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    Clinical Trial Results:
    Estudio ginecológico de extensión, fase IIIb, abierto y multicéntrico, para el seguimiento de un subgrupo de sujetos del estudio 580299/008 que presentaron, en la última visita del estudio (visita 10, mes 48), una citología cervical negativa pero eran positivas para HPV oncogénicos, o que se encontraban embarazadas en la última visita del estudio 580299/008

    Summary
    EudraCT number
    		 2008-008124-33
    Trial protocol
    		 FI   ES   DE   GB  
    Global end of trial date
    20 Jan 2014

    Results information
    Results version number
    		 v1
    This version publication date
    27 Apr 2016
    First version publication date
    24 Jan 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    112024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00937950
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •Proporcionar asistencia clínica y/o tratamiento a los sujetos que, al final del estudio HPV-008, mostraran una citología cervical normal pero un resultado positivo para infección por HPV oncogénicos o a las mujeres participantes que estuvieran embarazadas al final del estudio HPV-008 y a las que no hubiera podido recoger ninguna muestra cervical. •Notificar los AAG fatales, los AAG relacionados con la participación en el estudio y los AAG relacionados con medicación concomitante de GSK
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccine remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Aug 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 53
    Country: Number of subjects enrolled
    United Kingdom: 42
    Country: Number of subjects enrolled
    Finland: 764
    Country: Number of subjects enrolled
    Germany: 92
    Country: Number of subjects enrolled
    Australia: 49
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Brazil: 211
    Country: Number of subjects enrolled
    Canada: 40
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Philippines: 308
    Country: Number of subjects enrolled
    Taiwan: 105
    Country: Number of subjects enrolled
    Thailand: 249
    Country: Number of subjects enrolled
    United States: 95
    Worldwide total number of subjects
    2022
    EEA total number of subjects
    965
    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)
    0
    Adults (18-64 years)
    2022
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Pre-assignment period milestones
    Number of subjects started
    		 2022
    Number of subjects completed
    		 2003

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Subjects not eligible: 19
    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cervarix Arm
    Arm description
    		 The study group consisted a subset of HPV-008 subjects who at their last study visit of study HPV-008 (Visit 10, Month 48) displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit. In the HPV-008 study, the subjects in this group had received 3 doses of Havrix™.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Havrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 3 doses

    Number of subjects in period 1 [1]
    		Cervarix Arm
    Started
    2003
    Completed
    1787
    Not completed
    216
         Consent withdrawn by subject
    23
         Others
    18
         Migrated/moved from study area
    27
         Lost to follow-up
    144
         Missing confirmed
    4
    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: Out of the 2022 subjects enrolled, 19 did not fulfill eligibility criteria and were excluded, hence 2003 subjects started the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix Arm
    Reporting group description
    		 The study group consisted a subset of HPV-008 subjects who at their last study visit of study HPV-008 (Visit 10, Month 48) displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit. In the HPV-008 study, the subjects in this group had received 3 doses of Havrix™.

    Reporting group values
    		 Cervarix Arm Total
    Number of subjects
    		 2003 2003
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 24.3 ± 3.06 -
    Gender categorical
    Units: Subjects
        Female
    		 2003 2003
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cervarix Arm
    Reporting group description
    		 The study group consisted a subset of HPV-008 subjects who at their last study visit of study HPV-008 (Visit 10, Month 48) displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit. In the HPV-008 study, the subjects in this group had received 3 doses of Havrix™.

    Primary: Number of subjects with HPV DNA in cervical samples by HCII

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    End point title
    		 Number of subjects with HPV DNA in cervical samples by HCII [1]
    End point description
    Subjects that presented oncogenic HPV DNA in cervical samples by HPV DNA testing (Hybrid Capture® 2 test [HCII]).
    End point type
    Primary
    End point timeframe
    At Months 12, 24, 36, 48
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    1467
    Units: Subjects
        Positive DNA (Month 12 Post HPV-008)
    615
        Positive DNA (Month 24 Post HPV-008)
    418
        Positive DNA (Month 36 Post HPV-008)
    255
        Positive DNA (Month 48 Post HPV-008)
    144
        Negative DNA (Month 12 Post HPV-008)
    828
        Negative DNA (Month 24 Post HPV-008)
    444
        Negative DNA (Month 36 Post HPV-008)
    236
        Negative DNA (Month 48 Post HPV-008)
    107
    No statistical analyses for this end point

