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    Summary
    EudraCT Number:2012-002758-22
    Sponsor's Protocol Code Number:V503-003
    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:2012-08-23
    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 number2012-002758-22
    A.3Full title of the trial
    A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
    Ensayo clínico de fase III para estudiar la tolerabilidad y la inmunogenicidad de V503, una vacuna polivalente de partículas viroides (PV) L1 contra el virus del papiloma humano (VPH), en varones de 16 a 26 años y mujeres de 16 a 26 años
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study for V503 in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
    Estudio de V503 en varones de 16 a 26 años y mujeres de 16 a 26 años
    A.4.1Sponsor's protocol code numberV503-003
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number267 3051704
    B.5.5Fax number267 3056431
    B.5.6E-mailalain.luxembourg@merck.com
    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 No
    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.3.2Product code V503
    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 Nonavalent
    D.3.9.2Current sponsor codeV503
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 500
    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 No
    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
    Prevention of external genital lesions, anal cancers and related precancers, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58.
    Prevención de las lesiones genitales externas, los cánceres de ano y lesiones precancerosas relacionadas y la infección persistente causados por el virus del papiloma humano (VPH) 6, 11, 16, 18, 31, 33, 45, 52 y 58.
    E.1.1.1Medical condition in easily understood language
    Prevention of HPV infection.
    Prevención del papiloma humano (VPH)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) To evaluate the tolerability of the 9-valent HPV L1 VLP vaccine in young men and women 16 to 26 years of age.
    (2) To demonstrate that administration of the 9-valent HPV L1 VLP vaccine induces non-inferior Geometric Mean Titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 in young heterosexual men 16 to 26 years of age compared to young women 16 to 26 years of age.
    (1) Evaluar la tolerabilidad de la vacuna nonavalente de PV L1 del VPH en varones y mujeres jóvenes de 16 a 26 años de edad.
    (2)Demostrar que la administración de la vacuna nonavalente de PV L1 del VPH da lugar a unas medias geométricas de los títulos (MGT) de anticuerpos anti-VPH 6, anti-VPH 11, anti-VPH 16, anti-VPH 18, anti-VPH 31, anti-VPH 33, anti-VPH 45, anti-VPH 52 y anti-VPH 58 en suero en los varones jóvenes heterosexuales de 16 a 26 años no inferiores a las obtenidas en las mujeres jóvenes de 16 a 26 años.
    E.2.2Secondary objectives of the trial
    (1) Objective: To demonstrate that the 9-valent HPV L1 VLP vaccine induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in young heterosexual men 16 to 26 years of age compared to young women 16 to 26 years of age.
    (2) Objective: To evaluate serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 immune responses at 4 weeks post-dose 3 in MSM subjects.
    (1)Objetivo: demostrar que la vacuna nonavalente de PV L1 del VPH desencadena unas respuestas de anticuerpos en cuanto a porcentajes de seroconversión a los tipos 6, 11, 16, 18, 31, 33, 45, 52 y 58 de VPH en los varones jóvenes heterosexuales de 16 a 26 años que no son inferiores a las obtenidas en las mujeres jóvenes de 16 a 26 años.
    (2)Objetivo: evaluar las respuestas de anticuerpos séricas anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52 y anti-HPV 58 4 semanas después de la dosis 3 en varones MSM.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pendiente
    Pendiente.
    E.3Principal inclusion criteria
    1.Subject is male or female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment.
    2.Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
    3.Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
    4.Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
    5.Subject is able to read, understand, and complete the Vaccination Report Card.
    6.a) (HM and female subjects only) Subject has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment.
    b) (MSM subjects only) Subject has a lifetime history of up to 5 male and/or female sexual partners at the time of enrollment.
    Male or female partner is defined as someone with whom the subject has penile penetrative sexual intercourse or someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the subject's genitalia during sexual activity.
    7.(HM subjects only) Subject must be sexually naïve or a heterosexual male who has exclusively female sexual partners.
