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    Clinical Trial Results:
    A phase III, open-label, mono-centre, follow-up extension study to evaluate the persistence of immune response to GSK Biologicals’ HPV vaccine in healthy Chinese female subjects who received three doses of the vaccine in the HPV-058 study

    Summary
    EudraCT number
    		 2017-000255-50
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Jun 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Dec 2020
    First version publication date
    19 May 2019
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor changes implemented in the full study results to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    207347
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03355820
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 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
    20 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune response against HPV types 16 and 18 [as determined by Enzyme Linked Immunosorbent Assay (ELISA)] 7 to 8 years after completion of the vaccination schedule in the HPV-058 study.
    Protection of trial subjects
    All subjects were followed up for reporting of serious adverse events (SAEs) that were related to study participation (i.e. protocol-mandated procedures) or to a concurrent GSK medication/vaccine. Data were collected and recorded from the time the subject consented to participate in the study until the end of participation in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 227
    Worldwide total number of subjects
    227
    EEA total number of subjects
    0
    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)
    7
    Adults (18-64 years)
    220
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at a single center in China.

    Pre-assignment
    Screening details
    		 228 subjects were included in the Enrolled Set, 1 subject was excluded from all statistical analyses, thus 227 subjects formed the Exposed Set.

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

    Arms
    Arm title
    		 HPV Group
    Arm description
    		 Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    In order to assess the persistence of immune responses seven to eight years after the last vaccine dose in the primary study, a blood sample was taken from all the subjects at Day 1 in the present study. No vaccine was administered in this extension study. Subjects received 3 doses of the Cervarix vaccine administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the primary study HPV-058 (NCT00996125).

    Number of subjects in period 1
    		HPV Group
    Started
    227
    Completed
    227

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HPV Group
    Reporting group description
    		 Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) study.

    Reporting group values
    		 HPV Group Total
    Number of subjects
    		 227 227
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 7 7
        Adults (18-64 years)
    		 220 220
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 21.6 ± 2.3 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 227 227
        Male
    		 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        Asian - East Asian Heritage
    		 227 227

    End points

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    End points reporting groups
    Reporting group title
    HPV Group
    Reporting group description
    		 Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) study.

    Primary: Number of seropositive subjects for anti-HPV-16 antibodies at Day 1 in HPV-093 (NCT03355820) study

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    End point title
    		 Number of seropositive subjects for anti-HPV-16 antibodies at Day 1 in HPV-093 (NCT03355820) study [1]
    End point description
    A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: Subjects
        Anti-HPV-16
    223
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-HPV-18 antibodies at Day 1 in HPV-093 (NCT03355820) study

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    End point title
    		 Number of seropositive subjects for anti-HPV-18 antibodies at Day 1 in HPV-093 (NCT03355820) study [2]
    End point description
    A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: Subjects
        Anti-HPV-18
    223
    No statistical analyses for this end point

    Primary: Anti-HPV-16 antibody concentrations at Day 1 in HPV-093 (NCT03355820) study

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    End point title
    		 Anti-HPV-16 antibody concentrations at Day 1 in HPV-093 (NCT03355820) study [3]
    End point description
    Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
    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.
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-16
    1236.3 (1121.8 to 1362.4)
    No statistical analyses for this end point

    Primary: Anti-HPV-18 antibody concentrations at Day 1 in HPV-093 (NCT03355820) study

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    End point title
    		 Anti-HPV-18 antibody concentrations at Day 1 in HPV-093 (NCT03355820) study [4]
    End point description
    Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-HPV-18
    535.6 (478.6 to 599.4)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-HPV-16 antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

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    End point title
    		 Number of seropositive subjects for anti-HPV-16 antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies
    End point description
    A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38, Row "≥19 EL.U/mL, sero-, [Month 72]" and Row "≥19 EL.U/mL, sero+, [Month 72]").
    End point type
    Secondary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: Subjects
        HPV-093, Day 1
    223
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-HPV-18 antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

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    End point title
    		 Number of seropositive subjects for anti-HPV-18 antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies
    End point description
    A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39, Row "≥ 18 EL.U/mL, sero- [Month 72]" and Row "≥ 18 EL.U/mL, sero+ [Month 72]).
    End point type
    Secondary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: Subjects
        HPV-093, Day 1
    223
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

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    End point title
    		 Concentration of antibodies against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies
    End point description
    Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-16, sero-, [Month 72]" and Row "HPV-16, sero+, [Month 72]").
    End point type
    Secondary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        HPV-093, Day 1
    1236.3 (1121.8 to 1362.4)
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies

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    End point title
    		 Concentration of antibodies against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) studies
    End point description
    Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-18, sero-, [Month 72]" and Row "HPV-18, sero+, [Month 72]").
    End point type
    Secondary
    End point timeframe
    At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study
    End point values
    		 HPV Group
    Number of subjects analysed
    223
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        HPV-093, Day 1
    535.6 (478.6 to 599.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At Day 1
    Adverse event reporting additional description
    There were no adverse events (AEs) data collected during the entire study period (i.e. at Day 1). Only SAEs related to study procedures or concomitant GSK medications/vaccines and events with a fatal outcome were recorded and collected during the entire study period (i.e. at Day 1).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    HPV Group
    Reporting group description
    		 Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) study.

    Serious adverse events
    		 HPV Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 227 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HPV Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 227 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no adverse events (AEs) data collected during the entire study period (i.e. at Day 1). Only SAEs related to study procedures or concomitant GSK medications/vaccines and events with a fatal outcome were recorded and collected during the entire study period (i.e. at Day 1).

    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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