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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
    		 v2
    This version publication date
    07 Jan 2018
    First version publication date
    30 Apr 2017
    Other versions
    		 v1 , v3
    Version creation reason

    Trial information

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    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.

    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 ± 3.0 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 167 165 164 165 661
        Male
    		 0 0 0 0 0
    Geographic Ancestry
    Units: Subjects
        African Heritage/African American
    		 20 9 7 7 43
        Asian - Central/South Asian Heritage
    		 21 18 67 68 174
        Asian - East Asian Heritage
    		 3 2 1 0 6
        Asian - Japanese Heritage
    		 0 0 1 2 3
        Asian - South East Asian Heritage
    		 40 44 39 42 165
        White - Arabic/North African Heritage
    		 17 12 7 6 42
        White - Caucasian/European Heritage
    		 56 66 40 33 195
        Mixed Origin
    		 10 14 2 7 33

    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))
    506.0 (428.0 to 750.1)
    530.5 (423.0 to 720.0)
    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: 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) [15] [16]
    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
    [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
    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) [17]
    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
    [17] - 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) [18]
    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
    [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 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) [19]
    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
    [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
    0
    0
    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)
    41.0 (1.0 to 118.0)
    101.0 (43.0 to 215.0)
    1.0 (1.0 to 28.0)
    54.5 (1.0 to 88.0)
        CD4-All doubles,Anti-HPV-18,Day 0 (N=17;15;17;18)
    7.0 (1.0 to 116.0)
    87.0 (18.0 to 184.0)
    1.0 (1.0 to 82.0)
    1.0 (1.0 to 98.0)
        CD4-All doubles,Anti-HPV-16,Week 6 (N=16;14;16;18)
    445.5 (262.0 to 1028.0)
    345.5 (227.0 to 1034.0)
    298.0 (173.0 to 540.5)
    661.0 (234.0 to 982.0)
        CD4-All doubles,Anti-HPV-18,Week 6 (N=16;14;16;18)
    396.0 (163.0 to 832.0)
    309.5 (203.0 to 852.0)
    237.0 (81.0 to 421.5)
    320.5 (117.0 to 524.0)
        CD4-All doubles,Anti-HPV-16,Week 10(N=14;14;19;18)
    2955.5 (1075.0 to 5200.0)
    1449.0 (922.0 to 1778.0)
    1767.0 (916.0 to 4428.0)
    1268.5 (648.0 to 2453.0)
        CD4-All doubles,Anti-HPV-18,Week 10(N=14;14;19;18)
    2036.5 (951.0 to 3123.0)
    602.0 (498.0 to 2079.0)
    1243.0 (587.0 to 3400.0)
    515.5 (414.0 to 1178.0)
        CD4-All doubles,Anti-HPV-16,Month 7(N=17;15;17;18)
    3693.0 (1870.0 to 5153.0)
    1679.5 (1052.0 to 2734.0)
    3414.5 (1424.5 to 4520.0)