    8.(MSM subjects only) Subjects must identify themselves as a man who has sex with men and must have engaged in either insertive or receptive anal intercourse or oral sex with another male sexual partner within the past year.
    9.(Female subjects only) Subject has never had Pap testing or has only had normal Pap test results.
    *(Female subjects only) Since the first day of the subjects last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse). Effective contraception is defined as a marketed, approved contraceptive product that the subject has used per the manufacturers instructions with every act of sexual intercourse. The subject understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable methods per the protocol.
    1.El paciente es varón o mujer, con una edad comprendida entre los 16 años y 0 días y los 26 años y 364 días el día del reclutamiento.
    2.El paciente tiene una buena salud física a juzgar por la historia clínica, la exploración física y los resultados de laboratorio.
    3.El paciente (o, en el caso de menores, el progenitor/tutor y el paciente) comprende plenamente los procedimientos del estudio, los tratamientos alternativos disponibles y los riesgos de participar en el estudio y acepta participar voluntariamente otorgando su consentimiento informado por escrito. También podrá otorgar su consentimiento/asentimiento para participar en la investigación biomédica futura. No obstante, podrá participar en el ensayo principal sin participar en la investigación biomédica futura.
    4.El paciente se compromete a facilitar al personal del estudio un número de teléfono principal y otro alternativo para fines de seguimiento.
    5.El paciente es capaz de leer, comprender y cumplimentar la tarjeta de vacunación.
    6.a)(Varones heterosexuales y mujeres solamente) El paciente ha tenido entre 0 y 4 parejas sexuales masculinas o femeninas durante toda su vida en el momento del reclutamiento.
    b)(Varones MSM solamente) El paciente no ha tenido más de 5 parejas sexuales masculinas o femeninas durante toda su vida en el momento del reclutamiento.
    La pareja masculina o femenina se define como alguien con quien el paciente ha mantenido una relación sexual con penetración con el pene, o alguien que ha mantenido contacto con los genitales del paciente durante una relación sexual, ya sea con o sin penetración (con los dedos u otros objetos).
    7.(Varones heterosexuales solamente) El paciente no ha mantenido relaciones sexuales previamente o bien es un varón heterosexual que tiene parejas sexuales exclusivamente femeninas.

    8.(Varones MSM solamente) El paciente debe identificarse como un varón que mantiene relaciones homosexuales y debe haber mantenido relaciones sexuales con penetración o recepción anal o sexo oral con otra pareja sexual masculina en el último año.
    9.(Mujeres solamente) La paciente nunca se ha sometido a una citología vaginal o solo ha tenido resultados normales en ellas.
    10.* (Mujeres solamente) Entre el primer día de la última menstruación y el día 1, la paciente no ha mantenido relaciones sexuales con varones o bien ha mantenido relaciones sexuales con varones y ha utilizado métodos anticonceptivos eficaces sin ningún fallo (un ejemplo de fallo es la rotura de un preservativo masculino durante las relaciones sexuales). Un método anticonceptivo eficaz se define como un producto anticonceptivo comercializado y aprobado que la paciente haya utilizado siguiendo las instrucciones del fabricante en todas sus relaciones sexuales. La paciente entiende y acepta que, durante el período comprendido entre el día 1 y el mes 7, no deberá mantener relaciones sexuales con varones sin métodos anticonceptivos eficaces, así como que el uso del método del ritmo aislado, el coito interrumpido aislado y los anticonceptivos de urgencia, no son métodos aceptables según el protocolo.
    E.4Principal exclusion criteria
    1.Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE? (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for a serious adverse experience.
    2.Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
    3.Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
    4.Subject is concurrently enrolled in another clinical study of investigational agents.
    5.(Female subjects only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL -hCG).
    6.(Female subjects only) Subject is expecting to donate eggs during Day 1 through Month 7 of the study.
    7.Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
    8.Subject has had a splenectomy.
    9.Subject is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava?), TNF-? antagonists, monoclonal antibody therapies (including rituximab [Rituxan?]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if he/she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high-dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. Subjects using inhaled, nasal or topical steroids are considered eligible for the study.
