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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
    14 Dec 2015

    Results information
    Results version number
    		 v2
    This version publication date
    11 May 2016
    First version publication date
    22 May 2015
    Other versions
    		 v1 , v3
    Version creation reason
    • New data added to full data set
    Data for secondary endpoints have been added.

    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
    Final
    Date of interim/final analysis
    14 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 7 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 34206
    Worldwide total number of subjects
    34206
    EEA total number of subjects
    34206
    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)
    34206
    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 study start, Cervarix™ vaccine was not licensed for use in boys so male subjects receiving the vaccine were considered as part of a Phase III trial. Although 34206 subjects were enrolled, only 32175 subjects were vaccinated and started the study.

    Pre-assignment period milestones
    Number of subjects started
    		 34206
    Number of subjects completed
    		 32175

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 2031
    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
    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 [1]
    		Cervarix pooled Group Engerix-B pooled Group
    Started
    14837
    17338
    Completed Month 12
    14713
    17188
    Completed
    8346
    5547
    Not completed
    6491
    11791
         Subject unable to read
    -
    1
         Migrated/Moved from the study area
    14
    13
         Mentally disabled
    1
    -
         Refused participation to study
    1665
    883
         ICF not returned
    -
    1
         Consent withdrawn by subject
    4
    5
         Already received HPV vaccine
    -
    1
         Adverse event, non-fatal
    1
    -
         Death
    5
    5
         Pregnancy
    6
    4
         Lost to follow-up
    4793
    10875
         Blinded treatment broken
    2
    -
         Received without ICF
    -
    1
         Rejected origin of signature
    -
    2
    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: Although 34206 subjects were enrolled, only 32175 subjects were vaccinated and started the study.

    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
    		 14837 17338 32175
    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 ± 0.8 14.1 ± 0.8 -
    Gender categorical
    Units: Subjects
        Female
    		 12399 8119 20518
        Male
    		 2438 9219 11657

    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.

    Subject analysis set title
    Cervarix/Engerix-B A Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    90% of male and female adolescents received Cervarix™ vaccine. Rest of the subjects received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Subject analysis set title
    Cervarix/Engerix-B B Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    90% of the female adolescents received Cervarix™ vaccine. Male adolescents and rest of the female adolescents received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Subject analysis set title
    Engerix-B Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All adolescents were vaccinated with 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.

    Subject analysis set title
    No-vaccine Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who were enrolled but not vaccinated.

    Subject analysis set title
    Cervarix/Engerix-B pooled Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male and female subjects receiving Cervarix™/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: Number of female subjects with vaccine overall effectiveness against genital infection with Human Papilloma Virus (HPV) 16/18 serotypes

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    End point title
    		 Number of female subjects with vaccine overall effectiveness against genital infection with Human Papilloma Virus (HPV) 16/18 serotypes
    End point description
    The analysis of overall effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated arm/prevalence rate in all subjects from Arm C).
    End point type
    Primary
    End point timeframe
    At the time of Visit 5 (at 18.5 years of age)
    End point values
    		 Cervarix/Engerix-B A Group Cervarix/Engerix-B B Group Engerix-B Group
    Number of subjects analysed
    3629
    4029
    3168
    Units: Subjects
        Anti-HPV16/18
    139
    117
    329
    Statistical analysis title
    		 Overall efectiveness against HPV-16/18 Arm A vs C
    Statistical analysis description
    The analysis of overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Arm A versus Arm C was based on stratified Mantel-Haenszel adjusted for clustering.
    Comparison groups
    Cervarix/Engerix-B A Group v Engerix-B Group
    Number of subjects included in analysis
    6797
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.232
    Method
    		 Mantel-Haenszel
    Parameter type
    		 1-Odds Ratio
    Point estimate
    23.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19
         upper limit
    		 51.1
    Notes
    [1] - Efectiveness
    Statistical analysis title
    		 Overall efectiveness against HPV-16/18 Arm B vs C
    Statistical analysis description
    The analysis of overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Arm B versus Arm C was based on stratified Mantel-Haenszel adjusted for clustering.
    Comparison groups
    Cervarix/Engerix-B B Group v Engerix-B Group
    Number of subjects included in analysis
    7197
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.004
    Method
    		 Mantel-Haenszel
    Parameter type
    		 1-Odds Ratio
    Point estimate
    49.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.1
         upper limit
    		 68.2
    Notes
    [2] - Effectiveness
    Statistical analysis title
    		 Overall efectiveness against HPV-16/18 Arm A vs B
    Statistical analysis description
    The analysis of overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Arm A versus Arm B was based on stratified Mantel-Haenszel adjusted for clustering.
    Comparison groups
    Cervarix/Engerix-B B Group v Cervarix/Engerix-B A Group
    Number of subjects included in analysis
    7658
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.069
    Method
    		 Mantel-Haenszel
    Parameter type
    		 1-Odds Ratio
    Point estimate
    -52.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -139.4
         upper limit
    		 3.3
    Notes
    [3] - Effectiveness

