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    Clinical Trial Results:
    A Phase IIIb observer-blind, randomized, multicentre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine and Merck's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, when administered intramuscularly according to alternative 2-dose schedules in 9-14-year-old healthy females.

    Summary
    EudraCT number
    		 2011-002035-26
    Trial protocol
    		 FR   SE  
    Global end of trial date
    27 Oct 2015

    Results information
    Results version number
    		 v3(current)
    This version publication date
    12 Apr 2020
    First version publication date
    21 Apr 2016
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    115411
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01462357
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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
    22 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate sequentially if the immunogenicity (as determined by enzyme-linked immunosorbent assay [ELISA]) of GSK Biologicals’ HPV-16/18 L1 Virus-like-particle (VLP) AS04 vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior/superior to that of Merck's HPV-6/11/16/18 L1 VLP recombinant vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year-old females, 1 month after the last dose (Month 7).
    Protection of trial subjects
    All subjects were observed closely for 30 min after vaccination/product administration, with appropriate medical treatment readily available in case of a rare anaphylactic reaction. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Nov 2011
    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
    Sweden: 72
    Country: Number of subjects enrolled
    France: 231
    Country: Number of subjects enrolled
    Hong Kong: 534
    Country: Number of subjects enrolled
    Singapore: 242
    Worldwide total number of subjects
    1079
    EEA total number of subjects
    303
    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)
    551
    Adolescents (12-17 years)
    528
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1079 subjects entered this study, of which 4 subjects signed an informed consent but did not receive a single dose of the vaccine and were hence not counted as starting the study.

    Pre-assignment period milestones
    Number of subjects started
    		 1079
    Number of subjects completed
    		 1075

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccine administered: 4
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Data was collected in an observer-blind manner. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. immunogenicity, reactogenicity, and safety) were all unaware of which vaccine was administered. To do so, vaccine preparation and administration were be done by authorised medical personnel who did not participate in any of the study clinical evaluation assays.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cervarix 2 dose Group
    Arm description
    		 Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 (Cervarix 2 dose Group and Gardasil 2 dose Group) to maintain blinding.

    Arm title
    		 Gardasil 2 dose Group
    Arm description
    		 Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 (Cervarix 2 dose Group and Gardasil 2 dose Group) to maintain blinding.

    Investigational medicinal product name
    Gardasil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.

    Arm title
    		 Gardasil 3 dose Group
    Arm description
    		 Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gardasil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.

    Number of subjects in period 1 [1]
    		Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Started
    359
    358
    358
    Completed
    351
    339
    346
    Not completed
    8
    19
    12
         Consent withdrawal (not due to an adverse event)
    3
    11
    3
         Death
    -
    -
    1
         Migrated/moved from study area
    2
    3
    1
         Lost to follow-up
    3
    5
    7
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1079 subjects entered this study, of which 4 subjects signed an informed consent but did not receive a single dose of the vaccine and were hence not counted as starting the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix 2 dose Group
    Reporting group description
    		 Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Gardasil 2 dose Group
    Reporting group description
    		 Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Gardasil 3 dose Group
    Reporting group description
    		 Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Reporting group values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group Total
    Number of subjects
    		 359 358 358 1075
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 11.5 ( 1.64 ) 11.5 ( 1.56 ) 11.6 ( 1.64 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 359 358 358 1075
        Male
    		 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 4 6 4 14
        Asian - Central / South Asian Heritage
    		 1 1 2 4
        Asian - East Asian Heritage
    		 179 178 179 536
        Asian - South East Asian Heritage
    		 81 78 83 242
        White - Arabic / North African Heritage
    		 5 7 7 19
        White - Caucasian / European Heritage
    		 89 86 83 258
        White - Caucasian / African Heritage
    		 0 1 0 1
        African - White / Caucasian Heritage
    		 0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Cervarix 2 dose Group
    Reporting group description
    		 Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Gardasil 2 dose Group
    Reporting group description
    		 Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Gardasil 3 dose Group
    Reporting group description
    		 Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Primary: Number of seroconverted subjects for anti-HPV-16/18 antibodies as assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 based on the ATP cohort for immunogenicity

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    End point title
    		 Number of seroconverted subjects for anti-HPV-16/18 antibodies as assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 based on the ATP cohort for immunogenicity
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.
    End point type
    Primary
    End point timeframe
    At Month 7 (i.e. one month after the last dose of study vaccine)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    334
    331
    333
    Units: Subjects
        Anti-HPV-16 (N=330, 327, 322)
    330
    327
    322
        Anti-HPV-18 (N=334, 331, 333)
    334
    331
    333
    Statistical analysis title
    		 Immune response to anti-HPV-16 in terms of SCR
    Statistical analysis description
    Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
    Comparison groups
    Cervarix 2 dose Group v Gardasil 2 dose Group
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in SCR
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.16
         upper limit
    		 1.15
    Notes
    [1] - Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.
    Statistical analysis title
    		 Immune response to anti-HPV-18 in terms of SCR
    Statistical analysis description
    Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
    Comparison groups
    Gardasil 2 dose Group v Cervarix 2 dose Group
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in SCR
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.15
         upper limit
    		 1.14
    Notes
    [2] - Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.

    Primary: Anti-HPV-16/18 antibody titers as assessed by ELISA at Month 7 based on the ATP cohort for immunogenicity

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    End point title
    		 Anti-HPV-16/18 antibody titers as assessed by ELISA at Month 7 based on the ATP cohort for immunogenicity
    End point description
    Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Month 7 (i.e. one month after the last dose of study vaccine)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    334
    331
    333
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 (N=330,327,322)
    8244.1 (7678.3 to 8851.7)
    5056.0 (4596.5 to 5561.5)
    4807.4 (4420.8 to 5227.7)
        Anti-HPV-18 (N=334,331,333)
    5277.4 (4858.6 to 5732.4)
    1207.2 (1092.9 to 1333.4)
    1653.5 (1484.4 to 1841.8)
    Statistical analysis title
    		 Immune response to anti-HPV-16 in terms of GMT
    Statistical analysis description
    Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
    Comparison groups
    Gardasil 2 dose Group v Cervarix 2 dose Group
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 ANOVA
    Parameter type
    		 GMT ratio
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 0.69
    Notes
    [3] - Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.
    Statistical analysis title
    		 Immune response to anti-HPV-18 in terms of GMT
    Statistical analysis description
    Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.
    Comparison groups
    Gardasil 2 dose Group v Cervarix 2 dose Group
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 ANOVA
    Parameter type
    		 GMT ratio
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.26
    Notes
    [4] - Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.

    Primary: Anti-HPV-16/18 antibody titers as assessed by ELISA at Month 7 based on the Total Vaccinated Cohort (TVC)

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    End point title
    		 Anti-HPV-16/18 antibody titers as assessed by ELISA at Month 7 based on the Total Vaccinated Cohort (TVC)
    End point description
    Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Month 7 (i.e. one month after the last dose of study vaccine)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    357
    353
    351
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 (N=357, 353, 351)
    8256.4 (7650.3 to 8910.6)
    4886.1 (4435.4 to 5382.6)
    4789.2 (4409.6 to 5201.4)
        Anti-HPV-18 (N=357, 353, 351)
    5267.8 (4857.1 to 5713.2)
    1166.3 (1056 to 1288.2)
    1635.8 (1470 to 1820.4)
    Statistical analysis title
    		 Anti-HPV-18 immune response
    Statistical analysis description
    Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.
    Comparison groups
    Cervarix 2 dose Group v Gardasil 2 dose Group
    Number of subjects included in analysis
    710
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    Method
    		 ANOVA
    Parameter type
    		 GMT ratio
    Point estimate
    4.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.97
         upper limit
    		 5.13
    Notes
    [5] - Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.
    Statistical analysis title
    		 Anti-HPV-16 immune response
    Statistical analysis description
    Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.
    Comparison groups
    Cervarix 2 dose Group v Gardasil 2 dose Group
    Number of subjects included in analysis
    710
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    		 ANOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.49
         upper limit
    		 1.91
    Notes
    [6] - Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.

