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    Summary
    EudraCT Number:2013-000464-29
    Sponsor's Protocol Code Number:0113-CL-2001
    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:2014-04-01
    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 number2013-000464-29
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ from a CMV-Seropositive Donor
    Estudio de fase 2 aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de una vacuna, ASP0113, en receptores CMV-Seronegativos de trasplante de riñon procedente de donante CMV-Seropositivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)- Seronegative Kidney Transplant Recipients Receiving an Organ from a CMV-Seropositive Donor, when compared against placebo in a randomised, double blind manner.
    A.4.1Sponsor's protocol code number0113-CL-2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01974206
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    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 supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTI Clinical Trial & Consulting Services Spain S.L.
    B.5.2Functional name of contact pointClinical Research Organization
    B.5.3 Address:
    B.5.3.1Street AddressZurbano, 76
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28010
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913990797
    B.5.5Fax number+34918057159
    B.5.6E-mailgrevilla@ctifacts.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 Yes
    D.2.5.1Orphan drug designation numberEU /3/12/1042
    D.3 Description of the IMP
    D.3.2Product code ASP0113
    D.3.4Pharmaceutical form Solution 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 INNnot available
    D.3.9.1CAS number 1498125-70-4
    D.3.9.2Current sponsor codeASP0113, VCL-CB01, bivalent vaccine
    D.3.9.3Other descriptive nameCovalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes.
    D.3.9.4EV Substance CodeSUB88620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CMV reactivation after Kidney Transplantation Receiving an Organ from a CMV-Seropositive Donor
    Reactivación de Citomegalovirus (CMV) tras un transplante de riñon procedente de un donante CMV seropositivo.
    E.1.1.1Medical condition in easily understood language
    CMV infection, disease, and related complications occuring in people after Kidney Transplantation
    Receiving an Organ from a CMV-Seropositive Donor
    Infeccion por Citomegalovirus (CMV), enfermedad y complicaciones relacionadas en pacientes que han recibido un transplante de riñon de un donante Citomegalovirus (CMV) sepositivo.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10049107
    E.1.2Term CMV viraemia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of CMV viremia (defined as plasma viral load ≥ 1000 IU/mL by central laboratory assay) through one year post first Study Drug injection in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.
    Evaluar la eficacia de ASP0113 en comparación con el placebo en la reducción de la incidencia de la viremia por CMV definida como carga vírica plasmática ≥ 1000 UI/ml mediante análisis en el laboratorio central) durante un año después de la primera inyección del fármaco del estudio en pacientes seronegativos para CMV que reciben un riñón de un donante seropositivo para CMV.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of ASP0113 in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor
    Evaluar la seguridad de ASP0113 en pacientes seronegativos para CMV que reciben un riñón de un donante seropositivo para CMV.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomics Sub-Study,
    The retrospective pharmacogenomic research that will be conducted in the future with acquired blood samples is exploratory. The objective of this research is to comprehensively analyze:
    Suspected disease-related genes.
    Genes of relevance to clinical response, pharmacokinetics, and
    toxicity/safety issues, to be identified in a precautionary/retrospective setting.
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability (HIPAA) Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-specific procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is willing to comply with the protocol.
    3. Subject is ? 18 years of age or the legal age of consent (whichever is greater).
    4. Subject is CMV-seronegative at time of transplant and has received a kidney from a CMVseropositive living or deceased donor. CMV serostatus of the recipient can be determined from 8 weeks prior to transplant, by local laboratory, through day of transplantation. If CMV serostatus is not available from this time period, CMV serostatus may be assessed at the Screening Visit, by local laboratory, with results available prior to Randomization.
    5. Subject started valganciclovir or ganciclovir within 10 days of transplant and has received it through Randomization, per regulatory label (package insert).
    6. Female subject must be either:
    * Of non child-bearing potential:
    o post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
    o documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
    * Or, if of childbearing potential:
    o must have a negative urine pregnancy test at Screening, and
    o if heterosexually active must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and during the Primary Study Period.
    7. Female subject must not be breastfeeding at Screening and during the Primary Study Period.
    8. Female subject must not donate ova starting at Screening and during the Primary Study Period.
    9. Male subject and his female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and during the Primary Study Period .
    *Acceptable forms of birth control include:
    * Established use of oral, injected or implanted hormonal methods of contraception.
    * Placement of intrauterine device (IUD) or intrauterine system (IUS).
    * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    * Partner male sterilization (i.e., vasectomy)
    10. Male subject must not donate sperm starting at Screening and during the Primary Study Period.
    11. Subject agrees not to participate in another interventional drug study while on treatment.
    1. Debe obtenerse del paciente o su representante legal antes de realizar ningún procedimiento específico del estudio (incluyendo la retirada de medicamentos prohibidos, si procede) el consentimiento informado por escrito del paciente aprobado por el comité ético de investigación clínica (CEIC) que incluya un texto sobre privacidad de conformidad con los reglamentos nacionales (como la autorización HIPAA [Health Insurance Portability and Accountability] para los centros en Estados Unidos).
    2. El paciente está dispuesto a cumplir con el protocolo.
    3. El paciente tiene al menos 18 años de edad o la edad de consentimiento (la que sea mayor).
    4. El paciente es seronegativo para CMV en el momento del trasplante y ha recibido un riñón de un donante seropositivo para CMV, vivo o muerto. El seroestado de CMV del receptor puede determinarse desde las 8 semanas anteriores al trasplante, mediante un laboratorio local, hasta el día del trasplante. Si no se dispone del estado sérico de CMV de este período de tiempo, puede evaluarse en la visita de selección, mediante laboratorio local, para obtener los resultados antes de la aleatorización.
    5. El paciente inició la utilización de valganciclovir o ganciclovir en los 10 días siguientes al trasplante y lo ha recibido durante la aleatorización, conforme al prospecto.
    6. Las pacientes deben:
    - Si no están en edad fértil:
    o ser posmenopáusicas (lo que se define como al menos 1 año sin menstruación) antes de la selección o
    o haberse documentado su esterilidad quirúrgica o poshisterectomía (al menos 1 mes antes de la selección).
    - Si están en edad fértil:
    o deben haber obtenido un resultado negativo en la prueba de embarazo en orina en el momento de la selección y
    o si son activas heterosexuales deben usar dos formas de anticoncepción* (al menos una de las cuales debe ser un método de barrera) desde el momento de la selección y durante el período de estudio principal.
    7. Las pacientes no deben estar en período de lactancia en la selección ni durante el período principal del estudio.
    8. Las pacientes no deben donar óvulos desde el momento de la selección durante el período principal del estudio.
    9. Los pacientes y sus cónyuges en edad fértil deben usar anticonceptivos de gran eficacia consistentes en dos formas de anticonceptivos* (una de las cuales al menos debe ser un método de barrera) comenzando en el momento de la selección y durante el período principal del estudio.
    *Las formas aceptables de anticoncepción incluyen:
    - Uso establecido de los métodos anticonceptivos hormonales por vía oral, inyectados o implantados.
    - Colocación de dispositivo intrauterino (DIU) o sistema intrauterino (SIU).
    - Métodos anticonceptivos de barrera: preservativo o dispositivos intrauterinos (diafragma o D.I.U) con espuma/gel/película/crema/supositorio espermicida.
    - Esterilización de la pareja masculina (es decir, vasectomía)
    10. El paciente no debe donar esperma desde el momento de la selección durante el período principal del estudio.
    11. El paciente acepta no participar en otro estudio farmacológico intervencional mientras dure este tratamiento.
    E.4Principal exclusion criteria
    1. Subject is planned to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
    2. Subject has received from one month prior to transplant or is planning to receive CMV immunoglobulin.
    3. Subject has had CMV viremia or CMV disease from time of transplant until time of Randomization.
    4. Subject has received, at any time, an organ transplant other than a kidney. (Dual allocation of a kidney is acceptable).
    5. Subject requires dialysis on the day of Randomization.
    6. Recipient or donor is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis B core IgM or IgG antibody.
    7. Subject is known to have latent or active tuberculosis which has not been adequately treated.
    8. Subject required desensitization for ABO blood type incompatibility or a positive T or B cell crossmatch.
    9. Subject has received any of the following substances or treatments:
    a. Investigational research products within 28 days or 5 half lives whichever is longer, prior toTransplantation, or subject is scheduled to receive investigational research products through one year after Randomization.
    b. Alemtuzumab within 90 days prior to Randomization or is scheduled to receive alemtuzumab any time through one year post Randomization.
    c. Rituximab within 120 days prior to Randomization or is scheduled to receive rituximab any time through one year post Randomization.
    d. Eculizumab or bortezomib from the Day of Transplantation through the Day of Randomization or is scheduled to receive eculizumab or bortezomib any time through one year post Randomization.
    e. IVIG and/or plasmapheresis from Day of Transplant through Day of Randomization.
    f. Live attenuated vaccines within one month (30 days) prior to the first dose of Study Drug or is scheduled to receive live attenuated vaccines within one month of any Study Drug injection.
