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    Clinical Trial Results:
    A phase I/II, observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy male subjects aged 10-18 years.

    Summary
    EudraCT number
    		 2005-005943-24
    Trial protocol
    		 FI  
    Global end of trial date
    19 Jun 2007

    Results information
    Results version number
    		 v1
    This version publication date
    11 May 2016
    First version publication date
    08 Jan 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    580299/011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00309166
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 004 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 004 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
    13 Dec 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate 1 month after the third dose (i.e. at Month 7), the immune responses to the candidate HPV-16/18 vaccine (as determined by anti-HPV-16/18 ELISA) in healthy male subjects aged 10-18 years old.
    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
    05 Apr 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 270
    Worldwide total number of subjects
    270
    EEA total number of subjects
    270
    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)
    270
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

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

    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 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12.

    Arm title
    		 Engerix-B Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12.

    Number of subjects in period 1
    		Cervarix Group Engerix-B Group
    Started
    181
    89
    Completed
    176
    86
    Not completed
    5
    3
         Consent withdrawn by subject
    4
    3
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 -

    Reporting group title
    Engerix-B Group
    Reporting group description
    		 -

    Reporting group values
    		 Cervarix Group Engerix-B Group Total
    Number of subjects
    		 181 89 270
    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)
    		 14.4 ( 2.14 ) 14.4 ( 2.02 ) -
    Gender categorical
    Units: Subjects
        Males
    		 181 89 270

    End points

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    End points reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 -

    Reporting group title
    Engerix-B Group
    Reporting group description
    		 -

    Primary: Number of seroconverted subjects for anti-HPV-16 and HPV-18

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    End point title
    		 Number of seroconverted subjects for anti-HPV-16 and HPV-18 [1]
    End point description
    Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 titres ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
    End point type
    Primary
    End point timeframe
    At 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    163
    86
    Units: Subjects
        HPV-16 (N=163, 83)
    163
    1
        HPV-18 (N=150, 86)
    150
    2
    No statistical analyses for this end point

    Primary: Anti-HPV-16 and HPV-18 antibody titers

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    End point title
    		 Anti-HPV-16 and HPV-18 antibody titers [2]
    End point description
    Titers were given as geometric mean titers(GMT).
    End point type
    Primary
    End point timeframe
    At Month 7
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    171
    86
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        HPV-16 (N=171, 86)
    22564.8 (19800.3 to 25715.4)
    4.2 (4 to 4.5)
        HPV-18 (N=170, 86)
    8460.3 (7306.1 to 9796.8)
    3.6 (3.4 to 3.8)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for HPV-16 and HPV-18

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    End point title
    		 Number of seroconverted subjects for HPV-16 and HPV-18
    End point description
    Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 titres ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Month 2
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    165
    86
    Units: Subjects
        HPV-16 (N=165, 83)
    165
    0
        HPV-18 (N=152, 86)
    152
    4
    No statistical analyses for this end point

    Secondary: Anti-HPV-16 and HPV-18 antibody titers

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    End point title
    		 Anti-HPV-16 and HPV-18 antibody titers
    End point description
    Titers were given as GMTs.
    End point type
    Secondary
    End point timeframe
    At Month 2
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    173
    86
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        HPV-16 (N=173, 86)
    5254.5 (4704.9 to 5868.2)
    4.1 (4 to 4.3)
        HPV-18 (N=172, 86)
    3696.9 (3275.9 to 4172.1)
    3.7 (3.5 to 3.8)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    The solicited symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling > 50 mm.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 - 6) after each and any vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    180
    88
    Units: Subjects
        Pain, Dose 1 (N=180, 88)
    149
    25
        Grade 3, Pain, Dose 1 (N=180, 88)
    1
    0
        Redness, Dose 1 (N=180, 88)
    24
    12
        Grade 3, Redness, Dose 1 (N=180, 88)
    0
    0
        Swelling, Dose 1 (N=180, 88)
    7
    3
        Grade 3, Swelling, Dose 1 (N=180, 88)
    0
    0
        Pain, Dose 2 (N=172, 86)
    114
    16
        Grade 3, Pain, Dose 2 (N=172, 86)
    2
    0
        Redness, Dose 2 (N=172, 86)
    30
    8
        Grade 3, Redness, Dose 2 (N=172, 86)
    0
    0
        Swelling, Dose 2 (N=172, 86)
    20
    2
        Grade 3, Swelling, Dose 2 (N=172, 86)
    0
    1
        Pain, Dose 3 (N=171, 85)
    115
    16
        Grade 3, Pain, Dose 3 (N=171, 85)
    7
    0
        Redness, Dose 3 (N=171, 85)
    33
    9
        Grade 3, Redness, Dose 3 (N=171, 85)
    0
    0
        Swelling, Dose 3 (N=171, 85)
    29
    3
        Grade 3, Swelling, Dose 3 (N=171, 85)
    2
    0
        Pain, Overall (N=180, 88)
    159
    39
        Grade 3, Pain, Overall (N=180, 88)
    8
    0
        Redness, Overall (N=180, 88)
    51
    15
        Grade 3, Redness, Overall (N=180, 88)
    0
    0
        Swelling, Overall (N=180, 88)
    36
    7
        Grade 3, Swelling, Overall (N=180, 88)
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited general symptoms

