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    Clinical Trial Results:
    Safety and immunogenicity of Cervarix™ in human immunodeficiency virus infected females

    Summary
    EudraCT number
    		 2013-003429-28
    Trial protocol
    		 EE  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    30 Apr 2017
    First version publication date
    30 Apr 2017
    Other versions
    		 v2 , v3

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    109823
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01031069
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 GSK eTrack: 109823
    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
    Interim
    Date of interim/final analysis
    07 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2016
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of both vaccines in HIV+ subjects for up to 1 month after the third dose of vaccine. To demonstrate non-inferiority of HPV1 versus (vs.) HPV2 in terms of geometric mean titres (GMTs) against HPV-16 and HPV-18 measured by Pseudovirion-based neutralization assay (PBNA) 1 month after administration of the third dose of vaccine in HIV+ subjects. If the first primary objective for immunogenicity was demonstrated, superiority of HPV1 over HPV2 in terms of GMTs against HPV-16 and HPV-18 measured by PBNA in HIV+ subjects was assessed following a sequential approach.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. 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
    26 Oct 2010
    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
    Brazil: 431
    Country: Number of subjects enrolled
    Estonia: 37
    Country: Number of subjects enrolled
    India: 224
    Country: Number of subjects enrolled
    Thailand: 181
    Worldwide total number of subjects
    873
    EEA total number of subjects
    37
    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)
    201
    Adults (18-64 years)
    460
    From 65 to 84 years
    212
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A number of 873 subjects were enrolled, out of which 212 did not receive any study vaccination.

    Pre-assignment
    Screening details
    		 Screening involved: checking of inclusion/exclusion criteria, demographic data, history and physical examination, AF B sputum test and/or chest X-ray, blood sampling for HIV testing and safety, urine pregnancy testing, birth control and HIV, STI, STD counselling, checking records for concomitant medication/vaccination, subject card distribution.

    Pre-assignment period milestones
    Number of subjects started
    		 873
    Number of subjects completed
    		 661

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 212
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HIV+/Cervarix Group
    Arm description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    HPV vaccine, GSK Biologicals’ HPV vaccine 580299
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

    Arm title
    		 HIV+/Gardasil Group
    Arm description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gardasil
    Investigational medicinal product code
    Other name
    Merck’s Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

    Arm title
    		 HIV-/Cervarix Group
    Arm description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    HPV vaccine, GSK Biologicals’ HPV vaccine 580299
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

    Arm title
    		 HIV-/Gardasil Group
    Arm description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gardasil
    Investigational medicinal product code
    Other name
    Merck’s Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

    Number of subjects in period 1 [1]
    		HIV+/Cervarix Group HIV+/Gardasil Group HIV-/Cervarix Group HIV-/Gardasil Group
    Started
    167
    165
    164
    165
    Completed
    151
    150
    136
    144
    Not completed
    16
    15
    28
    21
         Consent withdrawn by subject
    2
    3
    11
    10
         Adverse event, non-fatal
    -
    1
    -
    -
         Migrated/moved from study area
    1
    2
    1
    -
         Unspecified
    5
    5
    6
    5
         Lost to follow-up
    8
    4
    10
    6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A number of 873 subjects were enrolled, out of which 212 did not receive any study vaccination. and hence did not start the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HIV+/Cervarix Group
    Reporting group description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV+/Gardasil Group
    Reporting group description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV-/Cervarix Group
    Reporting group description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV-/Gardasil Group
    Reporting group description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group values
    		 HIV+/Cervarix Group HIV+/Gardasil Group HIV-/Cervarix Group HIV-/Gardasil Group Total
    Number of subjects
    		 167 165 164 165
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 20.3 ± 3.4 20.1 ± 3.4 19.4 ± 3.1 19.5 ± 3 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 167 165 164 165 661
        Male
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    HIV+/Cervarix Group
    Reporting group description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV+/Gardasil Group
    Reporting group description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV-/Cervarix Group
    Reporting group description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV-/Gardasil Group
    Reporting group description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Primary: Number of human immunodeficiency virus positive subjects (HIV+) subjects with serious adverse events (SAEs)

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    End point title
    		 Number of human immunodeficiency virus positive subjects (HIV+) subjects with serious adverse events (SAEs) [1] [2]
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Primary
    End point timeframe
    Up to 30 days after the last vaccination dose (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: This endpoint was descriptive, hence no statistical analyses were available.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: Subjects
    9
    9
    No statistical analyses for this end point

