysis
    Number of subjects analysed
    1165
    584
    Units: Participants
    918
    340
    No statistical analyses for this end point

    Primary: Percentage of Participants Who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72

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    End point title
    Percentage of Participants Who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 [4]
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
    End point type
    Primary
    End point timeframe
    Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
    Notes
    [4] - 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 hypothesis was planned for: Percentage of Participants Who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    550
    276
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=475, 151
    93.3 (90.6 to 95.3)
    91.4 (85.7 to 95.3)
        Type 11: n=475, 151
    96 (93.8 to 97.6)
    96.7 (92.4 to 98.9)
        Type 16: n=473, 154
    97.9 (96.1 to 99)
    97.4 (93.5 to 99.3)
        Type 18: n=477, 160
    74.4 (70.3 to 78.3)
    79.4 (72.3 to 85.4)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) for anti-HPV 6, 11, 16, and 18 at Month 72

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    End point title
    Geometric Mean Titers (GMTs) for anti-HPV 6, 11, 16, and 18 at Month 72 [5]
    End point description
    Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
    End point type
    Primary
    End point timeframe
    Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
    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 hypothesis was planned for: Geometric Mean Titers (GMTs) for anti-HPV 6, 11, 16, and 18 at Month 72
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    550
    276
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=475, 151
    118.9 (108.4 to 130.4)
    113.9 (95.7 to 135.6)
        Type 11: n=475, 151
    135.7 (122.6 to 150.3)
    137.9 (114.9 to 165.5)
        Type 16: n=473, 154
    521.2 (466.2 to 582.6)
    485.8 (396.4 to 595.3)
        Type 18: n=477, 160
    70.9 (61.8 to 81.4)
    67.7 (53.1 to 86.3)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers for anti-HPV 6, 11, 16, and 18 at Month 96

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    End point title
    Geometric Mean Titers for anti-HPV 6, 11, 16, and 18 at Month 96 [6]
    End point description
    Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
    End point type
    Primary
    End point timeframe
    Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)
    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 hypothesis was planned for: Geometric Mean Titers for anti-HPV 6, 11, 16, and 18 at Month 96
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    508
    267
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=451, 141
    71.4 (64.6 to 79)
    91 (76.4 to 108.6)
        Type 11: n=451, 141
    67.5 (60.1 to 75.7)
    90.3 (74 to 110.1)
        Type 16: n=447, 143
    325.5 (288.6 to 367.1)
    387.4 (314.7 to 476.9)
        Type 18: n=452, 152
    41.6 (36.5 to 47.5)
    48.3 (37.6 to 62)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96

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    End point title
    Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 [7]
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
    End point type
    Primary
    End point timeframe
    Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)
    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 hypothesis was planned for: Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    508
    267
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=451, 141
    88.2 (84.9 to 91.1)
    91.5 (85.6 to 95.5)
        Type 11: n=451, 141
    89.1 (85.9 to 91.9)
    93.6 (88.2 to 97)
        Type 16: n=447, 143
    96.9 (94.8 to 98.3)
    97.9 (94 to 99.6)
        Type 18: n=452, 152
    63.9 (59.3 to 68.4)
    69.1 (61.1 to 76.3)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers for anti-HPV 6, 11, 16, and 18 at Month 126

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    End point title
    Geometric Mean Titers for anti-HPV 6, 11, 16, and 18 at Month 126 [8]
    End point description
    Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
    End point type
    Primary
    End point timeframe
    Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
    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 hypothesis was planned for: Geometric Mean Titers for anti-HPV 6, 11, 16, and 18 at Month 126
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    454
    211
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=409, 112
    88 (78.9 to 98.2)
    99.3 (81 to 121.6)
        Type 11: n=409, 112
    74.6 (66.1 to 84.1)
    96 (76.1 to 121.1)
        Type 16: n=403, 115
    320.1 (281.2 to 364.4)
    351.6 (277.1 to 446.2)
        Type 18: n=408, 120
    36.5 (31.7 to 42.1)
    39.6 (30.7 to 51.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126

