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    Clinical Trial Results:
    A phase III, randomised, controlled, single-blind study to evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered according to a 2-dose schedule (0, 6 month) in 4-6 years old healthy female children.

    Summary
    EudraCT number
    		 2011-005604-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Oct 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Apr 2020
    First version publication date
    01 Apr 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    115887
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01627561
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the safety, reactogenicity and occurrence of clinically relevant abnormalities in biochemistry and haematology parameters after administration of the HPV-16/18 vaccine according to a 2-dose schedule at 0, 6 months in 4-6 year old females, up to one month after the last dose (Month 7). • To evaluate the immunogenicity (as determined by enzyme-linked immunosorbent assay [ELISA]) of the HPV-16/18 vaccine administered according to a 2-dose schedule at 0, 6 months in 4-6 year old females, one month after the last dose (Month 7).
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 26
    Country: Number of subjects enrolled
    Mexico: 25
    Country: Number of subjects enrolled
    Panama: 97
    Worldwide total number of subjects
    148
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    148
    Adolescents (12-17 years)
    0
    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
    		 This study was conducted by multiple investigators at 7 centers in Colombia, Mexico and Panama.

    Pre-assignment
    Screening details
    		 All 148 subjects enrolled in the study, received the study vaccination and were included in the Total Vaccinated cohort (TVC).

    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
    Blinding implementation details
    The study was single-blind from Day 0 up to Month 12, then the study was open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cervarix Group
    Arm description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
    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
    2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.

    Arm title
    		 Priorix + Infanrix Group
    Arm description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.

    Number of subjects in period 1
    		Cervarix Group Priorix + Infanrix Group
    Started
    74
    74
    Completed
    73
    71
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    1
         Migrated/moved from study area
    -
    2
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.

    Reporting group title
    Priorix + Infanrix Group
    Reporting group description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.

    Reporting group values
    		 Cervarix Group Priorix + Infanrix Group Total
    Number of subjects
    		 74 74 148
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 74 74 148
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.3 ( 0.5 ) 4.4 ( 0.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 74 74 148
        Male
    		 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 4 2 6
        White - Caucasian / European Heritage
    		 2 4 6
        Mixed origin
    		 68 68 136

    End points

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    End points reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.

    Reporting group title
    Priorix + Infanrix Group
    Reporting group description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.

    Primary: 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 [1]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
    End point type
    Primary
    End point timeframe
    During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
    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: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        Any Pain Dose 1 (N=74;74)
    45
    15
        Grade 3 Pain Dose 1 (N=74;74)
    2
    0
        Any Redness Dose 1 (N=74;74)
    10
    7
        Grade 3 Redness Dose 1 (N=74;74)
    1
    0
        Any Swelling Dose 1 (N=74;74)
    6
    6
        Grade 3 Swelling Dose 1 (N=74;74)
    1
    0
        Any Pain Dose 2 (N=72;71)
    43
    36
        Grade 3 Pain Dose 2 (N=72;71)
    2
    1
        Any Redness Dose 2 (N=72;71)
    12
    12
        Grade 3 Redness Dose 2 (N=72;71)
    0
    4
        Any Swelling Dose 2 (N=72;71)
    16
    15
        Grade 3 Swelling Dose 2 (N=72;71)
    3
    7
        Any Pain Across doses (N=74;74)
    54
    40
        Grade 3 Pain Across doses (N=74;74)
    4
    1
        Any Redness Across doses (N=74;74)
    18
    18
        Grade 3 Redness Across doses (N=74;74)
    1
    4
        Any Swelling Across doses (N=74;74)
    19
    18
        Grade 3 Swelling Across doses (N=74;74)
    4
    7
    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 [2]
    End point description
    Assessed solicited general symptoms were arthralgia (only in joints which were distal from the injection site), drowsiness, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, irritability/fussiness, loss of appetite, myalgia, rash (not urticaria, not measels/rubella-like rash), urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability/fussines = crying that could not be comforted/prevented normal activty. Grade 3 loss of appetite = did not eat at all. Related = symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
    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: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        Any Arthralgia Dose 1 (N=74;74)
    5
    8
        Grade 3 Arthralgia Dose 1 (N=74;74)
    0
    0
        Related Arthralgia Dose 1 (N=74;74)
    4
    8
        Any Drowsiness Dose 1 (N=74;74)
    14
    7
        Grade 3 Drowsiness Dose 1 (N=74;74)
    3
    0
        Related Drowsiness Dose 1 (N=74;74)
    12
    7
        Any Fatigue Dose 1 (N=74;74)
    8
    7
        Grade 3 Fatigue Dose 1 (N=74;74)
    0
    0
        Related Fatigue Dose 1 (N=74;74)
    7
    7
        Any Fever Dose 1 (N=74;74)
    6
    8
        Grade 3 Fever Dose 1 (N=74;74)
    1
    0
        Related Fever Dose 1 (N=74;74)
    3
    5
        Any Gastrointestinal Dose 1 (N=74;74)
    7
    12
        Grade 3 Gastrointestinal Dose 1 (N=74;74)
    0
    0
        Related Gastrointestinal Dose 1 (N=74;74)
    5
    10
        Any Headache Dose 1 (N=74;74)
    11
    19
        Grade 3 Headache Dose 1 (N=74;74)
    0
    1
        Related Headache Dose 1 (N=74;74)
    9
    17
        Any Irritability Dose 1 (N=74;74)
    13
    7
        Grade 3 Irritability Dose 1 (N=74;74)
    1
    0
        Related Irritability Dose 1 (N=74;74)
    12
    7
        Any Loss of appetite Dose 1 (N=74;74)
    15
    7
        Grade 3 Loss of appetite Dose 1 (N=74;74)
    0
    0
        Related Loss of appetite Dose 1 (N=74;74)
    13
    7
        Any Myalgia Dose 1 (N=74;74)
    13
    9
        Grade 3 Myalgia Dose 1 (N=74;74)
    0
    0
        Related Myalgia Dose 1 (N=74;74)
    13
    9
        Any Rash Dose 1 (N=74;74)
    3
    1
        Grade 3 Rash Dose 1 (N=74;74)
    0
    0
        Related Rash Dose 1 (N=74;74)
    2
    1
        Any Urticaria Dose 1 (N=74;74)
    5
    3
        Grade 3 Urticaria Dose 1 (N=74;74)
    0
    0
        Related Urticaria Dose 1 (N=74;74)
    4
    3
        Any Arthralgia Dose 2 (N=72;71)
    10
    8
        Grade 3 Arthralgia Dose 2 (N=72;71)
    0
    0
        Related Arthralgia Dose 2 (N=72;71)
    9
    8
        Any Drowsiness Dose 2 (N=72;71)
    9
    9
        Grade 3 Drowsiness Dose 2 (N=72;71)
    0
    0
        Related Drowsiness Dose 2 (N=72;71)
    9
    9
        Any Fatigue Dose 2 (N=72;71)
    9
    7
        Grade 3 Fatigue Dose 2 (N=72;71)
    0
    0
        Related Fatigue Dose 2 (N=72;71)
    9
    7
        Any Fever Dose 2 (N=72;71)
    7
    12
        Grade 3 Fever Dose 2 (N=72;71)
    0
    0
        Related Fever Dose 2 (N=72;71)
    7
    9
        Any Gastrointestinal Dose 2 (N=72;71)
    4
    9
        Grade 3 Gastrointestinal Dose 2 (N=72;71)
    0
    0
        Related Gastrointestinal Dose 2 (N=72;71)
    3
    8
        Any Headache Dose 2 (N=72;71)
    12
    13
        Grade 3 Headache Dose 2 (N=72;71)
    0
    0
        Related Headache Dose 2 (N=72;71)
    12
    12
        Any Irritability Dose 2 (N=72;71)
    18
    17
        Grade 3 Irritability Dose 2 (N=72;71)
    0
    0
        Related Irritability Dose 2 (N=72;71)
    18
    17
        Any Loss of appetite Dose 2 (N=72;71)
    9
    8
        Grade 3 Loss of appetite Dose 2 (N=72;71)
    1
    1
        Related Loss of appetite Dose 2 (N=72;71)
    9
    8
        Any Myalgia Dose 2 (N=72;71)
    13
    11
        Grade 3 Myalgia Dose 2 (N=72;71)
    0
    0
        Related Myalgia Dose 2 (N=72;71)
    12
    11
        Any Rash Dose 2 (N=72;71)
    3
    4
        Grade 3 Rash Dose 2 (N=72;71)
    0
    0
        Related Rash Dose 2 (N=72;71)
    3
    3
        Any Urticaria Dose 2 (N=72;71)
    5
    4
        Grade 3 Urticaria Dose 2 (N=72;71)
    0
    0
        Related Urticaria Dose 2 (N=72;71)
    4
    3
        Any Arthralgia Across doses (N=74;74)
    13
    11
        Grade 3 Arthralgia Across doses (N=74;74)
    0
    0
        Related Arthralgia Across doses (N=74;74)
    12
    11
        Any Drowsiness Across doses (N=74;74)
    16
    15
        Grade 3 Drowsiness Across doses (N=74;74)
    3
    0
        Related Drowsiness Across doses (N=74;74)
    15
    15
        Any Fatigue Across doses (N=74;74)
    15
    10
        Grade 3 Fatigue Across doses (N=74;74)
    0
    0
        Related Fatigue Across doses (N=74;74)
    14
    10
        Any Fever Across doses (N=74;74)
    12
    17
        Grade 3 Fever Across doses (N=74;74)
    1
    0
        Related Fever Across doses (N=74;74)
    9
    13
        Any Gastrointestinal Across doses (N=74;74)
    11
    16
        Grade 3 Gastrointestinal Across doses (N=74;74)
    0
    0
        Related Gastrointestinal Across doses (N=74;74)
    8
    15
        Any Headache Across doses (N=74;74)
    18
    25
        Grade 3 Headache Across doses (N=74;74)
    0
    1
        Related Headache Across doses (N=74;74)
    16
    23
        Any Irritability Across doses (N=74;74)
    22
    19
        Grade 3 Irritability Across doses (N=74;74)
    1
    0
        Related Irritability Across doses (N=74;74)
    22
    19
        Any Loss of appetite Across doses (N=74;74)
    21
    13
        Grade 3 Loss of appetite Across doses (N=74;74)
    1
    1
        Related Loss of appetite Across doses (N=74;74)
    19
    13
        Any Myalgia Across doses (N=74;74)
    21
    14
        Grade 3 Myalgia Across doses (N=74;74)
    0
    0
        Related Myalgia Across doses (N=74;74)
    21
    14
        Any Rash Across doses (N=74;74)
    6
    5
        Grade 3 Rash Across doses (N=74;74)
    0
    0
        Related Rash Across doses (N=74;74)
    5
    4
        Any Urticaria Across doses (N=74;74)
    10
    7
        Grade 3 Urticaria Across doses (N=74;74)
    0
    0
        Related Urticaria Across doses (N=74;74)
    8
    6
    No statistical analyses for this end point