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    End point title
    		 Number of subjects with any and Grade 3 solicited general symptoms
    End point description
    The solicited general symptoms assessed were Arthralgia, Fatigue, Fever (defined as axillary temperature ≥37.5 °C), Gastrointestinal, Headache, Myalgia, Rash and Urticaria. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature > 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 - 6) after each and any vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    180
    88
    Units: Subjects
        Arthralgia, Dose 1 (N=180, 88)
    17
    7
        Grade 3, Athralgia, Dose 1 (N=180, 88)
    0
    0
        Related, Athralgia, Dose 1 (N=180, 88)
    10
    3
        Fatigue, Dose 1 (N=180, 88)
    51
    32
        Grade 3, Fatigue, Dose 1 (N=180, 88)
    1
    0
        Related, Fatigue, Dose 1 (N=180, 88)
    26
    18
        Fever (axillary), Dose 1 (N=180, 88)
    24
    11
        Grade 3, Fever, Dose 1 (N=180, 88)
    0
    0
        Related, Fever, Dose 1 (N=180, 88)
    1
    1
        Gastrointestinal, Dose 1 (N=180, 88)
    33
    10
        Grade 3, Gastrointestinal, Dose 1 (N=180, 88)
    2
    0
        Related, Gastrointestinal, Dose 1 (N=180, 88)
    15
    5
        Headache, Dose 1 (N=180, 88)
    51
    21
        Grade 3, Headache, Dose 1 (N=180, 88)
    0
    0
        Related, Headache, Dose 1 (N=180, 88)
    24
    7
        Myalgia, Dose 1 (N=180, 88)
    67
    16
        Grade 3, Mylagia, Dose 1 (N=180, 88)
    1
    0
        Related, Mylagia, Dose 1 (N=180, 88)
    45
    7
        Rash, Dose 1 (N=180, 88)
    8
    1
        Grade 3, Rash, Dose 1 (N=180, 88)
    0
    0
        Related, Rash, Dose 1 (N=180, 88)
    2
    1
        Urticaria, Dose 1 (N=180, 88)
    3
    0
        Grade 3, Urticaria, Dose 1 (N=180, 88)
    0
    0
        Related, Urticaria, Dose 1 (N=180, 88)
    1
    0
        Arthralgia, Dose 2 (N=173, 86)
    6
    3
        Grade 3, Arthralgia, Dose 2 (173, 86)
    0
    1
        Related, Arthralgia, Dose 2 (N=173, 86)
    3
    0
        Fatigue, Dose 2 (N=173, 86)
    35
    14
        Grade 3, Fatigue, Dose 2 (N=173, 86)
    1
    0
        Related, Fatigue, Dose 2 (N=173, 86)
    21
    9
        Fever (axillary), Dose 2 (N=173, 86)
    14
    6
        Grade 3, Fever, Dose 2 (N=173, 86)
    0
    0
        Related, Fever, Dose 2 (N=173, 86)
    1
    0
        Gastrointestinal, Dose 2 (N=173, 86)
    18
    4
        Grade 3, Gastrointestinal, Dose 2 (N=173, 86)
    1
    1
        Related, Gastrointestinal, Dose 2 (N=173, 86)
    7
    0
        Headache, Dose 2 (N=173, 86)
    30
    13
        Grade 3, Headache, Dose 2 (N=173, 86)
    2
    1
        Related, Headache, Dose 2 (N=173, 86)
    14
    7
        Myalgia, Dose 2 (N=173, 86)
    35
    8
        Grade 3, Maylagia, Dose 2 (N=173, 86)
    1
    0
        Related, Maylagia, Dose 2 (N=173, 86)
    27
    7
        Rash, Dose 2 (N=173, 86)
    8
    2
        Grade 3, Rash, Dose 2 (N=173, 86)
    0
    0
        Related, Rash, Dose 2 (N=173, 86)
    3
    0
        Urticaria, Dose 2 (N=173, 86)
    1
    2
        Grade 3, Urticaria, Dose 2 (N=173, 86)
    0
    0
        Related, Urticaria, Dose 2 (N=173, 86)
    0
    0
        Arthralgia, Dose 3 (N=170, 85)
    12
    3
        Grade 3, Arthralgia, Dose 3 (N=170, 85)
    0
    0
        Related, Arthtralgia, Dose 3 (N=170, 85)
    12
    3
        Fatigue, Dose 3 (N=170, 85)
    44
    15
        Grade 3, Fatigue, Dose 3 (N=170, 85)
    2
    0
        Related, Fatigue, Dose 3 (N=170, 85)
    30
    11
        Fever (axillary), Dose 3 (N=170, 85)
    14
    4
        Grade 3, Fever, Dose 3 (N=170, 85)
    0
    0
        Related, Fever, Dose 3 (N=170, 85)
    1
    0
        Gastrointestinal, Dose 3 (N=170, 85)
    10
    5
        Grade 3, Gastrointestinal, Dose 3 (N=170, 85)
    1
    0
        Related, Gastrointestinal, Dose 3 (N=170, 85)
    8
    4
        Headache, Dose 3 (N=170, 85)
    30
    11
        Grade 3, Headache, Dose 3 (N=170, 85)
    3
    0
        Related, Headache, Dose 3 (N=170, 85)
    17
    8
        Myalgia, Dose 3 (N=170, 85)
    39
    8
        Grade 3, Mylagia, Dose 3 (N=170, 85)
    1
    0
        Related, Mylagia, Dose 3 (N=170, 85)
    35
    6
        Rash, Dose 3 (N=170, 85)
    3
    2
        Grade 3, Rash, Dose 3 (N=170, 85)
    0
    0
        Related, Rash, Dose 3 (N=170, 85)
    1
    0
        Urticaria, Dose 3 (N=170, 85)
    0
    0
        Grade 3, Urticaria, Dose 3 (N=170, 85)
    0
    0
        Related, Urticaria, Dose 3 (N=170, 85)
    0
    0
        Arthralgia, Overall (N=180, 88)
    29
    10
        Grade 3, Arthralgia, Overall (N=180, 88)
    0
    1
        Related, Arthralgia, Overall (N=180, 88)
    22
    5
        Fatigue, Overall (N=180, 88)
    82
    42
        Grade 3, Fatigue, Overall (N=180, 88)
    4
    0
        Related, Fatigue, Overall (N=180, 88)
    52
    33
        Fever (axillary), Overall (N=180, 88)
    35
    17
        Grade 3, Fever, Overall (N=180, 88)
    0
    0
        Related, Fever, Overall (N=180, 88)
    3
    1
        Gastrointestinal, Overall (N=180, 88)
    40
    14
        Grade 3, Gastrointestinal, Overall (N=180, 88)
    4
    1
        Related, Gastrointestinal, Overall (N=180, 88)
    19
    7
        Headache, Overall (N=180, 88)
    77
    33
        Grade 3, Headache, Overall (N=180, 88)
    5
    1
        Realated, Headache, Overall (N=180, 88)
    43
    16
        Myalgia, Overall (N=180, 88)
    88
    23
        Grade 3, Mylagia, Overall (N=180, 88)
    3
    0
        Related, Mylagia, Overall (N=180, 88)
    70
    14
        Rash, Overall (N=180, 88)
    16
    5
        Grade 3, Rash, Overall (N=180, 88)
    0
    0
        Related, Rash, Overall (N=180, 88)
    5
    1
        Urticaria, Overall (N=180, 88)
    4
    2
        Grade 3, Urticaria, Overall (N=180, 88)
    0
    0
        Related, Urticaria, Overall (N=180, 88)
    1
    0
    No statistical analyses for this end point

