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    Clinical Trial Results:
    A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ combined reduced-antigen diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Boostrix® Polio) in healthy female subjects aged 10–18 years.

    Summary
    EudraCT number
    		 2006-003807-38
    Trial protocol
    		 DE   FR   ES  
    Global end of trial date
    25 Jul 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    22 Feb 2021
    First version publication date
    22 Nov 2014
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

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    Trial identification
    Sponsor protocol code
    108464
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00426361
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, 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
    25 Jul 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate non-inferiority of the dTpa-IPV immune response at Month 1 when dTpa-IPV is co-administered with HPV-16/18 L1 AS04 vaccine at Month 0 compared to when dTpa-IPV is administered alone at Month 0.
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 262
    Country: Number of subjects enrolled
    France: 183
    Country: Number of subjects enrolled
    Germany: 306
    Worldwide total number of subjects
    751
    EEA total number of subjects
    751
    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)
    751
    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
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    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 Group
    Arm description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals’ HPV-16/18 L1 AS04 vaccine (Cervarix TM)
    Investigational medicinal product code
    Cervarix TM
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively

    Arm title
    		 Cervarix + Boostrix Polio Group
    Arm description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boostrix ® Polio
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    One dose of vaccine administered intramuscularly

    Investigational medicinal product name
    GSK Biologicals’ HPV-16/18 L1 AS04 vaccine (Cervarix TM)
    Investigational medicinal product code
    Cervarix TM
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively

    Arm title
    		 Boostrix Polio → Cervarix Group
    Arm description
    		 Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals’ HPV-16/18 L1 AS04 vaccine (Cervarix TM)
    Investigational medicinal product code
    Cervarix TM
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively

    Investigational medicinal product name
    Boostrix ® Polio
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    One dose of vaccine administered intramuscularly

    Number of subjects in period 1
    		Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Started
    248
    255
    248
    Completed
    244
    250
    243
    Not completed
    4
    5
    5
         Consent withdrawn by subject
    1
    3
    -
         Lost to follow-up
    3
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.

    Reporting group title
    Cervarix + Boostrix Polio Group
    Reporting group description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.

    Reporting group title
    Boostrix Polio → Cervarix Group
    Reporting group description
    		 Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.

    Reporting group values
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group Total
    Number of subjects
    		 248 255 248 751
    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
        median (standard deviation)
    		 13.9 ± 2.59 14 ± 2.43 13.9 ± 2.47 -
    Gender categorical
    Units: Subjects
        Female
    		 248 255 248 751
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.

    Reporting group title
    Cervarix + Boostrix Polio Group
    Reporting group description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.

    Reporting group title
    Boostrix Polio → Cervarix Group
    Reporting group description
    		 Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.

    Primary: Number of subjects seroprotected against diphtheria and tetanus

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    End point title
    		 Number of subjects seroprotected against diphtheria and tetanus [1] [2]
    End point description
    Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
    End point type
    Primary
    End point timeframe
    One month after vaccination with Boostrix Polio
    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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    240
    233
    Units: Subjects
        Diphtheria
    238
    233
        Tetanus
    240
    233
    No statistical analyses for this end point

    Primary: Titers of anti-pertussis toxoid (anti-PT), anti-pertactin toxoid (anti-PRN) and anti-filamentous hemagglutinin (anti-FHA) antibodies

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    End point title
    		 Titers of anti-pertussis toxoid (anti-PT), anti-pertactin toxoid (anti-PRN) and anti-filamentous hemagglutinin (anti-FHA) antibodies [3] [4]
    End point description
    Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    One month after vaccination with Boostrix Polio
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [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: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    240
    233
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT (n=238, 229)
    84.2 (73.6 to 96.4)
    75.4 (65.6 to 86.8)
        Anti-FHA (n=240, 233)
    611.7 (553.6 to 675.9)
    615.2 (552.3 to 685.2)
        Anti-PRN (n=239, 233)
    426.2 (368.1 to 493.4)
    360 (299.3 to 433.1)
    No statistical analyses for this end point

