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    Clinical Trial Results:
    A phase I/II, partially blind, randomized, multicentre, age-stratified, dose-range study in healthy females aged 9 - 25 years to assess the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 2-dose schedule (0, 2-month or 0, 6-month) when compared to a standard 3-dose schedule of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2007-002777-32
    Trial protocol
    DE  
    Global end of trial date
    18 Mar 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    08 Jul 2016
    First version publication date
    04 Apr 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

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    Trial identification
    Sponsor protocol code
    110659
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00541970
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, 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
    18 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of the HPV-16/18 L1 VLP AS04 vaccine one month after the last dose when administered at different dosages (20 or 40 µg of each HPV antigen) and on different schedules (0, 2- or 0, 6-months) compared with the standard HPV-16/18 L1 VLP AS04 vaccine administered on a 3-dose schedule (0, 1, 6-months). To evaluate the reactogenicity of the HPV-16/18 L1 VLP AS04 vaccine when administered at different dosages (20 or 40 µg of each HPV type) and on different schedules (0, 2- or 0, 6-months) with respect to the occurrence, intensity and relationship to vaccination of solicited local and general symptoms reported within 7 days (Days 0 - 6) after each and any vaccination.
    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 vaccinee remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    60 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 482
    Country: Number of subjects enrolled
    Germany: 479
    Worldwide total number of subjects
    961
    EEA total number of subjects
    479
    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)
    961
    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
    The study included two phases, an active vaccination phase (Months 0-7) followed by a safety follow-up phase (up to the end of the study at Month 60).

    Pre-assignment
    Screening details
    The study was run in an open manner for subjects in the groups receiving the Cervarix vaccine on a 3-dose vaccination schedule. For subjects in the group receiving the Cervarix vaccine on a 2-dose vaccination schedule, the study was run in an observer-blind manner until Month 24, and then in an open manner.

    Pre-assignment period milestones
    Number of subjects started
    961
    Number of subjects completed
    960

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Protocol deviation: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cervarix 1/Placebo Group
    Arm description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine 580299
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Arm title
    Cervarix 1/Placebo/Cervarix 1 Group
    Arm description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine 580299
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Arm title
    Cervarix 2/Placebo/Cervarix 2 Group
    Arm description
    Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine 580299
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Arm title
    Cervarix 2 Group
    Arm description
    Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine 580299
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, different dosing /schedule

    Number of subjects in period 1 [1]
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Started
    240
    241
    240
    239
    Month 7
    240
    241
    240
    239
    Month 12
    240
    241
    240
    239
    Month 18
    240
    241
    240
    239
    Month 24
    240
    241
    240
    239
    Month 36
    240
    241
    240
    239
    Month 48
    240
    241
    240
    239
    Completed
    162
    164
    158
    167
    Not completed
    78
    77
    82
    72
         Protocol deviation
    78
    77
    82
    72
    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: Although 961 subjects were enrolled, only 960 subjects were vaccinated and started the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix 1/Placebo Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 1/Placebo/Cervarix 1 Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 2/Placebo/Cervarix 2 Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 2 Group
    Reporting group description
    Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group Total
    Number of subjects
    240 241 240 239 960
    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)
    17.1 ± 4.3 17.2 ± 4.3 17.3 ± 4.25 17.2 ± 4.38 -
    Gender categorical
    Units: Subjects
        Female
    240 241 240 239 960
        Male
    0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cervarix 1/Placebo Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 1/Placebo/Cervarix 1 Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 2/Placebo/Cervarix 2 Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 2 Group
    Reporting group description
    Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.

    Primary: Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies

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    End point title
    Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies [1]
    End point description
    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    224
    206
    204
    208
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 [N=224;204;204;208]
    5844.6 (5259.6 to 6494.7)
    10500.9 (9356.9 to 11784.8)
    7741.6 (6868.2 to 8726.1)
    13045.3 (11211.4 to 15179.2)
        Anti-HPV-18 [N=223;206;204;208]
    3543.2 (3126.6 to 4015.3)
    5997.5 (5310.9 to 6772.8)
    4811.4 (4282.7 to 5405.3)
    5087.1 (4460.2 to 5802.1)
    No statistical analyses for this end point

    Primary: Number of subjects with report of any, and grade 3 solicited local symptoms

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    End point title
    Number of subjects with report of any, and grade 3 solicited local symptoms [2]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).
    End point type
    Primary
    End point timeframe
    Within 7 days (Day 0-6) after vaccination.
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    238
    239
    238
    238
    Units: Subjects
        Any Pain
    222
    225
    222
    225
        Grade 3 Pain
    18
    27
    26
    35
        Any Redness
    109
    112
    123
    145
        Redness > 50 mm
    3
    4
    1
    3
        Any Swelling
    92
    88
    83
    118
        Swelling > 50 mm
    4
    3
    1
    5
    No statistical analyses for this end point