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

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    End point title
    		 Nubmer of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days (Day 0-29) after any vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    181
    89
    Units: Subjects
        Any AEs
    68
    31
        Grade 3 AEs
    5
    2
        Related AEs
    5
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with New Onset of Chronic Diseases (NOCDs) and other medically significant conditions

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    End point title
    		 Number of subjects with New Onset of Chronic Diseases (NOCDs) and other medically significant conditions
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Month 7 and up to Month 12
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    181
    89
    Units: Subjects
        NOCDs, Month 7 (N=181, 89)
    2
    1
        MSCs, Month 7 (N=181, 89)
    22
    10
        NOCDs, Month 7 to 12 (N=175,86)
    0
    0
        MSCs, Month 7 to 12 (N=175,86)
    1
    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
    End point type
    Secondary
    End point timeframe
    Up to Month 7 and up to Month 12
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    181
    89
    Units: Number
        SAEs, Month 7 (N=181,89)
    2
    0
        SAEs, Month 12 (N=175, 86)
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Alanine Transferase (Alt)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Alanine Transferase (Alt)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    172
    86
    Units: Subjects
        Alt, Normal, Month 2, Normal (N=172, 86)
    166
    79
        Alt, Normal, Month 2, Below (N=172, 86)
    3
    0
        Alt, Normal, Month 2, Above (N=172, 86)
    3
    2
        Alt, Normal, Month 2, Missing (N=172, 86)
    0
    5
        Alt, Normal, Month 7, Normal (N=171, 84)
    165
    81
        Alt, Normal, Month 7, Below (N=171, 84)
    1
    0
        Alt, Normal, Month 7, Above (N=171, 84)
    5
    3
        Alt, Below, Month 2, Normal (N=1, 0)
    0
    0
        Alt, Below, Month 2, Below (N=1, 0)
    1
    0
        Alt, Below, Month 2, Above (N=1, 0)
    0
    0
        Alt, Below, Month 7, Normal (N=1, 0)
    0
    0
        Alt, Below, Month 7, Below (N=1, 0)
    1
    0
        Alt, Below, Month 7, Above (N=1, 0)
    0
    0
        Alt, Above, Month 2, Normal (N=4, 1)
    2
    0
        Alt, Above, Month 2, Below (N=4, 1)
    0
    0
        Alt, Above, Month 2, Above (N=4, 1)
    2
    0
        Alt, Above, Month 2, Missing (N=4, 1)
    0
    1
        Alt, Above, Month 7, Normal (N=3, 1)
    2
    0
        Alt, Above, Month 7, Below (N=3, 1)
    0
    0
        Alt, Above, Month 7, Above (N=3, 1)
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Basophils (Bas)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Basophils (Bas)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    146
    76
    Units: Subjects
        Bas, Normal, Month 2, Normal (N=146, 76)
    140
    65
        Bas, Normal, Month 2, Below (N=146, 76)
    0
    0
        Bas, Normal, Month 2, Above (N=146, 76)
    3
    3
        Bas, Normal, Month 2, Missing (N=146, 76)
    3
    8
        Bas, Normal, Month 7, Normal (N=145, 74)
    134
    66
        Bas, Normal, Month 7, Below (N=145, 74)
    0
    0
        Bas, Normal, Month 7, Above (N=145, 74)
    11
    8
        Bas, Above, Month 2, Normal (N=18, 6)
    12
    5
        Bas, Above, Month 2, Below (N=18, 6)
    0
    0
        Bas, Above, Month 2, Above (N=18, 6)
    6
    1
        Bas, Above, Month 7, Normal (N=18, 6)
    14
    4
        Bas, Above, Month 7, Below (N=18, 6)
    0
    0
        Bas, Above, Month 7, Above (N=18, 6)
    4
    2
    No statistical analyses for this end point

    Secondary: nmNumber of subjects with clinically relevant abnormalities in Eosinophils (Eos)