    Primary: Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs) reported during the 43-day period following the vaccination at Day 0

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    End point title
    		 Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs) reported during the 43-day period following the vaccination at Day 0 [3]
    End point description
    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
    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: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        Any AE(s)
    40
    40
        Grade 3 AE(s)
    3
    2
        Related AE(s)
    1
    5
    No statistical analyses for this end point

    Primary: Number of subjects with any, Grade 3 and related unsolicited AEs reported during the 30-day period following the vaccination at Month 6

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    End point title
    		 Number of subjects with any, Grade 3 and related unsolicited AEs reported during the 30-day period following the vaccination at Month 6 [4]
    End point description
    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    71
    Units: Subjects
        Any AE(s)
    18
    13
        Grade 3 AE(s)
    0
    0
        Related AE(s)
    0
    1
    No statistical analyses for this end point

    Primary: Number of subjects with clinically relevant abnormalities in biochemical and haematological parameters at Day 42 by baseline ranges

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    End point title
    		 Number of subjects with clinically relevant abnormalities in biochemical and haematological parameters at Day 42 by baseline ranges [5]
    End point description
    The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes [white blood cells] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Day 42 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALAT Below (baseline) - Within (Day 42) = ALAT with below normal value at baseline and within normal values at Day 42].
    End point type
    Primary
    End point timeframe
    At Day 42 (i.e. 42 days after the vaccination at Day 0)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    73
    Units: Subjects
        ALAT, Unknown (baseline) - Below (Day 42) (N=2;2)
    0
    0
        ALAT, Unknown (baseline) - Within (Day 42) (N=2;2)
    2
    1
        ALAT, Unknown (baseline) - Above (Day 42) (N=2;2)
    0
    1
        ALAT, Below (baseline) - Below (Day 42) (N=2;1)
    1
    0
        ALAT, Below (baseline) - Within (Day 42) (N=2;1)
    1
    1
        ALAT, Below (baseline) - Above (Day 42) (N=2;1)
    0
    0
        ALAT, Within (baseline) - Below (Day 42) (N=66;62)
    0
    0
        ALAT, Within (baseline) -Within (Day 42) (N=66;62)
    64
    60
        ALAT, Within (baseline) - Above (Day 42) (N=66;62)
    2
    2
        ALAT, Above (baseline) - Below (Day 42) (N=4;7)
    0
    0
        ALAT, Above (baseline) - Within (Day 42) (N=4;7)
    1
    4
        ALAT, Above (baseline) - Above (Day 42) (N=4;7)
    3
    3
        BAS, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        BAS, Unknown (baseline) - Within (Day 42) (N=1;0)
    1
    0
        BAS, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        BAS, Below (baseline) - Below (Day 42) (N=0;0)
    0
    0
        BAS, Below (baseline) - Within (Day 42) (N=0;0)
    0
    0
        BAS, Below (baseline) - Above (Day 42) (N=0;0)
    0
    0
        BAS, Within (baseline) - Below (Day 42) (N=71;69)
    0
    0
        BAS, Within (baseline) - Within (Day 42) (N=71;69)
    71
    69
        BAS, Within (baseline) - Above (Day 42) (N=71;69)
    0
    0
        BAS, Above (baseline) - Below (Day 42) (N=0;4)
    0
    0
        BAS, Above (baseline) - Within (Day 42) (N=0;4)
    0
    4
        BAS, Above (baseline) - Above (Day 42) (N=0;4)
    0
    0
        CREA, Unknown (baseline) - Below (Day 42) (N=2;1)
    0
    1
        CREA, Unknown (baseline) - Within (Day 42) (N=2;1)
    2
    0
        CREA, Unknown (baseline) - Above (Day 42) (N=2;1)
    0
    0
        CREA, Below (baseline) - Below (Day 42) (N=30;27)
    22
    17
        CREA, Below (baseline) - Within (Day 42) (N=30;27)
    8
    10
        CREA, Below (baseline) - Above (Day 42) (N=30;27)
    0
    0
        CREA, Within (baseline) - Below (Day 42) (N=42;45)
    7
    12
        CREA, Within (baseline) -Within (Day 42) (N=42;45)
    35
    33
        CREA, Within (baseline) - Above (Day 42) (N=42;45)
    0
    0
        CREA, Above (baseline) - Below (Day 42) (N=0;0)
    0
    0
        CREA, Above (baseline) - Within (Day 42) (N=0;0)
    0
    0
        CREA, Above (baseline) - Above (Day 42) (N=0;0)
    0
    0
        EOS, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        EOS, Unknown (baseline) - Within (Day 42) (N=1;0)
    1
    0
        EOS, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        EOS, Below (baseline) - Below (Day 42) (N=1;0)
    0
    0
        EOS, Below (baseline) - Within (Day 42) (N=1;0)
    1
    0
        EOS, Below (baseline) - Above (Day 42) (N=1;0)
    0
    0
        EOS, Within (baseline) - Below (Day 42) (N=49;50)
    1
    1
        EOS, Within (baseline) - Within (Day 42) (N=49;50)
    42
    38
        EOS, Within (baseline) - Above (Day 42) (N=49;50)
    6
    11
        EOS, Above (baseline) - Below (Day 42) (N=21;23)
    0
    1
        EOS, Above (baseline) - Within (Day 42) (N=21;23)
    4
    10
        EOS, Above (baseline) - Above (Day 42) (N=21;23)
    17
    12
        RBC, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        RBC, Unknown (baseline) - Within (Day 42) (N=1;0)
    1
    0
        RBC, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        RBC, Below (baseline) - Below (Day 42) (N=5;5)
    0
    1
        RBC, Below (baseline) - Within (Day 42) (N=5;5)
    5
    4
        RBC, Below (baseline) - Above (Day 42) (N=5;5)
    0
    0
        RBC, Within (baseline) - Below (Day 42) (N=66;66)
    5
    2
        RBC, Within (baseline) - Within (Day 42) (N=66;66)
    60
    63
        RBC, Within (baseline) - Above (Day 42) (N=66;66)
    1
    1
        RBC, Above (baseline) - Below (Day 42) (N=0;2)
    0
    0
        RBC, Above (baseline) - Within (Day 42) (N=0;2)
    0
    1
        RBC, Above (baseline) - Above (Day 42) (N=0;2)
    0
    1
        HCT, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        HCT, Unknown (baseline) - Within (Day 42) (N=1;0)
    1
    0
        HCT, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        HCT, Below (baseline) - Below (Day 42) (N=25;24)
