Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase IIa Randomized, Double-Blinded, Controlled With GARDASIL™ Clinical Trial to Study the Tolerability and Immunogenicity of V505 (a Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Healthy 16- to 26-Year-Old Women

    Summary
    EudraCT number
    		 2017-000108-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 May 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2017
    First version publication date
    10 Mar 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    v505-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00520598
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison with GARDASIL™. The primary hypothesis of the study is that administration of a 3-dose regimen of at least 1 of 2 formulations of V505 generates anti-HPV 6, 11, 16, and 18 geometric mean antibody titers 4 weeks post dose 3 that are noninferior to those generated by GARDASIL™ in 16- to 26-year old adolescent and young adult women who are seronegative at Day 1 and polymerase chain reaction (PCR) negative Day 1 through Month 7 to the relevant HPV type(s) and the vaccines are well-tolerated.
    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
    18 Oct 2007
    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
    Australia: 212
    Country: Number of subjects enrolled
    New Zealand: 299
    Worldwide total number of subjects
    511
    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)
    0
    Adolescents (12-17 years)
    65
    Adults (18-64 years)
    446
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Twelve clinical sites participated in this study in Australia and New Zealand.

    Pre-assignment
    Screening details
    		 A total of 529 participants were screened for inclusion in this study and 511 participants were randomized. A total of 17 non-randomized participants did not meet inclusion/exclusion criteria.

    Period 1
    Period 1 title
    Day 1 Through Month 7
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V505 Formulation 1 Vaccine [3 doses]
    Arm description
    		 V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V505 Formulation 1 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Arm title
    		 V505 Formulation 2 Vaccine [3 doses]
    Arm description
    		 V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V505 Formulation 2 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Arm title
    		 V505 Formulation 2 Vaccine [2 doses]
    Arm description
    		 V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo vaccine [1 dose] intramuscular (Month 2)

    Investigational medicinal product name
    V505 Formulation 2 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)

    Arm title
    		 V505 Formulation 3 Vaccine [2 doses]
    Arm description
    		 V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo vaccine [1 dose] intramuscular (Month 2)

    Investigational medicinal product name
    V505 Formulation 3 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)

    Arm title
    		 qHPV Vaccine [3 doses]
    Arm description
    		 HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™), 3 doses (Day 1, Month 2, and Month 6)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    GARDASIL™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™) [3 doses] (Day 1, Month 2, and Month 6)

    Number of subjects in period 1
    		V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Started
    101
    105
    103
    101
    101
    Vaccination 1
    101
    105
    103
    101
    101
    Vaccination 2
    99
    102
    102
    101
    99
    Vaccination 3
    98
    101
    99
    100
    96
    Completed
    97
    101
    97
    100
    96
    Not completed
    4
    4
    6
    1
    5
         Consent withdrawn by subject
    -
    3
    2
    1
    1
         Lost to follow-up
    4
    1
    4
    -
    4
    Period 2
    Period 2 title
    Month 7 to Month 36
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V505 Formulation 1 Vaccine [3 doses]
    Arm description
    		 V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V505 Formulation 1 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Arm title
    		 V505 Formulation 2 Vaccine [3 doses]
    Arm description
    		 V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V505 Formulation 2 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Arm title
    		 V505 Formulation 2 Vaccine [2 doses]
    Arm description
    		 V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo vaccine [1 dose] intramuscular (Month 2)

    Investigational medicinal product name
    V505 Formulation 2 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)

    Arm title
    		 V505 Formulation 3 Vaccine [2 doses]
    Arm description
    		 V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V505 Formulation 3 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)

    Investigational medicinal product name
    Placebo to vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo vaccine [1 dose] intramuscular (Month 2)

    Arm title
    		 qHPV Vaccine [3 doses]
    Arm description
    		 HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™), 3 doses (Day 1, Month 2, and Month 6)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    qHPV Vaccine
    Investigational medicinal product code
    Other name
    GARDASIL™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™), 3 doses (Day 1, Month 2, and Month 6)