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    End point title
    Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 [9]
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.
    End point type
    Primary
    End point timeframe
    Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
    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 hypothesis was planned for: Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    454
    211
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=409, 112
    89 (85.6 to 91.9)
    91.1 (84.2 to 95.6)
        Type 11: n=409, 112
    88.8 (85.3 to 91.6)
    92.9 (86.4 to 96.9)
        Type 16: n=403, 115
    96 (93.6 to 97.7)
    96.5 (91.3 to 99)
        Type 18: n=408, 120
    60.5 (55.6 to 65.3)
    65 (55.8 to 73.5)
    No statistical analyses for this end point

    Primary: Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up

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    End point title
    Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up [10]
    End point description
    A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported. The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.
    End point type
    Primary
    End point timeframe
    Month 37 to Month 126 (31 to 120 months Post-dose 3 for the Original qHPV Vaccine Cohort and 1 to 90 months Post-dose 3 for the Extension Group)
    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 hypothesis was planned for: Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up
    End point values
    qHPV Vaccine in Base Study: Safety Analysis qHPV Vaccine in Extension Study: Safety Analysis
    Number of subjects analysed
    821
    424
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Secondary: Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)

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    End point title
    Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 Month Postdose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    1082
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=953
    99.8 (99.2 to 100)
        Type 11: n=954
    99.8 (99.2 to 100)
        Type 16: n=949
    99.7 (99.1 to 99.9)
        Type 18: n=956
    99.7 (99.1 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).

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    End point title
    Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 18 (12 Months Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    1106
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=937
    97.8 (96.6 to 98.6)
        Type 11: n=938
    99.3 (98.5 to 99.7)
        Type 16: n=933
    99.6 (98.9 to 99.9)
        Type 18: n=940
    91.6 (89.6 to 93.3)
    No statistical analyses for this end point

    Secondary: Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)

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    End point title
    Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 24 (18 Months Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    595
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=446
    95.1 (92.6 to 96.9)
        Type 11: n=447
    98.2 (96.5 to 99.2)
        Type 16: n=442
    98.4 (96.8 to 99.4)
        Type 18: n=447
    87.5 (84 to 90.4)
    No statistical analyses for this end point

    Secondary: Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)

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    End point title
    Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 30 (24 Months Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    911
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=799
    95.6 (94 to 96.9)
        Type 11: n=800
    97.5 (96.2 to 98.5)
        Type 16: n=795
    98.6 (97.5 to 99.3)
        Type 18: n=803
    84.3 (81.6 to 86.8)
    No statistical analyses for this end point

    Secondary: Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).

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    End point title
    Percentage of Original qHPV Vaccine Participants who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 37 (31 Months Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    772
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=657
    94.5 (92.5 to 96.1)
        Type 11: n=657
    96 (94.3 to 97.4)
        Type 16: n=655
    98.2 (96.8 to 99)
        Type 18: n=660
    81.1 (77.9 to 84)
    No statistical analyses for this end point

    Secondary: Percentage of Participants in the Extension Group who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)

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    End point title
    Percentage of Participants in the Extension Group who are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)
    End point description
    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 37 (1 Month Post-dose 3 of qHPV)
    End point values
    qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    440
    Units: Percentage of participants
    number (confidence interval 95%)
        Type 6: n=246
    99.6 (97.8 to 100)
        Type 11: n=246
    100 (98.5 to 100)
        Type 16: n=246
    100 (98.5 to 100)
        Type 18: n=255
    98.8 (96.6 to 99.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 1 Postdose 3 of qHPV vaccine (Month 7)

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    End point title
    Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 1 Postdose 3 of qHPV vaccine (Month 7)
    End point description
    Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 Month Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    1082
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=953
    929.2 (871 to 991.4)
        Type 11: n=954
    1362.8 (1279.8 to 1451.3)
        Type 16: n=949
    5512.7 (5109.9 to 5947.2)
        Type 18: n=956
    1278.9 (1183.2 to 1382.4)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 12 Postdose 3 of qHPV vaccine (Month 18)

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    End point title
    Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 12 Postdose 3 of qHPV vaccine (Month 18)
    End point description
    Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 18 (Month 12 Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    1106
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=937
    219.3 (204.9 to 234.7)
        Type 11: n=938
    296.9 (276.9 to 318.3)
        Type 16: n=933
    1314.8 (1220.5 to 1416.5)
        Type 18: n=940
    203 (184.1 to 223.9)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 18 Postdose 3 of qHPV vaccine (Month 24)

