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    Clinical Trial Results:
    Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents

    Summary
    EudraCT number
    		 2007-001731-55
    Trial protocol
    		 FI  
    Global end of trial date
    17 Dec 2014

    Results information
    Results version number
    		 v1
    This version publication date
    13 Apr 2016
    First version publication date
    22 May 2015
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    106636
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00534638
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    25 Oct 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    CO-PRIMARY OBJECTIVES • To demonstrate the overall (direct and indirect) effectiveness of GSK Biologicals’ HPV-16/18 vaccine in reducing the prevalence of HPV-16/18 genital infection in females approximately 18.5 years of age following community-based vaccination of 12 - 15 year old females only (Arm B versus Arm C). • To demonstrate the overall (direct and indirect) effectiveness of GSK Biologicals’ HPV-16/18 vaccine in reducing the prevalence of HPV-16/18 genital infection in females approximately 18.5 years of age, following community-based vaccination of 12 - 15 year old females and males (Arm A versus Arm C).
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 32176
    Worldwide total number of subjects
    32176
    EEA total number of subjects
    32176
    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)
    32176
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Immunisation phase (Visit 1 at Day 0 to Phone contact at Month 12) = adolescents (birth cohorts 1992-95) were vaccinated with Cervarix™ or Engerix™-B vaccine. Effectiveness evaluation phase (Visit 5) = the impact of the vaccine intervention was assessed on female subjects of approximately 18.5 years of age.

    Pre-assignment
    Screening details
    		 At the time when the study was initiated, the Cervarix™ vaccine was not licensed for use in boys; therefore, male adolescents from communities who received Cervarix™ vaccine were considered to be part of a Phase III trial.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    All subjects knew of the intervention Arm their community had been assigned to (Arm A, B or C – see Treatment Section below). Blinding was as follows: - Study participants in Arm A communities and female study participants in Arm B communities were blinded to their treatment allocation (HPV or HBV vaccine). - Study participants (males and females) in Arm C communities and male study participants in Arm B communities were aware of their treatment allocation as they all received HBV vaccine.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cervarix pooled Group
    Arm description
    		 Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses by intramuscular injection in the deltoid region of the non-dominant arm

    Arm title
    		 Engerix-B pooled Group
    Arm description
    		 Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Engerix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses by intramuscular injection in the deltoid region of the non-dominant arm

    Number of subjects in period 1
    		Cervarix pooled Group Engerix-B pooled Group
    Started
    14838
    17338
    Completed
    14713
    17188
    Not completed
    125
    150
         Consent withdrawn by subject
    17
    36
         Lost to follow-up (subjects with complete vaccinat
    22
    24
         Other - ae:urticaria
    2
    1
         Adverse event, non-fatal
    3
    3
         Other - lost to follow-up
    2
    -
         Non-Serious Adverse Event/ Protocol violation
    2
    8
         Migrated/moved from study area
    2
    7
         Other - consent withdrawal / did not want to come,
    46
    30
         Other – other
    6
    9
         Lost to follow-up
    -
    2
         Lost to follow-up (subjects with incomplete vaccin
    22
    29
         Other - ae/allergic reaction after vaccination
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix pooled Group
    Reporting group description
    		 Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group title
    Engerix-B pooled Group
    Reporting group description
    		 Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group values
    		 Cervarix pooled Group Engerix-B pooled Group Total
    Number of subjects
    		 14838 17338 32176
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.1 ( 0.75 ) 14.1 ( 0.76 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12398 8117 20515
        Male
    		 2440 9221 11661

    End points

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    End points reporting groups
    Reporting group title
    Cervarix pooled Group
    Reporting group description
    		 Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group title
    Engerix-B pooled Group
    Reporting group description
    		 Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Primary: Genital Human papillomavirus 16 and/or 18 (HPV-16 and/or HPV-18) deoxyribonucleic acid (DNA) positivity (by polymerase chain reaction [PCR])

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    End point title
    		 Genital Human papillomavirus 16 and/or 18 (HPV-16 and/or HPV-18) deoxyribonucleic acid (DNA) positivity (by polymerase chain reaction [PCR]) [1]
    End point description
    End point type
    Primary
    End point timeframe
    At the time of visit 5 (at 18.5 years of age)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Subjects
    Notes
    [2] - Results were not available at the time of this assessment.
    [3] - Results were not available at the time of this assessment.
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and severe (Grade 3) solicited local symptoms, in a subset of subjects.