    1505.0 (995.0 to 2205.0)
        CD4-All doubles,Anti-HPV-18,Month 7(N=17;15;17;18)
    1866.0 (1267.0 to 2875.0)
    840.5 (518.0 to 1641.0)
    2084.5 (911.0 to 4110.0)
    669.0 (470.0 to 1035.0)
        CD4-d-CD40L, Anti-HPV-16, Day 0 (N=17;15;17;18)
    22.0 (1.0 to 118.0)
    99.0 (60.0 to 215.0)
    1.0 (1.0 to 58.0)
    46.0 (1.0 to 81.0)
        CD4-d-CD40L, Anti-HPV-18, Day 0 (N=17;15;17;18)
    36.0 (1.0 to 81.0)
    89.0 (1.0 to 176.0)
    1.0 (1.0 to 54.0)
    13.5 (1.0 to 100.0)
        CD4-d-CD40L, Anti-HPV-16, Week 6 (N=16;14;16;18)
    426.0 (258.5 to 999.5)
    326.5 (196.0 to 1034.0)
    298.0 (209.5 to 540.0)
    582.0 (223.0 to 967.0)
        CD4-d-CD40L, Anti-HPV-18, Week 6 (N=16;14;16;18)
    403.5 (144.0 to 835.0)
    296.0 (216.0 to 840.0)
    242.5 (36.5 to 393.0)
    310.0 (95.0 to 521.0)
        CD4-d-CD40L, Anti-HPV-16, Week 10 (N=14;14;19;18)
    2893.5 (988.0 to 5006.0)
    1440.0 (882.0 to 1814.0)
    1678.0 (917.0 to 4306.0)
    1239.0 (562.0 to 2362.0)
        CD4-d-CD40L, Anti-HPV-18, Week 10 (N=14;14;19;18)
    2015.0 (944.0 to 3021.0)
    564.5 (507.0 to 2045.0)
    1051.0 (631.0 to 3317.0)
    474.5 (385.0 to 811.0)
        CD4-d-CD40L, Anti-HPV-16, Month 7 (N=13;14;16;17)
    3658.0 (1804.0 to 5070.0)
    1619.5 (1071.0 to 2600.0)
    3290.0 (1464.5 to 4387.5)
    1389.0 (949.0 to 2133.0)
        CD4-d-CD40L, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1839.0 (1066.0 to 2893.0)
    833.5 (518.0 to 1605.0)
    2014.0 (979.0 to 3878.5)
    647.0 (442.0 to 981.0)
        CD4-d-IFNG, Anti-HPV-16, Day 0 (N=17;15;17;18)
    27.0 (1.0 to 63.0)
    30.0 (1.0 to 51.0)
    1.0 (1.0 to 45.0)
    39.0 (1.0 to 61.0)
        CD4-d-IFNG, Anti-HPV-18, Day 0 (N=17;15;17;18)
    4.0 (1.0 to 42.0)
    51.0 (1.0 to 59.0)
    1.0 (1.0 to 54.0)
    21.0 (1.0 to 46.0)
        CD4-d-IFNG, Anti-HPV-16, Week 6 (N=16;14;16;18)
    222.5 (117.0 to 393.0)
    116.0 (75.0 to 222.0)
    42.5 (1.0 to 127.5)
    241.5 (71.0 to 404.0)
        CD4-d-IFNG, Anti-HPV-18, Week 6 (N=16;14;16;18)
    98.0 (25.0 to 361.0)
    104.5 (35.0 to 211.0)
    1.0 (1.0 to 44.0)
    129.5 (1.0 to 182.0)
        CD4-d-IFNG, Anti-HPV-16, Week 10 (N=14;14;19;18)
    1220.0 (554.0 to 1478.0)
    450.0 (245.0 to 527.0)
    332.0 (282.0 to 1251.0)
    442.0 (160.0 to 935.0)
        CD4-d-IFNG, Anti-HPV-18, Week 10 (N=14;14;19;18)
    694.0 (342.0 to 1207.0)
    326.5 (121.0 to 455.0)
    222.0 (124.0 to 569.0)
    202.0 (122.0 to 279.0)
        CD4-d-IFNG, Anti-HPV-16, Month 7 (N=13;14;16;17)
    1513.0 (891.0 to 1993.0)
    585.5 (190.0 to 846.0)
    731.0 (267.5 to 1245.0)
    495.0 (319.0 to 859.0)
        CD4-d-IFNG, Anti-HPV-18, Month 7 (N=13;14;16;17)
    694.0 (409.0 to 868.0)
    306.0 (171.0 to 382.0)
    414.5 (245.5 to 616.5)
    198.0 (126.0 to 435.0)
        CD4-d-IL-2, Anti-HPV-16, Day 0 (N=17;15;17;18)
    43.0 (1.0 to 81.0)
    30.0 (7.0 to 121.0)
    1.0 (1.0 to 58.0)
    1.0 (1.0 to 21.0)
        CD4-d-IL-2, Anti-HPV-18, Day 0 (N=17;15;17;18)
    46.0 (1.0 to 115.0)
    37.0 (1.0 to 102.0)
    1.0 (1.0 to 31.0)
    13.5 (1.0 to 57.0)