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    End point title
    Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 18 Postdose 3 of qHPV vaccine (Month 24)
    End point description
    Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 24 (18 Months Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    595
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=446
    143.5 (129.2 to 159.5)
        Type 11: n=447
    206.6 (186.9 to 228.3)
        Type 16: n=442
    932.1 (833.3 to 1042.7)
        Type 18: n=447
    136.2 (118.5 to 156.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 24 Postdose 3 of qHPV vaccine (Month 30)

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    End point title
    Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 24 Postdose 3 of qHPV vaccine (Month 30)
    End point description
    Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 30 (24 Months Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    911
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=799
    146.5 (135.6 to 158.2)
        Type 11: n=800
    177 (163.6 to 191.5)
        Type 16: n=795
    826.1 (757.8 to 900.5)
        Type 18: n=803
    114.7 (102.8 to 127.9)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 31 Postdose 3 of qHPV vaccine (Month 37)

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    End point title
    Geometric Mean Titers of Original qHPV Vaccine Cohort for anti-HPV 6, 11, 16, and 18 at month 31 Postdose 3 of qHPV vaccine (Month 37)
    End point description
    Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 37 (31 Months Post-dose 3)
    End point values
    qHPV Vaccine in Base Study: Immunogenicity Analysis
    Number of subjects analysed
    772
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=657
    128.6 (118.2 to 139.9)
        Type 11: n=657
    149.7 (137 to 163.6)
        Type 16: n=655
    680.4 (617.2 to 750.1)
        Type 18: n=660
    102.4 (90.9 to 115.3)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers in the Extension Group for anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)

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    End point title
    Geometric Mean Titers in the Extension Group for anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)
    End point description
    Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.
    End point type
    Secondary
    End point timeframe
    Month 37 (1 Month Post-dose 3 of qHPV)
    End point values
    qHPV Vaccine in Extension Study: Immunogenicity Analysis
    Number of subjects analysed
    440
    Units: milliMerck units/mL
    geometric mean (confidence interval 95%)
        Type 6: n=246
    768.6 (676.6 to 873)
        Type 11: n=246
    1041 (919.8 to 1178.2)
        Type 16: n=246
    4312.7 (3715.6 to 5005.7)
        Type 18: n=255
    830.1 (714 to 965.1)
    No statistical analyses for this end point

    Secondary: Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females

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    End point title
    Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females
    End point description
    The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants. Per-Protocol Effectiveness population: female participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.
    End point type
    Secondary
    End point timeframe
    Up to Month 126 (up to 120 Months Post-dose 3 for Original qHPV Vaccine Cohort and up to 90 Months Post-dose 3 for Extension Group)
    End point values
    qHPV in Base Study: Effectiveness Analysis qHPV Vaccine in Extension Study: Effectiveness Analysis
    Number of subjects analysed
    259
    96
    Units: Incidence per 100 person-years at risk
        number (confidence interval 95%)
    0.2 (0.1 to 0.7)
    0.2 (0 to 1.4)
    No statistical analyses for this end point

    Secondary: Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males

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    End point title
    Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males
    End point description
    The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants. Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.
    End point type
    Secondary
    End point timeframe
    Up to Month 126 (up to 120 Months Post-dose 3 for Original qHPV Vaccine Cohort and up to 90 Months Post-dose 3 for Extension Group)
    End point values
    qHPV in Base Study: Effectiveness Analysis qHPV Vaccine in Extension Study: Effectiveness Analysis
    Number of subjects analysed
    179
    62
    Units: Incidence per 100 person-years at risk
        number (confidence interval 95%)
    0.6 (0.2 to 1.5)
    0.3 (0 to 1.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Month 30 and Month 30 to Month 126
    Adverse event reporting additional description
    Day 1 to Month 30: All adverse events were collected up to Day 15 after any vaccination. Month 30 to Month 126: Nonserious AEs were not collected. Deaths and related SAEs were collected throughout the study. Non-serious AEs were not solicited during the Extension Study; any reported non-serious AEs were unsolicited and not systematically assessed.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    qHPV Vaccine in Base Study: Day 1 to Month 30
    Reporting group description
    Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.