    Primary: Number of subjects seroprotected against Poliovirus type 1 (Polio 1), Polio 2 and Polio 3

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    End point title
    		 Number of subjects seroprotected against Poliovirus type 1 (Polio 1), Polio 2 and Polio 3 [5] [6]
    End point description
    Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).
    End point type
    Primary
    End point timeframe
    One month after vaccination with Boostrix Polio
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    240
    232
    Units: Subjects
        Polio 1 (n=240, 231)
    239
    231
        Polio 2 (n=240, 232)
    240
    232
        Polio 3 (n=239, 232)
    239
    232
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies after completing the Cervarix vaccination course

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    End point title
    		 Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies after completing the Cervarix vaccination course
    End point description
    Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 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
    Secondary
    End point timeframe
    One month post Cervarix Dose 3 (Month 7/8)
    End point values
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    198
    204
    204
    Units: Subjects
        Anti-HPV-16 (n=198, 202, 204)
    198
    201
    204
        Anti-HPV-18 (n=191, 204, 203)
    191
    203
    203
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies after incomplete Cervarix vaccination course

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    End point title
    		 Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies after incomplete Cervarix vaccination course [7]
    End point description
    Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 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
    Secondary
    End point timeframe
    One month post Cervarix Dose 1
    Notes
    [7] - 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: Only subjects who had received HPV vaccination were included in the analysis.
    End point values
    		 Cervarix Group Cervarix + Boostrix Polio Group
    Number of subjects analysed
    198
    204
    Units: Subjects
        Anti-HPV-16 (n=198, 202)
    198
    201
        Anti-HPV-18 (n=191, 204)
    191
    203
    No statistical analyses for this end point

    Secondary: Titers of anti-human Papilloma virus 16 (anti-HPV-16) and anti-human Papilloma virus 18 (anti-HPV-18) antibodies After Completing the Cervarix Vaccination Course

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    End point title
    		 Titers of anti-human Papilloma virus 16 (anti-HPV-16) and anti-human Papilloma virus 18 (anti-HPV-18) antibodies After Completing the Cervarix Vaccination Course
    End point description
    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    One month post Cervarix Dose 3 (Month 7/8)]
    End point values
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    213
    222
    218
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16 (n= 213, 222, 218)
    18363.6 (16243 to 20761)
    15370.2 (13350.9 to 17694.8)
    14089.5 (12460.9 to 15930.9)
        Anti-HPV-18 (n= 210, 218, 216)
    7032.8 (6220.7 to 7950.9)
    6630.4 (5768 to 7621.6)
    5135 (4537.3 to 5811.5)
    No statistical analyses for this end point

    Secondary: Titers of anti-diphtheria and anti-tetanus antibodies

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    End point title
    		 Titers of anti-diphtheria and anti-tetanus antibodies [8]
    End point description
    Titers are given as Geometric Mean Titers (GMTs) and expressed as IU/mL.
    End point type
    Secondary
    End point timeframe
    One month after vaccination with Boostrix-Polio
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    240
    233
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria
    5.085 (4.551 to 5.681)
    5.466 (4.896 to 6.103)
        Anti-tetanus
    8.552 (7.889 to 9.272)
    9.039 (8.321 to 9.818)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria and anti-tetanus antibody titers above 1.0 International Units per Milliliter (IU/mL)

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    End point title
    		 Number of subjects with anti-diphtheria and anti-tetanus antibody titers above 1.0 International Units per Milliliter (IU/mL) [9]
    End point description
    Anti-diphtheria and anti-tetanus antibodies cut-off value assessed include 1.0 IU/mL.
    End point type
    Secondary
    End point timeframe
    One month after vaccination with Boostrix Polio
    Notes
    [9] - 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: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    240
    233
    Units: Subjects
        Anti-diphtheria
    231
    226
        Anti-tetanus
    239
    233
    No statistical analyses for this end point

    Secondary: Anti-poliovirus type 1 (anti-polio 1), anti-polio 2 and anti-polio 3 antibody titers