    Primary: Number of HIV+ subjects with medically significant conditions (MSCs)

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    End point title
    		 Number of HIV+ subjects with medically significant conditions (MSCs) [3] [4]
    End point description
    Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that are not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that are not related to common diseases.
    End point type
    Primary
    End point timeframe
    Up to 30 days after the last vaccination dose (Month 7)
    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 endpoint was descriptive, hence no statistical analyses were available.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: Subjects
    14
    19
    No statistical analyses for this end point

    Primary: Number of HIV+ subjects with pregnancies and pregnancy outcomes

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    End point title
    		 Number of HIV+ subjects with pregnancies and pregnancy outcomes [5] [6]
    End point description
    Pregnancy related outcomes were: live infant with no apparent congenital anomaly/with congenital anomaly, elective termination (termin.) for no apparent congenital anomaly/for apparent congenital anomaly, ectopic pregnancy, spontaneous abortion with no apparent congenital (congen.) anomaly, stillbirth with no apparent congenital anomaly/with apparent congenital anomaly, lost to follow-up, ongoing pregnancy, missing pregnancy.
    End point type
    Primary
    End point timeframe
    Up to 30 days after the last vaccination dose (Month 7)
    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 endpoint was descriptive, hence no statistical analyses were available.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: Subjects
        Any pregnancies
    16
    15
        Live infant with NO apparent congenital anomaly
    12
    13
        Live infant with congenital anomaly
    0
    0
        Elective termin. - NO apparent congenital anomaly
    1
    0
        Elective termin. - congenital anomaly
    0
    0
        Ectopic pregnancy
    0
    0
        Spontaneous abortion - NO apparent congen. anomaly
    1
    1
        Stillbirth with NO apparent congenital anomaly
    0
    0
        Stillbirth with congenital anomaly
    0
    0
        Lost to follow-up
    2
    0
        Pregnancy ongoing
    0
    1
        Missing pregnancy
    0
    0
    No statistical analyses for this end point

    Primary: Number of HIV+ subjects with haematological and biochemical parameter abnormalities

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    End point title
    		 Number of HIV+ subjects with haematological and biochemical parameter abnormalities [7] [8]
    End point description
    Among assessed haematological and biochemical parameters were: alanine aminotransferase [ALAT], basophilis [BSPH], creatinine [CRT], eosinophils [ESPH], haematocrit [HTCR], haemoglobin [HGB], lymphocytes [LYMP], monocytes [MONO], neutrophils [NTPH], platelets [PLAT], red blood cells [RBC] and white blood cells [WBC]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
    End point type
    Primary
    End point timeframe
    At 30 days after the last vaccination dose (Month 7)
    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 endpoint was descriptive, hence no statistical analyses were available.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: Subjects
        ALAT, Unknown (N=151;150)
    0
    0
        BSPH, Unknown (N=151;150)
    0
    0
        CRT, Unknown (N=151;149)
    0
    0
        ESPH, Unknown (N=151;150)
    0
    0
        HTCR, Unknown (N=151;150)
    0
    0
        HGB, Unknown (N=151;150)
    0
    0
        LYMP, Unknown (N=151;150)
    0
    0
        MONO, Unknown (N=151;150)
    0
    0
        NTPH, Unknown (N=151;150)
    0
    0
        PLAT, Unknown (N=151;150)
    0
    0
        RBC, Unknown (N=151;150)
    0
    0
        WBC, Unknown (N=151;150)
    0
    0
        ALAT, Below (N=151;150)
    5
    10
        BSPH, Below (N=151;150)
    0
    0
        CRT, Below (N=151;149)
    31
    42
        ESPH, Below (N=151;150)
    15
    15
        HTCR, Below (N=151;150)
    30
    35
        HGB, Below (N=151;150)
    44
    47
        LYMP, Below (N=151;150)
    14
    11
        MONO, Below (N=151;150)
    10
    10
        NTPH, Below (N=151;150)
    18
    18
        PLAT, Below (N=151;150)
    1
    3
        RBC, Below (N=151;150)
    47
    38
        WBC, Below (N=151;150)
    13
    10
        ALAT, Within (N=151;150)
    137
    125
        BSPH, Within (N=151;150)
    150
    150
        CRT, Within (N=151;149)
    118
    107
        ESPH, Within (N=151;150)
    132
    130
        HTCR, Within (N=151;150)
    120
    113
        HGB, Within (N=151;150)
    106
    102
        LYMP, Within (N=151;150)
    122
    124
        MONO, Within (N=151;150)
    124
    117
        NTPH, Within (N=151;150)
    123
    118
        PLAT, Within (N=151;150)
    148
    143
        RBC, Within (N=151;150)
    101
    107
        WBC, Within (N=151;150)
    130
    133
        ALAT, Above (N=151;150)
    9
    15
        BSPH, Above (N=151;150)
    1
    0
        CRT, Above (N=151;149)
    2
    0
        ESPH, Above (N=151;150)
    4
    5
        HTCR, Above (N=151;150)
    1
    2
        HGB, Above (N=151;150)
    1
    1
        LYMP, Above (N=151;150)
    15
    15
        MONO, Above (N=151;150)
    17
    23
        NTPH, Above (N=151;150)
    10
    14
        PLAT, Above (N=151;150)
    2
    4
        RBC, Above (N=151;150)
    3
    5
        WBC, Above (N=151;150)
    8
    7
    No statistical analyses for this end point