    Number of subjects in period 2
    		V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Started
    97
    101
    97
    100
    96
    Completed
    92
    95
    91
    92
    82
    Not completed
    5
    6
    6
    8
    14
         Consent withdrawn by subject
    3
    1
    -
    1
    6
         Study Terminated By Sponsor
    -
    -
    -
    1
    -
         Lost to follow-up
    2
    5
    6
    6
    8

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    V505 Formulation 1 Vaccine [3 doses]
    Reporting group description
    		 V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 Vaccine [3 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    V505 Formulation 3 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    qHPV Vaccine [3 doses]
    Reporting group description
    		 HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™), 3 doses (Day 1, Month 2, and Month 6)

    Reporting group values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses] Total
    Number of subjects
    		 101 105 103 101 101 511
    Age Categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 17 15 10 10 13 65
        Adults (18-64 years)
    		 84 90 93 91 88 446
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 20.6 ( 2.8 ) 20.6 ( 2.6 ) 20.5 ( 2.5 ) 21 ( 2.5 ) 20.4 ( 2.6 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 101 105 103 101 101 511
        Male
    		 0 0 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    V505 Formulation 1 Vaccine [3 doses]
    Reporting group description
    		 V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 Vaccine [3 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    V505 Formulation 3 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    qHPV Vaccine [3 doses]
    Reporting group description
    		 HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™), 3 doses (Day 1, Month 2, and Month 6)
    Reporting group title
    V505 Formulation 1 Vaccine [3 doses]
    Reporting group description
    		 V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 Vaccine [3 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    V505 Formulation 3 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    qHPV Vaccine [3 doses]
    Reporting group description
    		 HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™), 3 doses (Day 1, Month 2, and Month 6)

    Subject analysis set title
    V505 Formulation 1 Vaccine [3 doses]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Subject analysis set title
    V505 Formulation 2 Vaccine [3 doses]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Subject analysis set title
    V505 Formulation 2 Vaccine [2 doses]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)

    Subject analysis set title
    V505 Formulation 3 Vaccine [2 doses]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)

    Subject analysis set title
    qHPV Vaccine [3 doses]
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™) [3 doses] (Day 1, Month 2, and Month 6)

    Primary: Percentage of participants with injection-site adverse events

    		 Close Top of page
    End point title
    		 Percentage of participants with injection-site adverse events [1]
    End point description
    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Vaccination Report Cards were used to collect these AEs. The safety population included all participants who received at least 1 study vaccination and had follow-up data. Participants were summarized according to the clinical material received.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 5 following any vaccination
    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 analysis was planned or performed for this end point.
    End point values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    101
    105
    102
    100
    99
    Units: Percentage of participants
        number (not applicable)
    97
    100
    98
    100
    88.9
    No statistical analyses for this end point

    Primary: Percentage of participants with maximum temperatures (oral or oral equivalent ≥ 37.8 °C [100.0 °F])

    		 Close Top of page
    End point title
    		 Percentage of participants with maximum temperatures (oral or oral equivalent ≥ 37.8 °C [100.0 °F])
    End point description
    Multiple occurrences of maximum temperature were counted only once. Non-oral temperatures were converted to oral equivalent. Vaccination Report Cards were used to collect these AEs. The safety population included all participants who received at least 1 study vaccination and had follow-up data. Participants were summarized according to the clinical material received.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 5 following any vaccination.
    End point values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    101
    105
    101
    100
    99
    Units: Percentage of participants
        number (not applicable)
    8.9
    12.4
    8.9
    7
    6.1
    Statistical analysis title
    		 Difference in % vs qHPV Vaccine
    Statistical analysis description
    Difference in % vs qHPV Vaccine
    Comparison groups
    V505 Formulation 1 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.445
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in % vs qHPV Vaccine
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 10.9
    Statistical analysis title
    		 Difference in % vs qHPV Vaccine
    Statistical analysis description
    Difference in % vs qHPV Vaccine
    Comparison groups
    V505 Formulation 2 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.121
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in % vs qHPV Vaccine
    Point estimate
    6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 14.8
    Statistical analysis title
    		 Difference in % vs qHPV Vaccine
    Statistical analysis description
    Difference in % vs qHPV Vaccine
    Comparison groups
    V505 Formulation 2 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.445
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in % vs qHPV Vaccine
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 10.9
    Statistical analysis title
    		 Difference in % vs qHPV Vaccine
    Statistical analysis description
    Difference in % vs qHPV Vaccine
    Comparison groups
    V505 Formulation 3 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.789
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in % vs qHPV Vaccine
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 8.5