    12
    15
        HCT, Below (baseline) - Within (Day 42) (N=25;24)
    13
    8
        HCT, Below (baseline) - Above (Day 42) (N=25;24)
    0
    1
        HCT, Within (baseline) - Below (Day 42) (N=43;45)
    5
    2
        HCT, Within (baseline) - Within (Day 42) (N=43;45)
    37
    38
        HCT, Within (baseline) - Above (Day 42) (N=43;45)
    1
    5
        HCT, Above (baseline) - Below (Day 42) (N=3;4)
    0
    0
        HCT, Above (baseline) - Within (Day 42) (N=3;4)
    2
    4
        HCT, Above (baseline) - Above (Day 42) (N=3;4)
    1
    0
        HGB, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        HGB, Unknown (baseline) - Within (Day 42) (N=1;0)
    0
    0
        HGB, Unknown (baseline) - Above (Day 42) (N=1;0)
    1
    0
        HGB, Below (baseline) - Below (Day 42) (N=20;14)
    10
    5
        HGB, Below (baseline) - Within (Day 42) (N=20;14)
    10
    9
        HGB, Below (baseline) - Above (Day 42) (N=20;14)
    0
    0
        HGB, Within (baseline) - Below (Day 42) (N=46;53)
    4
    7
        HGB, Within (baseline) - Within (Day 42) (N=46;53)
    38
    42
        HGB, Within (baseline) - Above (Day 42) (N=46;53)
    4
    4
        HGB, Above (baseline) - Below (Day 42) (N=5;6)
    0
    0
        HGB, Above (baseline) - Within (Day 42) (N=5;6)
    3
    5
        HGB, Above (baseline) - Above (Day 42) (N=5;6)
    2
    1
        WBC, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        WBC, Unknown (baseline) - Within (Day 42) (N=1;0)
    1
    0
        WBC, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        WBC, Below (baseline) - Below (Day 42) (N=5;7)
    1
    5
        WBC, Below (baseline) - Within (Day 42) (N=5;7)
    3
    1
        WBC, Below (baseline) - Above (Day 42) (N=5;7)
    1
    1
        WBC, Within (baseline) - Below (Day 42) (N=62;59)
    2
    1
        WBC, Within (baseline) - Within (Day 42) (N=62;59)
    57
    54
        WBC, Within (baseline) - Above (Day 42) (N=62;59)
    3
    4
        WBC, Above (baseline) - Below (Day 42) (N=4;7)
    0
    0
        WBC, Above (baseline) - Within (Day 42) (N=4;7)
    1
    4
        WBC, Above (baseline) - Above (Day 42) (N=4;7)
    3
    3
        LYM, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        LYM, Unknown (baseline) - Within (Day 42) (N=1;0)
    1
    0
        LYM, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        LYM, Below (baseline) - Below (Day 42) (N=7;10)
    4
    6
        LYM, Below (baseline) - Within (Day 42) (N=7;10)
    2
    2
        LYM, Below (baseline) - Above (Day 42) (N=7;10)
    1
    2
        LYM, Within (baseline) - Below (Day 42) (N=48;42)
    7
    2
        LYM, Within (baseline) - Within (Day 42) (N=48;42)
    38
    34
        LYM, Within (baseline) - Above (Day 42) (N=48;42)
    3
    6
        LYM, Above (baseline) - Below (Day 42) (N=16:21)
    0
    2
        LYM, Above (baseline) - Within (Day 42) (N=16:21)
    5
    5
        LYM, Above (baseline) - Above (Day 42) (N=16:21)
    11
    14
        MONO, Unknown (baseline) - Below (Day 42) (N=1;0)
    1
    0
        MONO, Unknown (baseline) - Within (Day 42) (N=1;0)
    0
    0
        MONO, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        MONO, Below (baseline) - Below (Day 42) (N=8;9)
    4
    5
        MONO, Below (baseline) - Within (Day 42) (N=8;9)
    4
    4
        MONO, Below (baseline) - Above (Day 42) (N=8;9)
    0
    0
        MONO, Within (baseline) - Below (Day 42) (N=51;55)
    3
    2
        MONO, Within (baseline) -Within (Day 42) (N=51;55)
    42
    48
        MONO, Within (baseline) - Above (Day 42) (N=51;55)
    6
    5
        MONO, Above (baseline) - Below (Day 42) (N=12;9)
    0
    0
        MONO, Above (baseline) - Within (Day 42) (N=12;9)
    6
    3
        MONO, Above (baseline) - Above (Day 42) (N=12;9)
    6
    6
        NEU, Unknown (baseline) - Below (Day 42) (N=1;0)
    0
    0
        NEU, Unknown (baseline) - Within (Day 42) (N=1;0)
    1
    0
        NEU, Unknown (baseline) - Above (Day 42) (N=1;0)
    0
    0
        NEU, Below (baseline) - Below (Day 42) (N=15;21)
    9
    14
        NEU, Below (baseline) - Within (Day 42) (N=15;21)
    6
    6
        NEU, Below (baseline) - Above (Day 42) (N=15;21)
    0
    1
        NEU, Within (baseline) - Below (Day 42) (N=52;46)
    4
    6
        NEU, Within (baseline) - Within (Day 42) (N=52;46)
    41
    39
        NEU, Within (baseline) - Above (Day 42) (N=52;46)
    7
    1
        NEU, Above (baseline) - Within (Day 42) (N=4;6)
    3
    3
        NEU, Above (baseline) - Above (Day 42) (N=4;6)
    1
    3
        PLA, Unknown (baseline) - Below (Day 42) (N=2;0)
    0
    0
        PLA, Unknown (baseline) - Within (Day 42) (N=2;0)
    2
    0
        PLA, Unknown (baseline) - Above (Day 42) (N=2;0)
    0
    0
        PLA, Below (baseline) - Below (Day 42) (N=0;2)
    0
    0
        PLA, Below (baseline) - Within (Day 42) (N=0;2)
    0
    2
        PLA, Below (baseline) - Above (Day 42) (N=0;2)
    0
    0
        PLA, Within (baseline) - Below (Day 42) (N=59;56)
    0
    0
        PLA, Within (baseline) - Within (Day 42) (N=59;56)
    51
    52
        PLA, Within (baseline) - Above (Day 42) (N=59;56)
    8
    4
        PLA, Above (baseline) - Below (Day 42) (N=11;15)
    0
    0
        PLA, Above (baseline) - Within (Day 42) (N=11;15)
    4
    9
        PLA, Above (baseline) - Above (Day 42) (N=11;15)
    7
    6
        BUN, Unknown (baseline) - Below (Day 42) (N=2;1)
    0
    0
        BUN, Unknown (baseline) - Within (Day 42) (N=2;1)
    2
    1
        BUN, Unknown (baseline) - Above (Day 42) (N=2;1)
    0
    0
        BUN, Below (baseline) - Below (Day 42) (N=12;4)
    4
    1
        BUN, Below (baseline) - Within (Day 42) (N=12;4)
    8
    3
        BUN, Below (baseline) - Above (Day 42) (N=12;4)
    0
    0
        BUN, Within (baseline) - Below (Day 42) (N=54;62)
    2
    5
        BUN, Within (baseline) - Within (Day 42) (N=54;62)
    50
    57
        BUN, Within (baseline) - Above (Day 42) (N=54;62)
    2
    0
        BUN, Above (baseline) - Below (Day 42) (N=6;6)
    0
    0
        BUN, Above (baseline) - Within (Day 42) (N=6;6)
    6
    6
        BUN, Above (baseline) - Above (Day 42) (N=6;6)
    0
    0
        NEU, Above (baseline) - Below (Day 42) (N=4;6)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with clinically relevant abnormalities in biochemical and haematological parameters at Month 7 by baseline ranges