    Primary: 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 [3]
    End point description
    Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.
    End point type
    Primary
    End point timeframe
    Within 7 days (Day 0-6) after vaccination.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    238
    239
    238
    238
    Units: Subjects
        Any Arthralgia
    45
    57
    39
    43
        Related Arthralgia
    39
    43
    35
    35
        Grade 3 Arthralgia
    0
    3
    4
    3
        Any Fatigue
    100
    109
    104
    107
        Related Fatigue
    76
    82
    87
    83
        Grade 3 Fatigue
    11
    4
    5
    8
        Any Fever (Axillary Temperature >= 37.5°C)
    23
    20
    22
    39
        Related Fever
    18
    15
    16
    27
        Grade 3 Fever (Axillary Temperature >= 39.0°C)
    1
    0
    1
    0
        Any Gastrointestinal Symptoms
    48
    48
    36
    68
        Related Gastrointestinal Symptoms
    36
    43
    27
    50
        Grade 3 Gastrointestinal Symptoms
    3
    7
    2
    7
        Any Headache
    101
    116
    112
    125
        Related Headache
    79
    81
    91
    95
        Grade 3 Headache
    9
    9
    7
    12
        Any Myalgia
    79
    109
    98
    99
        Related Myalgia
    62
    87
    75
    77
        Grade 3 Myalgia
    3
    9
    6
    7
        Any Rash
    12
    12
    10
    15
        Related Rash
    8
    9
    8
    9
        Grade 3 Rash
    0
    0
    1
    1
        Any Urticaria
    2
    4
    4
    5
        Related Urticaria
    1
    3
    4
    3
        Grade 3 Urticaria
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies.

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    End point title
    Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies. [4]
    End point description
    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.
    End point type
    Secondary
    End point timeframe
    At Month 3, 1 month after the second dose of vaccine or placebo
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group
    Number of subjects analysed
    224
    204
    203
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 [N=224;204;203]
    5844.6 (5259.6 to 6494.7)
    397.9 (337.4 to 469.2)
    266.4 (227.2 to 312.4)
        Anti-HPV-18 [N=223;206;203]
    3543.2 (3126.6 to 4015.3)
    228.3 (196.7 to 265)
    181.9 (156.8 to 211.1)
    No statistical analyses for this end point

    Secondary: Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies

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    End point title
    Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies
    End point description
    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.
    End point type
    Secondary
    End point timeframe
    At Month 7, 1 month after the last dose of vaccine or placebo.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    221
    206
    204
    208
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        9-14 years, Anti-HPV-16 [N=76;62;69;75]
    2003.9 (1635.7 to 2455)
    15028.4 (12611.3 to 17908.6)
    11058.6 (9273.8 to 13186.7)
    22066.3 (18140.7 to 26841.2)
        15-19 years, Anti-HPV-16 [N=72;74;70;66]
    1168.5 (957.4 to 1426.2)
    10818.7 (8979.8 to 13034.2)
    7869.6 (6488.9 to 9543.9)
    12817.4 (9723.2 to 16896.2)
        20-25 years, Anti-HPV-16 [N=73;68;65;67]
    1371.2 (1092.2 to 1721.6)
    7331.4 (5965.2 to 9010.4)
    5209.2 (4166.5 to 6512.7)
    7370 (5673.6 to 9573.6)
        9-14 years, Anti-HPV-18 [N=76;64;69;75]
    1134.3 (922.8 to 1394.3)
    8085.8 (6654.5 to 9825)
    5630.7 (4772.1 to 6643.7)
    7192.9 (5952.6 to 8691.6)
        15-19 years, Anti-HPV-18 [N=72;74;69;66]
    719.8 (571.2 to 907)
    6170.1 (5046.8 to 7543.5)
    5039.3 (4283.4 to 5928.5)
    4907 (3780.8 to 6368.7)
        20-25 years, Anti-HPV-18 [N=72;68;66;67]
    656.5 (514.6 to 837.5)
    4389.6 (3525.6 to 5465.4)
    3889.2 (2980.9 to 5074.3)
    3576.8 (2886.5 to 4432.2)
    No statistical analyses for this end point