    Secondary: Number of subjects with solicited local symptoms, in a subset of subjects.

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    End point title
    		 Number of subjects with 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
    131
        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 with solicited general symptoms, in a subset of subjects.

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    End point title
    		 Number of subjects with solicited general symptoms, in a subset of subjects.
    End point description
    The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.
    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
        Urticaria, Any
    4
    15
        Urticaria, Grade 3
    0
    0
        Urticaria, Related
    3
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs), in a subset of subjects.

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    End point title
    		 Number of subjects with 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
    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) 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) 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
    During the entire study period (from Dose 1-Day 0 to Visit 5-18.5 years of age)
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    14837
    17338
    Units: Subjects
        Subjects with SAEs assessed as related to vaccine
    25
    30
    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
    14837
    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
    14837
    17338
    Units: Subjects
        Subjects with any NOAD(s)
    144
    176
    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
    728
    524
    Units: Subjects
        Live infant no apparent anomaly
    232
    161
        Elective termination no apparent anomaly
    431
    314
        Spontaneous abortion no apparent anomaly
    58
    41
        Stillbirth no apparent congenital anomaly
    0
    1
        Lost to follow up
    0
    1
        Ectopic pregnancy
    5
    5
        Molar pregnancy
    2
    1
    No statistical analyses for this end point

    Secondary: Number of female subjects with vaccine effectiveness against oropharyngeal infection with HPV-16/18 serotypes

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    End point title
    		 Number of female subjects with vaccine effectiveness against oropharyngeal infection with HPV-16/18 serotypes
    End point description
    The analysis of total effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in HPV vaccinated subjects from the investigated group (prevalence rate in HPV vaccinated subjects from the investigated arm/prevalence rate in all subjects from Arm C).
    End point type
    Secondary
    End point timeframe
    At the time of visit 5 (at 18.5 years of age)
    End point values
    		 No-vaccine Group Cervarix/Engerix-B pooled Group
    Number of subjects analysed
    3192
    233
    Units: Subjects
        Anti-HPV 16/18
    9
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with HPV-16 and HPV-18 antibody concentrations equal to or above the cut-off values, by gender, in a subset of subjects.