        CD4-d-IL-2, Anti-HPV-16, Week 6 (N=16;14;16;18)
    361.0 (235.5 to 966.0)
    300.0 (234.0 to 827.0)
    245.5 (137.0 to 468.0)
    454.5 (228.0 to 816.0)
        CD4-d-IL-2, Anti-HPV-18, Week 6 (N=16;14;16;18)
    364.5 (161.0 to 858.0)
    193.5 (94.0 to 687.0)
    227.5 (131.5 to 379.5)
    286.0 (129.0 to 413.0)
        CD4-d-IL-2, Anti-HPV-16, Week 10 (N=14;14;19;18)
    2503.0 (938.0 to 4606.0)
    1221.0 (678.0 to 1584.0)
    1542.0 (776.0 to 3499.0)
    929.5 (435.0 to 2128.0)
        CD4-d-IL-2, Anti-HPV-18, Week 10 (N=14;14;19;18)
    1668.5 (635.0 to 2183.0)
    555.5 (349.0 to 1687.0)
    1183.0 (456.0 to 2311.0)
    411.0 (245.0 to 891.0)
        CD4-d-IL-2, Anti-HPV-16, Month 7 (N=13;14;16;17)
    2847.0 (1557.0 to 4064.0)
    1318.5 (672.0 to 2141.0)
    2608.5 (1147.5 to 3875.0)
    1128.0 (697.0 to 1574.0)
        CD4-d-IL-2, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1522.0 (914.0 to 2285.0)
    615.0 (472.0 to 1234.0)
    1442.0 (811.0 to 3471.0)
    537.0 (341.0 to 643.0)
        CD4-d-TNFA, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 58.0)
    71.0 (1.0 to 252.0)
    32.0 (1.0 to 74.0)
    34.0 (1.0 to 76.0)
        CD4-d-TNFA, Anti-HPV-18, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 52.0)
    35.0 (1.0 to 131.0)
    25.0 (1.0 to 39.0)
    15.5 (1.0 to 83.0)
        CD4-d-TNFA, Anti-HPV-16, Week 6 (N=16;14;16;18)
    326.5 (49.5 to 714.0)
    171.0 (133.0 to 701.0)
    237.0 (89.5 to 325.0)
    337.5 (183.0 to 648.0)
        CD4-d-TNFA, Anti-HPV-18, Week 6 (N=16;14;16;18)
    234.0 (66.0 to 579.0)
    204.0 (94.0 to 539.0)
    162.5 (75.5 to 247.0)
    156.5 (72.0 to 398.0)
        CD4-d-TNFA, Anti-HPV-16, Week 10 (N=14;14;19;18)
    2086.0 (519.0 to 4016.0)
    903.5 (606.0 to 1355.0)
    1260.0 (764.0 to 3094.0)
    865.5 (453.0 to 2100.0)
        CD4-d-TNFA, Anti-HPV-18, Week 10 (N=14;14;19;18)
    1493.5 (592.0 to 2341.0)
    443.0 (248.0 to 1432.0)
    899.0 (415.0 to 2310.0)
    334.5 (203.0 to 958.0)
        CD4-d-TNFA, Anti-HPV-16, Month 7 (N=13;14;16;17)
    2688.0 (1399.0 to 3994.0)
    1109.0 (670.0 to 2066.0)
    2621.0 (1062.0 to 3652.5)
    1215.0 (792.0 to 1665.0)
        CD4-d-TNFA, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1366.0 (1126.0 to 2449.0)
    598.0 (362.0 to 1522.0)
    1614.0 (760.5 to 3463.5)
    505.0 (330.0 to 683.0)
        CD8-All doubles,Anti-HPV-16, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 40.0)
    1.0 (1.0 to 43.0)
    1.0 (1.0 to 28.0)
    1.0 (1.0 to 29.0)
        CD8-All doubles,Anti-HPV-18, Day 0 (N=17;15;17;18)
    6.0 (1.0 to 50.0)
    23.0 (1.0 to 60.0)
    21.0 (1.0 to 54.0)
    1.0 (1.0 to 35.0)
        CD8-All doubles,Anti-HPV-16,Week 6 (N=16;14;16;18)
    2.0 (1.0 to 34.5)
    13.0 (1.0 to 70.0)
    1.0 (1.0 to 14.5)
    1.0 (1.0 to 3.0)
        CD8-All doubles,Anti-HPV-18,Week 6 (N=16;14;16;18)
    37.5 (9.0 to 66.5)
    2.0 (1.0 to 42.0)
    1.0 (1.0 to 42.5)
    30.5 (1.0 to 74.0)
        CD8-All doubles,Anti-HPV-16,Week 10(N=14;14;19;18)
    41.0 (1.0 to 75.0)
    3.5 (1.0 to 36.0)
    1.0 (1.0 to 54.0)