    Secondary: Anti-HPV-16/18 seroconversion rates as assessed by ELISA

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    End point title
    		 Anti-HPV-16/18 seroconversion rates as assessed by ELISA
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥ 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 12, 18, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    322
    310
    320
    Units: Subjects
        Anti-HPV-16, Day 0 (N=318, 306, 309)
    0
    0
    0
        Anti-HPV-18, Day 0 (N=322, 310, 320)
    0
    0
    0
        Anti-HPV-16, Month 12 (N=317, 305, 308)
    316
    305
    308
        Anti-HPV-18, Month 12 (N=321, 309, 319)
    320
    309
    319
        Anti-HPV-16, Month 18 (N=316, 305, 309)
    316
    304
    309
        Anti-HPV-18, Month 18 (N=320, 309, 320)
    320
    294
    313
        Anti-HPV-16, Month 24 (N=314, 304, 307)
    314
    303
    307
        Anti-HPV-18, Month 24 (N=318, 308, 318)
    318
    287
    308
        Anti-HPV-16, Month 36 (N=318, 306, 309)
    318
    304
    308
        Anti-HPV-18, Month 36 (N=322, 310, 320)
    322
    267
    297
    No statistical analyses for this end point

    Secondary: Anti-HPV-16/18 antibody titers as assessed by ELISA

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    End point title
    		 Anti-HPV-16/18 antibody titers as assessed by ELISA
    End point description
    Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in EL.U/mL based on ELISA.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 12, 18, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    322
    310
    320
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16, Day 0 (N=318, 306, 309)
    9.5 (9.5 to 9.5)
    9.5 (9.5 to 9.5)
    9.5 (9.5 to 9.5)
        Anti-HPV-18, Day 0 (N=322, 310, 320)
    9.0 (9.0 to 9.0)
    9.0 (9.0 to 9.0)
    9.0 (9.0 to 9.0)
        Anti-HPV-16, Month 12 (N=317, 305, 308)
    2209.2 (2014 to 2423.4)
    1294.8 (1160.4 to 1444.9)
    1600.7 (1457.3 to 1758.2)
        Anti-HPV-18, Month 12 (N=321, 309, 319)
    1299.3 (1176.2 to 1435.6)
    266.6 (236.3 to 300.8)
    478.5 (422.8 to 541.6)
        Anti-HPV-16, Month 18 (N=316, 305, 309)
    1488.8 (1365.5 to 1623.3)
    684.4 (605.8 to 773.2)
    824.0 (744.4 to 912.2)
        Anti-HPV-18, Month 18 (N=320, 309, 320)
    754.2 (682.6 to 833.2)
    134.8 (118.1 to 154)
    231.3 (202.4 to 264.4)
        Anti-HPV-16, Month 24 (N=314, 304, 307)
    1285.0 (1181.1 to 1398.0)
    514.1 (455.4 to 580.3)
    637.1 (575.8 to 704.9)
        Anti-HPV-18, Month 24 (N=318, 308, 318)
    613.7 (555.0 to 678.6)
    106.3 (93.2 to 121.3)
    182.0 (159.3 to 208.0)
        Anti-HPV-16, Month 36 (N=318, 306, 309)
    1061.4 (971.8 to 1159.4)
    379.8 (333.4 to 432.7)
    472.4 (425 to 525.0)
        Anti-HPV-18, Month 36 (N=322, 310, 320)
    486.5 (437.8 to 540.6)
    71.0 (62.0 to 81.2)
    119.1 (103.4 to 137.1)
    No statistical analyses for this end point

    Secondary: Anti-HPV-16/18 antibody titers as assessed by ELISA at Month 36

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    End point title
    		 Anti-HPV-16/18 antibody titers as assessed by ELISA at Month 36
    End point description
    Data at Month 36 were also expressed as International Units per milliliter (IU)/mL. Conversion factor from EU/mL to IU/mL was determined to be 1/6.1 for HPV-16 and 1/5.7 for HPV-18, using the WHO International Standards (NIBSC codes 05-134 and 10-140 for HPV-16 and HPV-18, respectively). The assay cut-offs were therefore 3.1 IU/mL and 3.2 IU/mL for anti-HPV-16 and anti-HPV-18 antibodies, respectively.
    End point type
    Secondary
    End point timeframe
    At Month 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    322
    310
    320
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 (N=318,306,309)
    174.0 (159.3 to 190.1)
    62.3 (54.7 to 71.0)
    77.4 (69.6 to 86.0)
        Anti-HPV-18 (N=322,310,320)
    85.3 (76.7 to 94.8)
    12.5 (10.9 to 14.3)
    20.9 (18.2 to 24.1)
    No statistical analyses for this end point

    Secondary: Anti-HPV-16/18 seroconversion rates as assessed by pseudovirion-based neutralization assay (PBNA) in a subset of subjects, based on the Month 36 ATP cohort for immunogenicity

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    End point title
    		 Anti-HPV-16/18 seroconversion rates as assessed by pseudovirion-based neutralization assay (PBNA) in a subset of subjects, based on the Month 36 ATP cohort for immunogenicity
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 7, 12, 18, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    89
    87
    91
    Units: Subjects
        Anti-HPV-16, Day 0 (N=89, 85, 91)
    0
    0
    0
        Anti-HPV-18, Day 0 (N=89, 87, 91)
    0
    0
    0
        Anti-HPV-16, Month 7 (N=89, 85, 91)
    89
    85
    91
        Anti-HPV-18, Month 7 (N=89, 87, 91)
    89
    87
    91
        Anti-HPV-16, Month 12 (N=88, 85, 91)
    88
    85
    91
        Anti-HPV-18, Month 12 (N=88, 87, 91)
    88
    86
    91
        Anti-HPV-16, Month 18 (N=88, 85, 90)
    88
    83
    89
        Anti-HPV-18, Month 18 (N=87, 87, 91)
    87
    77
    89
        Anti-HPV-16, Month 24 (N=86, 83, 91)
    86
    83
    90
        Anti-HPV-18, Month 24 (N=86, 83, 91)
    86
    75
    88
        Anti-HPV-16, Month 36 (N=89, 85, 91)
    89
    85
    91
        Anti-HPV-18, Month 36 (N=89, 87, 91)
    89
    75
    86
    No statistical analyses for this end point

    Secondary: Anti-HPV-16/18 antibody titers as assessed by PBNA in a subset of subjects, based on the Month 36 ATP cohort for immunogenicity