    Primary: Geometric mean titers (GMTs) to HPV 6 in the vaccines administered in a 3-dose regimen

    		 Close Top of page
    End point title
    		 Geometric mean titers (GMTs) to HPV 6 in the vaccines administered in a 3-dose regimen
    End point description
    GMT (milli Merck Units/mL [mMU/mL]) for all participants who completed a 3-dose vaccination series. The per-protocol immunogenicity population (PPI) included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Primary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    68
    70
    65
    Units: Milli Merck units (mMU)/mL
        geometric mean (confidence interval 95%)
    2257 (1814 to 2808)
    3567 (2876 to 4423)
    856 (685 to 1070)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 1 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    2.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.97
         upper limit
    		 3.53
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    4.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.09
         upper limit
    		 5.63

    Primary: GMTs to HPV 11 in the vaccines administered in a 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV 11 in the vaccines administered in a 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 3-dose vaccination series. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Primary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    68
    70
    65
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1551 (1236 to 1946)
    2714 (2170 to 3395)
    890 (705 to 1122)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 1 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 2.35
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    3.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.17
         upper limit
    		 4.29

    Primary: GMTs to HPV 16 in the vaccines administered in a 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV 16 in the vaccines administered in a 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 3-dose vaccination series. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Primary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    67
    72
    66
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    6665 (5607 to 7922)
    9911 (8389 to 11709)
    3126 (2627 to 3721)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 1 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.73
         upper limit
    		 2.62
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    3.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 4.01

    Primary: GMTs to HPV 18 in the vaccines administered in a 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV 18 in the vaccines administered in a 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 3-dose vaccination series. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Primary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    73
    74
    71
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    2112 (1629 to 2737)
    3620 (2798 to 4683)
    693 (533 to 901)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 1 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    3.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.15
         upper limit
    		 4.32
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [3 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    5.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.66
         upper limit
    		 7.47

    Secondary: GMTs to HPV Types 31, 33, 45, 52, and 58 in the vaccines administered in a 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV Types 31, 33, 45, 52, and 58 in the vaccines administered in a 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 3-dose vaccination series. Gardasil does not contain the following HPV types, HPV 31/33/45/52/58. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range. A value of 99999 indicates a GMT that is less than quantifiable.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 Vaccine [3 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    101
    105
    101
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 31 (n=68, 77, 68)
    2265 (1752 to 2929)
    2632 (2067 to 3351)
    10 (8 to 13)
        Anti-HPV 33 (n=73, 76, 70)
    930 (749 to 1155)
    1244 (1006 to 1539)
    99999 (99999 to 99999)
        Anti-HPV 45 (n=74, 78, 73)
    797 (624 to 1019)
    1136 (894 to 1443)
    99999 (99999 to 99999)
        Anti-HPV 52 (n=74, 74, 71)
    1058 (826 to 1356)
    1814 (1415 to 2325)
    99999 (99999 to 99999)
        Anti-HPV 58 (n=68, 74, 71)
    1940 (1460 to 2579)
    2642 (2011 to 3471)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: GMTs to HPV 6 in the vaccines administered in a 2-dose or 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV 6 in the vaccines administered in a 2-dose or 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 2-dose or 3-dose vaccination series. Participants who received a 2-dose vaccination regimen received in addition placebo at Month 2. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    60
    62
    65
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    3140 (2489 to 3962)
    3805 (3027 to 4783)
    856 (685 to 1070)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    3.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.72
         upper limit
    		 4.94
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 3 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    4.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.22
         upper limit
    		 6.13