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    End point title
    		 Anti-poliovirus type 1 (anti-polio 1), anti-polio 2 and anti-polio 3 antibody titers [10]
    End point description
    Titers are given as Geometric Mean Titers (GMTs). The titer is a serum dilution giving 50 percent reduction of signal compared to control without serum.
    End point type
    Secondary
    End point timeframe
    One month after vaccination with Boostrix Polio
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    240
    232
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-polio 1 (n=240, 231)
    2045.1 (1714.7 to 2439.2)
    2390.5 (2021.4 to 2826.9)
        Anti-polio 2 (n=240, 232)
    2151.1 (1806.5 to 2561.6)
    2158.1 (1821.3 to 2557.1)
        Anti-polio 3 (n=239, 232)
    2777.2 (2376.5 to 3245.4)
    2732.5 (2318 to 3221.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with booster response to diphtheria and tetanus

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    End point title
    		 Number of subjects with booster response to diphtheria and tetanus [11]
    End point description
    Booster responses to diphtheria and tetanus were defined as: - For initially seronegative subjects (pre-vaccination titer below cut-off value of 0.1 International Units per Milliliter): antibody titers at least four times the cut-off (post-vaccination titer greater than or equal to 0.4 IU/mL), and - For initially seropositive subjects (pre-vaccination titer greater than or equal to 0.1 IU/mL): an increase in antibody titers of at least four times the pre-vaccination titer.
    End point type
    Secondary
    End point timeframe
    One month after vaccination with Boostrix Polio
    Notes
    [11] - 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: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    240
    232
    Units: Subjects
        Diphtheria
    160
    159
        Tetanus
    167
    161
    No statistical analyses for this end point

    Secondary: Number of subjects with booster response to pertussis toxoid (PT), pertactin toxoid (PRN) and filamentous hemagglutinin (FHA)

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    End point title
    		 Number of subjects with booster response to pertussis toxoid (PT), pertactin toxoid (PRN) and filamentous hemagglutinin (FHA) [12]
    End point description
    Booster response to PT, FHA and PRN were defined as: - For initially seronegative subjects [pre-vaccination titer below cut-off value of 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)]: antibody titers at least 4 times the cut-off, - For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer, - For initially seropositive subjects with pre-vaccination titer above 20 EL.U/mL: an increase in antibody titers of at least 2 times the pre-vaccination titer.
    End point type
    Secondary
    End point timeframe
    One month after vaccination with Boostrix Polio
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only subjects who had received DTPa vaccination were included in the analysis.
    End point values
    		 Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    238
    230
    Units: Subjects
        PT (n=236, 228)
    199
    182
        FHA (n=235, 226)
    210
    205
        PRN (n=238, 230)
    222
    207
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited symptoms

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    End point title
    		 Number of subjects reporting solicited symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.
    End point type
    Secondary
    End point timeframe
    During the 7-day period (Day 0-6) following each vaccination
    End point values
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    246
    253
    247
    Units: Subjects
        Pain
    225
    237
    233
        Redness
    110
    128
    140
        Swelling
    124
    125
    123
        Arthralgia
    58
    71
    77
        Fatigue
    109
    135
    121
        Fever
    30
    46
    37
        Gastrointestinal symptoms
    51
    63
    61
        Headache
    111
    138
    122
        Myalgia
    107
    144
    127
        Rash
    20
    27
    17
        Urticaria
    12
    11
    15
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events

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    End point title
    		 Number of subjects reporting unsolicited adverse events
    End point description
    Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    During the 30-day period (Day 0-29) following vaccination
    End point values
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    248
    255
    248
    Units: Subjects
        unsolicited adverse events
    85
    74
    99
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)

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    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)
    End point description
    NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
    End point type
    Secondary
    End point timeframe
    During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)
    End point values
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    248
    255
    248
    Units: Subjects
        NOCDs [Active phase] (n=248, 255, 248)
    5
    9
    9
        NOCDs [Safety follow-up] (n=244, 250, 243)
    0
    0
    0
        MSAEs [Active phase] (n=248, 255, 248)
    35
    27
    49
        MSAEs [Safety follow-up] (n=244, 250, 243)
    7
    3
    5
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs)