    1.0 (1.0 to 29.0)
        CD8-All doubles,Anti-HPV-18,Week 10(N=14;14;19;18)
    11.0 (1.0 to 60.0)
    1.0 (1.0 to 60.0)
    5.0 (1.0 to 84.0)
    1.0 (1.0 to 41.0)
        CD8-All doubles,Anti-HPV-16,Month 7(N=13;14;16;17)
    51.0 (18.0 to 69.0)
    9.5 (1.0 to 33.0)
    1.0 (1.0 to 74.5)
    2.0 (1.0 to 54.0)
        CD8-All doubles,Anti-HPV-18,Month 7(N=13;14;16;17)
    41.0 (1.0 to 159.0)
    30.0 (3.0 to 49.0)
    15.5 (1.0 to 106.5)
    24.0 (1.0 to 54.0)
        CD8-d-CD40L, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 29.0)
    1.0 (1.0 to 6.0)
    1.0 (1.0 to 10.0)
    1.0 (1.0 to 7.0)
        CD8-d-CD40L, Anti-HPV-18, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 29.0)
    1.0 (1.0 to 19.0)
    1.0 (1.0 to 33.0)
    1.0 (1.0 to 16.0)
        CD8-d-CD40L, Anti-HPV-16, Week 6 (N=16;14;16;18)
    1.0 (1.0 to 24.5)
    1.0 (1.0 to 32.0)
    1.0 (1.0 to 18.0)
    1.0 (1.0 to 1.0)
        CD8-d-CD40L, Anti-HPV-18, Week 6 (N=16;14;16;18)
    9.5 (1.0 to 27.5)
    1.0 (1.0 to 17.0)
    1.0 (1.0 to 23.0)
    1.0 (1.0 to 36.0)
        CD8-d-CD40L, Anti-HPV-16, Week 10 (N=14;14;19;18)
    18.5 (1.0 to 73.0)
    1.0 (1.0 to 29.0)
    1.0 (1.0 to 41.0)
    1.0 (1.0 to 27.0)
        CD8-d-CD40L, Anti-HPV-18, Week 10 (N=14;14;19;18)
    10.5 (1.0 to 34.0)
    2.5 (1.0 to 34.0)
    26.0 (1.0 to 72.0)
    1.0 (1.0 to 30.0)
        CD8-d-CD40L, Anti-HPV-16, Month 7 (N=13;14;16;17)
    26.0 (1.0 to 63.0)
    3.0 (1.0 to 20.0)
    2.0 (1.0 to 52.0)
    1.0 (1.0 to 36.0)
        CD8-d-CD40L, Anti-HPV-18, Month 7 (N=13;14;16;17)
    4.0 (1.0 to 42.0)
    15.0 (1.0 to 31.0)
    38.0 (1.0 to 92.0)
    4.0 (1.0 to 33.0)
        CD8-d-IFNG, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 29.0)
    1.0 (1.0 to 43.0)
    1.0 (1.0 to 28.0)
    1.0 (1.0 to 2.0)
        CD8-d-IFNG, Anti-HPV-18, Day 0 (N=17;15;17;18)
    6.0 (1.0 to 33.0)
    19.0 (1.0 to 47.0)
    21.0 (1.0 to 54.0)
    4.0 (1.0 to 35.0)
        CD8-d-IFNG, Anti-HPV-16, Week 6 (N=16;14;16;18)
    2.5 (1.0 to 39.5)
    17.5 (1.0 to 78.0)
    1.0 (1.0 to 14.5)
    1.0 (1.0 to 11.0)
        CD8-d-IFNG, Anti-HPV-18, Week 6 (N=16;14;16;18)
    27.5 (1.0 to 55.5)
    1.0 (1.0 to 47.0)
    1.0 (1.0 to 42.5)
    35.5 (1.0 to 84.0)
        CD8-d-IFNG, Anti-HPV-16, Week 10 (N=14;14;19;18)
    34.0 (1.0 to 99.0)
    25.0 (1.0 to 30.0)
    1.0 (1.0 to 38.0)
    1.0 (1.0 to 29.0)
        CD8-d-IFNG, Anti-HPV-18, Week 10 (N=14;14;19;18)
    3.0 (1.0 to 68.0)
    7.5 (1.0 to 34.0)
    24.0 (1.0 to 76.0)
    1.0 (1.0 to 1.0)
        CD8-d-IFNG, Anti-HPV-16, Month 7 (N=13;14;16;17)
    46.0 (1.0 to 68.0)
    1.0 (1.0 to 26.0)
    1.0 (1.0 to 74.5)
    1.0 (1.0 to 50.0)
        CD8-d-IFNG, Anti-HPV-18, Month 7 (N=13;14;16;17)
    41.0 (1.0 to 68.0)
    21.0 (1.0 to 41.0)
    4.0 (1.0 to 90.5)
    3.0 (1.0 to 52.0)
        CD8-d-IL-2, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 16.0)
        CD8-d-IL-2, Anti-HPV-18, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        CD8-d-IL-2, Anti-HPV-16, Week 6 (N=16;14;16;18)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        CD8-d-IL-2, Anti-HPV-18, Week 6 (N=16;14;16;18)