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    End point title
    		 Number of subjects with clinically relevant abnormalities in biochemical and haematological parameters at Month 7 by baseline ranges [6]
    End point description
    The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes [white blood cells] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Month 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALAT Below (baseline) - Within (Month 7) = ALAT with below normal value at baseline and within normal values at Month 7].
    End point type
    Primary
    End point timeframe
    At Month 7 (i.e. 30 days after the vaccination at Month 6)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    72
    Units: Subjects
        ALAT, Unknown (baseline) -Below (Month 7) (N=2;2)
    0
    0
        ALAT, Unknown (baseline) -Within (Month 7) (N=2;2)
    2
    2
        ALAT, Unknown (baseline) -Above (Month 7) (N=2;2)
    0
    0
        ALAT, Below (baseline) - Below (Month 7) (N=2;1)
    1
    0
        ALAT, Below (baseline) -Within (Month 7) (N=2;1)
    1
    1
        ALAT, Below (baseline) -Above (Month 7) (N=2;1)
    0
    0
        ALAT, Within(baseline) -Below (Month 7) (N=65;62)
    1
    1
        ALAT, Within(baseline) -Within (Month 7) (N=65;62)
    64
    60
        ALAT, Within (baseline) -Above (Month 7) (N=65;62)
    0
    1
        ALAT, Above (baseline) - Below (Month 7) (N=4;7)
    0
    0
        ALAT, Above (baseline) -Within (Month 7) (N=4;7)
    3
    7
        ALAT, Above (baseline) - Above (Month 7) (N=4;7)
    1
    0
        BAS, Unknown (baseline) -Below (Month 7) (N=1;0)
    0
    0
        BAS, Unknown (baseline) -Within (Month 7) (N=1;0)
    1
    0
        BAS, Unknown (baseline) - Above (Month 7) (N=1;0)
    0
    0
        BAS, Below (baseline) - Below (Month 7) (N=0;0)
    0
    0
        BAS, Below (baseline) - Within (Month 7) (N=0;0)
    0
    0
        BAS, Below (baseline) - Above (Month 7) (N=0;0)
    0
    0
        BAS, Within (baseline) -Below (Month 7) (N=73;68)
    0
    0
        BAS, Within (baseline) -Within (Month 7) (N=73;68)
    72
    67
        BAS, Within (baseline) - Above (Month 7) (N=73;68)
    1
    1
        BAS, Above (baseline) - Below (Month 7) (N=0;4)
    0
    0
        BAS, Above (baseline) -Within (Month 7) (N=0;4)
    0
    2
        BAS, Above (baseline) - Above (Month 7) (N=0;4)
    0
    2
        CREA, Unknown(baseline) -Below (Month 7) (N=2;1)
    1
    1
        CREA, Unknown(baseline) -Within (Month 7) (N=2;1)
    1
    0
        CREA, Unknown(baseline) -Above (Month 7) (N=2;1)
    0
    0
        CREA, Below(baseline) -Below (Month 7) (N=29;26)
    23
    21
        CREA, Below(baseline) -Within (Month 7) (N=29;26)
    6
    5
        CREA, Below(baseline) -Above (Month 7) (N=29;26)
    0
    0
        CREA, Within(baseline) -Below (Month 7) (N=42;45)
    8
    9
        CREA, Within(baseline) -Within (Month 7) (N=42;45)
    34
    36
        CREA, Within(baseline) -Above (Month 7) (N=42;45)
    0
    0
        CREA, Above(baseline) -Below (Month 7) (N=0;0)
    0
    0
        CREA, Above(baseline) -Within (Month 7) (N=0;0)
    0
    0
        CREA, Above(baseline) -Above (Month 7) (N=0;0)
    0
    0
        EOS, Unknown (baseline) -Below (Month 7) (N=1;0)
    0
    0
        EOS, Unknown (baseline) -Within (Month 7) (N=1;0)
    1
    0
        EOS, Unknown (baseline) -Above (Month 7) (N=1;0)
    0
    0
        EOS, Below (baseline) - Below (Month 7) (N=1;0)
    0
    0
        EOS, Below (baseline) -Within (Month 7) (N=1;0)
    1
    0
        EOS, Below (baseline) - Above (Month 7) (N=1;0)
    0
    0
        EOS, Within (baseline) -Below (Month 7) (N=51;49)
    0
    1
        EOS, Within (baseline) -Within (Month 7) (N=51;49)
    42
    38
        EOS, Within (baseline) -Above (Month 7) (N=51;49)
    9
    10
        EOS, Above (baseline) - Below (Month 7) (N=21;23)
    0
    0
        EOS, Above (baseline) -Within (Month 7) (N=21;23)
    3
    10
        EOS, Above (baseline) - Above (Month 7) (N=21;23)
    18
    13
        RBC, Unknown (baseline) -Below (Month 7) (N=1;0)
    0
    0
        RBC, Unknown (baseline) -Within (Month 7) (N=1;0)
    1
    0
        RBC, Unknown (baseline) -Above (Month 7) (N=1;0)
    0
    0
        RBC, Below (baseline) - Below (Month 7) (N=5;5)
    1
    2
        RBC, Below (baseline) -Within (Month 7) (N=5;5)
    4
    3
        RBC, Below (baseline) - Above (Month 7) (N=5;5)
    0
    0
        RBC, Within (baseline) -Below (Month 7) (N=68;65)
    4
    4
        RBC, Within (baseline) -Within (Month 7) (N=68;65)
    63
    61
        RBC, Within (baseline) -Above (Month 7) (N=68;65)
    1
    0
        RBC, Above (baseline) - Below (Month 7) (N=0;2)
    0
    0
        RBC, Above (baseline) -Within (Month 7) (N=0;2)
    0
    1
        RBC, Above (baseline) - Above (Month 7) (N=0;2)
    0
    1
        HCT, Unknown (baseline) - Below (Month 7) (N=1;0)
    0
    0
        HCT, Unknown (baseline) -Within (Month 7) (N=1;0)
    0
    0
        HCT, Unknown (baseline) -Above (Month 7) (N=1;0)
    1
    0
        HCT, Below (baseline) - Below (Month 7) (N=26;24)
    15
    15
        HCT, Below (baseline) -Within (Month 7) (N=26;24)
    11
    9
        HCT, Below (baseline) - Above (Month 7) (N=25;24)
    0
    0
        HCT, Within (baseline) -Below (Month 7) (N=44;44)
    2
    4
        HCT, Within (baseline) -Within (Month 7) (N=44;44)
    41
    40
        HCT, Within (baseline) - Above (Month 7) (N=44;44)
    1
    0
        HCT, Above (baseline) - Below (Month 7) (N=3;4)
    0
    0
        HCT, Above (baseline) -Within (Month 7) (N=3;4)
    3
    4
        HCT, Above (baseline) - Above (Month 7) (N=3;4)
    0
    0
        HGB, Unknown (baseline) -Below (Month 7) (N=1;0)
    0
    0