    Secondary: Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies

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    End point title
    Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies
    End point description
    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    216
    198
    195
    198
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 at Month 12 [216;191;195;198]
    1064.7 (937.5 to 1209.1)
    3256 (2918.8 to 3632.1)
    2438.7 (2167.2 to 2744.2)
    4726.7 (4036.8 to 5534.6)
        Anti-HPV-16 at Month 18 [212;196;194;197]
    968.1 (845.2 to 1109)
    2229.4 (1983.2 to 2506.2)
    1659.1 (1466.9 to 1876.4)
    3185.1 (2735.1 to 3709.2)
        Anti-HPV-16 at Month 24 [199;184;186;190]
    821.2 (718.5 to 938.5)
    1756.4 (1556.6 to 1981.9)
    1285.1 (1139.6 to 1449.2)
    2425.9 (2071.1 to 2841.5)
        Anti-HPV-16 at Month 36 [166;158;162;153]
    688.3 (592.2 to 799.9)
    1462.2 (1288.8 to 1658.8)
    1094 (961.1 to 1245.1)
    2195.4 (1850.8 to 2604.1)
        Anti-HPV-16 at Month 48 [160;151;157;148]
    649.5 (556 to 758.8)
    1261.2 (1106.4 to 1437.7)
    953.5 (835.5 to 1088.2)
    1892.3 (1594.2 to 2246)
        Anti-HPV-18 at Month 12 [215;193;194;198]
    472.9 (410.5 to 544.8)
    1760.1 (1531.5 to 2022.8)
    1426.2 (1250.8 to 1626.1)
    1714.5 (1469.7 to 2000)
        Anti-HPV-18 at Month 18 [211;198;193;197]
    389.2 (338.7 to 447.2)
    1025.2 (889 to 1182.2)
    883.1 (774.7 to 1006.8)
    1096.6 (939.4 to 1280.1)
        Anti-HPV-18 at Month 24 [198;186;185;190]
    345.9 (299.3 to 399.8)
    818.2 (706.5 to 947.5)
    674.6 (591.8 to 769)
    866.8 (741.2 to 1013.6)
        Anti-HPV-18 at Month 36 [166;160;162;153]
    302.2 (254.9 to 358.2)
    712.8 (605.4 to 839.3)
    617.9 (532.3 to 717.2)
    874.2 (734.9 to 1040)
        Anti-HPV-18 at Month 48 [160;153;157;148]
    260.4 (218.5 to 310.2)
    626.3 (531 to 738.7)
    517 (446.2 to 599.1)
    723.2 (607.2 to 861.4)
    No statistical analyses for this end point