    10.Subject has received any immune globulin product (including RhoGAM [Ortho-Clinical Diagnostics]) or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
    11.*Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
    12.Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
    13.*Subject has had a fever (defined as an oral temperature of > = to 100.0°F or >= to 37.8°C) within the 24-hour period prior to the Day 1 vaccination.
    14.Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
    15.Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
    16.Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
    17.Subject has a history of a positive test for HPV.
    18.(Male subjects only) Subject has a history of HPV-related external genital lesions (e.g., condyloma acuminata).
    19.(Female subjects only) Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse).
    20.(Female subjects only) Subject has a history of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.)
    1.El paciente tiene alergia conocida a alguno de los componentes de la vacuna, como aluminio, levaduras o BENZONASE? (nucleasa, Nycomed [que se emplea para eliminar los ácidos nucleicos residuales de ésta y otras vacunas]). En este criterio de exclusión, una alergia a los componentes de la vacuna se define como una reacción alérgica que cumpla los criterios de acontecimiento adverso grave.
    2.El paciente tiene antecedentes de una reacción alérgica grave (por ejemplo, edema de la boca y la garganta, problemas para respirar, hipotensión o shock) que exigió una intervención médica.
    3.El paciente tiene trombocitopenia o cualquier trastorno de la coagulación que contraindique las inyecciones intramusculares.
    4.El paciente está participando simultáneamente en otro estudio clínico de fármacos en investigación.
    5.(Mujeres solamente) La paciente está embarazada (a juzgar por una prueba de embarazo en suero u orina que sea sensible a 25 mUI/ml de ?-hCG).
    6.(Mujeres solamente) La paciente tiene previsto donar óvulos durante el período comprendido entre el día 1 y el mes 7 del estudio.
    7.El paciente está inmunodeprimido o ha sido diagnosticado de una inmunodeficiencia congénita o adquirida, infección por el VIH, linfoma, leucemia, lupus eritematoso sistémico (LES), artritis reumatoide, artritis reumatoide juvenil (ARJ), enfermedad inflamatoria intestinal u otra enfermedad autoinmunitaria.
    8.El paciente se ha sometido a una esplenectomía.
    9.El paciente está recibiendo o ha recibido en el año previo al reclutamiento los tratamientos inmunodepresores siguientes: radioterapia, ciclofosfamida, azatioprina, metotrexato, cualquier tipo de quimioterapia, ciclosporina, leflunomida (Arava?), antagonistas del TNF-?, tratamientos con anticuerpos monoclonales (como rituximab [Rituxan?]), gammaglobulina intravenosa (IGIV), suero antilinfocitario u otro tratamiento con interferencia conocida en la respuesta inmunitaria. En cuanto a los corticoides sistémicos, se excluirá al paciente si está recibiendo tratamiento con esteroides en la actualidad, ha recibido dicho tratamiento recientemente (definido como las 2 semanas anteriores al reclutamiento) o ha recibido 2 ciclos o más de corticoides en dosis altas (por vía oral o parenteral) de una semana de duración como mínimo en el año previo al reclutamiento. Los pacientes que estén utilizando esteroides inhalados, nasales o tópicos podrán participar en el estudio.
    10.El paciente ha recibido cualquier producto de inmunoglobulinas (como RhoGAM? [Ortho-Clinical Diagnostics]) o hemoderivado en los 3 meses anteriores a la vacunación del día 1, o prevé recibir dicho producto durante el período comprendido entre el día 1 y el mes 7 del estudio.
    11.*El paciente ha recibido vacunas inactivadas en los 14 días anteriores a la vacunación del día 1 o ha recibido vacunas de virus vivos en los 21 días anteriores a la vacunación del día 1.
    12.El paciente ha recibido una vacuna contra el VPH comercializada o ha participado en un ensayo clínico de una vacuna contra el VPH y ha recibido el producto activo o placebo.
    13.*El paciente ha tenido fiebre (definida como una temperatura bucal ? 37,8 °C) en el período de 24 horas anterior a la vacunación del día 1.