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    End point title
    		 nmNumber of subjects with clinically relevant abnormalities in Eosinophils (Eos)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    125
    68
    Units: Subjects
        Eos, Normal, Month 2, Normal (N=125,68)
    102
    48
        Eos, Normal, Month 2, Below (N=125,68)
    4
    2
        Eos, Normal, Month 2, Above (N=125,68)
    17
    10
        Eos, Normal, Month 2, Missing (N=125,68)
    2
    8
        Eos, Normal, Month 7, Normal (N=125,67)
    108
    54
        Eos, Normal, Month 7, Below (N=125,67)
    8
    4
        Eos, Normal, Month 7, Above (N=125,67)
    9
    9
        Eos, Below, Month 2, Normal (N=4,3)
    4
    2
        Eos, Below, Month 2, Below (N=4,3)
    0
    1
        Eos, Below, Month 2, Above (N=4,3)
    0
    0
        Eos, Below, Month 7, Normal (N=4,2)
    2
    1
        Eos, Below, Month 7, Below (N=4,2)
    2
    1
        Eos, Below, Month 7, Above (N=4,2)
    0
    0
        Eos, Above, Month 2, Normal (N=36,11)
    6
    5
        Eos, Above, Month 2, Below (N=36,11)
    0
    0
        Eos, Above, Month 2, Above (N=36,11)
    30
    6
        Eos, Above, Month 7, Normal (N=35,11)
    8
    5
        Eos, Above, Month 7, Below (N=35,11)
    0
    0
        Eos, Above, Month 7, Above (N=35,11)
    27
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Hematocrit (Hem)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Hematocrit (Hem)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    159
    81
    Units: Subjects
        Hem, Normal, Month 2, Normal (N=159, 81)
    155
    76
        Hem, Normal, Month 2, Below (N=159, 81)
    2
    0
        Hem, Normal, Month 2, Above (N=159, 81)
    2
    0
        Hem, Normal, Month 2, Missing (N=159, 81)
    0
    5
        Hem, Normal, Month 7, Normal (N=158, 79)
    147
    73
        Hem, Normal, Month 7, Below (N=158, 79)
    9
    6
        Hem, Normal, Month 7, Above (N=158, 79)
    2
    0
        Hem, Below, Month 2, Normal (N=4, 1)
    3
    1
        Hem, Below, Month 2, Below (N=4, 1)
    1
    0
        Hem, Below, Month 2, Above (N=4, 1)
    0
    0
        Hem, Below, Month 7, Normal (N=4, 1)
    2
    1
        Hem, Below, Month 7, Below (N=4, 1)
    2
    0
        Hem, Below, Month 7, Above (N=4, 1)
    0
    0
        Hem, Above, Month 2, Normal (N=6, 2)
    3
    0
        Hem, Above, Month 2, Below (N=6, 2)
    0
    0
        Hem, Above, Month 2, Above (N=6, 2)
    3
    1
        Hem, Above, Month 2, Missing (N=6, 2)
    0
    1
        Hem, Above, Month 7, Normal (N=6, 2)
    6
    1
        Hem, Above, Month 7, Below (N=6, 2)
    0
    0
        Hem, Above, Month 7, Above (N=6, 2)
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Lymphocytes (Lym)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Lymphocytes (Lym)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    142
    71
    Units: Subjects
        Lym, Normal, Month 2, Normal (N=142, 71)
    117
    56
        Lym, Normal, Month 2, Below (N=142, 71)
    5
    1
        Lym, Normal, Month 2, Above (N=142, 71)
    18
    6
        Lym, Normal, Month 2, Missing (N=142, 71)
    2
    8
        Lym, Normal, Month 7, Normal (N=142, 69)
    126
    63
        Lym, Normal, Month 7, Below (N=142, 69)
    4
    1
        Lym, Normal, Month 7, Above (N=142, 69)
    12
    5
        Lym, Below , Month 2, Normal (N=3, 1)
    1
    1
        Lym, Below , Month 2, Below (N=3, 1)
    2
    0
        Lym, Below , Month 2, Above (N=3, 1)
    0
    0
        Lym, Below , Month 7, Normal (N=3, 1)
    2
    1