    Primary: Cluster of differentiation 4 (CD4+) cell count in HIV+ subjects

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    End point title
    		 Cluster of differentiation 4 (CD4+) cell count in HIV+ subjects [9] [10]
    End point description
    CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.
    End point type
    Primary
    End point timeframe
    At 30 days after the last vaccination dose (Month 7)
    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 endpoint was descriptive, hence no statistical analyses were available.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: cells/mm3
        median (inter-quartile range (Q1-Q3))
    506 (428 to 750.1)
    530.5 (423 to 720)
    No statistical analyses for this end point

    Primary: HIV viral load (VL) in HIV+ subjects

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    End point title
    		 HIV viral load (VL) in HIV+ subjects [11] [12]
    End point description
    HIV VL, expressed in copies/milliliter (mL), was assessed for HIV+ subjects.
    End point type
    Primary
    End point timeframe
    At 30 days after the last vaccination dose (Month 7)
    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 endpoint was descriptive, hence no statistical analyses were available.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: HIV copies/mL
        median (inter-quartile range (Q1-Q3))
    2.5 (1.3 to 3.2)
    2.5 (1.6 to 3.3)
    No statistical analyses for this end point

    Primary: Number of HIV+ subjects by WHO HIV clinical staging

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    End point title
    		 Number of HIV+ subjects by WHO HIV clinical staging [13] [14]
    End point description
    HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification.
    End point type
    Primary
    End point timeframe
    At 30 days after the last vaccination dose (Month 7)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical analyses were available.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: Subjects
        Clinical Stage 1
    143
    143
        Clinical Stage 2
    6
    2
        Clinical Stage 3
    1
    1
        Clinical Stage 4
    1
    4
    No statistical analyses for this end point

    Primary: Pseudovirion-Based Neutralization Assay (PBNA) Titers of anti-HPV-16/18 antibodies in HIV+ subjects

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    End point title
    		 Pseudovirion-Based Neutralization Assay (PBNA) Titers of anti-HPV-16/18 antibodies in HIV+ subjects [15] [16]
    End point description
    Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], in HIV+ subjects.
    End point type
    Primary
    End point timeframe
    At 30 days after the last vaccination dose (Month 7)
    Notes
    [15] - 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 endpoint was descriptive, hence no statistical analyses were available.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    76
    77
    Units: ED50
    geometric mean (confidence interval 95%)
        Anti-HPV-16
    25098.9 (19137.8 to 32916.8)
    8508.2 (5902.4 to 12264.3)
        Anti-HPV-18
    13544.6 (10152.4 to 18070.3)
    1842.8 (1236.5 to 2746.3)
    No statistical analyses for this end point

    Primary: Number of HIV+ subjects with potential immune-mediated diseases (pIMDs)

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    End point title
    		 Number of HIV+ subjects with potential immune-mediated diseases (pIMDs) [17] [18]
    End point description
    Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Primary
    End point timeframe
    Up to 30 days after the last vaccination dose (Month 7)
    Notes
    [17] - 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 endpoint was descriptive, hence no statistical analyses were available.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV positive subjects.
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group
    Number of subjects analysed
    167
    165
    Units: Subjects
    1
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of HIV- subjects with serious adverse events (SAEs) [19]
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after the last vaccination dose (Month 7)
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV negative subjects.
    End point values
    		 HIV-/Cervarix Group HIV-/Gardasil Group
    Number of subjects analysed
    164
    165
    Units: Subjects
    2
    2
    No statistical analyses for this end point