    Secondary: GMTs to HPV 11 in the vaccines administered in a 2-dose or 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV 11 in the vaccines administered in a 2-dose or 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 2-dose or 3-dose vaccination series. Participants who received a 2-dose vaccination regimen received in addition placebo at Month 2. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    60
    62
    65
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    2533 (1989 to 3225)
    2425 (1912 to 3075)
    890 (705 to 1122)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    2.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.08
         upper limit
    		 3.89
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 3 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [2]
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.94
         upper limit
    		 3.82
    Notes
    [2] - Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.

    Secondary: GMTs to HPV 16 in the vaccines administered in a 2-dose or 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV 16 in the vaccines administered in a 2-dose or 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 2-dose or 3-dose vaccination series. Participants who received a 2-dose vaccination regimen received in addition placebo at Month 2. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    60
    61
    66
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    9717 (8095 to 11664)
    10561 (8811 to 12658)
    3126 (2627 to 3721)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    3.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.37
         upper limit
    		 4.08
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 3 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    3.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.66
         upper limit
    		 4.3

    Secondary: GMTs to HPV 18 in the vaccines administered in a 2-dose or 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV 18 in the vaccines administered in a 2-dose or 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 2-dose or 3-dose vaccination series. Participants who received a 2-dose vaccination regimen received in addition placebo at Month 2. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    65
    69
    71
    Units: mMU/mL
        geometric mean (confidence interval 95%)
    1948 (1480 to 2564)
    3360 (2573 to 4387)
    693 (533 to 901)
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 2 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    2.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.01
         upper limit
    		 3.93
    Statistical analysis title
    		 Estimated Fold Difference Exp./Comparator Vaccines
    Statistical analysis description
    Non-inferiority for GMTs is defined as statistically less than a 2-fold decrease.
    Comparison groups
    V505 Formulation 3 Vaccine [2 doses] v qHPV Vaccine [3 doses]
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Estimated Difference Exp./Comp. Vaccines
    Point estimate
    4.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.36
         upper limit
    		 7

    Secondary: GMTs to HPV Types 31, 33, 45, 52, and 58 in the vaccines administered in a 2-dose or 3-dose regimen

    		 Close Top of page
    End point title
    		 GMTs to HPV Types 31, 33, 45, 52, and 58 in the vaccines administered in a 2-dose or 3-dose regimen
    End point description
    GMT (mMU/mL) for all participants who completed a 3-dose vaccination series. Participants who received a 2-dose vaccination regimen received in addition placebo at Month 2. The PPI population included all participants who were not general protocol violators, received all vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range. A value of 99999 indicates a GMT that is less than quantifiable.
    End point type
    Secondary
    End point timeframe
    Month 7 (1 month post-dose 3)
    End point values
    		 V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Number of subjects analysed
    103
    101
    101
    Units: mMU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV 31 (n=64, 68, 68)
    1938 (1487 to 2526)
    2265 (1751 to 2928)
    10 (8 to 13)
        Anti-HPV 33 (n=67, 68, 70)
    1723 (1374 to 2160)
    1692 (1352 to 2118)
    99999 (99999 to 99999)
        Anti-HPV 45 (n=67, 70, 73)
    520 (402 to 673)
    740 (575 to 953)
    99999 (99999 to 99999)
        Anti-HPV 52 (n=66, 70, 71)
    819 (630 to 1065)
    690 (535 to 891)
    99999 (99999 to 99999)
        Anti-HPV 58 (n=68, 67, 71)
    1840 (1384 to 2445)
    2718 (2041 to 3621)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 36 months
    Adverse event reporting additional description
    For the present vaccine study, the number of participants with follow-up and not the actual count of participants who were randomized and vaccinated are displayed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    V505 Formulation 1 Vaccine [3 doses]
    Reporting group description
    		 V505 Formulation 1 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 [3 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [3 doses] (Day 1, Month 2, Month 6)