        Lym, Below , Month 7, Below (N=3, 1)
    1
    0
        Lym, Below , Month 7, Above (N=3, 1)
    0
    0
        Lym, Above, Month 2, Normal (N=20, 10)
    11
    5
        Lym, Above, Month 2, Below (N=20, 10)
    1
    0
        Lym, Above, Month 2, Above (N=20, 10)
    8
    5
        Lym, Above, Month 7, Normal (N=19, 10)
    11
    8
        Lym, Above, Month 7, Below (N=19, 10)
    0
    0
        Lym, Above, Month 7, Above (N=19, 10)
    8
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Monocytes (Mon)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Monocytes (Mon)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    108
    50
    Units: Subjects
        Mon, Normal, Month 2, Normal (N=108, 50)
    92
    38
        Mon, Normal, Month 2, Below (N=108, 50)
    0
    0
        Mon, Normal, Month 2, Above (N=108, 50)
    15
    5
        Mon, Normal, Month 2, Missing (N=108, 50)
    1
    7
        Mon, Normal, Month 7, Normal (N=108, 48)
    93
    43
        Mon, Normal, Month 7, Below (N=108, 48)
    0
    1
        Mon, Normal, Month 7, Above (N=108, 48)
    15
    4
        Mon, Below, Month 2, Normal (N=1, 3)
    1
    3
        Mon, Below, Month 2, Below (N=1, 3)
    0
    0
        Mon, Below, Month 2, Above (N=1, 3)
    0
    0
        Mon, Below, Month 7, Normal (N=1, 3)
    0
    3
        Mon, Below, Month 7, Below (N=1, 3)
    1
    0
        Mon, Below, Month 7, Above (N=1, 3)
    0
    0
        Mon, Above, Month 2, Normal (N=56, 29)
    7
    8
        Mon, Above, Month 2, Below (N=56, 29)
    0
    0
        Mon, Above, Month 2, Above (N=56, 29)
    48
    20
        Mon, Above, Month 2, Missing (N=56, 29)
    1
    1
        Mon, Above, Month 7, Normal (N=55, 29)
    13
    7
        Mon, Above, Month 7, Below (N=55, 29)
    0
    0
        Mon, Above, Month 7, Above (N=55, 29)
    42
    22
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Neutrophils (Neu)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Neutrophils (Neu)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    152
    74
    Units: Subjects
        Neu, Normal, Month 2, Normal (N=152, 74)
    130
    60
        Neu, Normal, Month 2, Below (N=152, 74)
    20
    6
        Neu, Normal, Month 2, Above (N=152, 74)
    0
    0
        Neu, Normal, Month 2, Missing (N=152, 74)
    2
    8
        Neu, Normal, Month 7, Normal (N=152, 72)
    135
    63
        Neu, Normal, Month 7, Below (N=152, 72)
    14
    8
        Neu, Normal, Month 7, Above (N=152, 72)
    3
    1
        Neu, Below, Month 2, Normal (N=13, 8)
    10
    5
        Neu, Below, Month 2, Below (N=13, 8)
    3
    3
        Neu, Below, Month 2, Above (N=13, 8)
    0
    0
        Neu, Below, Month 7, Normal (N=12, 8)
    8
    6
        Neu, Below, Month 7, Below (N=12, 8)
    3
    2
        Neu, Below, Month 7, Above (N=12, 8)
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Platelets (Pla)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Platelets (Pla)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    164
    78
    Units: Subjects
        Pla, Normal, Month 2, Normal (N=164, 78)
    158
    68
        Pla, Normal, Month 2, Below (N=164, 78)
    3
    2
        Pla, Normal, Month 2, Above (N=164, 78)
    3
    2
        Pla, Normal, Month 2, Missing (N=164, 78)
    0
    6
        Pla, Normal, Month 7, Normal (N=163, 76)
    156
    71
        Pla, Normal, Month 7, Below (N=163, 76)
    2
    1
        Pla, Normal, Month 7, Above (N=163, 76)
    5
    4
        Pla, Below, Month 2, Normal (N=2, 3)
    0
    2
        Pla, Below, Month 2, Below (N=2, 3)