        HGB, Unknown (baseline) -Within (Month 7) (N=1;0)
    0
    0
        HGB, Unknown (baseline) -Above (Month 7) (N=1;0)
    1
    0
        HGB, Below (baseline) - Below (Month 7) (N=21;14)
    10
    7
        HGB, Below (baseline) -Within (Month 7) (N=21;14)
    11
    7
        HGB, Below (baseline) - Above (Month 7) (N=21;14)
    0
    0
        HGB, Within (baseline) - Below (Month 7) (N=47;52)
    1
    7
        HGB, Within (baseline) -Within (Month 7) (N=47;52)
    40
    44
        HGB, Within (baseline) - Above (Month 7) (N=47;52)
    6
    1
        HGB, Above (baseline) - Below (Month 7) (N=5;6)
    0
    0
        HGB, Above (baseline) -Within (Month 7) (N=5;6)
    3
    5
        HGB, Above (baseline) - Above (Month 7) (N=5;6)
    2
    1
        WBC, Unknown (baseline) -Below (Month 7) (N=1;0)
    0
    0
        WBC, Unknown (baseline) -Within (Month 7) (N=1;0)
    1
    0
        WBC, Unknown (baseline) -Above (Month 7) (N=1;0)
    0
    0
        WBC, Below (baseline) - Below (Month 7) (N=5;7)
    3
    4
        WBC, Below (baseline) -Within (Month 7) (N=5;7)
    2
    3
        WBC, Below (baseline) - Above (Month 7) (N=5;7)
    0
    0
        WBC, Within (baseline) - Below (Month 7) (N=63;58)
    1
    7
        WBC, Within (baseline) -Within (Month 7) (N=63;58)
    59
    48
        WBC, Within (baseline) - Above (Month 7) (N=63;58)
    3
    3
        WBC, Above (baseline) - Below (Month 7) (N=5;7)
    0
    0
        WBC, Above (baseline) -Within (Month 7) (N=5;7)
    3
    5
        WBC, Above (baseline) - Above (Month 7) (N=5;7)
    2
    2
        LYM, Unknown (baseline) -Below (Month 7) (N=1;0)
    0
    0
        LYM, Unknown (baseline) -Within (Month 7) (N=1;0)
    1
    0
        LYM, Unknown (baseline) -Above (Month 7) (N=1;0)
    0
    0
        LYM, Below (baseline) - Below (Month 7) (N=7;10)
    5
    6
        LYM, Below (baseline) -Within (Month 7) (N=7;10)
    1
    3
        LYM, Below (baseline) - Above (Month 7) (N=7;10)
    1
    1
        LYM, Within (baseline) - Below (Month 7) (N=49;42)
    6
    5
        LYM, Within (baseline) -Within (Month 7) (N=49;42)
    37
    36
        LYM, Within (baseline) - Above (Month 7) (N=49;42)
    6
    1
        LYM, Above (baseline) - Below (Month 7) (N=17;20)
    1
    1
        LYM, Above (baseline) -Within (Month 7) (N=17;20)
    10
    8
        LYM, Above (baseline) - Above (Month 7) (N=17;20)
    6
    11
        MONO, Unknown (baseline) -Below (Month 7) (N=1;0)
    1
    0
        MONO, Unknown(baseline) -Within (Month 7) (N=1;0)
    0
    0
        MONO, Unknown(baseline) -Above (Month 7) (N=1;0)
    0
    0
        MONO, Below (baseline) - Below (Month 7) (N=8;9)
    2
    4
        MONO, Below(baseline) -Within (Month 7) (N=8;9)
    6
    4
        MONO, Below (baseline) - Above (Month 7) (N=8;9)
    0
    1
        MONO, Within(baseline) -Below (Month 7) (N=53;54)
    4
    3
        MONO, Within(baseline) -Within (Month 7) (N=53;54)
    49
    51
        MONO, Within(baseline) -Above (Month 7) (N=53;54)
    0
    0
        MONO, Above(baseline) -Below (Month 7) (N=12;9)
    0
    0
        MONO, Above(baseline) -Within (Month 7) (N=12;9)
    11
    7
        MONO, Above(baseline) -Above (Month 7) (N=12;9)
    1
    2
        NEU, Unknown(baseline) -Below (Month 7) (N=1;0)
    0
    0
        NEU, Unknown(baseline) -Within (Month 7) (N=1;0)
    1
    0
        NEU, Unknown(baseline) -Above (Month 7) (N=1;0)
    0
    0
        NEU, Below (baseline) - Below (Month 7) (N=16;21)
    5
    10
        NEU, Below(baseline) -Within (Month 7) (N=16;21)
    10
    10
        NEU, Below (baseline) - Above (Month 7) (N=16;21)
    1
    1
        NEU, Within(baseline) -Below (Month 7) (N=53;45)
    4
    4
        NEU, Within(baseline) -Within (Month 7) (N=53;45)
    43
    35
        NEU, Within(baseline) -Above (Month 7) (N=53;45)
    6
    6
        NEU, Above(baseline) -Below (Month 7) (N=4;6)
    0
    1
        NEU, Above(baseline) -Within (Month 7) (N=4;6)
    2
    2
        NEU, Above(baseline) -Above (Month 7) (N=4;6)
    2
    3
        PLA, Unknown(baseline) -Below (Month 7) (N=2;0)
    0
    0
        PLA, Unknown(baseline) -Within (Month 7) (N=2;0)
    2
    0
        PLA, Unknown(baseline) -Above (Month 7) (N=2;0)
    0
    0
        PLA, Below (baseline) -Below (Month 7) (N=0;2)
    0
    0
        PLA, Below (baseline) -Within (Month 7) (N=0;2)
    0
    2
        PLA, Below (baseline) -Above (Month 7) (N=0;2)
    0
    0
        PLA, Within (baseline) -Below (Month 7) (N=60;55)
    0
    0
        PLA, Within (baseline) -Within (Month 7) (N=60;55)
    56
    53
        PLA, Within (baseline) -Above (Month 7) (N=60;55)
    4
    2
        PLA, Above (baseline) - Below (Month 7) (N=12;15)
    0
    0
        PLA, Above (baseline) -Within (Month 7) (N=12;15)
    7
    8
        PLA, Above (baseline) - Above (Month 7) (N=12;15)
    5
    7
        BUN, Unknown (baseline) -Below (Month 7) (N=2;1)
    0
    0
        BUN, Unknown (baseline) -Within (Month 7) (N=2;1)
    2
    1
        BUN, Unknown (baseline) -Above (Month 7) (N=2;1)
    0
    0
        BUN, Below (baseline) - Below (Month 7) (N=12;4)
    5
    0
        BUN, Below (baseline) -Within (Month 7) (N=12;4)
    7
    4
        BUN, Below (baseline) - Above (Month 7) (N=12;4)
    0
    0
        BUN, Within (baseline) -Below (Month 7) (N=52;61)
    4
    10
        BUN, Within(baseline) -Within (Month 7) (N=52;61)
    47
    51
        BUN, Within (baseline) -Above (Month 7) (N=52;61)
    1
    0
        BUN, Above (baseline) - Below (Month 7) (N=6;6)
    0
    0
        BUN, Above (baseline) -Within (Month 7) (N=6;6)
    6
    6
        BUN, Above (baseline) - Above (Month 7) (N=6;6)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with serious adverse events (SAEs) from Day 0 up to Month 7