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

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    End point title
    		 Number of HIV- subjects with medically significant conditions (MSCs) [20]
    End point description
    Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that are not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that are not related to common diseases.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after the last vaccination dose (Month 7)
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV negative subjects.
    End point values
    		 HIV-/Cervarix Group HIV-/Gardasil Group
    Number of subjects analysed
    164
    165
    Units: Subjects
    7
    13
    No statistical analyses for this end point

    Secondary: Number of HIV- subjects with potential immune-mediated disease (pIMDs)

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    End point title
    		 Number of HIV- subjects with potential immune-mediated disease (pIMDs) [21]
    End point description
    Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after the last vaccination dose (Month 7)
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV negative subjects.
    End point values
    		 HIV-/Cervarix Group HIV-/Gardasil Group
    Number of subjects analysed
    164
    165
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Pseudovirion-Based Neutralization Assay (PBNA) Titers of anti-HPV-16/18 antibodies in HIV- subjects

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    End point title
    		 Pseudovirion-Based Neutralization Assay (PBNA) Titers of anti-HPV-16/18 antibodies in HIV- subjects [22]
    End point description
    Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], for HIV- subjects.
    End point type
    Secondary
    End point timeframe
    At 30 days after the last vaccination dose (Month 7)
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for HIV negative subjects.
    End point values
    		 HIV-/Cervarix Group HIV-/Gardasil Group
    Number of subjects analysed
    164
    165
    Units: ED50
    geometric mean (confidence interval 95%)
        Anti-HPV-16
    78785.5 (62298.1 to 99636.5)
    26583.1 (21472.8 to 32909.5)
        Anti-HPV-18
    43360.6 (33790.4 to 55641.4)
    6793.3 (5235.4 to 8814.8)
    No statistical analyses for this end point

    Secondary: Frequency of cluster of differentiation 4/8 [CD4+/CD8+] T-cell response