    2
    1
        Pla, Below, Month 2, Above (N=2, 3)
    0
    0
        Pla, Below, Month 7, Normal (N=2, 3)
    1
    0
        Pla, Below, Month 7, Below (N=2, 3)
    1
    2
        Pla, Below, Month 7, Above (N=2, 3)
    0
    0
        Pla, Below, Month 7, Missing (N=2, 3)
    0
    1
        Pla, Above, Month 2, Normal (N=3, 3)
    2
    1
        Pla, Above, Month 2, Below (N=3, 3)
    0
    0
        Pla, Above, Month 2, Above (N=3, 3)
    1
    2
        Pla, Above, Month 7, Normal (N=3, 3)
    0
    0
        Pla, Above, Month 7, Below (N=3, 3)
    0
    0
        Pla, Above, Month 7, Above (N=3, 3)
    3
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Red Blood Cells (RBC)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Red Blood Cells (RBC)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    154
    82
    Units: Subjects
        RBC, Normal, Month 2, Normal (N=154, 82)
    149
    75
        RBC, Normal, Month 2, Below (N=154, 82)
    0
    0
        RBC, Normal, Month 2, Above (N=154, 82)
    5
    2
        RBC, Normal, Month 2, Missing (N=154, 82)
    0
    5
        RBC, Normal, Month 7, Normal (N=153, 80)
    148
    78
        RBC, Normal, Month 7, Below (N=153, 80)
    2
    1
        RBC, Normal, Month 7, Above (N=153, 80)
    3
    1
        RBC, Below, Month 2, Normal (N=2, 0)
    2
    0
        RBC, Below, Month 2, Below (N=2, 0)
    0
    0
        RBC, Below, Month 2, Above (N=2, 0)
    0
    0
        RBC, Below, Month 7, Normal (N=2, 0)
    2
    0
        RBC, Below, Month 7, Below (N=2, 0)
    0
    0
        RBC, Below, Month 7, Above (N=2, 0)
    0
    0
        RBC, Above, Month 2, Normal (N=13, 2)
    7
    0
        RBC, Above, Month 2, Below (N=13, 2)
    0
    0
        RBC, Above, Month 2, Above (N=13, 2)
    6
    1
        RBC, Above, Month 2, Missing (N=13, 2)
    0
    1
        RBC, Above, Month 7, Normal (N=13, 2)
    7
    0
        RBC, Above, Month 7, Below (N=13, 2)
    0
    0
        RBC, Above, Month 7, Above (N=13, 2)
    6
    1
        RBC, Above, Month 7, Missing (N=13, 2)
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in White Blood Cells (WBC)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in White Blood Cells (WBC)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    155
    75
    Units: Subjects
        WBC, Normal, Month 2, Normal (N=155, 75)
    142
    62
        WBC, Normal, Month 2, Below (N=155, 75)
    7
    3
        WBC, Normal, Month 2, Above (N=155, 75)
    6
    4
        WBC, Normal, Month 2, Missing (N=155, 75)
    0
    6
        WBC, Normal, Month 7, Normal (N=154, 73)
    133
    66
        WBC, Normal, Month 7, Below (N=154, 73)
    4
    2
        WBC, Normal, Month 7, Above (N=154, 73)
    17
    4
        WBC, Normal, Month 7, Missing (N=154, 73)
    0
    1
        WBC, Below, Month 2, Normal (N=4, 2)
    4
    1
        WBC, Below, Month 2, Below (N=4, 2)
    0
    1
        WBC, Below, Month 2, Above (N=4, 2)
    0
    0
        WBC, Below, Month 7, Normal (N=4, 2)
    4
    2
        WBC, Below, Month 7, Below (N=4, 2)
    0
    0
        WBC, Below, Month 7, Above (N=4, 2)
    0
    0
        WBC, Above, Month 2, Normal (N=10, 7)
    10
    7
        WBC, Above, Month 2, Below (N=10, 7)
    0
    0
        WBC, Above, Month 2, Above (N=10, 7)
    0
    0
        WBC, Above, Month 7, Normal (N=10, 7)
    9
    6
        WBC, Above, Month 7, Below (N=10, 7)
    0
    0
        WBC, Above, Month 7, Above (N=10, 7)
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with clinically relevant abnormalities in Creatinine (Crea)