    Reporting group title
    V505 Formulation 2 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 2 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    V505 Formulation 3 Vaccine [2 doses]
    Reporting group description
    		 V505 Formulation 3 vaccine [2 doses] (Day 1 and Month 6)

    Reporting group title
    qHPV Vaccine [3 doses]
    Reporting group description
    		 HPV 6/11/16/18 VLP - 20/40/40/20 mcg (GARDASIL™), 3 doses (Day 1, Month 2, and Month 6)

    Serious adverse events
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 [3 doses] V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 101 (4.95%)
    2 / 105 (1.90%)
    3 / 102 (2.94%)
    3 / 100 (3.00%)
    6 / 99 (6.06%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 105 (0.00%)
    1 / 102 (0.98%)
    2 / 100 (2.00%)
    4 / 99 (4.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 105 (0.95%)
    1 / 102 (0.98%)
    1 / 100 (1.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blighted ovum
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 105 (0.00%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brow presentation
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 105 (0.00%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal distress syndrome
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 105 (0.00%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 105 (0.95%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature separation of placenta
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 105 (0.95%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged labour
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 105 (0.00%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bartholin's abscess
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 105 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 105 (0.00%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V505 Formulation 1 Vaccine [3 doses] V505 Formulation 2 [3 doses] V505 Formulation 2 Vaccine [2 doses] V505 Formulation 3 Vaccine [2 doses] qHPV Vaccine [3 doses]
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 101 (99.01%)
    105 / 105 (100.00%)
    101 / 102 (99.02%)
    100 / 100 (100.00%)
    94 / 99 (94.95%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 101 (4.95%)
    13 / 105 (12.38%)
    8 / 102 (7.84%)
    4 / 100 (4.00%)
    4 / 99 (4.04%)
         occurrences all number
    5
    17
    9
    4
    5
    Headache
         subjects affected / exposed
    47 / 101 (46.53%)
    61 / 105 (58.10%)
    48 / 102 (47.06%)
    57 / 100 (57.00%)
    39 / 99 (39.39%)
         occurrences all number
    84
    113
    74
    103
    61
    Lethargy
         subjects affected / exposed
    2 / 101 (1.98%)
    6 / 105 (5.71%)
    1 / 102 (0.98%)
    5 / 100 (5.00%)
    3 / 99 (3.03%)
         occurrences all number
    2
    8
    1
    6
    5
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    3 / 101 (2.97%)
    5 / 105 (4.76%)
    7 / 102 (6.86%)
    2 / 100 (2.00%)
    2 / 99 (2.02%)
         occurrences all number
    3
    6
    7
    2
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 101 (9.90%)
    13 / 105 (12.38%)
    16 / 102 (15.69%)
    10 / 100 (10.00%)
    11 / 99 (11.11%)
         occurrences all number
    11
    14
    17
    11
    14
    Injection site erythema
         subjects affected / exposed
    50 / 101 (49.50%)
    51 / 105 (48.57%)
    35 / 102 (34.31%)
    46 / 100 (46.00%)
    24 / 99 (24.24%)
         occurrences all number
    77
    75
    44
    62
    35
    Injection site haematoma
         subjects affected / exposed
    6 / 101 (5.94%)
    8 / 105 (7.62%)