    Secondary: Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies

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    End point title
    Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies
    End point description
    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Month 7, 1 month after the last dose of vaccine or placebo.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    221
    204
    204
    208
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 [N=221;204;204;208]
    1483 (1311 to 1677.5)
    10500.9 (9356.9 to 11784.8)
    7741.6 (6868.2 to 8726.1)
    13045.3 (11211.4 to 15179.2)
        Anti-HPV-18 [N=220;206;204;208]
    817.3 (715.6 to 933.4)
    5997.5 (5310.9 to 6772.8)
    4811.4 (4282.7 to 5405.3)
    5087.1 (4460.2 to 5802.1)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    223
    221
    221
    225
    Units: Subjects
        BAS, PRE NORMAL [N=222;219;218;220], M7 NORMAL
    219
    214
    208
    214
        BAS, PRE NORMAL [N=222;219;218;220], M7 BELOW
    0
    0
    0
    0
        BAS, PRE NORMAL [N=222;219;218;220], M7 ABOVE
    2
    3
    6
    3
        BAS, PRE NORMAL [N=222;219;218;220], M7 MISSING
    1
    2
    4
    3
        BAS, PRE BELOW [N=0;0;1;1], M7 NORMAL
    0
    0
    1
    0
        BAS, PRE BELOW [N=0;0;1;1], M7 BELOW
    0
    0
    0
    1
        BAS, PRE BELOW [N=0;0;1;1], M7 ABOVE
    0
    0
    0
    0
        BAS, PRE ABOVE [N=1;2;2;4], M7 NORMAL
    1
    2
    2
    4
        BAS, PRE ABOVE [N=1;2;2;4], M7 BELOW
    0
    0
    0
    0
        BAS, PRE ABOVE [N=1;2;2;4], M7 ABOVE
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    226
    223
    223
    226
    Units: Subjects
        EOS, PRE NORMAL [N=209;214;212;214], M7 NORMAL
    203
    207
    200
    205
        EOS, PRE NORMAL [N=209;214;212;214], M7 BELOW
    0
    0
    0
    0
        EOS, PRE NORMAL [N=209;214;212;214], M7 ABOVE
    5
    6
    8
    6
        EOS, PRE NORMAL [N=209;214;212;214], M7 MISSING
    1
    1
    4
    3
        EOS, PRE BELOW [N=1;2;1;0], M7 NORMAL
    0
    1
    0
    0
        EOS, PRE BELOW [N=1;2;1;0], M7 BELOW
    0
    1
    1
    0
        EOS, PRE BELOW [N=1;2;1;0], M7 ABOVE
    1
    0
    0
    0
        EOS, PRE ABOVE [N=16;7;10;12], M7 NORMAL
    8
    3
    3
    7
        EOS, PRE ABOVE [N=16;7;10;12], M7 BELOW
    0
    0
    0
    0
        EOS, PRE ABOVE [N=16;7;10;12], M7 ABOVE
    8
    3
    7
    5
        EOS, PRE ABOVE [N=16;7;10;12], M7 MISSING
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    226
    225
    228
    229
    Units: Subjects
        CREA, PRE NORMAL [N=215;211;215;218], M7 NORMAL
    202
    200
    210
    206
        CREA, PRE NORMAL [N=215;211;215;218], M7 BELOW
    7
    4
    3
    6
        CREA, PRE NORMAL [N=215;211;215;218], M7 ABOVE
    5
    7
    1
    4
        CREA, PRE NORMAL [N=215;211;215;218], M7 MISSING
    1
    0
    1
    2
        CREA, PRE BELOW [N=8;7;7;6], M7 NORMAL
    6
    3
    3
    2
        CREA, PRE BELOW [N=8;7;7;6], M7 BELOW
    2
    4
    4
    3
        CREA, PRE BELOW [N=8;7;7;6], M7 ABOVE
    0
    0
    0
    0
        CREA, PRE BELOW [N=8;7;7;6], M7 MISSING
    0
    0
    0
    1
        CREA, PRE ABOVE [N=3;7;6;5], M7 NORMAL
    2
    4
    4
    2
        CREA, PRE ABOVE [N=3;7;6;5], M7 BELOW
    0
    0
    0
    0
        CREA, PRE ABOVE [N=3;7;6;5], M7 ABOVE
    1
    3
    2
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    229
    227
    229
    233
    Units: Subjects
        ALT, PRE NORMAL [N=215;219;225;218], M7 NORMAL
    211
    211
    213
    209
        ALT, PRE NORMAL [N=215;219;225;218], M7 BELOW
    3
    2
    4
    4
        ALT, PRE NORMAL [N=215;219;225;218], M7 ABOVE
    1
    6
    7
    5
        ALT, PRE NORMAL [N=215;219;225;218], M7 MISSING
    0
    0
    1
    0
        ALT, PRE BELOW [N=1;3;1;4], M7 NORMAL
    0
    2
    0
    2
        ALT, PRE BELOW [N=1;3;1;4], M7 BELOW
    1
    1
    1
    2
        ALT, PRE BELOW [N=1;3;1;4], M7 ABOVE
    0
    0
    0
    0
        ALT, PRE ABOVE [N=13;5;3;11], M7 NORMAL
    9
    4
    1
    7
        ALT, PRE ABOVE [N=13;5;3;11], M7 BELOW
    0
    0
    0
    0
        ALT, PRE ABOVE [N=13;5;3;11], M7 ABOVE
    4
    1
    2
    3
        ALT, PRE ABOVE [N=13;5;3;11], M7 MISSING
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    229
    228
    227
    233
    Units: Subjects
        Hct, PRE NORMAL [N=215;208;208;217], M7 NORMAL
    196
    193
    189
    208
        Hct, PRE NORMAL [N=215;208;208;217], M7 BELOW
    6
    5
    8
    2
        Hct, PRE NORMAL [N=215;208;208;217], M7 ABOVE
    11
    8
    7
    6
        Hct, PRE NORMAL [N=215;208;208;217], M7 MISSING
    2
    2
    4
    1
        Hct, PRE BELOW [N=6;7;7;3], M7 NORMAL
    3
    5
    4
    2
        Hct, PRE BELOW [N=6;7;7;3], M7 BELOW
    3
    2
    3
    1
        Hct, PRE BELOW [N=6;7;7;3], M7 ABOVE
    0
    0
    0
    0
        Hct, PRE ABOVE [N=8;13;12;13], M7 NORMAL
    7
    8
    10
    7
        Hct, PRE ABOVE [N=8;13;12;13], M7 BELOW
    0
    0
    0
    0
        Hct, PRE ABOVE [N=8;13;12;13], M7 ABOVE
    1
    5
    2
    6
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    226
    223
    223
    227
    Units: Subjects
        LYM, PRE NORMAL [N=211;211;204;213], M7 NORMAL
    201
    202
    192
    202
        LYM, PRE NORMAL [N=211;211;204;213], M7 BELOW
    3
    0
    3
    1
        LYM, PRE NORMAL [N=211;211;204;213], M7 ABOVE
    6
    7
    5
    7
        LYM, PRE NORMAL [N=211;211;204;213], M7 MISSING
    1
    2
    4
    3
        LYM, PRE BELOW [N=6;3;5;5], M7 NORMAL
    4
    3
    3
    1
        LYM, PRE BELOW [N=6;3;5;5], M7 BELOW
    2
    0
    2
    2
        LYM, PRE BELOW [N=6;3;5;5], M7 ABOVE
    0
    0
    0
    2
        LYM, PRE ABOVE [N=9;9;14;9], M7 NORMAL
    5
    7
    8
    5
        LYM, PRE ABOVE [N=9;9;14;9], M7 BELOW
    0
    0
    1
    0
        LYM, PRE ABOVE [N=9;9;14;9], M7 ABOVE
    4
    2
    5
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    226
    223
    223
    227
    Units: Subjects
        MON, PRE NORMAL [N=217;211;211;219], M7 NORMAL
    212
    202
    197
    208
        MON, PRE NORMAL [N=217;211;211;219], M7 BELOW
    0
    1
    2
    2
        MON, PRE NORMAL [N=217;211;211;219], M7 ABOVE
    4
    6
    9
    6
        MON, PRE NORMAL [N=217;211;211;219], M7 MISSING
    1
    2
    3
    3
        MON, PRE BELOW [N=3;2;0;2], M7 NORMAL
    1
    1
    0
    2
        MON, PRE BELOW [N=3;2;0;2], M7 BELOW
    2
    1
    0
    0
        MON, PRE BELOW [N=3;2;0;2], M7 ABOVE
    0
    0
    0
    0
        MON, PRE ABOVE [N=6;10;12;6], M7 NORMAL
    5
    6
    6
    4
        MON, PRE ABOVE [N=6;10;12;6], M7 BELOW
    0
    0
    0
    0
        MON, PRE ABOVE [N=6;10;12;6], M7 ABOVE
    1
    4
    5
    2
        MON, PRE ABOVE [N=6;10;12;6], M7 MISSING
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    224
    223
    223
    226
    Units: Subjects
        NEU, PRE NORMAL [N=206;207;202;204], M7 NORMAL
    184
    188
    185
    186
        NEU, PRE NORMAL [N=206;207;202;204], M7 BELOW
    16
    16
    9
    9
        NEU, PRE NORMAL [N=206;207;202;204], M7 ABOVE
    5
    1
    1
    3
        NEU, PRE NORMAL [N=206;207;202;204], M7 MISSING
    1
    2
    7
    6
        NEU, PRE BELOW [N=11;11;16;19], M7 NORMAL
    8
    6
    9
    15
        NEU, PRE BELOW [N=11;11;16;19], M7 BELOW
    2
    4
    7
    3
        NEU, PRE BELOW [N=11;11;16;19], M7 ABOVE
    0
    0
    0
    0
        NEU, PRE ABOVE [N=7;5;5;3], M7 NORMAL
    6
    5
    5
    1
        NEU, PRE ABOVE [N=7;5;5;3], M7 BELOW
    0
    0
    0
    2
        NEU, PRE ABOVE [N=7;5;5;3], M7 ABOVE
    1
    0
    0
    0
        NEU, PRE BELOW [N=11;11;16;19], M7 MISSING
    1
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    229
    228
    228
    233
    Units: Subjects
        RBC, PRE NORMAL [N=214;215;204;225], M7 NORMAL
    204
    204
    196
    213
        RBC, PRE NORMAL [N=214;215;204;225], M7 BELOW
    7
    7
    2
    7
        RBC, PRE NORMAL [N=214;215;204;225], M7 ABOVE
    2
    3
    2
    3
        RBC, PRE NORMAL [N=214;215;204;225], M7 MISSING
    1
    1
    4
    2
        RBC, PRE BELOW [N=6;6;12;4], M7 NORMAL
    4
    3
    2
    1
        RBC, PRE BELOW [N=6;6;12;4], M7 BELOW
    2
    3
    10
    3
        RBC, PRE BELOW [N=6;6;12;4], M7 ABOVE
    0
    0
    0
    0
        RBC, PRE ABOVE [N=9;7;12;4], M7 NORMAL
    5
    4
    6
    3
        RBC, PRE ABOVE [N=9;7;12;4], M7 BELOW
    0
    0
    0
    0
        RBC, PRE ABOVE [N=9;7;12;4], M7 ABOVE
    4
    3
    6
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    229
    228
    229
    233
    Units: Subjects
        WBC, PRE NORMAL [N=207;213;211;225], M7 NORMAL
    197
    199
    194
    212
        WBC, PRE NORMAL [N=207;213;211;225], M7 BELOW
    4
    9
    5
    9
        WBC, PRE NORMAL [N=207;213;211;225], M7 ABOVE
    5
    4
    8
    3
        WBC, PRE NORMAL [N=207;213;211;225], M7 MISSING
    1
    1
    4
    1
        WBC, PRE BELOW [N=8;9;6;4], M7 NORMAL
    4
    5
    3
    3
        WBC, PRE BELOW [N=8;9;6;4], M7 BELOW
    4
    4
    3
    1
        WBC, PRE BELOW [N=8;9;6;4], M7 ABOVE
    0
    0
    0
    0
        WBC, PRE ABOVE [N=14;6;12;4], M7 NORMAL
    10
    4
    9
    4
        WBC, PRE ABOVE [N=14;6;12;4], M7 BELOW
    0
    0
    0
    0
        WBC, PRE ABOVE [N=14;6;12;4], M7 ABOVE
    4
    2
    3
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.