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    End point title
    		 Number of subjects with clinically relevant abnormalities in Creatinine (Crea)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 2 and Month 7 post-vaccination
    End point values
    		 Cervarix Group Engerix-B Group
    Number of subjects analysed
    163
    82
    Units: Subjects
        Crea, Normal, Month 2, Normal (N=163, 82)
    158
    76
        Crea, Normal, Month 2, Below (N=163, 82)
    0
    0
        Crea, Normal, Month 2, Above (N=163, 82)
    5
    0
        Crea, Normal, Month 2, Missing (N=163, 82)
    0
    6
        Crea, Normal, Month 7, Normal (N=161, 80)
    159
    79
        Crea, Normal, Month 7, Below (N=161, 80)
    0
    0
        Crea, Normal, Month 7, Above (N=161, 80)
    2
    1
        Crea, Normal, Month 2, Normal (N=13, 5)
    10
    3
        Crea, Normal, Month 2, Below (N=13, 5)
    0
    0
        Crea, Normal, Month 2, Above (N=13, 5)
    3
    2
        Crea, Normal, Month 7, Normal (N=13, 5)
    10
    5
        Crea, Normal, Month 7, Below (N=13, 5)
    0
    0
        Crea, Normal, Month 7, Above (N=13, 5)
    3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events: 7 days post-vaccination. Unsolicited adverse events: 30 days post-vaccination. Serious adverse events: Throughout the study period: up to Month 12.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Subjects aged between 10 and 18 years at the time of the first vaccination, who received 3 doses of Cervarix vaccine, administered by intramuscular injection in the upper deltoid site of the left arm according to a 0, 1 and 6-month schedule and were followed up for 7 months after the first dose.