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    End point title
    		 Number of subjects with serious adverse events (SAEs) from Day 0 up to Month 7 [7]
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Primary
    End point timeframe
    From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        SAE(s)
    0
    2
    No statistical analyses for this end point

    Primary: Number of subjects with AEs and SAEs leading to withdrawal from Day 0 up to Month 7

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    End point title
    		 Number of subjects with AEs and SAEs leading to withdrawal from Day 0 up to Month 7 [8]
    End point description
    The number of subjects with AEs and SAEs leading to premature discontinuation of the study was assessed.
    End point type
    Primary
    End point timeframe
    From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        AE(s) and SAE(s) leading to withdrawal
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with potential immune-mediated diseases (pIMDs) from Day 0 up to Month 7

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    End point title
    		 Number of subjects with potential immune-mediated diseases (pIMDs) from Day 0 up to Month 7 [9]
    End point description
    pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.
    End point type
    Primary
    End point timeframe
    From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        pIMD(s)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with medically significant conditions (MSCs) from Day 0 up to Month 7

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    End point title
    		 Number of subjects with medically significant conditions (MSCs) from Day 0 up to Month 7 [10]
    End point description
    MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, and injury.
    End point type
    Primary
    End point timeframe
    From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        MSC(s)
    37
    28
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects for HPV-16 and HPV-18 antigens at Month 7

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    End point title
    		 Number of seroconverted subjects for HPV-16 and HPV-18 antigens at Month 7 [11]
    End point description
    Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and the cut-offs were 19 ELISA Units per milliliter (EU/mL) for HPV-16 and 18 EU/mL for HPV-18.
    End point type
    Primary
    End point timeframe
    At Month 7 (i.e. 30 days after the vaccination at Month 6)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    64
    44
    Units: Subjects
        Anti-HPV-16 (N=64;43)
    64
    1
        Anti-HPV-18 (N=62;44)
    62
    1
    No statistical analyses for this end point

    Primary: Anti-HPV-16/18 antibody concentrations at Month 7

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    End point title
    		 Anti-HPV-16/18 antibody concentrations at Month 7 [12]
    End point description
    Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EU/mL.
    End point type
    Primary
    End point timeframe
    At Month 7 (i.e. 30 days after the vaccination at Month 6)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This analysis was descriptive, hence no statistical analyses are available.
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    64
    44
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 (N=64;43)
    20080.0 (16831.8 to 23954.9)
    10.4 (8.7 to 12.5)
        Anti-HPV-18 (N=62;44)
    10621.8 (8865.3 to 12726.3)
    9.6 (8.4 to 11.1)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for HPV-16 and HPV-18 antigens at Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)

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    End point title
    		 Number of seroconverted subjects for HPV-16 and HPV-18 antigens at Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
    End point description
    Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by ELISA and the cut-offs were 19 EU/mL for HPV-16 and 18 EU/mL for HPV-18. Note: Month 7 data are also reported in the Primary outcome measure.
    End point type
    Secondary
    End point timeframe
    At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    67
    49
    Units: Subjects
        Anti-HPV-16, Month 7 (N=64;43)
    64
    1
        Anti-HPV-16, Month 12 (N=65;48)
    65
    1
        Anti-HPV-16, Month 18 (N=66;0)
    66
    0
        Anti-HPV-16, Month 24 (N=67;0)
    67
    0
        Anti-HPV-16, Month 36 (N=67;0)
    67
    0
        Anti-HPV-18, Month 7 (N=62;44)
    62
    1
        Anti-HPV-18, Month 12 (N=63;49)
    63
    0
        Anti-HPV-18, Month 18 (N=64;0)
    64
    0
        Anti-HPV-18, Month 24 (N=65;0)
    65
    0
        Anti-HPV-18, Month 36 (N=65;0)
    65
    0
    No statistical analyses for this end point

    Secondary: Anti-HPV-16 and anti-HPV-18 antibody concentrations at Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)

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    End point title
    		 Anti-HPV-16 and anti-HPV-18 antibody concentrations at Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
    End point description
    Antibody concentrations were assessed by ELISA and expressed as GMCs in EU/mL. Note: Month 7 data are also reported in the Primary outcome measure.
    End point type
    Secondary
    End point timeframe
    At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    67
    49
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16, Month 7 (N=64;43)
    20080.0 (16831.8 to 23954.9)
    10.4 (8.7 to 12.5)
        Anti-HPV-16, Month 12 (N=65;48)
    3246.5 (2617.4 to 4026.8)
    9.7 (9.3 to 10.2)
        Anti-HPV-16, Month 18 (N=66;0)
    2800.5 (2325.8 to 3372.0)
    0 (0 to 0)
        Anti-HPV-16, Month 24 (N=67;0)
    1951.9 (1553.7 to 2452.2)
    0 (0 to 0)
        Anti-HPV-16, Month 36 (N=67;0)
    1680.6 (1384.2 to 2040.4)
    0 (0 to 0)
        Anti-HPV-18, Month 7 (N=62;44)
    10621.8 (8865.3 to 12726.3)
    9.6 (8.4 to 11.1)
        Anti-HPV-18, Month 12 (N=63;49)
    1216.6 (953.1 to 1553.0)
    9.0 (9.0 to 9.0)
        Anti-HPV-18, Month 18 (N=64;0)
    802.9 (632.4 to 1019.5)
    0 (0 to 0)
        Anti-HPV-18, Month 24 (N=64;0)
    766.6 (603.3 to 974.2)
    0 (0 to 0)
        Anti-HPV-18, Month 36 (N=65;0)
    536.4 (420.6 to 684.0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for measles antigen