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    End point title
    Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed.
    End point description
    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.
    End point type
    Secondary
    End point timeframe
    At Month 7 (M7)
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    226
    227
    228
    232
    Units: Subjects
        PLA, PRE NORMAL [N=211;210;215;221], M7 NORMAL
    204
    204
    206
    218
        PLA, PRE NORMAL [N=211;210;215;221], M7 BELOW
    1
    2
    3
    0
        PLA, PRE NORMAL [N=211;210;215;221], M7 ABOVE
    5
    2
    2
    1
        PLA, PRE NORMAL [N=211;210;215;221], M7 MISSING
    1
    2
    4
    2
        PLA, PRE BELOW [N=0;3;0;3], M7 NORMAL
    0
    0
    0
    1
        PLA, PRE BELOW [N=0;3;0;3], M7 BELOW
    0
    3
    0
    2
        PLA, PRE BELOW [N=0;3;0;3], M7 ABOVE
    0
    0
    0
    0
        PLA, PRE ABOVE [N=15;14;13;8], M7 NORMAL
    9
    11
    8
    4
        PLA, PRE ABOVE [N=15;14;13;8], M7 BELOW
    0
    0
    0
    0
        PLA, PRE ABOVE [N=15;14;13;8], M7 ABOVE
    6
    3
    5
    4
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against human Papillomavirus 16 (HPV-16) and human Papillomavirus 18 (HPV-18)

