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    Clinical Trial Results:
    Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years.

    Summary
    EudraCT number
    		 2014-003177-42
    Trial protocol
    		 DK   ES   BE   FI   SI   NL   SE  
    Global end of trial date
    30 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2020
    First version publication date
    01 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    COHEAHR-WP4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02837926
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Catalan Institute of Oncology
    Sponsor organisation address
    Av. Gran Via de l'Hospitalet 199-203, L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    Public contact
    Laia Bruni, Catalan Institute of Oncology, +34 932607812, coheahr-@wp4iconcologia.net
    Scientific contact
    Xavier Bosch, Catalan Institute of Oncology, +34 932607812, coheahr-@wp4iconcologia.net
    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
    01 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) Assessment of uptake and compliance of HPV vaccination by women aged 25-45 years attending routine cervical cancer screening. 2) Identification of local determinants of HPV vaccine acceptability, and of logistic and programmatic issues associated with HPV vaccination of adult women, such as which information should be provided to women that are offered the vaccine and how should that information be offered.
    Protection of trial subjects
    All HPV vaccines administered to study subjects are approved and commercialized treatments. Therefore, measures taken to protect subjects were those of routine medical care.
    Background therapy
    		 There was no other study therapy apart from HPV vaccine administration.
    Evidence for comparator
    		 No comparator to HPV vaccine was used in this study.
    Actual start date of recruitment
    12 Apr 2016
    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
    United Kingdom: 434
    Country: Number of subjects enrolled
    France: 63
    Country: Number of subjects enrolled
    Germany: 323
    Country: Number of subjects enrolled
    Belgium: 308
    Country: Number of subjects enrolled
    Denmark: 347
    Country: Number of subjects enrolled
    Finland: 510
    Country: Number of subjects enrolled
    Slovenia: 610
    Country: Number of subjects enrolled
    Spain: 693
    Country: Number of subjects enrolled
    Sweden: 360
    Worldwide total number of subjects
    3648
    EEA total number of subjects
    3648
    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)
    3648
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrollment period: April 2016 - May 2018. Enrollment strategies: - Population-based (Denmark, Sweden). Women were invited by postal mail through cervical cancer screening registration lists. - Convenience (all other countries). Women were invited directly in cervical cancer screening clinics or private practices during their screening visit.

    Pre-assignment
    Screening details
    		 Eligible subjects were adult women aged 25-45 attending cervical cancer screening, non-HPV-vaccinated. Eligible subjects for HPV vaccinated were not pregnant or planning to be, with no history of allergy to vaccine components, immune disease or hysterectomy.

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

    Arms
    Arm title
    		 Single arm
    Arm description
    		 Study with a single arm in which all participating subjects completed a questionnaire assessing HPV vaccine acceptance. In all countries except the United Kingdom, women accepting HPV vaccine were offered to get it administered for free.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cervarix (HPV vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1.5 millilitres at 0, 1 and 6 months

    Investigational medicinal product name
    Gardasil (HPV vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1.5 millilitres at 0, 2 and 6 months

    Investigational medicinal product name
    Gardasil 9 (HPV vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1.5 millilitres at 0,2 and 6 months

    Number of subjects in period 1
    		Single arm
    Started
    3648
    Completed
    3648

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 3648 3648
    Age categorical
    Adult women within the age range of 25-45 attending cervical cancer screening with no previous history of HPV vaccine administration
    Units: Subjects
        Aged <30 yrs
    		 924 924
        Aged 30-34 yrs
    		 916 916
        Aged 35-39 yrs
    		 887 887
        Aged >39 yrs
    		 911 911
        No questionnaire
    		 10 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.3 ± 6.13 -
    Gender categorical
    Units: Subjects
        Female
    		 3648 3648
        Male
    		 0 0
    Countries
    Units: Subjects
        Belgium
    		 308 308
        Denmark
    		 347 347
        Finland
    		 510 510
        France
    		 63 63
        Germany
    		 323 323
        Slovenia
    		 610 610
        Spain
    		 693 693
        Sweden
    		 360 360
        United Kingdom
    		 434 434
    Subject analysis sets

    Subject analysis set title
    Entire Cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Total number of eligible study subjects that participated in the study by filling the questionnaire or accepting to receive HPV vaccination. All countries

    Subject analysis set title
    Entire Cohort (Compliance)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Total number of eligible study subjects that participated in the study by filling the questionnaire or accepting to receive HPV vaccinationin countries where HPV vaccine was administered as part of the study. Therefore, it does not include subjects from the United Kingdom.

    Subject analysis set title
    Safety cohort
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Total number of subjects that returned the self-reported safety card and/or reported AEs after the 6-month follow-up period out of those that received at least one dose of HPV vaccine (n=2151)

    Subject analysis sets values
    		 Entire Cohort Entire Cohort (Compliance) Safety cohort
    Number of subjects
    3648
    3214
    1921
    Age categorical
    Adult women within the age range of 25-45 attending cervical cancer screening with no previous history of HPV vaccine administration
    Units: Subjects
        Aged <30 yrs
    924
    924
    669
        Aged 30-34 yrs
    916
    776
    427
        Aged 35-39 yrs
    887
    752
    402
        Aged >39 yrs
    911
    752
    418
        No questionnaire
    10
    0
    5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.3 ± 6.13
    33.9 ± 6.17
    33.2 ± 6.36
    Gender categorical
    Units: Subjects
        Female
    3648
    3214
    1921
        Male
    0
    0
    0
    Countries
    Units: Subjects
        Belgium
    308
    308
    197
        Denmark
    347
    347
    144
        Finland
    510
    510
    425
        France
    63
    63
    22
        Germany
    323
    323
    188
        Slovenia
    610
    610
    303
        Spain
    693
    693
    538
        Sweden
    360
    360
    103
        United Kingdom
    434
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 Study with a single arm in which all participating subjects completed a questionnaire assessing HPV vaccine acceptance. In all countries except the United Kingdom, women accepting HPV vaccine were offered to get it administered for free.

    Subject analysis set title
    Entire Cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Total number of eligible study subjects that participated in the study by filling the questionnaire or accepting to receive HPV vaccination. All countries

    Subject analysis set title
    Entire Cohort (Compliance)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Total number of eligible study subjects that participated in the study by filling the questionnaire or accepting to receive HPV vaccinationin countries where HPV vaccine was administered as part of the study. Therefore, it does not include subjects from the United Kingdom.

    Subject analysis set title
    Safety cohort
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Total number of subjects that returned the self-reported safety card and/or reported AEs after the 6-month follow-up period out of those that received at least one dose of HPV vaccine (n=2151)

    Primary: HPV Vaccine Uptake

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    End point title
    		 HPV Vaccine Uptake [1]
    End point description
    Number of study subjects in each participating country that received at least the 1st dose of vaccine.
    End point type
    Primary
    End point timeframe
    Baseline
    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: Not applicable. Only proportions were estimated.
    End point values
    		 Single arm Entire Cohort
    Number of subjects analysed
    2567
    2567
    Units: Subjects
        Belgium
    238
    238
        Denmark
    145
    145
        Finland
    443
    443
        France
    50
    50
        Germany
    299
    299
        Slovenia
    303
    303
        Spain
    564
    564
        Sweden
    109
    109
        United Kingdom
    416
    416
    No statistical analyses for this end point

    Primary: HPV Vaccine Compliance

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    End point title
    		 HPV Vaccine Compliance [2]
    End point description
    Number of study subjects in each participating country that received all three doses of vaccine.
    End point type
    Primary
    End point timeframe
    One year for all study participants except for pregnant women who temporarily interrupted the vaccine schedule.
    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: Not applicable. Only proportions were estimated.
    End point values
    		 Single arm Entire Cohort (Compliance)
    Number of subjects analysed
    1958
    1958
    Units: subjects
        Belgium
    204
    204
        Denmark
    141
    141
        Finland
    421
    421
        France
    29
    29
        Germany
    254
    254
        Slovenia
    290
    290
        Spain
    513
    513
        Sweden
    106
    106
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6 months after administration of the third dose of HPV vaccine
    Adverse event reporting additional description
    AEs reported by vaccinated subjects that either returned the self-reported safety card and/or provided data on the 6-month follow-up period (Safety dataset)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Cervarix
    Reporting group description
    		 Subjects from Spain, Finland and Belgium that received Cervarix HPV vaccine and subsequently reported data on adverse events.

    Reporting group title
    Gardasil
    Reporting group description
    		 Subjects from Denmark, France and Germany that received Gardasil HPV vaccine and subsequently reported data on adverse events.

    Reporting group title
    Gardasil 9
    Reporting group description
    		 Subjects from Spain, Finland, Sweden and Slovenia that received Gardsail 9 HPV vaccine and subsequently reported data on adverse events.

    Serious adverse events
    		 Cervarix Gardasil Gardasil 9
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 738 (0.27%)
    0 / 355 (0.00%)
    0 / 828 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Skull fracture
    Additional description: Study participant was hospitalised due to a skull fracture caused by a bike accident
         subjects affected / exposed
    1 / 738 (0.14%)
    0 / 355 (0.00%)
    0 / 828 (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
    Vascular disorders
    Intracranial venous sinus thrombosis
    Additional description: Study participant hospitalised due to sinus thrombosis related to acute sinusitis, tobacco consumption and birth control pills use.
         subjects affected / exposed
    1 / 738 (0.14%)
    0 / 355 (0.00%)
    0 / 828 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Cervarix Gardasil Gardasil 9
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    308 / 738 (41.73%)
    117 / 355 (32.96%)
    244 / 828 (29.47%)
    Injury, poisoning and procedural complications
    Injection site induration
         subjects affected / exposed
    8 / 738 (1.08%)
    0 / 355 (0.00%)
    0 / 828 (0.00%)
         occurrences all number
    9
    0
    0
    Vaccination site pain
         subjects affected / exposed
    170 / 738 (23.04%)
    34 / 355 (9.58%)
    127 / 828 (15.34%)
         occurrences all number
    299
    55
    232
    vaccination site swelling
         subjects affected / exposed
    7 / 738 (0.95%)
    7 / 355 (1.97%)
    22 / 828 (2.66%)
         occurrences all number
    8
    10
    27
    Nervous system disorders
    dizziness
         subjects affected / exposed
    13 / 738 (1.76%)
    10 / 355 (2.82%)
    0 / 828 (0.00%)
         occurrences all number
    14
    14
    0
    Headache
         subjects affected / exposed
    41 / 738 (5.56%)
    23 / 355 (6.48%)
    27 / 828 (3.26%)
         occurrences all number
    49
    37
    39
    Migraine
         subjects affected / exposed
    7 / 738 (0.95%)
    4 / 355 (1.13%)
    0 / 828 (0.00%)
         occurrences all number
    8
    10
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    18 / 738 (2.44%)
    16 / 355 (4.51%)
    14 / 828 (1.69%)
         occurrences all number
    26
    22
    14
    Pyrexia
         subjects affected / exposed
    13 / 738 (1.76%)
    9 / 355 (2.54%)
    33 / 828 (3.99%)
         occurrences all number
    19
    11
    44
    Influenza like illness
         subjects affected / exposed
    0 / 738 (0.00%)
    9 / 355 (2.54%)
    9 / 828 (1.09%)
         occurrences all number
    0
    11
    11
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 738 (0.95%)
    4 / 355 (1.13%)
    10 / 828 (1.21%)
         occurrences all number
    8
    4
    12
    Nausea
         subjects affected / exposed
    0 / 738 (0.00%)
    12 / 355 (3.38%)
    6 / 828 (0.72%)
         occurrences all number
    0
    14
    9
    Vomiting
         subjects affected / exposed
    0 / 738 (0.00%)
    4 / 355 (1.13%)
    0 / 828 (0.00%)
         occurrences all number
    0
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 738 (1.08%)
    0 / 355 (0.00%)
    8 / 828 (0.97%)
         occurrences all number
    8
    0
    12
    Oropharyngeal pain
         subjects affected / exposed
    12 / 738 (1.63%)
    4 / 355 (1.13%)
    19 / 828 (2.29%)
         occurrences all number
    15
    5
    23
    Skin and subcutaneous tissue disorders
    Injection site erythema
         subjects affected / exposed
    9 / 738 (1.22%)
    0 / 355 (0.00%)
    9 / 828 (1.09%)
         occurrences all number
    10
    0
    17
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    24 / 738 (3.25%)
    0 / 355 (0.00%)
    0 / 828 (0.00%)
         occurrences all number
    35
    0
    0
    Pain in extremity
         subjects affected / exposed
    19 / 738 (2.57%)
    14 / 355 (3.94%)
    16 / 828 (1.93%)
         occurrences all number
    21
    20
    25
    Musculoskeletal pain
         subjects affected / exposed
    0 / 738 (0.00%)
    1 / 355 (0.28%)
    0 / 828 (0.00%)
         occurrences all number
    0
    5
    0
    Myalgia
         subjects affected / exposed
    0 / 738 (0.00%)
    5 / 355 (1.41%)
    0 / 828 (0.00%)
         occurrences all number
    0
    6
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    52 / 738 (7.05%)
    0 / 355 (0.00%)
    49 / 828 (5.92%)
         occurrences all number
    82
    0
    83

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Sep 2015
    The marketing authorization in Europe of the 9-valent vaccine (Gardasil 9®) by centralised procedure was approved by the European Commission on 10th June 2015. Participating countries originally planned to use Gardasil® (see Table 5, Section C4) were offered the possibility to use Gardasil 9® instead.
    13 Feb 2017
    Due to changes in the screening programmes of United Kingdom, Italy and the Netherlands, the participation of these countries in the interventional part of the study was not feasible. Instead, UK conducted an observational study using the baseline questionnaire to assess vaccine acceptance. Moreover, the number of patients to be recruited in Spain was increased, from 300 to 500, in order to maintain the total sample size of the study.
    07 Apr 2017
    Cervarix® will be used in Finland for 250 addiitonal women to be enrolled during 2017.

    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.
    Potential misrepresentation of general population due to low participation rate among women invited by postal mail (Denmark and Sweden) and over-representation of highly health-concerned / seeking free vaccination women invited in health centers
    For support, Contact us.
    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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