    Primary: Number of subjects with colposcopy referral and colposcopy adequacy

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    End point title
    		 Number of subjects with colposcopy referral and colposcopy adequacy [2]
    End point description
    Subjects with colposcopy referral and colposcopy adequacy.
    End point type
    Primary
    End point timeframe
    At Months 12, 24, 36, 48
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    2003
    Units: Subjects
        Colposcopy referral (Month 12) Yes
    572
        Colposcopy referral (Month 12) No
    1429
        Colposcopy referral (Month 12) Missing
    2
        Algorithm respected (Month 12) Yes
    371
        Algorithm respected (Month 12) No
    21
        Colposcopy adequacy (Month 12), Satisfactory
    370
        Colposcopy adequacy (Month 12), Unsatisfactory
    18
        Colposcopy adequacy (Month 12), Missing
    4
        Colposcopy referral (Month 24) Yes
    385
        Colposcopy referral (Month 24) No
    1615
        Colposcopy referral (Month 24) Missing
    3
        Algorithm respected (Month 24) Yes
    254
        Algorithm respected (Month 24) No
    8
        Algorithm respected (Month 24) Missing
    1
        Colposcopy adequacy (Month 24), Satisfactory
    245
        Colposcopy adequacy (Month 24), Unsatisfactory
    14
        Colposcopy adequacy (Month 24), Missing
    4
        Colposcopy referral (Month 36) Yes
    224
        Colposcopy referral (Month 36) No
    1776
        Colposcopy referral (Month 36) Missing
    3
        Algorithm respected (Month 36) Yes
    154
        Algorithm respected (Month 36) No
    4
        Colposcopy adequacy (Month 36), Satisfactory
    150
        Colposcopy adequacy (Month 36), Unsatisfactory
    7
        Colposcopy adequacy (Month 36), Missing
    1
        Colposcopy referral (Month 48) Yes
    133
        Colposcopy referral (Month 48) No
    1867
        Colposcopy referral (Month 48) Missing
    3
        Algorithm respected (Month 48) Yes
    96
        Algorithm respected (Month 48) No
    0
        Colposcopy adequacy (Month 48), Satisfactory
    92
        Colposcopy adequacy (Month 48), Unsatisfactory
    3
        Colposcopy adequacy (Month 48), Missing
    1
    No statistical analyses for this end point

    Primary: Number of subjects with cervical cytology

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    End point title
    		 Number of subjects with cervical cytology [3]
    End point description
    Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.
    End point type
    Primary
    End point timeframe
    At Months 12, 24, 36, 48
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    1467
    Units: Subjects
        Normal, Month 12 (N=1467)
    1193
        ASC-US, Month 12 (N=1467)
    154
        ASC-H, Month 12 (N=1467)
    8
        LSIL, Month 12 (N=1467)
    100
        HSIL, Month 12 (N=1467)
    8
        AGC, Month 12 (N=1467)
    4
        Normal, Month 24 (N=867)
    662
        ASC-US, Month 24 (N=867)
    117
        ASC-H, Month 24 (N=867)
    11
        LSIL, Month 24 (N=867)
    68
        HSIL, Month 24 (N=867)
    7
        AGC, Month 24 (N=867)
    2
        Normal, Month 36 (N=494)
    390
        ASC-US, Month 36 (N=494)
    58
        ASC-H, Month 36 (N=494)
    4
        LSIL, Month 36 (N=494)
    34
        HSIL, Month 36 (N=494)
    5
        AGC, Month 36 (N=494)
    3
        Normal, Month 48 (N=258)
    206
        ASC-US, Month 48 (N=258)
    28
        ASC-H, Month 48 (N=258)
    0
        LSIL, Month 48 (N=258)
    16
        HSIL, Month 48 (N=258)
    6
        AGC, Month 48 (N=258)
    2
    No statistical analyses for this end point