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    End point title
    		 Number of subjects reporting any and severe (Grade 3) solicited local symptoms, in a subset of subjects.
    End point description
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0 - 6) after any vaccination
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    603
    1028
    Units: Subjects
        Pain, Any
    506
    251
        Pain, Grade 3
    26
    2
        Redness, Any
    169
    1331
        Redness, Grade 3
    4
    0
        Swelling, Any
    131
    46
        Swelling, Grade 3
    8
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, severe (Grade 3) and related to vaccination solicited general symptoms, in a subset of subjects.

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    End point title
    		 Number of subjects reporting any, severe (Grade 3) and related to vaccination solicited general symptoms, in a subset of subjects.
    End point description
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0 - 6) after any vaccination
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    604
    1028
    Units: Subjects
        Arthralgia, Any
    107
    97
        Arthralgia, Grade 3
    1
    4
        Arthralgia, Related
    87
    81
        Fatigue, Any
    291
    411
        Fatigue, Grade 3
    7
    21
        Fatigue, Related
    233
    351
        Fever (axillary), Any
    48
    85
        Fever (axillary), Grade 3
    6
    9
        Fever (axillary), Related
    28
    53
        Gastrointestinal, Any
    106
    163
        Gastrointestinal, Grade 3
    11
    13
        Gastrointestinal, Related
    70
    128
        Headache, Any
    261
    371
        Headache, Grade 3
    15
    14
        Headache, Related
    176
    280
        Myalgia, Any
    321
    250
        Myalgia, Grade 3
    12
    3
        Myalgia, Related
    291
    211
        Rash, Any
    29
    33
        Rash, Grade 3
    0
    0
        Rash, Related
    14
    23
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, severe (Grade 3) and related to vaccination unsolicited adverse events (AEs), in a subset of subjects.

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    End point title
    		 Number of subjects reporting any, severe (Grade 3) and related to vaccination unsolicited adverse events (AEs), in a subset of subjects.
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days (Days 0 - 29) after any vaccination
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    643
    1047
    Units: Subjects
        Subjects with any AEs
    157
    202
        Subjects with Grade 3 AEs
    31
    46
        Subjects with related AEs
    12
    19
        Nasopharyngitis
    33
    17
        Oropharyngeal pain
    15
    32
        Headache
    23
    16
        Influenza
    0
    23
        Cough
    6
    14
        Rhinitis
    7
    9
        Tonsilitis
    6
    10
        Upper Respiratory Tract Infection
    13
    0
        Sinusitis
    0
    9
        Back pain
    0
    6
        Pain in extremities
    6
    0
        Dizziness
    5
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting rash and urticaria, in a subset of subjects.

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    End point title
    		 Number of subjects reporting rash and urticaria, in a subset of subjects.
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 minutes following vaccination
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    643
    1047
    Units: Subjects
        Confirmed after Dose 1 (n=643, 1047)
    0
    0
        Infirmed after Dose 1 (n=643, 1047)
    643
    1047
        Confirmed after Dose 2 (n=634, 1042)
    0
    0
        Infirmed after Dose 2 (n=634, 1042)
    634
    1042
        Confirmed after Dose 3 (n=631, 1039)
    0
    0
        Infirmed after Dose 3 (n=631,1039)
    630
    1039
        Missing Confirmed after Dose 3 (n=631, 1039)
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting medically significant conditions (MSCs), in a subset of subjects.

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    End point title
    		 Number of subjects reporting medically significant conditions (MSCs), in a subset of subjects.
    End point description
    MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
    End point type
    Secondary
    End point timeframe
    From Dose 1 (at Day 0) until Month 12 (phone contact)
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    643
    1047
    Units: Subjects
        Subjects with any MSC
    47
    76
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs) and SAEs causally related to vaccination, in a subset of subjects

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs) and SAEs causally related to vaccination, in a subset of subjects
    End point description
    An SAE is any untoward medical occurrence that: a.results in death, b.is life-threatening, c.requires hospitalisation or prolongation of existing hospitalisation, d.results in disability/incapacity, or e.is a congenital anomaly/birth defect in the offspring of a study participant.
    End point type
    Secondary
    End point timeframe
    From Dose 1 (at Day 0) until Month 12
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    2436
    1267
    Units: Subjects
        Subjects with any SAEs
    58
    25
        Subjects with SAEs assessed as related to vaccine
    4
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting SAEs assessed by the investigator as possibly related to vaccination.