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    End point title
    		 Number of seropositive subjects for measles antigen
    End point description
    A seropositive subject was defined as a subject whose anti-measles antibody titer was equal to or above (≥) 150 milli-International Units per milliliter (mIU/mL), as assessed by ELISA.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    68
    58
    Units: Subjects
        Anti-measles, Day 0 (N=66;55)
    65
    50
        Anti-measles, Day 42 (N=68;58)
    67
    58
    No statistical analyses for this end point

    Secondary: Anti-measles antibody concentrations

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    End point title
    		 Anti-measles antibody concentrations
    End point description
    Anti-measles antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-measles antibody concentration ≥ 150 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    68
    58
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-measles, Day 0 (N=66;55)
    1029.8 (852.8 to 1243.6)
    694.8 (524.0 to 921.3)
        Anti-measles, Day 42 (N=68;58)
    897.1 (748.8 to 1074.8)
    2512.3 (2140.3 to 2949.0)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for mumps antigen

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    End point title
    		 Number of seropositive subjects for mumps antigen
    End point description
    A seropositive subject was defined as a subject whose anti-mumps antibody titer was ≥ 231 U/mL, as assessed by ELISA.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    68
    58
    Units: Subjects
        Anti-mumps, Day 0 (N=66;55)
    64
    50
        Anti-mumps, Day 42 (N=68;58)
    66
    57
    No statistical analyses for this end point

    Secondary: Anti-mumps antibody concentrations

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    End point title
    		 Anti-mumps antibody concentrations
    End point description
    Anti-mumps antibody concentrations were measured by ELISA, expressed as GMCs, in U/mL. The cut-off of the assay was an anti-mumps antibody concentration ≥ 231 U/mL.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    68
    58
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-mumps, Day 0 (N=66;55)
    3613.7 (2742.1 to 4762.4)
    2142.6 (1492.7 to 3075.5)
        Anti-mumps, Day 42 (N=68;58)
    3594.1 (2749.1 to 4698.8)
    7001.1 (5414.9 to 9052.1)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for rubella antigen

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    End point title
    		 Number of seropositive subjects for rubella antigen
    End point description
    A seropositive subject was defined as a subject whose anti-rubella antibody titer was ≥ 4 IU/mL, as assessed by ELISA.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    68
    58
    Units: Subjects
        Anti-rubella, Day 0 (N=66;55)
    66
    53
        Anti-rubella, Day 42 (N=68;58)
    68
    58
    No statistical analyses for this end point

    Secondary: Anti-rubella antibody concentrations

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    End point title
    		 Anti-rubella antibody concentrations
    End point description
    Anti-rubella antibody concentrations were measured by ELISA, expressed as GMCs, in IU/mL. The cut-off of the assay was an anti-rubella antibody concentration ≥ 4 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    68
    58
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-rubella, Day 0 (N=66;55)
    82.0 (69.4 to 96.8)
    48.9 (36.3 to 65.9)
        Anti-rubella, Day 42 (N=68;58)
    79.3 (67.3 to 93.6)
    124.2 (107.0 to 144.2)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against diphtheria and tetanus antigens

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    End point title
    		 Number of seroprotected subjects against diphtheria and tetanus antigens
    End point description
    A seroprotected subject against diphtheria antigen was defined as a subject with an anti-diphtheria (anti-D) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA. A seroprotected subject against tetanus antigen was defined as a subject with an anti-tetanus (anti-T) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA.
    End point type
    Secondary
    End point timeframe
    At Month 7 (i.e. 30 days after the vaccination at Month 6)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    65
    47
    Units: Subjects
        Anti-D
    45
    47
        Anti-T
    60
    47
    No statistical analyses for this end point

    Secondary: Number of subjects with pIMDs from Day 0 up to Month 12

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    End point title
    		 Number of subjects with pIMDs from Day 0 up to Month 12
    End point description
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        pIMD(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with MSCs from Day 0 up to Month 12

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    End point title
    		 Number of subjects with MSCs from Day 0 up to Month 12
    End point description
    MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, and injury.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        MSC(s)
    38
    29
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs from Day 0 up to Month 12

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    End point title
    		 Number of subjects with SAEs from Day 0 up to Month 12
    End point description
    SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        SAE(s)
    1
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs related to the investigational products or any fatal SAE

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    End point title
    		 Number of subjects with SAEs related to the investigational products or any fatal SAE
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (i.e. from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        Related SAE(s)
    0
    0
        Fatal SAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with AEs/SAEs leading to withdrawal throughout the study period

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    End point title
    		 Number of subjects with AEs/SAEs leading to withdrawal throughout the study period
    End point description
    The number of subjects with AEs and SAEs leading to premature discontinuation of the study was assessed.
    End point type
    Secondary
    End point timeframe
    Throughout the study period (i.e from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        AE(s)/SAE(s) leading to withdrawal
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting the intake of concomitant medication during the 43-day period following the vaccination at Day 0

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    End point title
    		 Number of subjects reporting the intake of concomitant medication during the 43-day period following the vaccination at Day 0
    End point description
    Concomitant medication taken at least once during the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 included: any type of medicines, antipyretics, prophylactic antipyretics, and antibiotics.
    End point type
    Secondary
    End point timeframe
    During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        Any medication
    45
    36
        Any antipyretic
    29
    24
        Prophylactic antipyretic
    0
    0
        Any antibiotic
    18
    10
    No statistical analyses for this end point

    Secondary: Number of subjects reporting the intake of concomitant medication during the 30-day period following the vaccination at Month 6

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    End point title
    		 Number of subjects reporting the intake of concomitant medication during the 30-day period following the vaccination at Month 6
    End point description
    Concomitant medication taken at least once during the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6 included: any type of medicines, antipyretics, prophylactic antipyretics, and antibiotics.
    End point type
    Secondary
    End point timeframe
    During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    71
    Units: Subjects
        Any medication
    19
    23
        Any antipyretic
    10
    8
        Prophylactic antipyretic
    0
    0
        Any antibiotic
    6
    6
    No statistical analyses for this end point

    Secondary: Percentage of subjects completing the vaccination schedule in both groups

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    End point title
    		 Percentage of subjects completing the vaccination schedule in both groups
    End point description
    The percentage of subjects who received the specified total number of doses (dose 1, dose 2, any dose) is reported.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to Month 6 (i.e. from first vaccination at Day 0 up to the second vaccination at Month 6)
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Percentage of subjects
    number (not applicable)
        Subjects receiving only 1 dose
    0
    4.1
        Subjects receiving 2 doses
    100
    95.9
        Subjects receiving at least 1 dose
    100
    100
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related to vaccination solicited fever, measles/rubella-like rash, parotid gland swelling and signs of meningism including febrile convulsion

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    End point title
    		 Number of subjects with any, grade 3 and related to vaccination solicited fever, measles/rubella-like rash, parotid gland swelling and signs of meningism including febrile convulsion
    End point description
    Measles/Rubella-like rash: the presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface and/or papules, raised bumps on the skin usually below (<) 1 cm in diameter. Parotid/salivary gland swelling: swelling/tenderness in the mandibular/submandibular region. Suspected signs of meningism including febrile convulsions: febrile convulsions or any other neurological signs or symptoms indicative of meningism. Any = occurrence of any solicited symptom regardless of their intensity grade or relationship to vaccination. Any fever = axillary temperature equal to or above (≥) 37.5°C. Grade 3 AE = AE which prevented normal, everyday activities. Grade 3 measles/rubella-like rash = more than 150 lesions. Grade 3 parotid gland swelling = swelling with accompanying general symptoms. Grade 3 fever = axillary temperature above (>) 39.0°C. Related = any symptom assessed by the investigator as causally related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
    End point values
    		 Cervarix Group Priorix + Infanrix Group
    Number of subjects analysed
    74
    74
    Units: Subjects
        Any Fever
    30
    27
        Grade 3 Fever
    7
    2
        Related Fever
    6
    7
        Any Measles/Rubella-like rash
    1
    1
        Grade 3 Measles/Rubella-like rash
    0
    0
        Related Measles/Rubella-like rash
    1
    1
        Any Parotid gland swelling
    0
    0
        Grade 3 Parotid gland swelling
    0
    0
        Related Parotid gland swelling
    0
    0
        Any Signs of meningism
    0
    1
        Grade 3 Signs of meningism
    0
    0
        Related Signs of meningism
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 43-day period after the vaccination at Day 0 and during the 30-day period after the vaccination at Month 6. SAEs: From Day 0 up to Month 12.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6.