    Reporting group title
    Engerix-B Group
    Reporting group description
    		 Subjects aged between 10 and 18 years at the time of the first vaccination, who received 3 doses of Engerix-B vaccine, administered by intramuscular injection in the upper deltoid site of the left arm according to a 0, 1 and 6-month schedule and were followed up for 7 months after the first dose.

    Serious adverse events
    		 Cervarix Group Engerix-B Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 181 (1.66%)
    1 / 89 (1.12%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn’s disease
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondrosis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cervarix Group Engerix-B Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    159 / 181 (87.85%)
    42 / 89 (47.19%)
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 89 (2.25%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Headache (unsolicited)
         subjects affected / exposed
    17 / 181 (9.39%)
    9 / 89 (10.11%)
         occurrences all number
    17
    9
    Pyrexia
         subjects affected / exposed
    4 / 181 (2.21%)
    3 / 89 (3.37%)
         occurrences all number
    4
    3
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    159 / 181 (87.85%)
    39 / 89 (43.82%)
         occurrences all number
    159
    39
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    51 / 181 (28.18%)
    15 / 89 (16.85%)
         occurrences all number
    51
    15
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 181 (19.89%)
    7 / 89 (7.87%)
         occurrences all number
    36
    7
    Headache
         subjects affected / exposed [1]
    77 / 180 (42.78%)
    33 / 88 (37.50%)
         occurrences all number
    77
    33
    Fatigue
         subjects affected / exposed [2]
    82 / 180 (45.56%)
    42 / 88 (47.73%)
         occurrences all number
    82
    42
    Fever (axillary)
         subjects affected / exposed [3]
    35 / 180 (19.44%)
    17 / 88 (19.32%)
         occurrences all number
    35
    17
    Gastrointestinal
         subjects affected / exposed [4]
    40 / 180 (22.22%)
    14 / 88 (15.91%)
         occurrences all number
    40
    14
    Mylagia
         subjects affected / exposed [5]
    88 / 180 (48.89%)
    23 / 88 (26.14%)
         occurrences all number
    88
    23
    Rash
         subjects affected / exposed [6]
    16 / 180 (8.89%)
    5 / 88 (5.68%)
         occurrences all number
    16
    5
    Urticaria
         subjects affected / exposed [7]
    4 / 180 (2.22%)
    2 / 88 (2.27%)
         occurrences all number
    4
    2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 89 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 89 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    8 / 181 (4.42%)
    3 / 89 (3.37%)
         occurrences all number
    8
    3
    Cough
         subjects affected / exposed
    4 / 181 (2.21%)
    4 / 89 (4.49%)
         occurrences all number
    4
    4
    Epistaxis
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 89 (2.25%)
         occurrences all number
    1
    2
    Asthma
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 89 (2.25%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 181 (1.10%)
    2 / 89 (2.25%)
         occurrences all number
    2
    2
    Neck pain
         subjects affected / exposed
    3 / 181 (1.66%)
    1 / 89 (1.12%)
         occurrences all number
    3
    1
    Arthralgia (unsolicited)
         subjects affected / exposed
    3 / 181 (1.66%)
    0 / 89 (0.00%)
         occurrences all number
    3
    0
    Arthralgia
         subjects affected / exposed [8]
    29 / 180 (16.11%)
    10 / 88 (11.36%)
         occurrences all number
    29
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 181 (6.63%)
    3 / 89 (3.37%)
         occurrences all number
    12
    3
    Acute tonsillitis
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 89 (2.25%)
         occurrences all number
    0
    2
    Influenza
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 89 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 89 (0.00%)
         occurrences all number
    2
    0
    Varicella
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 89 (0.00%)
         occurrences all number
    2
    0
    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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with symptom sheets completed.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2006
    Human papillomavirus (HPV) infection has been clearly established as the central cause of cervical cancer. GlaxoSmithKline (GSK) Biological has developed a virus-like particle (VLP) vaccine against the oncogenic types HPV-16 and HPV-18 (which are the most common oncogenic HPV types, found in approximately 70% of all cervical cancers) formulated with the AS04 adjuvant system. AS04 is comprised of aluminum salts and 3-O-desacyl-4’-monophosphoryl lipid A (MPL). This vaccine (HPV-16/18 L1/AS04) has been shown to be safe and immunogenic in previous trials, and has prevented incident and persistent HPV 16/18 infection and their associated lesions in women in study 580299/001 (HPV-001).

    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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