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    End point title
    Number of seroconverted subjects against human Papillomavirus 16 (HPV-16) and human Papillomavirus 18 (HPV-18)
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.
    End point type
    Secondary
    End point timeframe
    At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    216
    196
    195
    198
    Units: Subjects
        Anti-HPV-16 at Month 12 [N=216;191;195;198]
    194
    162
    172
    169
        Anti-HPV-16 at Month 18 [N=212;196;194;197]
    192
    166
    172
    168
        Anti-HPV-16 at Month 24 [N=199;184;186;190]
    185
    155
    165
    162
        Anti-HPV-16 at Month 36 [N=166;158;162;153]
    156
    135
    146
    135
        Anti-HPV-16 at Month 48 [N=160;151;157;148]
    149
    130
    139
    129
        Anti-HPV-18 at Month 12 [N=215;193;194;198]
    187
    173
    166
    173
        Anti-HPV-18 at Month 18 [N=211;198;193;197]
    184
    177
    166
    173
        Anti-HPV-18 at Month 24 [N=198;186;185;190]
    173
    165
    159
    166
        Anti-HPV-18 at Month 36 [N=166;160;162;153]
    144
    145
    139
    132
        Anti-HPV-18 at Month 48 [N=160;153;157;148]
    138
    139
    135
    129
    No statistical analyses for this end point

    Secondary: Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies

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    End point title
    Titers of anti-Papillomavirus 16 (anti-HPV-16) and anti-human Papillomavirus 18 (anti-HPV-18) antibodies
    End point description
    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Month 60 of the safety follow-up phase
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    137
    134
    131
    146
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 at Month 60 [N=137;132;131;146]
    658 (560.4 to 772.5)
    1254 (1088.5 to 1444.8)
    976.1 (846.1 to 1126.1)
    1858.5 (1586.2 to 2177.6)
        Anti-HPV-18 at Month 60 [N=137;134;131;146]
    269.4 (223 to 325.5)
    622.2 (519 to 745.9)
    557.9 (473.7 to 657)
    745.3 (629.3 to 882.7)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against human Papillomavirus 16 (HPV-16) and human Papillomavirus 18 (HPV-18)