    Reporting group title
    Placebo in Base Study: Day 1 to Month 30
    Reporting group description
    Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup. Adverse events are reported for this group from Day 1 to Month 30.

    Reporting group title
    qHPV Vaccine in Base Stuty: Month 30 to Month 126
    Reporting group description
    Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.

    Reporting group title
    qHPV Vaccine in Extension Study: Month 30 to Month 126
    Reporting group description
    Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.

    Serious adverse events
    qHPV Vaccine in Base Study: Day 1 to Month 30 Placebo in Base Study: Day 1 to Month 30 qHPV Vaccine in Base Stuty: Month 30 to Month 126 qHPV Vaccine in Extension Study: Month 30 to Month 126
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 1165 (0.52%)
    0 / 584 (0.00%)
    2 / 932 (0.21%)
    3 / 481 (0.62%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 1165 (0.00%)
    0 / 584 (0.00%)
    1 / 932 (0.11%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 1165 (0.00%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    VIIth nerve paralysis
         subjects affected / exposed
    0 / 1165 (0.00%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonic clonic movements
         subjects affected / exposed
    0 / 1165 (0.00%)
    0 / 584 (0.00%)
    1 / 932 (0.11%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 1165 (0.00%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 1165 (0.09%)
    0 / 584 (0.00%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    qHPV Vaccine in Base Study: Day 1 to Month 30 Placebo in Base Study: Day 1 to Month 30 qHPV Vaccine in Base Stuty: Month 30 to Month 126 qHPV Vaccine in Extension Study: Month 30 to Month 126
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    918 / 1165 (78.80%)
    344 / 584 (58.90%)
    0 / 932 (0.00%)
    3 / 481 (0.62%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
    alternative dictionary used: MedDRA 7.1
         subjects affected / exposed
    52 / 1165 (4.46%)
    24 / 584 (4.11%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences all number
    56
    26
    0
    0
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 7.1
         subjects affected / exposed
    221 / 1165 (18.97%)
    111 / 584 (19.01%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences all number
    297
    163
    0
    0
    General disorders and administration site conditions
    Injection site erythema
    alternative dictionary used: MedDRA 7.1
         subjects affected / exposed
    237 / 1165 (20.34%)
    78 / 584 (13.36%)
    0 / 932 (0.00%)
    1 / 481 (0.21%)
         occurrences all number
    323
    109
    0
    1
    Injection site pain
         subjects affected / exposed
    853 / 1165 (73.22%)
    268 / 584 (45.89%)
    0 / 932 (0.00%)
    3 / 481 (0.62%)
         occurrences all number
    1705
    434
    0
    3
    Pyrexia
    alternative dictionary used: MedDRA 7.1
         subjects affected / exposed
    100 / 1165 (8.58%)
    44 / 584 (7.53%)
    0 / 932 (0.00%)
    0 / 481 (0.00%)
         occurrences all number
    114
    60
    0
    0
    Injection site swelling
         subjects affected / exposed
    241 / 1165 (20.69%)
    45 / 584 (7.71%)
    0 / 932 (0.00%)
    1 / 481 (0.21%)
         occurrences all number
    336
    63
    0
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Sep 2004
    Amendment 3 included changes to an analysis endpoint; language concerning participants who receive placebo; study visits; study assessments; rationale for capturing non-study vaccines throughout the course of the study; and language concerning participants who discontinue from test therapy but continue in the study.
    28 Nov 2005
    Amendment 5 included changes in the duration of the Base Study; placebo participants to be offered vaccination with GARDASIL starting at Month 30; Extension Study visits; details regarding SAE collection for placebo participants who receive GARDASIL; clarification that the Extension Study is open label; statement that participants in the placebo group who do not wish to participate in the Extension Study will be eligible to receive GARDASIL when or if it becomes available in their country; added required pregnancy tests for female participants in the placebo group who receive GARDASIL; added SAE assessment for participants in the placebo group who receive GARDASIL.
    27 Nov 2007
    Amendment 11 included additional clarification on characterization of breakthrough cases and reporting of overdoses.

    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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