    14.El paciente tiene antecedentes o signos actuales de cualquier proceso, tratamiento, anomalía analítica u otra circunstancia que podría confundir los resultados del estudio o interferir en su participación durante todo el estudio, de modo que no le conviene participar.
    15.Es poco probable que el paciente cumpla los procedimientos del estudio o acuda a las citas, o tiene previsto mudarse durante el estudio.
    16.En el momento de firmar el consentimiento informado, el paciente consume drogas o presenta antecedentes recientes (en el último año) de alcoholismo o drogadicción. Se define como alcohólicos a aquellas personas que beben a pesar de tener problemas sociales, interpersonales i/o legales recurrentes como consecuencia del consumo de alcohol.
    17.El paciente tiene antecedentes de un resultado positivo en la prueba del VPH.
    18.(Varones solamente) El paciente tiene antecedentes de lesiones en los genitales externos relacionadas con el VPH (por ejemplo, condilomas acuminados).
    19.(Mujeres solamente) La paciente tiene antecedentes de un resultado anómalo en una biopsia de cuello uterino (neoplasia intraepitelial cervical [NIC] o peor).
    20.(Mujeres solamente) La paciente tiene antecedentes de lesiones en los genitales externos relacionadas con el VPH (por ejemplo, condilomas acuminados o neoplasia intraepitelial vulvar [NIV]) o cáncer de los genitales externos, lesiones vaginales relacionadas con el VPH (por ejemplo, condilomas acuminados o neoplasia intraepitelial vaginal [NIVa]) o cáncer de vagina.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    Safety assessment will focus on the injection-site adverse experiences and elevated temperatures Day 1 to 5 post-vaccination, and systemic adverse experiences Day 1 to 15 post-vaccination, reported on the VRC. In addition, serious adverse experiences will be collected for the duration of the study.

    Immunogenicity Endpoints
    The primary immunogenicity endpoints for evaluating antibody response to 9-valent HPV L1 VLP are geometric mean titers (GMTs) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Week 4 Postdose 3.
    La evaluación de la seguridad se centrará en los acontecimientos adversos en el lugar de la inyección y la temperatura elevada entre los días 1 y 5 después de la vacunación, así como en los acontecimientos adversos sistémicos entre los días 1 y 15 después de la vacunación, notificados en la TV. Además, durante todo el estudio se recopilarán los acontecimientos adversos graves.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 through Month 7
    Día 1 a lo largo del mes 7.
    E.5.2Secondary end point(s)
    The secondary endpoints for evaluating antibody response to 9-valent HPV L1 VLP are the percentages of subjects who seroconvert for each HPV type (6, 11, 16, 18, 31, 33, 45, 52, and 58) by Week 4 Postdose 3. (Seroconversion is defined as changing serostatus from seronegative at baseline to seropositive by Week 4 Postdose 3. A subject with a cLIA titer at or above the serostatus cutoff for a given HPV type is considered seropositive for that type.)
    Los criterios de valoración secundarios para evaluar la respuesta de anticuerpos a la vacuna nonavalente de PV L1 del VPH serán los porcentajes de pacientes que presenten seroconversión a cada tipo de VPH (6, 11, 16, 18, 31, 33, 45, 52 y 58) en la semana 4 después de la dosis 3. (La seroconversión se define como la variación del estado serológico de seronegativo en el momento basal a seropositivo en la semana 4 después de la dosis 3. Un paciente con un título en el IALc situado en o por encima del punto de corte para un tipo de VPH dado se considerará seropositivo para ese tipo.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 through Month 7
    Día 1 a lo largo del mes 7.
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenidad
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Canada
    Colombia
    Denmark
    Finland
    Germany
    India
    Israel
    Malaysia
    Mexico
    Norway
    Peru
    Philippines
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Thailand
    Turkey
    United States
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 500
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 500
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2000
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 Yes
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 835
    F.4.2.2In the whole clinical trial 2500
    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)
    Pregnancy and Serious Adverse Experiences will be followed to outcome.
    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 Decision2012-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-04
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