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    End point title
    		 Frequency of cluster of differentiation 4/8 [CD4+/CD8+] T-cell response
    End point description
    The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 L (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by intracellular cytokine staining (ICS). At the time of posting this record, the results for Month 12 were not available. The record will be updated when the additional validated results are available.
    End point type
    Secondary
    End point timeframe
    At Day 0, Week 6, Week 10, Month 7 and Month 12
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group HIV-/Cervarix Group HIV-/Gardasil Group
    Number of subjects analysed
    17
    15
    19
    18
    Units: CD4 cells/million T-cells
    median (inter-quartile range (Q1-Q3))
        CD4-All doubles,Anti-HPV-16,Day 0 (N=17;15;17;18)
    41 (1 to 118)
    101 (43 to 215)
    1 (1 to 28)
    54.5 (1 to 88)
        CD4-All doubles,Anti-HPV-18,Day 0 (N=17;15;17;18)
    7 (1 to 116)
    87 (18 to 184)
    1 (1 to 82)
    1 (1 to 98)
        CD4-All doubles,Anti-HPV-16,Week 6 (N=16;14;16;18)
    445.5 (262 to 1028)
    345.5 (227 to 1034)
    298 (173 to 540.5)
    661 (234 to 982)
        CD4-All doubles,Anti-HPV-18,Week 6 (N=16;14;16;18)
    396 (163 to 832)
    309.5 (203 to 852)
    237 (81 to 421.5)
    320.5 (117 to 524)
        CD4-All doubles,Anti-HPV-16,Week 10(N=14;14;19;18)
    2955.5 (1075 to 5200)
    1449 (922 to 1778)
    1767 (916 to 4428)
    1268.5 (648 to 2453)
        CD4-All doubles,Anti-HPV-18,Week 10(N=14;14;19;18)
    2036.5 (951 to 3123)
    602 (498 to 2079)
    1243 (587 to 3400)
    515.5 (414 to 1178)
        CD4-All doubles,Anti-HPV-16,Month 7(N=17;15;17;18)
    3693 (1870 to 5153)
    1679.5 (1052 to 2734)
    3414.5 (1424.5 to 4520)
    1505 (995 to 2205)
        CD4-All doubles,Anti-HPV-18,Month 7(N=17;15;17;18)
    1866 (1267 to 2875)
    840.5 (518 to 1641)
    2084.5 (911 to 4110)
    669 (470 to 1035)
        CD4-d-CD40L, Anti-HPV-16, Day 0 (N=17;15;17;18)
    22 (1 to 118)
    99 (60 to 215)
    1 (1 to 58)
    46 (1 to 81)
        CD4-d-CD40L, Anti-HPV-18, Day 0 (N=17;15;17;18)
    36 (1 to 81)
    89 (1 to 176)
    1 (1 to 54)
    13.5 (1 to 100)
        CD4-d-CD40L, Anti-HPV-16, Week 6 (N=16;14;16;18)
    426 (258.5 to 999.5)
    326.5 (196 to 1034)
    298 (209.5 to 540)
    582 (223 to 967)
        CD4-d-CD40L, Anti-HPV-18, Week 6 (N=16;14;16;18)
    403.5 (144 to 835)
    296 (216 to 840)
    242.5 (36.5 to 393)
    310 (95 to 521)
        CD4-d-CD40L, Anti-HPV-16, Week 10 (N=14;14;19;18)
    2893.5 (988 to 5006)
    1440 (882 to 1814)
    1678 (917 to 4306)
    1239 (562 to 2362)
        CD4-d-CD40L, Anti-HPV-18, Week 10 (N=14;14;19;18)
    2015 (944 to 3021)
    564.5 (507 to 2045)
    1051 (631 to 3317)
    474.5 (385 to 811)
        CD4-d-CD40L, Anti-HPV-16, Month 7 (N=13;14;16;17)
    3658 (1804 to 5070)
    1619.5 (1071 to 2600)
    3290 (1464.5 to 4387.5)
    1389 (949 to 2133)
        CD4-d-CD40L, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1839 (1066 to 2893)
    833.5 (518 to 1605)
    2014 (979 to 3878.5)
    647 (442 to 981)
        CD4-d-IFNG, Anti-HPV-16, Day 0 (N=17;15;17;18)
    27 (1 to 63)
    30 (1 to 51)
    1 (1 to 45)
    39 (1 to 61)
        CD4-d-IFNG, Anti-HPV-18, Day 0 (N=17;15;17;18)
    4 (1 to 42)
    51 (1 to 59)
    1 (1 to 54)
    21 (1 to 46)
        CD4-d-IFNG, Anti-HPV-16, Week 6 (N=16;14;16;18)
    222.5 (117 to 393)
    116 (75 to 222)
    42.5 (1 to 127.5)
    241.5 (71 to 404)
        CD4-d-IFNG, Anti-HPV-18, Week 6 (N=16;14;16;18)
    98 (25 to 361)
    104.5 (35 to 211)
    1 (1 to 44)
    129.5 (1 to 182)
        CD4-d-IFNG, Anti-HPV-16, Week 10 (N=14;14;19;18)
    1220 (554 to 1478)
    450 (245 to 527)