    g. Subunit or killed vaccines within 14 days prior to the first dose of Study Drug or is scheduled to receive a subunit or killed vaccine within 14 days prior to any Study Drug injection.
    h. Administration of a CMV vaccine, including any prior exposure to ASP0113.
    i. Subject has received the following anti-viral therapies or it is planned for them to receive the AVT for prophylaxis of viral infections in excess of the following doses from time of transplant through Randomization:
    * Aciclovir: 1600 mg orally (total daily dose), or 500 mg/m2/dose Intravenous (IV) (total daily dose)
    * Valaciclovir: 1000 mg orally (total daily dose)
    * Famciclovir: 500 mg orally (total daily dose)
    10. Subject has received any anticoagulants including, but not limited to, vitamin K antagonists, heparin or its derivatives, low molecular weight heparin, factor X inhibitors, or thrombin inhibitors within 5 half-lives prior to Randomization or is expected to use anticoagulants within 5 half-lives prior to any Study Drug injection. Low dose anticoagulants that are used for prevention of deep vein thrombosis and antiplatelet agents are allowed.
    11. Subject has any contraindication to or cannot be dosed with valganciclovir or ganciclovir per package insert on the Day of Randomization for any reason.
    12.Subject has, or is expected to have during the Primary Study Period, a contraindication to an intramuscular injection.
    13. Subject, within 3 days prior to Randomization, has an Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) greater than 3 x Upper Limits of Normal (ULN) or total bilirubin greater than 2 x ULN unless secondary to suspected Gilbert?s disease.
    14. Subject has a current malignancy or a recent history of malignancy (within the past 5 years prior to Screening) except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or cancer in situ of the cervix uteri that has been successfully treated by local therapy.
    15. Subject is being treated for an active infection at the time of Randomization.
    16. Subject has any condition or an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will place the subject at unacceptable risk or interfere with compliance to protocol requirements.
    17. The subject has any other condition which, in the opinion of the Investigator, precludes the subjects participation in the trial.
    18. Subject has known allergies or previous adverse reactions to ganciclovir or valganciclovir.
    19. Subject has had an allergic reaction to any component of the vaccine, including aminoglycosides, as kanamycin is used during the manufacturing process of the vaccine.
    1. Se prevé que el paciente se someta a un curso de tratamiento profiláctico específico para el CMV con fármacos antivíricos con una duración superior a los 100 días.
    2. El paciente ha recibido inmunoglobulina de CMV desde un mes antes del trasplante o prevé hacerlo.
    3. El paciente ha presentado viremia por CMV o enfermedad por CMV desde el momento del trasplante hasta el momento de la aleatorización.
    4. El paciente ha recibido, en algún momento, un trasplante de un órgano distinto del riñón. (Se acepta la asignación doble de un riñón).
    5. El paciente requiere diálisis el día de la aleatorización.
    6. Se sabe que el receptor, o el donante, es positivo para el virus de la inmunodeficiencia humana (VIH), el antígeno de superficie de la hepatitis B o el anticuerpo IgG o IgM central de la hepatitis B.
    7. Se sabe que el paciente presenta tuberculosis activa o latente que no se ha tratado correctamente.
    8. El paciente requiere desensibilización por incompatibilidad del tipo de sangre ABO o de un cruce de linfocitos T o B positivo.
    9. El paciente ha recibido alguno de los siguientes tratamientos o sustancias:
    a. Productos en fase de investigación en los 28 días o 5 semividas, lo que sea más largo, antes del trasplante, o se prevé que el paciente vaya a recibirlos durante el año siguiente a la aleatorización.
    b. Alemtuzumab en los 90 días antes de la aleatorización o se prevé que se reciba en cualquier momento durante el año siguiente a la aleatorización.
    c. Rituximab en los 120 días antes de la aleatorización o se prevé que se reciba en cualquier momento durante el año siguiente a la aleatorización.
    d. Eculizumab o bortezomib desde el día del trasplante hasta el día de la aleatorización, o se prevé que se reciba alguno de ellos en cualquier momento durante el año siguiente a la aleatorización.
    e. IGIV o plasmaféresis desde el día del trasplante hasta el día de la aleatorización.
    f. Vacunas atenuadas vivas en el mes (30 días) anterior a la administración de la primera dosis del fármaco en estudio o se prevé que se reciban en el mes siguiente a cualquiera de las inyecciones del fármaco del estudio.
