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    Clinical Trial Results:
    Determination of the human papillomavirus (HPV)-specific antibody status in oral fluids of individuals vaccinated with a quadrivalent HPV vaccine

    Summary
    EudraCT number
    		 2008-008605-22
    Trial protocol
    		 AT  
    Global end of trial date
    01 Jun 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Prof Dr Reinhard Kirnbauer, Medical University of Vienna, +43 14040077680, reinhard.kirnbauer@meduniwien.ac.at
    Scientific contact
    Prof Dr Reinhard Kirnbauer, Medical University of Vienna, +43 14040077680, reinhard.kirnbauer@meduniwien.ac.at
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determination of the human papillomavirus (HPV)-specific antibody status in oral fluids of individuals vaccinated with the quadrivalent HPV vaccine Gardasil
    Protection of trial subjects
    Anonymization
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2009
    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
    Austria: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    0
    Adults (18-64 years)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 female students

    Pre-assignment
    Screening details
    		 questionning of elegible participants: inclusion if less than 4 life-long sexual partners and no antecedent history of anogenital warts, anogenital dysplasia and cancer and abnormal PAP smear

    Pre-assignment period milestones
    Number of subjects started
    		 34
    Number of subjects completed
    		 34

    Period 1
    Period 1 title
    Recruitment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    n.a.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 vaccinees
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gardasil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 ml in month 0, 2 and 6 intramuscular

    Arm title
    		 control
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		vaccinees control
    Started
    20
    14
    Completed
    20
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Recruitment
    Reporting group description
    		 -

    Reporting group values
    		 Recruitment Total
    Number of subjects
    		 34 34
    Age categorical
    adults
    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)
    		 0 0
        Adults (18-64 years)
    		 34 34
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    adults
    Units: years
        arithmetic mean (standard deviation)
    		 23.2 ( 4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    all participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    OMT and blood samples of all participants

    Subject analysis sets values
    		 all participants
    Number of subjects
    34
    Age categorical
    adults
    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)
    34
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    adults
    Units: years
        arithmetic mean (standard deviation)
    23.2 ( 4 )
    Gender categorical
    Units: Subjects
        Female
    34
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    vaccinees
    Reporting group description
    		 -

    Reporting group title
    control
    Reporting group description
    		 -

    Subject analysis set title
    all participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    OMT and blood samples of all participants

    Primary: change in titers

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    End point title
    		 change in titers
    End point description
    End point type
    Primary
    End point timeframe
    one month after final vaccination
    End point values
    		 vaccinees control
    Number of subjects analysed
    20
    14
    Units: all participants
    20
    14
    Statistical analysis title
    		 differences
    Comparison groups
    control v vaccinees
    Number of subjects included in analysis
    34
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    all participants
    Reporting group description
    		 -

    Serious adverse events
    		 all participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 all participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 34 (8.82%)
    Skin and subcutaneous tissue disorders
    Local reaction
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26867163
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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