    332 (282 to 1251)
    442 (160 to 935)
        CD4-d-IFNG, Anti-HPV-18, Week 10 (N=14;14;19;18)
    694 (342 to 1207)
    326.5 (121 to 455)
    222 (124 to 569)
    202 (122 to 279)
        CD4-d-IFNG, Anti-HPV-16, Month 7 (N=13;14;16;17)
    1513 (891 to 1993)
    585.5 (190 to 846)
    731 (267.5 to 1245)
    495 (319 to 859)
        CD4-d-IFNG, Anti-HPV-18, Month 7 (N=13;14;16;17)
    694 (409 to 868)
    306 (171 to 382)
    414.5 (245.5 to 616.5)
    198 (126 to 435)
        CD4-d-IL-2, Anti-HPV-16, Day 0 (N=17;15;17;18)
    43 (1 to 81)
    30 (7 to 121)
    1 (1 to 58)
    1 (1 to 21)
        CD4-d-IL-2, Anti-HPV-18, Day 0 (N=17;15;17;18)
    46 (1 to 115)
    37 (1 to 102)
    1 (1 to 31)
    13.5 (1 to 57)
        CD4-d-IL-2, Anti-HPV-16, Week 6 (N=16;14;16;18)
    361 (235.5 to 966)
    300 (234 to 827)
    245.5 (137 to 468)
    454.5 (228 to 816)
        CD4-d-IL-2, Anti-HPV-18, Week 6 (N=16;14;16;18)
    364.5 (161 to 858)
    193.5 (94 to 687)
    227.5 (131.5 to 379.5)
    286 (129 to 413)
        CD4-d-IL-2, Anti-HPV-16, Week 10 (N=14;14;19;18)
    2503 (938 to 4606)
    1221 (678 to 1584)
    1542 (776 to 3499)
    929.5 (435 to 2128)
        CD4-d-IL-2, Anti-HPV-18, Week 10 (N=14;14;19;18)
    1668.5 (635 to 2183)
    555.5 (349 to 1687)
    1183 (456 to 2311)
    411 (245 to 891)
        CD4-d-IL-2, Anti-HPV-16, Month 7 (N=13;14;16;17)
    2847 (1557 to 4064)
    1318.5 (672 to 2141)
    2608.5 (1147.5 to 3875)
    1128 (697 to 1574)
        CD4-d-IL-2, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1522 (914 to 2285)
    615 (472 to 1234)
    1442 (811 to 3471)
    537 (341 to 643)
        CD4-d-TNFA, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1 (1 to 58)
    71 (1 to 252)
    32 (1 to 74)
    34 (1 to 76)
        CD4-d-TNFA, Anti-HPV-18, Day 0 (N=17;15;17;18)
    1 (1 to 52)
    35 (1 to 131)
    25 (1 to 39)
    15.5 (1 to 83)
        CD4-d-TNFA, Anti-HPV-16, Week 6 (N=16;14;16;18)
    326.5 (49.5 to 714)
    171 (133 to 701)
    237 (89.5 to 325)
    337.5 (183 to 648)
        CD4-d-TNFA, Anti-HPV-18, Week 6 (N=16;14;16;18)
    234 (66 to 579)
    204 (94 to 539)
    162.5 (75.5 to 247)
    156.5 (72 to 398)
        CD4-d-TNFA, Anti-HPV-16, Week 10 (N=14;14;19;18)
    2086 (519 to 4016)
    903.5 (606 to 1355)
    1260 (764 to 3094)
    865.5 (453 to 2100)
        CD4-d-TNFA, Anti-HPV-18, Week 10 (N=14;14;19;18)
    1493.5 (592 to 2341)
    443 (248 to 1432)
    899 (415 to 2310)
    334.5 (203 to 958)
        CD4-d-TNFA, Anti-HPV-16, Month 7 (N=13;14;16;17)
    2688 (1399 to 3994)
    1109 (670 to 2066)
    2621 (1062 to 3652.5)
    1215 (792 to 1665)
        CD4-d-TNFA, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1366 (1126 to 2449)
    598 (362 to 1522)
    1614 (760.5 to 3463.5)
    505 (330 to 683)
        CD8-All doubles,Anti-HPV-16, Day 0 (N=17;15;17;18)
    1 (1 to 40)
    1 (1 to 43)
    1 (1 to 28)
    1 (1 to 29)
        CD8-All doubles,Anti-HPV-18, Day 0 (N=17;15;17;18)
    6 (1 to 50)
    23 (1 to 60)
    21 (1 to 54)
    1 (1 to 35)
        CD8-All doubles,Anti-HPV-16,Week 6 (N=16;14;16;18)
    2 (1 to 34.5)
    13 (1 to 70)
    1 (1 to 14.5)
    1 (1 to 3)
        CD8-All doubles,Anti-HPV-18,Week 6 (N=16;14;16;18)
    37.5 (9 to 66.5)
    2 (1 to 42)
    1 (1 to 42.5)
    30.5 (1 to 74)
        CD8-All doubles,Anti-HPV-16,Week 10(N=14;14;19;18)
    41 (1 to 75)
    3.5 (1 to 36)
    1 (1 to 54)
    1 (1 to 29)
        CD8-All doubles,Anti-HPV-18,Week 10(N=14;14;19;18)
    11 (1 to 60)
    1 (1 to 60)
    5 (1 to 84)
    1 (1 to 41)
        CD8-All doubles,Anti-HPV-16,Month 7(N=13;14;16;17)
    51 (18 to 69)
    9.5 (1 to 33)
    1 (1 to 74.5)
    2 (1 to 54)
        CD8-All doubles,Anti-HPV-18,Month 7(N=13;14;16;17)
    41 (1 to 159)
    30 (3 to 49)
    15.5 (1 to 106.5)
    24 (1 to 54)