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    End point title
    		 Number of subjects reporting SAEs assessed by the investigator as possibly related to vaccination.
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period up to the Visit 5 (18.5 years of age)
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    14838
    17338
    Units: Subjects
        Subjects with any related SAE(s)
    22
    30
    No statistical analyses for this end point

    Secondary: Number of subjects reporting new onset of autoimmune diseases (NOADs).

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    End point title
    		 Number of subjects reporting new onset of autoimmune diseases (NOADs).
    End point description
    NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.
    End point type
    Secondary
    End point timeframe
    Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    2436
    1267
    Units: Subjects
        Subjects with any NOAD(s)
    72
    101
    No statistical analyses for this end point

    Secondary: Number of subjects reporting pregnancies with onset and their outcomes.

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    End point title
    		 Number of subjects reporting pregnancies with onset and their outcomes.
    End point description
    End point type
    Secondary
    End point timeframe
    Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    100
    74
    Units: Subjects
        Live infant no apparent anomaly
    29
    16
        Elective termination no apparent anomaly
    29
    52
        Spontaneous abortion no apparent anomaly
    7
    2
        Molar pregnanacy
    1
    0
        Pregnancy ongoing
    3
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AEs occurring within the 30-day (Days 0-29) post-vaccination period. SAEs up to Month 12
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Cervarix Pooled Group
    Reporting group description
    		 Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Reporting group title
    Engerix-B Pooled Group
    Reporting group description
    		 Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Serious adverse events
    		 Cervarix Pooled Group Engerix-B Pooled Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    58 / 2436 (2.38%)
    25 / 1267 (1.97%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Astrocytoma, low grade
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular torsion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disturbance in social behaviour
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emotional disorder of childhood
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 2436 (0.12%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 2436 (0.16%)
    4 / 1267 (0.32%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    2 / 1267 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    2 / 1267 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    2 / 1267 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    2 / 1267 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic renal injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Vitello-intestinal duct remnant
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    2 / 1267 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Splenomegaly
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    2 / 1267 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acne
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Exostosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Juvenile arthritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 2436 (0.21%)
    3 / 1267 (0.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 2436 (0.16%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsilitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 2436 (0.16%)
    4 / 1267 (0.32%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 2436 (0.08%)
    2 / 1267 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 2436 (0.04%)
    1 / 1267 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cervarix Pooled Group Engerix-B Pooled Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    506 / 2436 (20.77%)
    411 / 1267 (32.44%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    506 / 603 (83.91%)
    251 / 1028 (24.42%)
         occurrences all number
    506
    251
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    131 / 603 (21.72%)
    169 / 1028 (16.44%)
         occurrences all number
    131
    169
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    131 / 603 (21.72%)
    46 / 1028 (4.47%)
         occurrences all number
    131
    46
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    107 / 604 (17.72%)
    97 / 1028 (9.44%)
         occurrences all number
    107
    97
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    291 / 604 (48.18%)
    411 / 1028 (39.98%)
         occurrences all number
    291
    411
    Fever (Axilarry)
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    48 / 604 (7.95%)
    85 / 1028 (8.27%)
         occurrences all number
    48
    85
    Gastrointestinal
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    106 / 604 (17.55%)
    163 / 1028 (15.86%)
         occurrences all number
    106
    163
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    261 / 604 (43.21%)
    371 / 1028 (36.09%)
         occurrences all number
    261
    371
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    321 / 604 (53.15%)
    250 / 1028 (24.32%)
         occurrences all number
    321
    250
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    29 / 604 (4.80%)
    33 / 1028 (3.21%)
         occurrences all number
    29
    33
    Urticaria
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    4 / 604 (0.66%)
    15 / 1267 (1.18%)
         occurrences all number
    4
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed [12]
    33 / 643 (5.13%)
    17 / 1047 (1.62%)
         occurrences all number
    33
    17
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Mar 2014
    Oropharyngeal samples are being collected from female subjects born in 1992 to maximize the chance of detecting vaccine effect against oropharyngeal infection.  Additional study objectives and endpoints to evaluate vaccine effectiveness against oropharyngeal infection were added.  The end-of-study analysis plan was clarified.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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