    1.0 (1.0 to 23.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        CD8-d-IL-2, Anti-HPV-16, Week 10 (N=14;14;19;18)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 32.0)
    1.0 (1.0 to 1.0)
        CD8-d-IL-2, Anti-HPV-18, Week 10 (N=14;14;19;18)
    1.0 (1.0 to 26.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 25.0)
    1.0 (1.0 to 1.0)
        CD8-d-IL-2, Anti-HPV-16, Month 7 (N=13;14;16;17)
    1.0 (1.0 to 23.0)
    1.0 (1.0 to 17.0)
    1.0 (1.0 to 37.5)
    1.0 (1.0 to 1.0)
        CD8-d-IL-2, Anti-HPV-18, Month 7 (N=13;14;16;17)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 29.0)
    1.0 (1.0 to 1.0)
        CD8-d-TNFA, Anti-HPV-16, Day 0 (N=17;15;17;18)
    1.0 (1.0 to 10.0)
    1.0 (1.0 to 35.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 29.0)
        CD8-d-TNFA, Anti-HPV-18, Day 0 (N=17;15;17;18)
    6.0 (1.0 to 50.0)
    7.0 (1.0 to 54.0)
    1.0 (1.0 to 33.0)
    1.0 (1.0 to 34.0)
        CD8-d-TNFA, Anti-HPV-16, Week 6 (N=16;14;16;18)
    1.0 (1.0 to 46.0)
    1.0 (1.0 to 35.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 31.0)
        CD8-d-TNFA, Anti-HPV-18, Week 6 (N=16;14;16;18)
    19.0 (1.0 to 50.0)
    1.0 (1.0 to 57.0)
    1.0 (1.0 to 28.0)
    1.0 (1.0 to 26.0)
        CD8-d-TNFA, Anti-HPV-16, Week 10 (N=14;14;19;18)
    1.5 (1.0 to 32.0)
    1.0 (1.0 to 24.0)
    1.0 (1.0 to 31.0)
    1.0 (1.0 to 26.0)
        CD8-d-TNFA, Anti-HPV-18, Week 10 (N=14;14;19;18)
    17.5 (1.0 to 34.0)
    14.0 (1.0 to 61.0)
    5.0 (1.0 to 42.0)
    1.0 (1.0 to 34.0)
        CD8-d-TNFA, Anti-HPV-16, Month 7 (N=13;14;16;17)
    34.0 (1.0 to 41.0)
    13.0 (1.0 to 33.0)
    1.0 (1.0 to 49.0)
    2.0 (1.0 to 33.0)
        CD8-d-TNFA, Anti-HPV-18, Month 7 (N=13;14;16;17)
    41.0 (1.0 to 111.0)
    26.5 (15.0 to 58.0)
    1.0 (1.0 to 58.0)
    1.0 (1.0 to 32.0)
    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)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 61.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        HPV-18, Day 0 (N=12;11;18;20)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        HPV-16, Week 6 (N=10;12;15;15)
    91.0 (1.0 to 154.0)
    1.0 (1.0 to 1.0)
    22.0 (1.0 to 154.0)
    1.0 (1.0 to 204.0)
        HPV-18, Week 6 (N=10;12;15;15)
    39.5 (1.0 to 693.0)
    1.0 (1.0 to 45.5)
    155.0 (1.0 to 345.0)
    33.0 (1.0 to 80.0)
        HPV-16, Week 10 (N=12;9;20;20)
    558.0 (95.5 to 989.5)
    198.0 (1.0 to 391.0)
    494.0 (90.5 to 834.0)
    150.5 (33.5 to 726.5)
        HPV-18, Week 10 (N=12;9;20;20)
    150.0 (31.0 to 471.0)
    1.0 (1.0 to 42.0)
    211.0 (84.0 to 656.0)
    29.5 (1.0 to 222.0)
        HPV-16, Month 7 (N=13;9;20;17)
    624.0 (457.0 to 1196.0)
    213.0 (165.0 to 632.0)
    1504.0 (481.0 to 3026.0)
    448.0 (257.0 to 890.0)
        HPV-18, Month 7 (N=13;9;20;17)
    332.0 (153.0 to 494.0)
    1.0 (1.0 to 392.0)
    513.5 (111.5 to 1292.0)
    65.0 (1.0 to 158.0)
    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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