        CD8-d-CD40L, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1 (1 to 29)
    1 (1 to 6)
    1 (1 to 10)
    1 (1 to 7)
        CD8-d-CD40L, Anti-HPV-18, Day 0 (N=17;15;17;18)
    1 (1 to 29)
    1 (1 to 19)
    1 (1 to 33)
    1 (1 to 16)
        CD8-d-CD40L, Anti-HPV-16, Week 6 (N=16;14;16;18)
    1 (1 to 24.5)
    1 (1 to 32)
    1 (1 to 18)
    1 (1 to 1)
        CD8-d-CD40L, Anti-HPV-18, Week 6 (N=16;14;16;18)
    9.5 (1 to 27.5)
    1 (1 to 17)
    1 (1 to 23)
    1 (1 to 36)
        CD8-d-CD40L, Anti-HPV-16, Week 10 (N=14;14;19;18)
    18.5 (1 to 73)
    1 (1 to 29)
    1 (1 to 41)
    1 (1 to 27)
        CD8-d-CD40L, Anti-HPV-18, Week 10 (N=14;14;19;18)
    10.5 (1 to 34)
    2.5 (1 to 34)
    26 (1 to 72)
    1 (1 to 30)
        CD8-d-CD40L, Anti-HPV-16, Month 7 (N=13;14;16;17)
    26 (1 to 63)
    3 (1 to 20)
    2 (1 to 52)
    1 (1 to 36)
        CD8-d-CD40L, Anti-HPV-18, Month 7 (N=13;14;16;17)
    4 (1 to 42)
    15 (1 to 31)
    38 (1 to 92)
    4 (1 to 33)
        CD8-d-IFNG, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1 (1 to 29)
    1 (1 to 43)
    1 (1 to 28)
    1 (1 to 2)
        CD8-d-IFNG, Anti-HPV-18, Day 0 (N=17;15;17;18)
    6 (1 to 33)
    19 (1 to 47)
    21 (1 to 54)
    4 (1 to 35)
        CD8-d-IFNG, Anti-HPV-16, Week 6 (N=16;14;16;18)
    2.5 (1 to 39.5)
    17.5 (1 to 78)
    1 (1 to 14.5)
    1 (1 to 11)
        CD8-d-IFNG, Anti-HPV-18, Week 6 (N=16;14;16;18)
    27.5 (1 to 55.5)
    1 (1 to 47)
    1 (1 to 42.5)
    35.5 (1 to 84)
        CD8-d-IFNG, Anti-HPV-16, Week 10 (N=14;14;19;18)
    34 (1 to 99)
    25 (1 to 30)
    1 (1 to 38)
    1 (1 to 29)
        CD8-d-IFNG, Anti-HPV-18, Week 10 (N=14;14;19;18)
    3 (1 to 68)
    7.5 (1 to 34)
    24 (1 to 76)
    1 (1 to 1)
        CD8-d-IFNG, Anti-HPV-16, Month 7 (N=13;14;16;17)
    46 (1 to 68)
    1 (1 to 26)
    1 (1 to 74.5)
    1 (1 to 50)
        CD8-d-IFNG, Anti-HPV-18, Month 7 (N=13;14;16;17)
    41 (1 to 68)
    21 (1 to 41)
    4 (1 to 90.5)
    3 (1 to 52)
        CD8-d-IL-2, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 16)
        CD8-d-IL-2, Anti-HPV-18, Day 0 (N=17;15;17;18)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-16, Week 6 (N=16;14;16;18)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Week 6 (N=16;14;16;18)
    1 (1 to 23)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-16, Week 10 (N=14;14;19;18)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 32)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Week 10 (N=14;14;19;18)
    1 (1 to 26)
    1 (1 to 1)
    1 (1 to 25)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-16, Month 7 (N=13;14;16;17)
    1 (1 to 23)
    1 (1 to 17)
    1 (1 to 37.5)
    1 (1 to 1)
        CD8-d-IL-2, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 29)
    1 (1 to 1)
        CD8-d-TNFA, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1 (1 to 10)
    1 (1 to 35)
    1 (1 to 1)
    1 (1 to 29)
        CD8-d-TNFA, Anti-HPV-18, Day 0 (N=17;15;17;18)
    6 (1 to 50)
    7 (1 to 54)
    1 (1 to 33)
    1 (1 to 34)
        CD8-d-TNFA, Anti-HPV-16, Week 6 (N=16;14;16;18)
    1 (1 to 46)
    1 (1 to 35)
    1 (1 to 1)
    1 (1 to 31)
        CD8-d-TNFA, Anti-HPV-18, Week 6 (N=16;14;16;18)
    19 (1 to 50)
    1 (1 to 57)
    1 (1 to 28)
    1 (1 to 26)
        CD8-d-TNFA, Anti-HPV-16, Week 10 (N=14;14;19;18)
    1.5 (1 to 32)
    1 (1 to 24)
    1 (1 to 31)
    1 (1 to 26)
        CD8-d-TNFA, Anti-HPV-18, Week 10 (N=14;14;19;18)
    17.5 (1 to 34)
    14 (1 to 61)
    5 (1 to 42)
    1 (1 to 34)
        CD8-d-TNFA, Anti-HPV-16, Month 7 (N=13;14;16;17)
    34 (1 to 41)
    13 (1 to 33)
    1 (1 to 49)
    2 (1 to 33)
        CD8-d-TNFA, Anti-HPV-18, Month 7 (N=13;14;16;17)
    41 (1 to 111)
    26.5 (15 to 58)
    1 (1 to 58)
    1 (1 to 32)
    No statistical analyses for this end point

