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    Clinical Trial Results:
    A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at, 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years.

    Summary
    EudraCT number
    		 2007-003256-11
    Trial protocol
    		 IT   SK  
    Global end of trial date
    20 Jul 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 May 2023
    First version publication date
    21 May 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    109179 (HPV-044 PRI)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00552279
    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
    10 Nov 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered according to an alternative schedule of 0, 1, 12 months is non-inferior to that of the vaccine administered according to a standard schedule of 0, 1, 6 months one month after the third dose.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products 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/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 268
    Country: Number of subjects enrolled
    Italy: 269
    Country: Number of subjects enrolled
    Romania: 268
    Worldwide total number of subjects
    805
    EEA total number of subjects
    805
    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)
    402
    Adults (18-64 years)
    403
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 805 subjects were enrolled and 804 subjects were vaccinated and included in the analyses.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cervarix-12 Group
    Arm description
    		 Women received 3 doses of Cervarix (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-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
    Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.

    Arm title
    		 Cervarix-6 Group
    Arm description
    		 Women received 3 doses of Cervarix (HPV vaccine) administered according to a 0, 1, 6-month schedule.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

    Number of subjects in period 1 [1]
    		Cervarix-12 Group Cervarix-6 Group
    Started
    403
    401
    Completed
    389
    398
    Not completed
    14
    3
         Consent withdrawn by subject
    12
    1
         Adverse event, non-fatal
    -
    1
         Other
    1
    1
         Migrated/moved from study area
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 805 subjects were enrolled and 804 subjects were vaccinated and included in the analyses.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix-12 Group
    Reporting group description
    		 Women received 3 doses of Cervarix (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.

    Reporting group title
    Cervarix-6 Group
    Reporting group description
    		 Women received 3 doses of Cervarix (HPV vaccine) administered according to a 0, 1, 6-month schedule.

    Reporting group values
    		 Cervarix-12 Group Cervarix-6 Group Total
    Number of subjects
    		 403 401 804
    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)
    		 18.6 ± 2.98 18.7 ± 3.13 -
    Gender categorical
    Units: Subjects
        Female
    		 403 401 804
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cervarix-12 Group
    Reporting group description
    		 Women received 3 doses of Cervarix (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.

    Reporting group title
    Cervarix-6 Group
    Reporting group description
    		 Women received 3 doses of Cervarix (HPV vaccine) administered according to a 0, 1, 6-month schedule.

    Primary: Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

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    End point title
    		 Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
    End point description
    Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer greater than or equal to [≥] cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
    End point type
    Primary
    End point timeframe
    One month after the third vaccine dose
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    346
    346
    Units: Subjects
        Anti-HPV-16 (N=337;342)
    337
    342
        Anti-HPV-18 (N=346;346)
    345
    346
    Statistical analysis title
    		 Difference in seroconversion rates
    Comparison groups
    Cervarix-12 Group v Cervarix-6 Group
    Number of subjects included in analysis
    692
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.11
         upper limit
    		 1.13
    Statistical analysis title
    		 Difference in seroconversion rates
    Comparison groups
    Cervarix-12 Group v Cervarix-6 Group
    Number of subjects included in analysis
    692
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 1.62

    Primary: Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies

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    End point title
    		 Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
    End point description
    Titer given as geometric mean titer (GMT).
    End point type
    Primary
    End point timeframe
    One month after the third vaccine dose
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    346
    346
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 (N=337;342)
    11337.2 (10238.2 to 12554.1)
    10050.9 (9180.9 to 11003.3)
        Anti-HPV-18 (N=346;346)
    4526.7 (4110.1 to 4985.6)
    3879.9 (3532.7 to 4261.2)
    Statistical analysis title
    		 Non-inferiority analysis for HPV-16 & HPV-18
    Comparison groups
    Cervarix-12 Group v Cervarix-6 Group
    Number of subjects included in analysis
    692
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1
    Statistical analysis title
    		 Non-inferiority analysis for HPV-16 & HPV-18
    Comparison groups
    Cervarix-12 Group v Cervarix-6 Group
    Number of subjects included in analysis
    692
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.01

    Secondary: Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies

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    End point title
    		 Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
    End point description
    Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
    End point type
    Secondary
    End point timeframe
    One month after the second vaccine dose
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    346
    346
    Units: Subjects
        Anti-HPV-16 (N=337;342)
    337
    342
        Anti-HPV-18 (N=346;346)
    346
    346
    No statistical analyses for this end point