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    End point title
    		 Number of subjects with HPV-16 and HPV-18 antibody concentrations equal to or above the cut-off values, by gender, in a subset of subjects. [4]
    End point description
    The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.
    End point type
    Secondary
    End point timeframe
    At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)
    Notes
    [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: The results were only assessed in subsets of subjects.
    End point values
    		 Cervarix pooled Group
    Number of subjects analysed
    1163
    Units: Subjects
        anti-HPV-16 >=8 EL.U/mL males [Day 0] (N=536)
    40
        anti-HPV-16 >=8 EL.U/mL males [Month 7] (N=536)
    536
        anti-HPV-16 >=8 EL.U/mL females [Day 0] (N=1163)
    86
        anti-HPV-16 >=8 EL.U/mL females [Month 7] (N=1163)
    1163
        anti-HPV-18 >=7 EL.U/mL males [Day 0] (N=535)
    31
        anti-HPV-18 >=7 EL.U/mL males [Month 7] (N=535)
    535
        anti-HPV-18 >=7 EL.U/mL females [Day 0] (N=1160)
    84
        anti-HPV-18 >=7 EL.U/mL females [Month 7] (N=1160)
    1160
        anti-HPV-16 >=19 EL.U/mL males [18.5Y] (N=217)
    217
        anti-HPV-16 >=19 EL.U/mL females [18.5Y] (N=688)
    688
        anti-HPV-18 >=18 EL.U/mL males [18.5Y] (N=217)
    217
        anti-HPV-18 >=18 EL.U/mL females [18.5Y] (N=686)
    685
    No statistical analyses for this end point

    Secondary: Titres for anti-HPV-16 and anti-HPV-18 antibodies, by gender, in a subset of subjects

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    End point title
    		 Titres for anti-HPV-16 and anti-HPV-18 antibodies, by gender, in a subset of subjects [5]
    End point description
    The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.
    End point type
    Secondary
    End point timeframe
    At the time of visits 1 and 4 (at Day 0 and Month 7) and at the time of Visit 5 (18.5 years of age)
    Notes
    [5] - 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: The results were only assessed in subsets of subjects.
    End point values
    		 Cervarix pooled Group
    Number of subjects analysed
    1163
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        anti-HPV-16 >=8 EL.U/mL males [Day 0] (N=536)
    4.5 (4.3 to 4.6)
        anti-HPV-16 >=8 EL.U/mL males [Month 7] (N=536)
    23959.1 (22301 to 25740.4)
        anti-HPV-16 >=8 EL.U/mL females [Day 0] (N=1163)
    4.5 (4.4 to 4.6)
        anti-HPV-16 >=8 EL.U/mL females [Month 7] (N=1163)
    21327.2 (20338.9 to 22363.5)
        anti-HPV-18 >=7 EL.U/mL males [Day 0] (N=535)
    3.8 (3.7 to 4)
        anti-HPV-18 >=7 EL.U/mL males [Month 7] (N=535)
    8583.9 (7974.7 to 9239.5)
        anti-HPV-18 >=7 EL.U/mL females [Day 0] (N=1160)
    3.9 (3.8 to 4)
        anti-HPV-18 >=7 EL.U/mL females [Month 7] (N=1160)
    8227.3 (7847.7 to 8625.4)
        anti-HPV-16 >=19 EL.U/mL males [18.5Y] (N=217)
    2759.5 (2432.1 to 3130.9)
        anti-HPV-16 >=19 EL.U/mL females [18.5Y] (N=688)
    2609.6 (2444.4 to 2785.9)
        anti-HPV-18 >=18 EL.U/mL males [18.5Y] (N=217)
    837.7 (727.3 to 964.9)
        anti-HPV-18 >=18 EL.U/mL females [18.5Y] (N=686)
    890 (826.2 to 958.7)
    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
    Serious adverse events (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
    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
        Any SAEs
    58
    25
        Related SAEs
    4
    1
    No statistical analyses for this end point

    Secondary: Number of female subjects reporting any SAEs that are causally related to vaccination

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    End point title
    		 Number of female subjects reporting any SAEs that are causally related to vaccination
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The outcome was assessed only in female subjects in the respective groups.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Dose 1-Day 0 to Visit 5-18.5 years of age)
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    12399
    8119
    Units: Subjects
        Related SAEs
    20
    16
    No statistical analyses for this end point

    Secondary: Number of male subjects reporting any SAEs that are causally related to vaccination

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    End point title
    		 Number of male subjects reporting any SAEs that are causally related to vaccination
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The outcome was assessed only in male subjects in the respective groups.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from dose1-Day 0 to Visit 5-18.5 years of age)
    End point values
    		 Cervarix pooled Group Engerix-B pooled Group
    Number of subjects analysed
    2438
    9219
    Units: Subjects
        Related SAEs
    5
    14
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs up to Visit 5 at Month 96
    Adverse event reporting additional description
    Adverse Events were collected in the Total Vaccinated Cohort Diary Card subset (TVC-DcS = a subset of males from Cervarix/Engerix-B and Engerix-B groups selected for active safety assessment using diary cards). SAEs were collected in the TVC-DcS and remaining Cervarix/Engerix-B Group male subjects. Related SAEs were collected in the TVC.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    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 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.