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    End point title
    		 Anti-HPV-16/18 antibody titers as assessed by PBNA in a subset of subjects, based on the Month 36 ATP cohort for immunogenicity
    End point description
    Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 7, 12, 18, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    89
    87
    91
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-HPV-16, Day 0 (N=89, 85, 91)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
        Anti-HPV-18, Day 0 (N=89, 87, 91)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
        Anti-HPV-16, Month 7 (N=89, 85, 91)
    52868.5 (44171.0 to 63278.5)
    19130.1 (15166.8 to 24129.0)
    22182.7 (17611.7 to 27940.1)
        Anti-HPV-18, Month 7 (N=89, 87, 91)
    24068.5 (19293.2 to 30025.8)
    4726.5 (3600.9 to 6204.0)
    8243.9 (6276.2 to 10828.4)
        Anti-HPV-16, Month 12 (N=88, 85, 91)
    10695.9 (8564.9 to 13357.1)
    4280.1 (3245.9 to 5643.6)
    5843.8 (4599.8 to 7424.1)
        Anti-HPV-18, Month 12 (N=88, 87, 91)
    3683.3 (2914.4 to 4655.2)
    689.0 (517.2 to 917.8)
    1788.6 (1308.6 to 2444.7)
        Anti-HPV-16, Month 18 (N=88, 85, 90)
    8436.3 (6650.6 to 10701.4)
    2129.7 (1512.8 to 2998.1)
    2987.2 (2218.5 to 4022.3)
        Anti-HPV-18, Month 18 (N=87, 87, 91)
    2426.3 (1885.7 to 3121.7)
    295.7 (217.0 to 402.8)
    812.1 (577.0 to 1143.0)
        Anti-HPV-16, Month 24 (N=86, 83, 91)
    5036.7 (4097.8 to 6190.7)
    1211.8 (893.8 to 1642.9)
    1967.2 (1507.5 to 2567.2)
        Anti-HPV-18, Month 24 (N=86, 83, 91)
    1763.0 (1384.5 to 2245.0)
    237.1 (177.2 to 317.1)
    573.1 (421.5 to 779.3)
        Anti-HPV-16, Month 36 (N=89, 85, 91)
    4357.8 (3577.8 to 5307.9)
    1128.9 (857.4 to 1486.4)
    1577.0 (1210.4 to 2054.5)
        Anti-HPV-18, Month 36 (N=89, 87, 91)
    1613.9 (1267.6 to 2054.7)
    185.8 (140.4 to 245.8)
    472.8 (345.8 to 646.4)
    No statistical analyses for this end point

    Secondary: Anti-HPV-16/18 seroconversion rates as assessed by PBNA in a subset of subjects, based on the Month 36 TVC

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    End point title
    		 Anti-HPV-16/18 seroconversion rates as assessed by PBNA in a subset of subjects, based on the Month 36 TVC
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 7, 12, 18, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    99
    92
    98
    Units: Subjects
        Anti-HPV-16, Day 0 (N=99, 90, 98)
    0
    0
    0
        Anti-HPV-18, Day 0 (N=99, 92, 98)
    0
    0
    0
        Anti-HPV-16, Month 7 (N= 99, 90, 98)
    99
    90
    98
        Anti-HPV-18, Month 7 (N= 99, 92, 98)
    99
    92
    98
        Anti-HPV-16, Month 12 (N= 98, 90, 98)
    97
    90
    98
        Anti-HPV-18, Month 12 (N=98, 92, 98)
    98
    91
    98
        Anti-HPV-16, Month 18 (N=98, 90, 97)
    97
    88
    96
        Anti-HPV-18, Month 18 (N=97, 92, 98)
    97
    82
    96
        Anti-HPV-16, Month 24 (N=96, 87, 98)
    95
    87
    97
        Anti-HPV-18, Month 24 (N=96, 87, 98)
    96
    79
    94
        Anti-HPV-16, Month 36 (N=98, 90, 98)
    97
    90
    98
        Anti-HPV-18, Month 36 (N=97, 92, 98)
    97
    80
    92
    No statistical analyses for this end point

    Secondary: Anti-HPV-16/18 antibody titers as assessed by PBNA in a subset of subjects, based on the Month 36 TVC

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    End point title
    		 Anti-HPV-16/18 antibody titers as assessed by PBNA in a subset of subjects, based on the Month 36 TVC
    End point description
    Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 7, 12, 18, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    99
    92
    98
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-HPV-16, Day 0 (N=99, 90, 98)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
        Anti-HPV-18, Day 0 (N=99, 92, 98)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
    20.0 (20.0 to 20.0)
        Anti-HPV-16, Month 7 (N=99, 90, 98)
    50000.7 (39742.9 to 62906.0)
    18573.7 (14876.8 to 23189.3)
    22294.2 (17763.8 to 27980.0)
        Anti-HPV-18, Month 7 (N= 99, 92, 98)
    23576.9 (18922.5 to 29376.2)
    4563.7 (3519.5 to 5917.8)
    8042.1 (6186.1 to 10454.8)
        Anti-HPV-16, Month 12 (N=98, 90, 98)
    10039.6 (7884.1 to 12784.5)
    4174.9 (3207.5 to 5434.2)
    5766.0 (4573.8 to 7268.9)
        Anti-HPV-18, Month 12 (N= 98, 92, 98)
    3546.9 (2829.7 to 4445.8)
    670.3 (510.0 to 880.9)
    1801.4 (1333.0 to 2434.2)
        Anti-HPV-16, Month 18 (N= 98, 90, 97)
    7508.8 (5819.8 to 9688.0)
    2070.2 (1494.9 to 2866.9)
    2961.5 (2233.9 to 3926.2)
        Anti-HPV-18, Month 18 (N=97, 92, 98)
    2240.5 (1763.3 to 2846.9)
    294.5 (219.5 to 395.1)
    797.6 (576.3 to 1104.0)
        Anti-HPV-16, Month 24 (N=96, 87, 98)
    4609.1 (3673.5 to 5782.9)
    1193.9 (889.6 to 1602.3)
    1932.0 (1499.4 to 2489.5)
        Anti-HPV-18, Month 24 (N=96, 87, 98)
    1638.6 (1297.9 to 2068.8)
    239.7 (181.2 to 317.1)
    564.6 (418.1 to 762.5)
        Anti-HPV-16, Month 36 (N=98, 90, 98)
    4011.7 (3229.7 to 4983.0)
    1111.4 (849.1 to 1454.6)
    1517.2 (1174.7 to 1959.4)
        Anti-HPV-18, Month 36 (N=97, 92, 98)
    1513.7 (1197.5 to 1913.2)
    185.8 (142.2 to 242.7)
    468.6 (346.3 to 634.0)
    No statistical analyses for this end point

    Secondary: T-cell-mediated immune responses in the sub-cohort for Cell-Mediated Immunity (CMI)