    Primary: Number of subjects with cervical biopsy results

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    End point title
    		 Number of subjects with cervical biopsy results [4]
    End point description
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
    End point type
    Primary
    End point timeframe
    At Month 12
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    199
    Units: Subjects
        Negative
    76
        Only CIN1(positive)
    41
        Only CIN1(negative)
    158
        Only CIN2 (positive)
    18
        Only CIN2 (negative)
    181
        Only CIN3 (positive)
    8
        Only CIN3 (negative)
    191
        CIN1 and CIN2 (positive)
    3
        CIN1 and CIN2(negative)
    196
        CIN1 and CIN3(positive)
    1
        CIN1 and CIN3 (negative)
    198
        CIN2 and CIN3 (positive)
    1
        CIN2 and CIN3 (negative)
    198
        CIN1 and CIN2 and CIN3 (positive)
    0
        CIN1 and CIN2 and CIN3 (negative)
    199
        AIS (positive)
    0
        AIS (negative)
    199
        Invasive malignancy (positive)
    0
        Invasive malignancy (negative)
    199
        Other
    85
    No statistical analyses for this end point

    Primary: Number of subjects with cervical biopsy results

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    End point title
    		 Number of subjects with cervical biopsy results [5]
    End point description
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
    End point type
    Primary
    End point timeframe
    At Month 24
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    147
    Units: Subjects
        Negative
    38
        Only CIN1(positive)
    47
        Only CIN1(negative)
    100
        Only CIN2 (positive)
    8
        Only CIN2 (negative)
    139
        Only CIN3 (positive)
    8
        Only CIN3 (negative)
    139
        CIN1 and CIN2 (positive)
    2
        CIN1 and CIN2(negative)
    145
        CIN1 and CIN3(positive)
    0
        CIN1 and CIN3 (negative)
    147
        CIN2 and CIN3 (positive)
    1
        CIN2 and CIN3 (negative)
    146
        CIN1 and CIN2 and CIN3 (positive)
    0
        CIN1 and CIN2 and CIN3 (negative)
    147
        AIS (positive)
    1
        AIS (negative)
    146
        Invasive malignancy (positive)
    0
        Invasive malignancy (negative)
    147
        Other
    56
    No statistical analyses for this end point

    Primary: Number of subjects with cervical biopsy results

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    End point title
    		 Number of subjects with cervical biopsy results [6]
    End point description
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
    End point type
    Primary
    End point timeframe
    At Month 36
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    88
    Units: Subjects
        Negative
    31
        Only CIN1(positive)
    31
        Only CIN1(negative)
    57
        Only CIN2 (positive)
    6
        Only CIN2 (negative)
    82
        Only CIN3 (positive)
    3
        Only CIN3 (negative)
    85
        CIN1 and CIN2 (positive)
    0
        CIN1 and CIN2(negative)
    88
        CIN1 and CIN3(positive)
    0
        CIN1 and CIN3 (negative)
    88
        CIN2 and CIN3 (positive)
    0
        CIN2 and CIN3 (negative)
    88
        CIN1 and CIN2 and CIN3 (positive)
    0
        CIN1 and CIN2 and CIN3 (negative)
    88
        AIS (positive)
    0
        AIS (negative)
    88
        Invasive malignancy (positive)
    0
        Invasive malignancy (negative)
    88
        Other
    25
    No statistical analyses for this end point

    Primary: Number of subjects with cervical biopsy results

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    End point title
    		 Number of subjects with cervical biopsy results [7]
    End point description
    Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
    End point type
    Primary
    End point timeframe
    At Month 48
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    54
    Units: Subjects
        Negative
    21
        Only CIN1(positive)
    15
        Only CIN1(negative)
    39
        Only CIN2 (positive)
    5
        Only CIN2 (negative)
    49
        Only CIN3 (positive)
    2
        Only CIN3 (negative)
    52
        CIN1 and CIN2 (positive)
    1
        CIN1 and CIN2(negative)
    53
        CIN1 and CIN3(positive)
    0
        CIN1 and CIN3 (negative)
    54
        CIN2 and CIN3 (positive)
    0
        CIN2 and CIN3 (negative)
    54
        CIN1 and CIN2 and CIN3 (positive)
    0
        CIN1 and CIN2 and CIN3 (negative)
    54
        AIS (positive)
    0
        AIS (negative)
    54
        Invasive malignancy (positive)
    0
        Invasive malignancy (negative)
    54
        Other
    11
    No statistical analyses for this end point