    Reporting group title
    Priorix + Infanrix Group
    Reporting group description
    		 Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine Month 6.

    Serious adverse events
    		 Cervarix Group Priorix + Infanrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 74 (1.35%)
    2 / 74 (2.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cervarix Group Priorix + Infanrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 74 (94.59%)
    65 / 74 (87.84%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    15 / 74 (20.27%)
    10 / 74 (13.51%)
         occurrences all number
    17
    14
    Influenza like illness
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    54 / 74 (72.97%)
    40 / 74 (54.05%)
         occurrences all number
    88
    51
    Pyrexia
         subjects affected / exposed
    36 / 74 (48.65%)
    33 / 74 (44.59%)
         occurrences all number
    39
    39
    Swelling
         subjects affected / exposed
    19 / 74 (25.68%)
    18 / 74 (24.32%)
         occurrences all number
    22
    21
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    3 / 74 (4.05%)
    0 / 74 (0.00%)
         occurrences all number
    3
    0
    Asthma
         subjects affected / exposed
    2 / 74 (2.70%)
    3 / 74 (4.05%)
         occurrences all number
    2
    3
    Asthmatic crisis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    2 / 74 (2.70%)
    1 / 74 (1.35%)
         occurrences all number
    3
    1
    Epistaxis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences all number
    2
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Vasomotor rhinitis
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    22 / 74 (29.73%)
    19 / 74 (25.68%)
         occurrences all number
    31
    24
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Clavicle fracture
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences all number
    1
    1
    Mouth injury
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Multiple injuries
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Stab wound
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 74 (24.32%)
    25 / 74 (33.78%)
         occurrences all number
    25
    35
    Meningism
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    16 / 74 (21.62%)
    15 / 74 (20.27%)
         occurrences all number
    23
    16
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Eye allergy
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences all number
    1
    1
    Anal fissure
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Food poisoning
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    11 / 74 (14.86%)
    16 / 74 (21.62%)
         occurrences all number
    11
    21
    Nausea
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    3 / 74 (4.05%)
    1 / 74 (1.35%)
         occurrences all number
    4
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    18 / 74 (24.32%)
    18 / 74 (24.32%)
         occurrences all number
    22
    19
    Rash
         subjects affected / exposed
    6 / 74 (8.11%)
    5 / 74 (6.76%)
         occurrences all number
    6
    5
    Rash morbilliform
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences all number
    1
    1
    Skin lesion
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    10 / 74 (13.51%)
    7 / 74 (9.46%)
         occurrences all number
    10
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    13 / 74 (17.57%)
    11 / 74 (14.86%)
         occurrences all number
    15
    16
    Myalgia
         subjects affected / exposed
    21 / 74 (28.38%)
    14 / 74 (18.92%)
         occurrences all number
    26
    20
    Neck pain
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences all number
    1
    1
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    Bronchitis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    5 / 74 (6.76%)
    7 / 74 (9.46%)
         occurrences all number
    5
    7
    Giardiasis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Gingival abscess
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    3 / 74 (4.05%)
    0 / 74 (0.00%)
         occurrences all number
    3
    0
    Infection parasitic
         subjects affected / exposed
    1 / 74 (1.35%)
    2 / 74 (2.70%)
         occurrences all number
    1
    2
    Influenza
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Lice infestation
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    24 / 74 (32.43%)
    27 / 74 (36.49%)
         occurrences all number
    28
    33
    Otitis externa
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Otitis media acute
         subjects affected / exposed
    2 / 74 (2.70%)
    1 / 74 (1.35%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    6 / 74 (8.11%)
    4 / 74 (5.41%)
         occurrences all number
    6
    4
    Pneumonia
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Pyoderma
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 74 (1.35%)
    2 / 74 (2.70%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    4 / 74 (5.41%)
    0 / 74 (0.00%)
         occurrences all number
    4
    0
    Tinea pedis
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    2 / 74 (2.70%)
    1 / 74 (1.35%)
         occurrences all number
    2
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    2 / 74 (2.70%)
    2 / 74 (2.70%)
         occurrences all number
    2
    3
    Vulvovaginitis
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 74 (1.35%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    21 / 74 (28.38%)
    13 / 74 (17.57%)
         occurrences all number
    24
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2013
    Rationale/background for changes: - Revise the extent of safety review prior to the administration of the second vaccination at Month 6 (Part A2 phase of the trial). - Update the section on receipt of MMR and DTP vaccines at Month 12. - Correct that GSK study staff was not unblinded at the time of final analyses, but instead, was not blinded during the study at all; since it was a single blind study in which only subjects or parents/LARs were blinded, while the study staff was aware of the study treatment. - Add an additional blood pregnancy test as a country specific requirement for Panama. - Update the list of contributing authors.
    05 Dec 2013
    Rationale/background for changes: - Update the assay cut-offs used to measure the anti-HPV-16 and anti-HPV-18 antibody concentrations using the Enzyme-Linked ImmunoSorbent Assay (ELISA). The existing assays were replaced by the improved versions with new cut-offs. - Provision of HPV vaccination for subjects in Priorix + Infanrix group. - Revision of the scope of the second interim analysis to allow duly safety analysis during Part B enrolment. - Correct and modify text for a better clarification of study procedures with respect to laboratory testing, priority ranking, study vaccine preparation, etc. - Update the list of contributing authors.
    07 Jul 2015
    Rationale/background for changes: - Given the increasing success of adolescent immunisation programmes, the medical need for paediatric HPV vaccination (below 9 years of age) has become less clear. In addition, due to the measles vaccination campaigns in several countries related to the Pan American Health Organization (PAHO)/World Health Organization (WHO)-led measles elimination strategy, the subjects in the Latin American region who can be potentially enrolled in Part B of the study are few in number, apart from approximately 150 subjects who have already been enrolled in Part A of the study. As a result of this, further recruitment in Part B of the study that was planned initially has been stopped. The main change in the study design due to the cancellation of recruitment of subjects in Part B of the study is that the number of subjects has been reduced from approximately 1000 to approximately 150. The number of study groups has been changed from 4 groups to 2 groups. Consequent to the cancellation of Part B recruitment, the number of study objectives and endpoints initially planned in Protocol Amendment 2 were no longer achievable and has been amended in this Protocol Amendment 3. - The glossary of terms has been amended to remove the definitions of adequate contraception, menarche and menopause, and to update the definitions of blinding and medically significant conditions. - The list of assays has been updated. - Some references have been updated. - The indication for Cervarix has been updated. - The list of contributing authors has been updated, and some typographic errors have been corrected.

    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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