    Secondary: Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies

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    End point title
    		 Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
    End point description
    Titer given as GMT.
    End point type
    Secondary
    End point timeframe
    One month after the second vaccine dose
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    346
    346
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 (N=337;342)
    3307 (3051 to 3584.5)
    3184.1 (2938.3 to 3450.5)
        Anti-HPV-18 (N=346;346)
    2382.3 (2179.2 to 2604.3)
    2256.3 (2070.7 to 2458.7)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local Symptoms

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    End point title
    		 Number of Subjects Reporting Solicited Local Symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling at the injection site.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) period following each vaccination
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    402
    401
    Units: Subjects
        Pain
    385
    386
        Redness
    201
    182
        Swelling
    158
    145
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited General Symptoms

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    End point title
    		 Number of Subjects Reporting Solicited General Symptoms
    End point description
    Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) period following each vaccination
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    402
    401
    Units: Subjects
        Arthralgia
    85
    78
        Fatigue
    245
    237
        Temperature ≥ 37.5°C
    37
    29
        Gastro-intestinal symptoms
    85
    86
        Headache
    203
    199
        Myalgia
    167
    168
        Rash
    30
    34
        Urticaria
    12
    18
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events (AE)

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    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During the 30-day (Days 0-29) period following each vaccination
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    403
    401
    Units: Subjects
    117
    129
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset autoimmune diseases (NOADs), serious adverse events (SAEs), and Medically Significant Conditions (MSCs)

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    End point title
    		 Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset autoimmune diseases (NOADs), serious adverse events (SAEs), and Medically Significant Conditions (MSCs)
    End point description
    Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6. NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses. An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    During the entire study period (up to Month 18 or up to Month 12)
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    403
    401
    Units: Subjects
        MSCs
    42
    44
        NOCDs
    0
    5
        NOADs
    0
    2
        SAEs
    12
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with pregnancies and their outcomes

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    End point title
    		 Number of subjects with pregnancies and their outcomes
    End point description
    Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6 Number of pregnancies and pregnancy outcomes.
    End point type
    Secondary
    End point timeframe
    During the entire study period (up to Month 18 or Month 12)
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    5
    3
    Units: Subjects
        Normal infant
    2
    1
        Elective abortion
    0
    2
        Abortion threatened
    1
    0
        Ongoing
    1
    0
        Foetal distress syndrome
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects completing the 3-dose vaccination schedule

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    End point title
    		 Number of subjects completing the 3-dose vaccination schedule
    End point description
    End point type
    Secondary
    End point timeframe
    After the third vaccine dose
    End point values
    		 Cervarix-12 Group Cervarix-6 Group
    Number of subjects analysed
    403
    401
    Units: Subjects
        D3
    388
    397
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    - Solicited local and general symptoms: during the 7 day - (Day 0-Day 6) after each vaccination. - Unsolicited adverse events: during the 30 day (Day 0 - Day 29) after each vaccination. - Serious adverse event: up to Month 12 and up to Month 18.
    Adverse event reporting additional description
    Analysis for other adverse events were performed on the Total vaccinated cohort, on subjects with available data.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Cervarix-6 Group
    Reporting group description
    		 Women received 3 doses of Cervarix (HPV vaccine) administered according to a 0, 1, 6-month schedule.

    Reporting group title
    Cervarix-12 Group
    Reporting group description
    		 Women received 3 doses of Cervarix (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.

    Serious adverse events
    		 Cervarix-6 Group Cervarix-12 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 401 (2.24%)
    12 / 403 (2.98%)
         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)
    Breast cancer female
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion threatened
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cephalhaematoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foetal distress syndrome
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         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
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Brain hypoxia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroiditis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chondropathy
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cervarix-6 Group Cervarix-12 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    389 / 401 (97.01%)
    388 / 403 (96.28%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    386 / 401 (96.26%)
    385 / 403 (95.53%)
         occurrences all number
    386
    385
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    182 / 401 (45.39%)
    201 / 403 (49.88%)
         occurrences all number
    182
    201
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    145 / 401 (36.16%)
    158 / 403 (39.21%)
         occurrences all number
    145
    158
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    78 / 401 (19.45%)
    85 / 403 (21.09%)
         occurrences all number
    78
    85
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    237 / 401 (59.10%)
    245 / 403 (60.79%)
         occurrences all number
    237
    245
    Temperature ≥ 37.5°C
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 401 (7.23%)
    37 / 403 (9.18%)
         occurrences all number
    29
    37
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed
    86 / 401 (21.45%)
    85 / 403 (21.09%)
         occurrences all number
    86
    85
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    199 / 401 (49.63%)
    203 / 403 (50.37%)
         occurrences all number
    199
    203
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    168 / 401 (41.90%)
    167 / 403 (41.44%)
         occurrences all number
    168
    167
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 401 (8.48%)
    30 / 403 (7.44%)
         occurrences all number
    34
    30

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

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

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