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    Serious adverse events assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)
    End point values
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Number of subjects analysed
    248
    255
    248
    Units: Subjects
        Active phase (n=248, 255, 248)
    2
    4
    2
        Safety follow-up (n=244, 250, 243)
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Other (non-serious) adverse events: During the 7 day follow-up period after any vaccination. SAEs: During the entire study period (12 months for Cervarix and Cervarix + Boostrix Polio groups and 13 months for Boostrix Polio → Cervarix group).
    Adverse event reporting additional description
    For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Cervarix Group
    Reporting group description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.

    Reporting group title
    Cervarix + Boostrix Polio Group
    Reporting group description
    		 Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.

    Reporting group title
    Boostrix Polio → Cervarix Group
    Reporting group description
    		 Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.

    Serious adverse events
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 248 (1.21%)
    4 / 255 (1.57%)
    3 / 248 (1.21%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Muscle rupture
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 255 (0.39%)
    0 / 248 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 255 (0.00%)
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Imminent abortion
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 255 (0.39%)
    0 / 248 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 255 (0.00%)
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 255 (0.00%)
    0 / 248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 255 (0.00%)
    0 / 248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Scoliosis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 255 (0.39%)
    0 / 248 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 255 (0.39%)
    0 / 248 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 255 (0.00%)
    0 / 248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis streptococcal
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 255 (0.00%)
    1 / 248 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    232 / 248 (93.55%)
    245 / 255 (96.08%)
    242 / 248 (97.58%)
    Nervous system disorders
    Headache (unsolicited AE)
         subjects affected / exposed
    4 / 248 (1.61%)
    6 / 255 (2.35%)
    14 / 248 (5.65%)
         occurrences all number
    4
    6
    14
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    225 / 246 (91.46%)
    237 / 253 (93.68%)
    233 / 247 (94.33%)
         occurrences all number
    225
    237
    233
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    110 / 246 (44.72%)
    128 / 253 (50.59%)
    140 / 247 (56.68%)
         occurrences all number
    110
    128
    140
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    124 / 246 (50.41%)
    125 / 253 (49.41%)
    123 / 247 (49.80%)
         occurrences all number
    124
    125
    123
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    58 / 246 (23.58%)
    71 / 253 (28.06%)
    77 / 247 (31.17%)
         occurrences all number
    58
    71
    77
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    109 / 246 (44.31%)
    135 / 253 (53.36%)
    121 / 247 (48.99%)
         occurrences all number
    109
    135
    121
    Fever (above 37.5 degree Celsius)
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    30 / 246 (12.20%)
    46 / 253 (18.18%)
    37 / 247 (14.98%)
         occurrences all number
    30
    46
    37
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    51 / 246 (20.73%)
    63 / 253 (24.90%)
    61 / 247 (24.70%)
         occurrences all number
    51
    63
    61
    Headache (solicited general symptom AE)
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    111 / 246 (45.12%)
    138 / 253 (54.55%)
    122 / 247 (49.39%)
         occurrences all number
    111
    138
    122
    Myalgia
         subjects affected / exposed [9]
    107 / 246 (43.50%)
    144 / 253 (56.92%)
    127 / 247 (51.42%)
         occurrences all number
    107
    144
    127
    Rash
         subjects affected / exposed [10]
    20 / 246 (8.13%)
    27 / 253 (10.67%)
    17 / 247 (6.88%)
         occurrences all number
    20
    27
    17
    Urticaria
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    12 / 246 (4.88%)
    11 / 253 (4.35%)
    15 / 247 (6.07%)
         occurrences all number
    12
    11
    15
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 248 (5.65%)
    4 / 255 (1.57%)
    10 / 248 (4.03%)
         occurrences all number
    14
    4
    10
    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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with 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 subjects with symptom sheets completed.

    More information

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

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

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