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    End point title
    		 T-cell-mediated immune responses in the sub-cohort for Cell-Mediated Immunity (CMI)
    End point description
    Among immune markers expressed were Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumor necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L). The assay was performed on a sub-cohort of approximately 100 subjects per study group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 7, 12, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    67
    60
    74
    Units: T-cells/million cells
    median (inter-quartile range (Q1-Q3))
        CD4+ All doubles, Anti-HPV-16,Day 0 (N=53, 42, 53)
    10 (1 to 78)
    22 (1 to 90)
    33 (1 to 80)
        CD4+ All doubles, Anti-HPV-18,Day 0 (N=53, 42, 54)
    28 (1 to 83)
    47.5 (1 to 102)
    26 (1 to 92)
        CD4+ All doubles,Anti-HPV-16,Month 7(N=63, 58, 62)
    1662 (644 to 3221)
    872 (479 to 1275)
    1121 (694 to 1890)
        CD4+ All doubles,Anti-HPV-18,Month 7(N=63, 58, 63)
    897 (496 to 2497)
    427 (259 to 744)
    640 (355 to 1304)
        CD4+All doubles,Anti-HPV-16,Month 12(N=67, 58, 66)
    916 (641 to 2340)
    585.5 (316 to 1250)
    819.5 (554 to 1623)
        CD4+All doubles,Anti-HPV-18,Month 12(N=67, 59, 66)
    789 (384 to 1492)
    327 (184 to 658)
    446 (205 to 824)
        CD4+All doubles,Anti-HPV-16,Month 24 N=66, 60, 74)
    1068.5 (495 to 2410)
    750.5 (366.5 to 1142.5)
    968.5 (588 to 1830)
        CD4+All doubles Anti-HPV-18,Month 24(N=65, 60, 73)
    645 (311 to 1406)
    352 (196.5 to 503)
    578 (267 to 972)
        CD4+All doubles.Anti-HPV-16,Month 36(N=58, 55, 64)
    1012 (427 to 2373)
    685 (385 to 1321)
    842.5 (437.5 to 1624)
        CD4+All doubles,Anti-HPV-18,Month 36(N=57, 55, 63)
    682 (313 to 1425)
    350 (196 to 665)
    516 (270 to 1029)
        CD4-d-CD40L, Anti-HPV-16, Day 0 (N=53, 42, 53)
    1 (1 to 73)
    14 (1 to 72)
    30 (1 to 73)
        CD4-d-CD40L, Anti-HPV-18, Day 0 (N=53, 42, 54)
    14 (1 to 83)
    39.5 (1 to 102)
    27.5 (1 to 70)
        CD4-d-CD40L, Anti-HPV-16, Month 7 (N=63, 58, 62)
    1515 (638 to 3098)
    779 (456 to 1211)
    1025.5 (670 to 1848)
        CD4-d-CD40L, Anti-HPV-18, Month 7 (N=63, 58, 63)
    866 (496 to 2483)
    386.5 (237 to 708)
    574 (328 to 1224)
        CD4-d-CD40L, Anti-HPV-16, Month 12 (N=67, 58, 66)
    889 (591 to 2236)
    524 (280 to 1135)
    761.5 (484 to 1425)
        CD4-d-CD40L, Anti-HPV-18, Month 12 (N=67, 59, 66)
    688 (344 to 1435)
    317 (147 to 633)
    383.5 (214 to 729)
        CD4-d-CD40L, Anti-HPV-16, Month 24 (N=66, 60, 74)
    1045.5 (518 to 2269)
    736 (348 to 1101.5)
    937 (588 to 1801)
        CD4-d-CD40L, Anti-HPV-18, Month 24 (N=65, 60, 73)
    639 (310 to 1374)
    332 (204 to 510.5)
    564 (289 to 940)
        CD4-d-CD40L, Anti-HPV-16, Month 36 (N=58, 55, 64)
    957 (465 to 2303)
    685 (349 to 1321)
    778.5 (416.5 to 1560.5)
        CD4-d-CD40L, Anti-HPV-18, Month 36 (N=57, 55, 63)
    671 (290 to 1435)
    337 (204 to 648)
    499 (264 to 1020)
        CD4-d- IFNγ, Anti-HPV-16, Day 0 (N=53, 42, 53)
    12 (1 to 30)
    19 (1 to 42)
    1 (1 to 28)
        CD4-d- IFNγ, Anti-HPV-18, Day 0 (N=53, 42, 54)
    14 (1 to 33)
    13.5 (1 to 36)
    3.5 (1 to 30)
        CD4-d- IFNγ, Anti-HPV-16, Month 7 (N=63, 58, 62)
    365 (161 to 881)
    320 (157 to 533)
    422.5 (206 to 708)
        CD4-d- IFNγ, Anti-HPV-18, Month 7 (N=63, 58, 63)
    242 (111 to 712)
    133.5 (83 to 240)
    181 (78 to 409)
        CD4-d- IFNγ, Anti-HPV-16, Month 12 (N=67, 58, 66)
    326 (110 to 644)
    235 (108 to 501)
    356 (135 to 734)
        CD4-d- IFNγ, Anti-HPV-18, Month 12 (N=67, 59, 66)
    175 (87 to 444)
    112 (55 to 240)
    164 (57 to 315)
        CD4-d- IFNγ, Anti-HPV-16, Month 24 (N=66, 60, 74)
    300.5 (119 to 781)
    317.5 (146.5 to 514)
    421 (157 to 767)
        CD4-d- IFNγ, Anti-HPV-18, Month 24 (N=65, 60, 73)
    171 (68 to 462)
    112 (49.5 to 229.5)
    220 (65 to 348)
        CD4-d-IFNγ, Anti-HPV-16, Month 36 (N=58, 55, 64)
    253.5 (81 to 667)
    301 (134 to 571)
    270.5 (129 to 666.5)
        CD4-d-IFNγ, Anti-HPV-18, Month 36 (N=57, 55, 63)
    193 (51 to 376)
    109 (27 to 230)
    155 (45 to 314)
        CD4-d-IL-2, Anti-HPV-16, Day 0 (N=53, 42, 53)
    14 (1 to 52)
    25 (1 to 72)
    33 (1 to 56)
        CD4-d-IL-2, Anti-HPV-18, Day 0 (N=53, 42, 54)
    1 (1 to 49)
    36.5 (1 to 76)
    22 (1 to 60)
        CD4-d-IL-2, Anti-HPV-16, Month 7 (N=63, 58, 62)
    1357 (537 to 2660)
    712.5 (378 to 1037)
    866 (561 to 1420)
        CD4-d-IL-2, Anti-HPV-18, Month 7 (N=63, 58, 63)
    737 (420 to 2185)
    304 (206 to 573)
    486 (281 to 959)
        CD4-d-IL-2, Anti-HPV-16, Month 12 (N=67, 58, 66)
    832 (493 to 2050)
    479 (283 to 946)
    674.5 (450 to 1316)
        CD4-d-IL-2, Anti-HPV-18, Month 12 (N=67, 59, 66)
    620 (304 to 1157)
    259 (144 to 547)
    354 (155 to 622)
        CD4-d-IL-2, Anti-HPV-16, Month 24 (N=66, 60, 74)
    855 (390 to 1711)
    579.5 (270.5 to 934.5)
    700 (479 to 1459)
        CD4-d-IL-2, Anti-HPV-18, Month 24 (N=65, 60, 73)
    494 (252 to 994)
    240 (125.5 to 387.5)
    426 (216 to 695)
        CD4-d-IL-2, Anti-HPV-16, Month 36 (N=58,55, 64)
    784 (331 to 1673)
    517 (295 to 1014)
    680 (308 to 1245.5)
        CD4-d-IL-2, Anti-HPV-18, Month 36 (N=57, 55, 63)
    507 (213 to 1069)
    274 (137 to 467)
    341 (168 to 798)
        CD4-d-TNFα, Anti-HPV-16, Day 0 (N=53, 42, 53)
    6 (1 to 50)
    33 (1 to 82)
    16 (1 to 69)
        CD4-d-TNFα, Anti-HPV-18, Day 0 (N=53, 42, 54)
    27 (1 to 75)
    22.5 (1 to 82)
    23 (1 to 60)
        CD4-d-TNFα, Anti-HPV-16, Month 7 (N=63, 58, 62)
    1111 (430 to 2386)
    625 (292 to 899)
    796 (458 to 1448)
        CD4-d-TNFα, Anti-HPV-18, Month 7 (N=63, 58, 63)