    Secondary: Frequency of specific B-cells for HPV-16/18 antigens

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    End point title
    		 Frequency of specific B-cells for HPV-16/18 antigens
    End point description
    B cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-). At the time of posting this record, the results for Month 12 were not available. The record will be updated when the additional validated results are available.
    End point type
    Secondary
    End point timeframe
    At Day 0, Week 6, Week 10, Month 7 and Month 12
    End point values
    		 HIV+/Cervarix Group HIV+/Gardasil Group HIV-/Cervarix Group HIV-/Gardasil Group
    Number of subjects analysed
    13
    12
    20
    20
    Units: B-cells/million cells
    median (inter-quartile range (Q1-Q3))
        HPV-16, Day 0 (N=12;11;18;20)
    1 (1 to 1)
    1 (1 to 61)
    1 (1 to 1)
    1 (1 to 1)
        HPV-18, Day 0 (N=12;11;18;20)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
        HPV-16, Week 6 (N=10;12;15;15)
    91 (1 to 154)
    1 (1 to 1)
    22 (1 to 154)
    1 (1 to 204)
        HPV-18, Week 6 (N=10;12;15;15)
    39.5 (1 to 693)
    1 (1 to 45.5)
    155 (1 to 345)
    33 (1 to 80)
        HPV-16, Week 10 (N=12;9;20;20)
    558 (95.5 to 989.5)
    198 (1 to 391)
    494 (90.5 to 834)
    150.5 (33.5 to 726.5)
        HPV-18, Week 10 (N=12;9;20;20)
    150 (31 to 471)
    1 (1 to 42)
    211 (84 to 656)
    29.5 (1 to 222)
        HPV-16, Month 7 (N=13;9;20;17)
    624 (457 to 1196)
    213 (165 to 632)
    1504 (481 to 3026)
    448 (257 to 890)
        HPV-18, Month 7 (N=13;9;20;17)
    332 (153 to 494)
    1 (1 to 392)
    513.5 (111.5 to 1292)
    65 (1 to 158)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Solicited and unsolicited AEs: within the 30 day (Days 0-29) post-vaccination period; SAEs: up to Month 7.
    Adverse event reporting additional description
    At the time of posting this record, the solicited local, general and unsolicited symptoms were being re-analysed. They will be added as soon as validated results become available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    HIV+/Cervarix Group
    Reporting group description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV+/Gardasil Group
    Reporting group description
    		 HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV-/Cervarix Group
    Reporting group description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix™ vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Reporting group title
    HIV-/Gardasil Group
    Reporting group description
    		 HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil® vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: At the time of posting this record, the solicited local, general and unsolicited symptoms were being re-analysed. They will be added as soon as validated results become available.
    Serious adverse events
    		 HIV+/Cervarix Group HIV+/Gardasil Group HIV-/Cervarix Group HIV-/Gardasil Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 167 (5.39%)
    9 / 165 (5.45%)
    2 / 164 (1.22%)
    2 / 165 (1.21%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous complete
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 165 (0.00%)
    1 / 164 (0.61%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Monarthritis
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 167 (0.00%)
    2 / 165 (1.21%)
    0 / 164 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 165 (0.00%)
    1 / 164 (0.61%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 167 (0.60%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 165 (0.61%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginitis gardnerella
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 165 (0.00%)
    1 / 164 (0.61%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HIV+/Cervarix Group HIV+/Gardasil Group HIV-/Cervarix Group HIV-/Gardasil Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 165 (0.00%)
    0 / 164 (0.00%)
    0 / 165 (0.00%)

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    At the time of posting this record, the solicited local and general symptoms were being re-analysed. They will be added as soon as validated results become available.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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