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    End point title
    Number of seroconverted subjects against human Papillomavirus 16 (HPV-16) and human Papillomavirus 18 (HPV-18)
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.
    End point type
    Secondary
    End point timeframe
    At Month 60 of the safety follow-up phase
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    130
    122
    119
    127
    Units: Subjects
        Anti-HPV-16 at Month 60 [N=130;114;119;127]
    130
    114
    119
    127
        Anti-HPV-18 at Month 60 [N=117;122;116;125]
    116
    122
    116
    125
    No statistical analyses for this end point

    Secondary: Number of subjects with pregnancy outcomes.

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    End point title
    Number of subjects with pregnancy outcomes.
    End point description
    Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 48.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    23
    16
    24
    20
    Units: Subjects
        Ectopic pregnancy
    1
    0
    0
    0
        Elective termination with NO ACA
    5
    3
    3
    5
        Elective termination with CA
    0
    0
    1
    0
        Live infant with NO ACA
    15
    12
    15
    12
        Lost to follow up
    1
    0
    0
    0
        Pregnancy ongoing
    0
    1
    2
    2
        Spontaneous abortion with NO ACA
    1
    0
    3
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with pregnancy outcomes.

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    End point title
    Number of subjects with pregnancy outcomes.
    End point description
    Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.
    End point type
    Secondary
    End point timeframe
    Throughout the study period, from Month 0 to Month 60.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    32
    23
    30
    26
    Units: Subjects
        Ectopic pregnancy
    1
    0
    0
    1
        Elective termination NO apparent congenital anom.
    5
    6
    4
    6
        Elective termination congenital anomaly
    0
    0
    1
    0
        Live infant NO apparent congenital anomaly
    22
    16
    22
    18
        Lost to follow up
    1
    0
    0
    0
        Molar pregnancy
    1
    0
    0
    0
        Spontaneous abortion NO apparent congenital anom.
    2
    1
    3
    1
    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 adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 30 days (Day 0-29) after vaccination.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        Any unsolicited AE(s)
    83
    85
    76
    107
        Grade 3 unsolicited AE(s)
    11
    8
    6
    14
        Related unsolicited AE(s)
    26
    20
    16
    27
    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 were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 7.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        MSCs reported up to Month 7 [Units:subjects]
    40
    48
    45
    42
    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 were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 48.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        MSCs reported up to Month 48
    79
    94
    88
    82
    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 were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
    End point type
    Secondary
    End point timeframe
    Throughout the study period, from Month 0 to Month 60.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        MSCs
    85
    97
    92
    89
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Autoimmune Diseases (NOADs)

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    End point title
    Number of subjects with New Onset of Autoimmune Diseases (NOADs)
    End point description
    NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 7.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        NOADs reported up to Month 7
    1
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Autoimmune Diseases (NOADs)

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    End point title
    Number of subjects with New Onset of Autoimmune Diseases (NOADs)
    End point description
    NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 48.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        NOADs reported up to Month 48
    3
    4
    5
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Autoimmune Diseases (NOADs)

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    End point title
    Number of subjects with New Onset of Autoimmune Diseases (NOADs)
    End point description
    NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
    End point type
    Secondary
    End point timeframe
    Throughout the study period, from Month 0 to Month 60.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        (NOADs)
    4
    4
    5
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Chronic Diseases (NOCDs)

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    End point title
    Number of subjects with New Onset of Chronic Diseases (NOCDs)
    End point description
    NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 7.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        NOCDs reported up to Month 7
    4
    2
    6
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Chronic Diseases (NOCDs)

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    End point title
    Number of subjects with New Onset of Chronic Diseases (NOCDs)
    End point description
    NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 48.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        NOCDs reported up to Month 48
    8
    11
    13
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Chronic Diseases (NOCDs)

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    End point title
    Number of subjects with New Onset of Chronic Diseases (NOCDs)
    End point description
    NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
    End point type
    Secondary
    End point timeframe
    Throughout the study period, from Month 0 to Month 60.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        (NOCDs)
    8
    11
    14
    7
    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 result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 7.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        SAE(s) up to Month 7
    4
    4
    4
    2
    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 result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 48.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        SAEs up to Month 48
    10
    13
    19
    13
    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 result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Throughout the study period, from Month 0 to Month 60.
    End point values
    Cervarix 1/Placebo Group Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 2 Group
    Number of subjects analysed
    240
    241
    240
    239
    Units: Subjects
        (SAEs)
    14
    16
    19
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events: From Month 0 to Month 60. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination.
    Adverse event reporting additional description
    3 among the serious adverse events (SAEs) listed below are SAEs reported for the subject’s offsprings (Spina bifida, Foetal distress syndrome and Premature baby).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Cervarix 1/Placebo/Cervarix 1 Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 2 Group
    Reporting group description
    Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 2/Placebo/Cervarix 2 Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Reporting group title
    Cervarix 1/Placebo Group
    Reporting group description
    Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.