    647 (336 to 1415)
    283.5 (168 to 594)
    457 (266 to 978)
        CD4-d-TNFα, Anti-HPV-16, Month 12 (N=67, 58, 66)
    790 (488 to 1924)
    482 (210 to 932)
    716 (457 to 1445)
        CD4-d-TNFα, Anti-HPV-18, Month 12 (N=67, 59, 66)
    674 (288 to 1272)
    266 (133 to 588)
    384.5 (175 to 714)
        CD4-d-TNFα, Anti-HPV-16, Month 24 (N=66, 60, 74)
    795.5 (343 to 1668)
    563.5 (241.5 to 895)
    760.5 (443 to 1494)
        CD4-d-TNFα, Anti-HPV-18, Month 24 (N=65, 60, 73)
    510 (183 to 1164)
    239 (127.5 to 440.5)
    522 (228 to 710)
        CD4-d-TNFα, Anti-HPV-16, Month 36 (N=58, 55, 64)
    786.5 (343 to 1930)
    547 (282 to 1005)
    724.5 (368 to 1338)
        CD4-d-TNFα, Anti-HPV-18, Month 36 (N=57, 55, 63)
    588 (250 to 1138)
    301 (120 to 453)
    479 (200 to 808)
        CD8-All Doubles, Anti-HPV-16, Day 0 (N=53, 42, 53)
    1 (1 to 14)
    4 (1 to 49)
    1 (1 to 25)
        CD8-All Doubles, Anti-HPV-18, Day 0 (N=53, 42, 54)
    1 (1 to 16)
    1 (1 to 29)
    1 (1 to 22)
        CD8-All Doubles,Anti-HPV-16,Month 7(N=63, 58, 62)
    1 (1 to 34)
    1 (1 to 41)
    1 (1 to 30)
        CD8-All Doubles,Anti-HPV-18,Month 7(N=63, 58, 63)
    1 (1 to 19)
    1 (1 to 40)
    1 (1 to 40)
        CD8-All Doubles,Anti-HPV-16,Month 12(N=67, 58, 66)
    1 (1 to 31)
    1 (1 to 29)
    1 (1 to 29)
        CD8-All Doubles,Anti-HPV-18,Month 12(N=67, 59, 66)
    1 (1 to 27)
    1 (1 to 27)
    1 (1 to 20)
        CD8-All Doubles,Anti-HPV-16,Month 24(N=66, 60, 74)
    1 (1 to 25)
    1 (1 to 1)
    1 (1 to 1)
        CD8-All Doubles,Anti-HPV-18,Month 24(N=65, 60, 73)
    1 (1 to 32)
    1 (1 to 23)
    1 (1 to 28)
        CD8-All doubles,Anti-HPV-16,Month 36(N=58, 55, 64)
    1 (1 to 48)
    1 (1 to 28)
    1 (1 to 38.5)
        CD8-All doubles,Anti-HPV-18,Month 36(N=57, 55, 63)
    4 (1 to 40)
    2 (1 to 41)
    1 (1 to 28)
        CD8-d-CD40L, Anti-HPV-16, Day 0 (N=53, 42, 53)
    1 (1 to 1)
    1 (1 to 26)
    1 (1 to 1)
        CD8-d-CD40L, Anti-HPV-18, Day 0 (N=53, 42, 54)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-CD40L, Anti-HPV-16, Month 7 (N=63, 58, 62)
    1 (1 to 1)
    1 (1 to 29)
    1 (1 to 24)
        CD8-d-CD40L, Anti-HPV-18, Month 7 (N=63, 58, 63)
    1 (1 to 1)
    1 (1 to 24)
    1 (1 to 23)
        CD8-d-CD40L, Anti-HPV-16, Month 12 (N=67, 58, 66)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 3)
        CD8-d-CD40L, Anti-HPV-18, Month 12 (N=67, 59, 66)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-CD40L, Anti-HPV-16, Month 24 (N=66, 60, 74)
    1 (1 to 16)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-CD40L, Anti-HPV-18, Month 24 (N=65, 60, 73)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 18)
        CD8-d-CD40L, Anti-HPV-16, Month 36 (N=58, 55, 64)
    1 (1 to 31)
    1 (1 to 24)
    1 (1 to 29)
        CD8-d-CD40L, Anti-HPV-18, Month 36 (N=57, 55, 63)
    1 (1 to 6)
    1 (1 to 27)
    1 (1 to 28)
        CD8-d-IFNγ, Anti-HPV-16, Day 0 (N=53, 42, 53)
    1 (1 to 1)
    1 (1 to 39)
    1 (1 to 26)
        CD8-d-IFNγ, Anti-HPV-18, Day 0 (N=53, 42, 54)
    1 (1 to 2)
    1 (1 to 23)
    1 (1 to 18)
        CD8-d-IFNγ, Anti-HPV-16, Month 7 (N=63, 58, 62)
    1 (1 to 32)
    1 (1 to 40)
    1 (1 to 30)
        CD8-d-IFNγ, Anti-HPV-18, Month 7 (N=63, 58, 63)
    1 (1 to 1)
    1 (1 to 28)
    1 (1 to 28)
        CD8-d-IFNγ, Anti-HPV-16, Month 12 (N=67, 58, 66)
    1 (1 to 28)
    1 (1 to 26)
    1 (1 to 27)
        CD8-d-IFNγ, Anti-HPV-18, Month 12 (N=67, 59, 66)
    1 (1 to 22)
    1 (1 to 26)
    1 (1 to 10)
        CD8-d-IFNγ, Anti-HPV-16, Month 24 (N=66, 60, 74)
    1 (1 to 16)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IFNγ, Anti-HPV-18, Month 24 (N=65, 60, 73)
    1 (1 to 18)
    1 (1 to 23)
    1 (1 to 1)
        CD8-d-IFNγ, Anti-HPV-16, Month 36 (N=58, 55, 64)
    1 (1 to 47)
    1 (1 to 25)
    1 (1 to 33)
        CD8-d-IFNγ, Anti-HPV-18, Month 36 (N=57, 55, 63)
    1 (1 to 31)
    2 (1 to 40)
    1 (1 to 25)
        CD8-d-IL-2, Anti-HPV-16, Day 0 (N=53, 42, 53)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Day 0 (N=53, 42, 54)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-16, Month 7 (N=63, 58, 62)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Month 7 (N=63, 58, 63)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-16, Month 12 (N=67, 58, 66)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Month 12 (N=67, 59, 66)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-16, Month 24 (N=66, 60, 74)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Month 24 (N=65, 60, 73)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-16, Month 36 (N=58, 55, 64)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Month 36 (N=57, 55, 63)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-TNFα, Anti-HPV-16, Day 0 (N=53, 42, 53)
    1 (1 to 1)
    1 (1 to 36)
    1 (1 to 16)
        CD8-d-TNFα, Anti-HPV-18, Day 0 (N=53, 42, 54)
    1 (1 to 27)
    1 (1 to 29)
    1 (1 to 26)
        CD8-d-TNFα, Anti-HPV-16, Month 7 (N=63, 58, 62)
    1 (1 to 28)
    1 (1 to 26)
    1 (1 to 18)
        CD8-d-TNFα, Anti-HPV-18, Month 7 (N=63, 58, 63)
    1 (1 to 1)
    1 (1 to 2)
    1 (1 to 24)
        CD8-d-TNFα, Anti-HPV-16, Month 12 (N=67, 58, 66)
    1 (1 to 1)
    1 (1 to 25)
    1 (1 to 28)
        CD8-d-TNFα, Anti-HPV-18, Month 12 (N=67, 59, 66)
    1 (1 to 8)
    1 (1 to 21)
    1 (1 to 24)
        CD8-d-TNFα, Anti-HPV-16, Month 24 (N=66, 60, 74)
    1 (1 to 20)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-TNFα, Anti-HPV-18, Month 24 (N=65, 60, 73)
    1 (1 to 28)
    1 (1 to 7)
    1 (1 to 18)
        CD8-d-TNFα, Anti-HPV-16, Month 36 (N=58, 55, 64)
    1 (1 to 24)
    1 (1 to 1)
    1 (1 to 26)
        CD8-d-TNFα, Anti-HPV-18, Month 36 (N=57, 55, 63)
    1 (1 to 31)
    1 (1 to 21)
    1 (1 to 12)
    No statistical analyses for this end point