    4 / 102 (3.92%)
    9 / 100 (9.00%)
    6 / 99 (6.06%)
         occurrences all number
    7
    10
    4
    11
    7
    Injection site mass
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 105 (5.71%)
    3 / 102 (2.94%)
    2 / 100 (2.00%)
    2 / 99 (2.02%)
         occurrences all number
    4
    7
    5
    2
    2
    Injection site pain
         subjects affected / exposed
    99 / 101 (98.02%)
    105 / 105 (100.00%)
    100 / 102 (98.04%)
    100 / 100 (100.00%)
    87 / 99 (87.88%)
         occurrences all number
    267
    289
    228
    231
    181
    Injection site pruritus
         subjects affected / exposed
    8 / 101 (7.92%)
    11 / 105 (10.48%)
    2 / 102 (1.96%)
    1 / 100 (1.00%)
    4 / 99 (4.04%)
         occurrences all number
    12
    14
    3
    1
    4
    Injection site swelling
         subjects affected / exposed
    60 / 101 (59.41%)
    68 / 105 (64.76%)
    49 / 102 (48.04%)
    60 / 100 (60.00%)
    24 / 99 (24.24%)
         occurrences all number
    106
    124
    74
    88
    38
    Pain
         subjects affected / exposed
    2 / 101 (1.98%)
    12 / 105 (11.43%)
    5 / 102 (4.90%)
    8 / 100 (8.00%)
    3 / 99 (3.03%)
         occurrences all number
    4
    14
    5
    10
    4
    Pyrexia
         subjects affected / exposed
    9 / 101 (8.91%)
    12 / 105 (11.43%)
    11 / 102 (10.78%)
    11 / 100 (11.00%)
    7 / 99 (7.07%)
         occurrences all number
    9
    18
    13
    12
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 101 (3.96%)
    0 / 105 (0.00%)
    3 / 102 (2.94%)
    3 / 100 (3.00%)
    6 / 99 (6.06%)
         occurrences all number
    4
    0
    3
    3
    6
    Diarrhoea
         subjects affected / exposed
    4 / 101 (3.96%)
    3 / 105 (2.86%)
    3 / 102 (2.94%)
    5 / 100 (5.00%)
    6 / 99 (6.06%)
         occurrences all number
    4
    3
    3
    5
    7
    Nausea
         subjects affected / exposed
    13 / 101 (12.87%)
    14 / 105 (13.33%)
    19 / 102 (18.63%)
    14 / 100 (14.00%)
    12 / 99 (12.12%)
         occurrences all number
    14
    18
    26
    18
    13
    Vomiting
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 105 (5.71%)
    7 / 102 (6.86%)
    5 / 100 (5.00%)
    4 / 99 (4.04%)
         occurrences all number
    4
    6
    7
    5
    4
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    8 / 101 (7.92%)
    3 / 105 (2.86%)
    4 / 102 (3.92%)
    3 / 100 (3.00%)
    4 / 99 (4.04%)
         occurrences all number
    9
    4
    4
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    10 / 101 (9.90%)
    8 / 105 (7.62%)
    7 / 102 (6.86%)
    10 / 100 (10.00%)
    7 / 99 (7.07%)
         occurrences all number
    11
    10
    7
    10
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 101 (0.00%)
    4 / 105 (3.81%)
    2 / 102 (1.96%)
    6 / 100 (6.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    5
    2
    6
    0
    Back pain
         subjects affected / exposed
    3 / 101 (2.97%)
    8 / 105 (7.62%)
    3 / 102 (2.94%)
    6 / 100 (6.00%)
    5 / 99 (5.05%)
         occurrences all number
    4
    10
    3
    6
    5
    Myalgia
         subjects affected / exposed
    4 / 101 (3.96%)
    10 / 105 (9.52%)
    6 / 102 (5.88%)
    8 / 100 (8.00%)
    4 / 99 (4.04%)
         occurrences all number
    5
    10
    8
    8
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 101 (7.92%)
    5 / 105 (4.76%)
    10 / 102 (9.80%)
    7 / 100 (7.00%)
    6 / 99 (6.06%)
         occurrences all number
    8
    5
    12
    7
    6

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 03:03:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA