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    Summary
    EudraCT Number:2014-003177-42
    Sponsor's Protocol Code Number:COHEAHR-WP4
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003177-42
    A.3Full title of the trial
    Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years
    Estudio multinacional para evaluar la aceptación a la vacunación frente a VPH en mujeres entre 25 y 45 años que acuden al cribado de cáncer de cuello uterino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in several countries to assess the proportion of adult women (25-45 yrs) who accept to receive the HPV vaccine, the reasons to accept it and how many of these women receive the three doses and why.
    A.4.1Sponsor's protocol code numberCOHEAHR-WP4
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCatalan Institute of Oncology
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Commission, 7 th framework programme
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportGlaxoSmithKline Biologicals S.A.
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportSanofi Pasteur MSD SNC.
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCatalan Institute of Oncology
    B.5.2Functional name of contact pointCoheaHr-WP4 Contact person
    B.5.3 Address:
    B.5.3.1Street AddressAv. Gran Via s/n , Km 2.7
    B.5.3.2Town/ cityL?Hospitalet de Llobregat ? Barcelona
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932607812
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cervarix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals s.a.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus type 16 L1 protein
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22593
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus type 18 L1 protein
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22594
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gardasil
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 6 L1 protein
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22591
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 11 L1 protein
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22592
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 16 L1 protein
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22593
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus1 Type 18 L1 protein
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22594
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cervical cancer
    Cancer de cérvix
    E.1.1.1Medical condition in easily understood language
    Tumor in the cervix
    Tumor en el cérvix o cuello uterino
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10056576
    E.1.2Term Cervical intraepithelial neoplasia
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main aim of the study is:
    - To assess the uptake and identify the determinants of acceptability of HPV vaccination by women attending routinely screening visits.
    - To identify any logistic and programmatic issues such as
    (i) which information and how it is provided to women when offered the HPV vaccine,
    (ii) where is the vaccine stored, who should administer it and how should be adequately monitored and
    (iii) which is the best country-specific approach
    since women identification from screening visits until she is vaccinated.

    The same objectives as above will be performed in a sub-study targeting under screened women in Spain.
    El objetivo principal del estudio es:
    - Estimar la aceptabilidad así como identificar los determinantes globales y locales de aceptabilidad de la vacunación frente a VPH por parte de mujeres que atienden de forma rutinaria a cribado de cuello uterino.
    - Identificar cualquier impedimento logístico y de programación, como pueden ser
    (i) qué información y cómo proporcionarla al ofrecer la vacuna de VPH,
    (ii) dónde se almacena la vacuna, quien debe administrarla y como se deben monitorizar
    adecuadamente los registros de la vacuna e
    (iii) identificar cual es el mejor procedimiento, por país,
    desde la identificación de mujeres elegibles mediante cribado hasta la administración de vacuna.

    Estos mismos objetivos se realizaran en un sub-estudio, únicamente en España, en mujeres con una baja participación a cribado de cuello uterino.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study include:
    - Estimation of compliance with 1-, 2- and 3- doses of HPV vaccine
    - Monitoring of any adverse effects in the targeted population

    The same objectives as above will be performed in a sub-study targeting under screened women in Spain.
    Los objetivos secundarios del estudio incluyen:
    - Estimar la adherencia a 1-, 2- y 3- dosis de vacuna frente a VPH
    - Monitorizar cualquier acontecimiento adverso en la población de estudio


    Estos mismos objetivos se realizaran en un sub-estudio, únicamente en España, en mujeres con una baja participación a cribado de cuello uterino.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult women within the age range of 24-45 attending cervical cancer screening with no previous history of HPV vaccine administration.
    In Spain, also, women aged 35-40 yrs old with no screening record in the preceding 5 years
    Mujeres adultas entre 24-45 años que participan en programas de cribado de cáncer de cuello uterino y que no han
    recibido previamente la vacuna frente a VPH.
    En España, además, mujeres con edades entre 30 y 45 años que no se hayan realizado ninguna prueba de cribado en los 5 años anteriores
    E.4Principal exclusion criteria
    1. Known history of severe allergic reaction or hypersensitivty to any of the components of the HPV vaccines.
    2. Known history of immune-related disorders
    3. Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever. When recovered, the vaccine can be administered
    4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
    5. Current pregnancy (reported), breast-feeding or planning to get pregnant in the coming 12 months.
    6. Hysterectomized women
    1. Historia previa de reacción alérgica o hipersensibilidad a alguno de los componentes de la vacuna.
    2. Historia previa de trastornos inmunes
    3. En el momento de administrar la vacuna, enfermedad aguda grave con fiebre, excepto en caso de infección leve como una infección respiratoria leve del tracto respiratorio superior o de fiebre leve. Una vez superado, la vacuna puede ser administrada.
    4. Administración de inmunoglobulina o productos derivados de la sangre en los 6 meses previos a la fecha programada para la primera dosis de vacuna.
    5. Embarazo actual (reportado), lactancia o embarazo planeado en los próximos 12 meses.
    6. Mujeres histerectomizadas
    E.5 End points
    E.5.1Primary end point(s)
    Uptake of HPV vaccine in eligible women, by country and age strata
    Aceptabilidad de la vacuna frente a VPH en mujeres elegibles, por país y por grupo de edad
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study
    Final del estudio
    E.5.2Secondary end point(s)
    Compliance of HPV vaccine administration schedule
    Adherencia al esquema de administración de la vacuna frente a VPH
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Final del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Drug uptake
    Adherence to drug administration schedule
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3250
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3250
    F.4.2.2In the whole clinical trial 3250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
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