    Secondary: B-cell-mediated immune responses in the sub-cohort for CMI

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    End point title
    		 B-cell-mediated immune responses in the sub-cohort for CMI
    End point description
    The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented. The assay was performed on a sub-cohort of 100 subjects per study group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Months 7, 12, 24 and 36
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    71
    65
    76
    Units: B-cells/million cells
    median (inter-quartile range (Q1-Q3))
        HPV-16, Day 0 (N=69, 55, 70)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        HPV-18, Day 0 (N=69, 55, 70)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        HPV-16, Month 7 (N=71, 65, 76)
    1733 (577 to 3733)
    1254 (495 to 2173)
    733 (106.5 to 1966.5)
        HPV-18, Month 7 (N=71, 65, 76)
    558 (106 to 1847)
    155 (1 to 379)
    111 (1 to 343.5)
        HPV-16, Month 12 (N=51, 51, 53)
    408 (90 to 1186)
    278 (66 to 794)
    289 (66 to 982)
        HPV-18, Month 12 (N=51, 51, 53)
    249 (73 to 658)
    69 (1 to 184)
    69 (1 to 250)
        HPV-16, Month 24 (N=54, 46, 63)
    270 (49 to 724)
    218.5 (28 to 651)
    249 (37 to 601)
        HPV-18, Month 24 (N=54, 46, 63)
    128.5 (35 to 402)
    57.5 (1 to 203)
    111 (1 to 317)
        HPV-16, Month 36 (N=59, 54, 53)
    353 (91 to 927)
    382.5 (166 to 614)
    246 (21 to 565)
        HPV-18, Month 36 (N=59, 54, 53)
    116 (1 to 329)
    25 (1 to 228)
    63 (1 to 150)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    357
    356
    Units: Subjects
        Any Pain - Dose 1 (N=359, 357, 356)
    311
    235
    231
        Any Pain - Dose 2 (N=357, 353, 354)
    193
    183
    215
        Any Pain - Dose 3 (N=356, 348, 350)
    280
    194
    222
        Any Pain - Across doses (N=359, 357, 356)
    329
    276
    295
        Grade 3 Pain - Dose 1 (N=359, 357, 356)
    22
    4
    6
        Grade 3 Pain - Dose 2 (N=357, 353, 354)
    8
    8
    8
        Grade 3 Pain - Dose 3 (N=356, 348, 350)
    23
    11
    10
        Grade 3 Pain - Across doses (N=359, 357, 356)
    42
    17
    18
        Any Redness - Dose 1 (N=359, 357, 356)
    137
    84
    87
        Any Redness - Dose 2 (N=357, 353, 354)
    100
    84
    99
        Any Redness - Dose 3 (N=356, 348, 350)
    133
    92
    102
        Any Redness - Across doses (N=359, 357, 356)
    191
    134
    157
        Grade 3 Redness - Dose 1 (N=359, 357, 356)
    0
    0
    1
        Grade 3 Redness - Dose 2 (N=357, 353, 354)
    0
    0
    0
        Grade 3 Redness - Dose 3 (N=356, 348, 350)
    0
    0
    1
        Grade 3 Redness - Across doses (N=359, 357, 356)
    0
    0
    2
        Any Swelling - Dose 1 (N=359, 357, 356)
    112
    44
    39
        Any Swelling - Dose 2 (N=357, 353, 354)
    63
    35
    76
        Any Swelling - Dose 3 (N=356, 348, 350)
    113
    67
    85
        Any Swelling - Across doses (N=359, 357, 356)
    163
    98
    118
        Grade 3 Swelling - Dose 1 (N=359, 357, 356)
    3
    0
    0
        Grade 3 Swelling - Dose 2 (N=357, 353, 354)
    0
    0
    0
        Grade 3 Swelling - Dose 3 (N=356, 348, 350)
    2
    0
    2
        Grade 3 Swelling - Across doses (N=359, 357, 356)
    5
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    357
    356
    Units: Subjects
        Any Arthralgia - Dose 1 (N=359, 357, 355)
    44
    50
    39
        Any Arthralgia - Dose 2 (N=357, 353, 354)
    23
    30
    34
        Any Arthralgia - Dose 3 (N=354, 347, 351)
    31
    38
    35
        Any Arthralgia - Across doses (N=359, 357, 356)
    68
    81
    67
        Grade 3 Arthralgia - Dose 1 (N=359, 357, 355)
    5
    1
    1
        Grade 3 Arthralgia - Dose 2 (N=357, 353, 354)
    1
    2
    1
        Grade 3 Arthralgia - Dose 3 (N=354, 347, 351)
    2
    3
    1
        Grade 3 Arthralgia -Across doses (N=359, 357, 356)
    6
    4
    1
        Related Arthralgia - Dose 1 (N=359, 357, 355)
    29
    32
    28
        Related Arthralgia - Dose 2 (N=357, 353, 354)
    17
    17
    18
        Related Arthralgia - Dose 3 (N=354, 347, 351)
    20
    27
    27
        Related Arthralgia -Across doses (N=359, 357, 356)
    51
    55
    51
        Any Fatigue - Dose 1 (N=359, 357, 355)
    163
    157
    168
        Any Fatigue - Dose 2 (N=357, 353, 354)
    103
    104
    119
        Any Fatigue - Dose 3 (N=354, 347, 351)
    108
    97
    103
        Any Fatigue - Across doses (N=359, 357, 356)
    192
    199
    193
        Grade 3 Fatigue - Dose 1 (N=359, 357, 355)
    7
    10
    5
        Grade 3 Fatigue - Dose 2 (N=357, 353, 354)
    12
    3
    2
        Grade 3 Fatigue - Dose 3 (N=354, 347, 351)
    7
    3
    3
        Grade 3 Fatigue - Across doses (N=359, 357, 356)
    18
    15
    7
        Related Fatigue - Dose 1 (N=359, 357, 355)
    103
    102
    98
        Related Fatigue - Dose 2 (N=357, 353, 354)
    68
    66
    67
        Related Fatigue - Dose 3 (N=354, 347, 351)
    70
    67
    67
        Related Fatigue -Across doses (N=359, 357, 356)
    152
    151
    143
        Any Gastrointestinal - Dose 1 (N=359, 357, 355)
    34
    52
    44
        Any Gastrointestinal - Dose 2 (N=357, 353, 354)
    19
    22
    23
        Any Gastrointestinal - Dose 3 (N=354, 347, 351)
    16
    29
    24
        Any Gastrointestinal -Across doses (N=359,357,356)
    55
    74
    70
        Grade 3 Gastrointestinal -Dose 1 (N=359, 357, 355)
    3
    2
    2
        Grade 3 Gastrointestinal -Dose 2 (N=357, 353, 354)
    2
    1
    0
        Grade 3 Gastrointestinal -Dose 3 (N=354, 347, 351)
    1
    4
    2
        Grade 3 Gastro -Across doses (N=359, 357, 356)
    5
    6
    3
        Related Gastrointestinal -Dose 1 (N=359, 357, 355)
    21
    26
    22
        Related Gastrointestinal -Dose 2 (N=357, 353, 354)
    8
    17
    6
        Related Gastrointestinal -Dose 3 (N=354, 347, 351)
    10
    20
    17
        Related Gastro - Across doses (N=359, 357, 356)
    32
    49
    40
        Any Headache - Dose 1 (N=359, 357, 355)
    102
    87
    90
        Any Headache - Dose 2 (N=357, 353, 354)
    62
    64
    73
        Any Headache - Dose 3 (N=354, 347, 351)
    63
    54
    65
        Any Headache -Across doses (N=359, 357, 356)
    147
    133
    151
        Grade 3 Headache - Dose 1 (N=359, 357, 355)
    7
    6
    1
        Grade 3 Headache - Dose 2 (N=357, 353, 354)
    6
    2
    4
        Grade 3 Headache - Dose 3 (N=354, 347, 351)
    7
    1
    1
        Grade 3 Headache -Across doses (N=359, 357, 356)
    17
    7
    4
        Related Headache - Dose 1 (N=359, 357, 355)
    61
    51
    48
        Related Headache - Dose 2 (N=357, 353, 354)
    39
    37
    41
        Related Headache - Dose 3 (N=354, 347, 351)
    45
    33
    42
        Related Headache -Across doses (N=359, 357, 356)
    107
    88
    100
        Any Myalgia - Dose 1 (N=359, 357, 355)
    131
    101
    101
        Any Myalgia - Dose 2 (N=357, 353, 354)
    59
    60
    80
        Any Myalgia - Dose 3 (N=354, 347, 351)
    77
    68
    72
        Any Myalgia - Across doses (N=359, 357, 356)
    166
    143
    136
        Grade 3 Myalgia - Dose 1 (N=359, 357, 355)
    5
    3
    2
        Grade 3 Myalgia - Dose 2 (N=357, 353, 354)
    2
    3
    2
        Grade 3 Myalgia - Dose 3 (N=354, 347, 351)
    3
    4
    5
        Grade 3 Myalgia -Across doses (N=359, 357, 356)
    8
    8
    6
        Related Myalgia - Dose 1 (N=359, 357, 355)
    91
    70
    67
        Related Myalgia - Dose 2 (N=357, 353, 354)
    36
    40
    51
        Related Myalgia - Dose 3 (N=354, 347, 351)
    50
    49
    46
        Related Myalgia -Across doses (N=359, 357, 356)
    128
    111
    100
        Any Rash - Dose 1 (N=359, 357, 355)
    14
    7
    10
        Any Rash - Dose 2 (N=357, 353, 354)
    10
    5
    8
        Any Rash - Dose 3 (N=354, 347, 351)
    7
    5
    4
        Any Rash - Across doses (N=359, 357, 356)
    25
    16
    18
        Grade 3 Rash - Dose 1 (N=359, 357, 356)
    0
    0
    0
        Grade 3 Rash - Dose 2 (N=357, 353, 354)
    0
    0
    0
        Grade 3 Rash - Dose 3 (N=354, 347, 351)
    0
    0
    0
        Grade 3 Rash -Across doses (N=359, 357, 356)
    0
    0
    0
        Related Rash - Dose 1 (N=359, 357, 355)
    6
    5
    6
        Related Rash - Dose 2 (N=357, 353, 354)
    6
    3
    4
        Related Rash - Dose 3 (N=354, 347, 351)
    6
    3
    3
        Related Rash - Across doses (N=359, 357, 356)
    16
    10
    12
        Any Temperature(≥ 37.5°C) -Dose 1(N=359, 357, 355)
    19
    23
    18
        Any Temperature(≥ 37.5°C) -Dose 2(N=357, 353, 354)
    13
    21
    19
        Any Temperature(≥ 37.5°C) -Dose 3(N=354, 347, 351)
    32
    22
    22
        Any Temp (≥ 37.5°C) -Across doses(N=359, 357, 356)
    53
    59
    47
        Grade 3 Temp (> 39.0°C) - Dose 1 (N=359, 357, 355)
    2
    2
    2
        Grade 3 Temp (> 39.0°C) - Dose 2 (N=357, 353, 354)
    0
    0
    2
        Grade 3 Temp (> 39.0°C) - Dose 3 (N=354, 347, 351)
    6
    0
    0
        Grade 3 Temp(>39.0°C) -Across doses(N=359,357,356)
    7
    2
    4
        Related Temperature - Dose 1 (N=359, 357, 355)
    13
    11
    7
        Related Temperature - Dose 2 (N=357, 353, 354)
    8
    9
    11
        Related Temperature - Dose 3 (N=354, 347, 351)
    19
    12
    15
        Related Temperature -Across doses(N=359, 357, 356)
    35
    31
    30
        Any Urticaria - Dose 1 (N=359, 357, 355)
    15
    7
    12
        Any Urticaria - Dose 2 (N=357, 353, 354)
    8
    5
    12
        Any Urticaria - Dose 3 (N=354, 347, 351)
    11
    4
    9
        Any Urticaria - Across doses (N=359, 357, 356)
    28
    13
    25
        Grade 3 Urticaria - Dose 1 (N=359, 357, 355)
    2
    0
    0
        Grade 3 Urticaria - Dose 2 (N=357, 353, 354)
    0
    1
    0
        Grade 3 Urticaria - Dose 3 (N=354, 347, 351)
    2
    0
    0
        Grade 3 Urticaria -Across doses (N=359, 357, 356)
    4
    1
    0
        Related Urticaria - Dose 1 (N=359, 357, 355)
    7
    6
    7
        Related Urticaria - Dose 2 (N=357, 353, 354)
    5
    4
    4
        Related Urticaria - Dose 3 (N=354, 347, 351)
    6
    4
    2
        Related Urticaria -Across doses (N=359, 357, 356)
    15
    11
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    358
    358
    Units: Subjects
        Subjects with any AE(s) (N=359, 358, 358)
    91
    96
    101
        Subjects with any Grade 3 AE(s) (N=359, 358, 358)
    18
    8
    20
        Subjects with any Related AE(s) (N=359, 358, 358)
    8
    14
    15
    No statistical analyses for this end point