    Serious adverse events
    		 Engerix-B Pooled Group Cervarix Pooled Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 1267 (1.97%)
    58 / 2436 (2.38%)
         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
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular torsion
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disturbance in social behaviour
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emotional disorder of childhood
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic disorder
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 1267 (0.08%)
    3 / 2436 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 1267 (0.00%)
    4 / 2436 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    1 / 1267 (0.08%)
    2 / 2436 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 1267 (0.00%)
    2 / 2436 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    2 / 1267 (0.16%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    1 / 1267 (0.08%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 1267 (0.00%)
    2 / 2436 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 1267 (0.00%)
    2 / 2436 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic renal injury
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Vitello-intestinal duct remnant
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 1267 (0.00%)
    2 / 2436 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Splenomegaly
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 1267 (0.00%)
    2 / 2436 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Exostosis
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Juvenile arthritis
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    3 / 1267 (0.24%)
    5 / 2436 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 1267 (0.08%)
    4 / 2436 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsilitis
         subjects affected / exposed
    0 / 1267 (0.00%)
    4 / 2436 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1267 (0.08%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 1267 (0.08%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 1267 (0.00%)
    2 / 2436 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 1267 (0.00%)
    1 / 2436 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis bacterial
         subjects affected / exposed
    1 / 1267 (0.08%)
    0 / 2436 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 1267 (0.08%)
    1 / 2436 (0.04%)
         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
    		 Engerix-B Pooled Group Cervarix Pooled Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    411 / 1267 (32.44%)
    506 / 2436 (20.77%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    251 / 1028 (24.42%)
    506 / 603 (83.91%)
         occurrences all number
    251
    506
    Redness
         subjects affected / exposed [2]
    131 / 1028 (12.74%)
    169 / 603 (28.03%)
         occurrences all number
    131
    169
    Swelling
         subjects affected / exposed [3]
    46 / 1028 (4.47%)
    131 / 603 (21.72%)
         occurrences all number
    46
    131
    Arthralgia
         subjects affected / exposed [4]
    97 / 1028 (9.44%)
    107 / 604 (17.72%)
         occurrences all number
    97
    107
    Fatigue
         subjects affected / exposed [5]
    411 / 1028 (39.98%)
    291 / 604 (48.18%)
         occurrences all number
    411
    291
    Fever (Axilarry)
         subjects affected / exposed [6]
    85 / 1028 (8.27%)
    48 / 604 (7.95%)
         occurrences all number
    85
    48
    Gastrointestinal
         subjects affected / exposed [7]
    163 / 1028 (15.86%)
    106 / 604 (17.55%)
         occurrences all number
    163
    106
    Headache
         subjects affected / exposed [8]
    371 / 1028 (36.09%)
    261 / 604 (43.21%)
         occurrences all number
    371
    261
    Myalgia
         subjects affected / exposed [9]
    250 / 1028 (24.32%)
    321 / 604 (53.15%)
         occurrences all number
    250
    321
    Rash
         subjects affected / exposed [10]
    33 / 1028 (3.21%)
    29 / 604 (4.80%)
         occurrences all number
    33
    29
    Urticaria
         subjects affected / exposed [11]
    15 / 1267 (1.18%)
    4 / 604 (0.66%)
         occurrences all number
    15
    4
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed [12]
    17 / 1047 (1.62%)
    33 / 643 (5.13%)
         occurrences all number
    17
    33
    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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