    Serious adverse events
    Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 1/Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 241 (6.64%)
    15 / 239 (6.28%)
    19 / 240 (7.92%)
    14 / 240 (5.83%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Circulatory collapse
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibrosarcoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma stage IV
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign hydatidiform mole
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    2 / 240 (0.83%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal distress syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature baby
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion missed
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anorexia nervosa
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bulimia nervosa
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    1 / 239 (0.42%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stab wound
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hyperventilation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Basilar artery thrombosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine with aura
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    3 / 240 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendix disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia, obstructive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 241 (0.83%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatomegaly
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Cystitis haemorrhagic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema multiforme
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Coccydynia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament laxity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Spina bifida
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basedow’s disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 241 (0.83%)
    1 / 239 (0.42%)
    4 / 240 (1.67%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometritis decidual
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    2 / 239 (0.84%)
    0 / 240 (0.00%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 240 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 241 (0.00%)
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 241 (0.41%)
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 240 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cervarix 1/Placebo/Cervarix 1 Group Cervarix 2 Group Cervarix 2/Placebo/Cervarix 2 Group Cervarix 1/Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    225 / 241 (93.36%)
    225 / 239 (94.14%)
    222 / 240 (92.50%)
    222 / 240 (92.50%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    225 / 239 (94.14%)
    225 / 238 (94.54%)
    222 / 238 (93.28%)
    222 / 238 (93.28%)
         occurrences all number
    225
    225
    222
    222
    Redness
         subjects affected / exposed [2]
    112 / 239 (46.86%)
    145 / 238 (60.92%)
    123 / 238 (51.68%)
    109 / 238 (45.80%)
         occurrences all number
    112
    145
    123
    109
    Swelling
         subjects affected / exposed [3]
    88 / 239 (36.82%)
    118 / 238 (49.58%)
    83 / 238 (34.87%)
    92 / 238 (38.66%)
         occurrences all number
    88
    118
    83
    92
    Arthralgia
         subjects affected / exposed [4]
    57 / 239 (23.85%)
    43 / 238 (18.07%)
    39 / 238 (16.39%)
    45 / 238 (18.91%)
         occurrences all number
    57
    43
    39
    45
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed [5]
    109 / 239 (45.61%)
    107 / 238 (44.96%)
    104 / 238 (43.70%)
    100 / 238 (42.02%)
         occurrences all number
    109
    107
    104
    100
    Fever
         subjects affected / exposed [6]
    20 / 239 (8.37%)
    39 / 238 (16.39%)
    22 / 238 (9.24%)
    23 / 238 (9.66%)
         occurrences all number
    20
    39
    22
    23
    Gastrointestinal
         subjects affected / exposed [7]
    48 / 239 (20.08%)
    68 / 238 (28.57%)
    36 / 238 (15.13%)
    48 / 238 (20.17%)
         occurrences all number
    48
    68
    36
    48
    Headache
         subjects affected / exposed [8]
    116 / 239 (48.54%)
    125 / 238 (52.52%)
    112 / 238 (47.06%)
    101 / 238 (42.44%)
         occurrences all number
    116
    125
    112
    101
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed [9]
    12 / 239 (5.02%)
    15 / 238 (6.30%)
    10 / 238 (4.20%)
    12 / 238 (5.04%)
         occurrences all number
    12
    15
    10
    12
    Gastrointestinal disorders
    Myalgia
         subjects affected / exposed [10]
    109 / 239 (45.61%)
    99 / 238 (41.60%)
    98 / 238 (41.18%)
    79 / 238 (33.19%)
         occurrences all number
    109
    99
    98
    79
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 241 (4.56%)
    15 / 239 (6.28%)
    9 / 240 (3.75%)
    10 / 240 (4.17%)
         occurrences all number
    11
    15
    9
    10
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2009
    Amendment 1 • In the purpose of collecting long-term immunogenicity and safety data for the HPV-16/18 L1 VLP AS04 vaccine in an alternative 2-dose schedule versus the 3-dose schedule, the study was extended by three years to include three additional visits planned for Months 36, 48 and 60. • The protocol was amended to allow subjects who miss one or more follow-up study visits to be invited to attend the next visit. • Administrative changes were made.

    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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