    Secondary: Number of subjects with potentially immune mediated diseases (pIMDs)

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    End point title
    		 Number of subjects with potentially immune mediated diseases (pIMDs)
    End point description
    pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 12
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    358
    358
    Units: Subjects
        pIMD(s)
    3
    3
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with medically significant conditions (MSCs)

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    End point title
    		 Number of subjects with medically significant conditions (MSCs)
    End point description
    MSCs are defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 36 (throughout the study period)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    358
    358
    Units: Subjects
    77
    79
    63
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 36 (throughout the study period)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    358
    358
    Units: Subjects
    21
    11
    14
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs related to the investigational product, to study participation, to GSK concomitant products or any fatal SAE

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    End point title
    		 Number of subjects with SAEs related to the investigational product, to study participation, to GSK concomitant products or any fatal SAE
    End point description
    SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related = an event assessed by the investigator as causally related to the investigational product, to study participation or to GSK concomitant products.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 36 (throughout the study period)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    358
    358
    Units: Subjects
        Related SAE(s) (N=359, 358, 358)
    0
    0
    0
        Fatal SAE(s) (N=359, 358, 358)
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting pregnancies and outcomes of reported pregnancies

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    End point title
    		 Number of subjects reporting pregnancies and outcomes of reported pregnancies
    End point description
    Outcomes of pregnancies were: Live infant NO apparent congenital anomaly (ACA), Live infant congenital anomaly (CA), Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 36 (throughout the study period)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    0 [7]
    0 [8]
    1
    Units: Subjects
        Live infant NO ACA
    0
        Live infant CA
    0
        Elective termination NO ACA
    1
        Elective termination CA
    0
        Ectopic pregnancy
    0
        Spontaneous abortion NO ACA
    0
        Stillbirth NO ACA
    0
        Stillbirth CA
    0
        Lost to follow up
    0
        Pregnancy ongoing
    0
        Missing
    0
    Notes
    [7] - No pregnancies were reported for this group.
    [8] - No pregnancies were reported for this group.
    No statistical analyses for this end point