    Primary: Number of subjects with treatment referrals by treatment type

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    End point title
    		 Number of subjects with treatment referrals by treatment type [8]
    End point description
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
    End point type
    Primary
    End point timeframe
    At Month 12
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    392
    Units: Subjects
        Treatment referral, Yes
    33
        Treatment referral, No
    359
        Loop excision of cervix, Yes
    14
        Loop excision of cervix, No
    18
        Loop cone of cervix, Yes
    15
        Loop cone of cervix, No
    17
        Cold knife cone of cervix, Yes
    0
        Cold knife cone of cervix, No
    32
        Laser excision, Yes
    1
        Laser excision, No
    31
        Other
    4
    No statistical analyses for this end point

    Primary: Number of subjects with treatment referrals by treatment type

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    End point title
    		 Number of subjects with treatment referrals by treatment type [9]
    End point description
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
    End point type
    Primary
    End point timeframe
    At Month 24
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    263
    Units: Subjects
        Treatment referral, Yes
    19
        Treatment referral, No
    243
        Treatment referral, Missing
    1
        Loop excision of cervix, Yes
    9
        Loop excision of cervix, No
    8
        Loop cone of cervix, Yes
    4
        Loop cone of cervix, No
    13
        Cold knife cone of cervix, Yes
    1
        Cold knife cone of cervix, No
    16
        Laser excision, Yes
    0
        Laser excision, No
    17
        Other
    4
    No statistical analyses for this end point

    Primary: Number of subjects with treatment referrals by treatment type

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    End point title
    		 Number of subjects with treatment referrals by treatment type [10]
    End point description
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
    End point type
    Primary
    End point timeframe
    At Month 36
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    158
    Units: Subjects
        Treatment referral, Yes
    13
        Treatment referral, No
    145
        Loop excision of cervix, Yes
    4
        Loop excision of cervix, No
    6
        Loop cone of cervix, Yes
    4
        Loop cone of cervix, No
    6
        Cold knife cone of cervix, Yes
    0
        Cold knife cone of cervix, No
    10
        Laser excision, Yes
    0
        Laser excision, No
    10
        Other
    2
    No statistical analyses for this end point

    Primary: Number of subjects with treatment referrals by treatment type

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    End point title
    		 Number of subjects with treatment referrals by treatment type [11]
    End point description
    Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
    End point type
    Primary
    End point timeframe
    At Month 48
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    96
    Units: Subjects
        Treatment referral, Yes
    9
        Treatment referral, No
    87
        Loop excision of cervix, Yes
    1
        Loop excision of cervix, No
    7
        Loop cone of cervix, Yes
    5
        Loop cone of cervix, No
    3
        Cold knife cone of cervix, Yes
    0
        Cold knife cone of cervix, No
    8
        Laser excision, Yes
    1
        Laser excision, No
    7
        Other
    1
    No statistical analyses for this end point

    Primary: Number of subjects with AEs or SAEs leading to withdrawal

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    End point title
    		 Number of subjects with AEs or SAEs leading to withdrawal [12]
    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
    Primary
    End point timeframe
    Up to Month 48
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    2003
    Units: Subjects
    216
    No statistical analyses for this end point

    Primary: Number of subjects with any fatal SAEs, with any SAEs assessed as possibly related to study participation or to a concurrent GSK medication.

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    End point title
    		 Number of subjects with any fatal SAEs, with any SAEs assessed as possibly related to study participation or to a concurrent GSK medication. [13]
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Primary
    End point timeframe
    Up to Month 48
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Arm
    Number of subjects analysed
    2003
    Units: Subjects
        Subjects with fatal SAEs
    0
        Subjects with any related SAEs
    0
        Subjects with any SAEs due to concurrent GSK medic
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs and SAEs:From Day 0 to Month 48.
    Adverse event reporting additional description
    Other Adverse Events were not assessed in this study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events reported.

    More information

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

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

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