    Secondary: Number of subjects using a concomitant medication throughout the study period

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    End point title
    		 Number of subjects using a concomitant medication throughout the study period
    End point description
    The number of subjects who have used any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 36 (throughout the study period) following vaccination after each dose and across doses
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    358
    358
    Units: Subjects
        Any, Dose 1 (N=359, 358, 358)
    85
    87
    93
        Any antipyretic, Dose 1 (N=359, 358, 358)
    51
    53
    47
        Prophylactic antipyretic, Dose 1 (N=359, 358, 358)
    4
    0
    0
        Any antibiotic, Dose 1 (N=359, 358, 358)
    15
    13
    23
        Prophylactic antibiotic, Dose 1 (N=359, 358, 358)
    0
    0
    0
        Any, Dose 2 (N=358, 356, 356)
    52
    55
    47
        Any antipyretic, Dose 2 (N=358, 356, 356)
    32
    26
    29
        Prophylactic antipyretic, Dose 2 (N=358, 356, 356)
    0
    1
    2
        Any antibiotic, Dose 2 (N=358, 356, 356)
    8
    13
    12
        Prophylactic antibiotic, Dose 2 (N=358, 356, 356)
    0
    0
    0
        Any, Dose 3 (N=357, 352, 354)
    90
    83
    81
        Any antipyretic, Dose 3 (N=357, 352, 354)
    48
    45
    38
        Prophylactic antipyretic, Dose 3 (N=357, 352, 354)
    3
    1
    0
        Any antibiotic, Dose 3 (N=357, 352, 354)
    28
    21
    24
        Prophylactic antibiotic, Dose 3 (N=357, 352, 354)
    0
    0
    0
        Any, Across doses (N=359, 358, 358)
    171
    157
    161
        Any antipyretic, Across doses (N=359, 358, 358)
    110
    102
    95
        Prophylactic antipyretic,Across doses N359,358,358
    5
    2
    2
        Any antibiotic, Across doses (N=359, 358, 358)
    48
    42
    50
        Prophylactic antibiotic,Across doses N=359,358,358
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects completing the vaccination schedule

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    End point title
    		 Number of subjects completing the vaccination schedule
    End point description
    The number of subjects who have completed the three-dose vaccination schedule in all groups.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 36 (throughout the study period)
    End point values
    		 Cervarix 2 dose Group Gardasil 2 dose Group Gardasil 3 dose Group
    Number of subjects analysed
    359
    358
    358
    Units: Subjects
    351
    339
    346
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 7-day period after vaccination. Unsolicited AEs: during the 30-day period after vaccination. SAEs: throughout the study period (from Day 0 up to Month 36).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Cervarix 2 dose Group
    Reporting group description
    		 Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Gardasil 3 dose Group
    Reporting group description
    		 Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Reporting group title
    Gardasil 2 dose Group
    Reporting group description
    		 Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.

    Serious adverse events
    		 Cervarix 2 dose Group Gardasil 3 dose Group Gardasil 2 dose Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 359 (5.85%)
    14 / 358 (3.91%)
    11 / 358 (3.07%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Teratoma
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous incomplete
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulval ulceration
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 359 (0.56%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Depression
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    2 / 359 (0.56%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mouth cyst
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema nodosum
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Juvenile idiopathic arthritis
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 359 (0.84%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 359 (0.56%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 359 (0.28%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 358 (0.28%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 358 (0.00%)
    0 / 358 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 358 (0.00%)
    1 / 358 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cervarix 2 dose Group Gardasil 3 dose Group Gardasil 2 dose Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    343 / 359 (95.54%)
    324 / 358 (90.50%)
    321 / 358 (89.66%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    149 / 359 (41.50%)
    152 / 358 (42.46%)
    134 / 358 (37.43%)
         occurrences all number
    241
    232
    213
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    192 / 359 (53.48%)
    193 / 358 (53.91%)
    199 / 358 (55.59%)
         occurrences all number
    374
    390
    359
    Pain
         subjects affected / exposed
    329 / 359 (91.64%)
    295 / 358 (82.40%)
    277 / 358 (77.37%)
         occurrences all number
    784
    669
    613
    Pyrexia
         subjects affected / exposed
    59 / 359 (16.43%)
    53 / 358 (14.80%)
    64 / 358 (17.88%)
         occurrences all number
    70
    65
    71
    Swelling
         subjects affected / exposed
    163 / 359 (45.40%)
    118 / 358 (32.96%)
    98 / 358 (27.37%)
         occurrences all number
    288
    200
    146
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    55 / 359 (15.32%)
    70 / 358 (19.55%)
    74 / 358 (20.67%)
         occurrences all number
    69
    91
    103
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    191 / 359 (53.20%)
    157 / 358 (43.85%)
    135 / 358 (37.71%)
         occurrences all number
    370
    288
    261
    Rash
         subjects affected / exposed
    26 / 359 (7.24%)
    18 / 358 (5.03%)
    16 / 358 (4.47%)
         occurrences all number
    32
    23
    17
    Urticaria
         subjects affected / exposed
    28 / 359 (7.80%)
    25 / 358 (6.98%)
    13 / 358 (3.63%)
         occurrences all number
    36
    33
    16
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    68 / 359 (18.94%)
    67 / 358 (18.72%)
    82 / 358 (22.91%)
         occurrences all number
    98
    108
    119
    Myalgia
         subjects affected / exposed
    166 / 359 (46.24%)
    136 / 358 (37.99%)
    144 / 358 (40.22%)
         occurrences all number
    267
    254
    230
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 359 (2.23%)
    20 / 358 (5.59%)
    11 / 358 (3.07%)
         occurrences all number
    10
    22
    12
    Upper respiratory tract infection
         subjects affected / exposed
    27 / 359 (7.52%)
    31 / 358 (8.66%)
    29 / 358 (8.10%)
         occurrences all number
    31
    34
    33

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jul 2012
    Amendment 1: At the European Medicines Agency’s (EMA) request, GSK Biologicals has updated its procedure for emergency unblinding during the conduct of a clinical study. According to the revised procedure, the responsibility and the decision to break the treatment code in emergency situations resides solely with the investigator and consequently, the investigator had full authority to break the treatment code.
    28 Nov 2013
    Amendment 2: The assay used to measure anti-HPV-16/-18 antibody concentrations at the designated laboratory was improved to increase the assay precision by changing the assay cut-off value from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18. This change in the assay was implemented for the testing of samples at all time points.
    24 Jun 2014
    Amendment 3: At the time of study initiation, Cervarix was approved to be administered according to a 3-dose vaccination course. Subjects belonging to the Cervarix 2 dose Group and Gardasil 2 dose Group received two doses of either Cervarix or Gardasil during the primary study epoch. These subjects were to be offered a third dose of the vaccine that they received at the end of the study, at Month 36. Recently, the 2-dose schedule of Cervarix and Gardasil has been approved in some countries, and hence the protocol is being amended to reflect that a third dose of the vaccine that they received was offered to the subjects in the two 2-dose groups (Cervarix 2 dose Group and Gardasil 2 dose Group) only if required based on local prescribing recommendations. In addition, the indication for Cervarix and the list of contributing authors have been updated. The number of countries in which Cervarix and Gardasil are licensed has been updated. Minor changes have been made in a few sections to correct typographical errors.

    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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