    g. Vacunas con subunidades o inactivadas en los 14 días anteriores a la administración de la primera dosis del fármaco en estudio o se prevé que se reciban en los 14 días anteriores a cualquier inyección del fármaco en estudio.
    h. Administración de una vacuna contra el CMV, incluyendo toda exposición anterior a ASP0113.
    i. El paciente ha recibido los siguientes tratamientos antivíricos o se prevé que reciba la TAV para la profilaxis de infecciones víricas que exceda las dosis siguientes desde el momento del trasplante hasta la aleatorización: (dosis detallas en protocolo)
     Aciclovir
     Valaciclovir
     Famciclovir
    10. El paciente ha recibido algún anticoagulante que incluye, entre otros: antagonistas de la vitamina K, heparina o sus derivados, heparina de bajo peso molecular, inhibidores del factor X o inhibidores de la trombina en las 5 semividas anteriores a la aleatorización o se prevé que los use en las 5 semividas antes de cualquier inyección del fármaco en estudio. Se permiten los anticoagulantes en dosis bajas usados para la prevención de la trombosis venosa profunda y los antiagregantes plaquetarios.
    11. El paciente presenta alguna contraindicación o no puede recibir la dosis de valganciclovir o ganciclovir conforme al prospecto el día de la aleatorización, por cualquier razón.
    12. El paciente presenta, o se prevé que presente durante el período principal del estudio, una contraindicación contra las inyecciones intramusculares.
    13. El paciente presenta, en los 3 días anteriores a la aleatorización, una concentración de aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) superior a 3 veces el límite superior de la normalidad (LSN) o bilirrubina total superior a 2 veces el LSN a menos que sea secundario a sospecha de enfermedad de Gilbert.
    14. El paciente presenta una neoplasia actual o antecedentes recientes de neoplasia (en los últimos 5 años antes de la selección) excepto carcinoma basocelular o escamocelular de la piel no metastásicos que se hayan tratado con éxito o cáncer cervicouterino in situ que se haya tratado con éxito mediante tratamiento local.
    15. El paciente está recibiendo tratamiento en el momento de la aleatorización.
    16. El paciente presenta un riesgo inaceptable o que interferirá con el cumplimiento de los requisitos del protocolo a criterio dle investigador (trastorno médico o psiquiátrico inestable, antecedentes de drogadicción o alcoholismo)
    18. El paciente presenta alergias o reacciones adversas conocidas anteriores a ganciclovir o valganciclovir.
    19. El paciente ha sufrido una reacción alérgica a algún componente de la vacuna o a algún aminoglucósido, ya que la canamicina se usa durante el proceso de fabricación de la vacuna.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of CMV viremia (defined as plasma viral load of ≥ 1000 IU/mL by central assay) through one year post first Study Drug injection.
    Incidencia de la viremia por CMV (definida como carga vírica plasmática ≥ 1000 UI/ml por análisis central) durante el año siguiente a la primera inyección del fármaco en estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through one year post-transplant.
    Seguimiento hasta un año post-transplante.
    E.5.2Secondary end point(s)
    Incidence of:
    * Adjudicated CMV disease, including CMV syndrome and CMV tissue-invasive disease through one year post first Study Drug injection.
    * CMV viremia (defined as plasma viral load ? the lower limit of quantification [LOQ]) by central assay through one year post first Study Drug injection.
    * Adjudicated CMV-specific antiviral therapy for the treatment of CMV viremia or disease through one year post first Study Drug injection.
    * Graft survival through one year post first Study Drug injection.
    * Subject survival through one year post first Study Drug injection.
    Incidencia de:
    - Enfermedad CMV adjudicada, incluyendo síndrome por CMV y enfermedad invasora de tejidos por CMV durante el año siguiente a la primera inyección del fármaco en estudio.
    - Viremia por CMV (definida como carga vírica plasmática ≥ al límite mínimo de cuantificación [LMC]) mediante análisis central en el año siguiente a la primera inyección del fármaco en estudio.
    - Tratamiento antivírico específico contra CMV adjudicado para el tratamiento de la viremia o enfermedad por CMV durante el año siguiente a la primera inyección del fármaco del estudio.
    - Supervivencia del injerto durante el año siguiente a la primera inyección del fármaco en estudio
    - Supervivencia del paciente durante el año siguiente a la primera inyección del fármaco en estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through one year post-transplant.
    Seguimiento hasta un año post-transplante.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Canada
    France
    Germany
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of trial in all participating countries is defined as the Last Subjects Last Visit at the end of the Primary Study Period (Day 395). The Long Term Follow Up will continue after the end of trials Primary Study Period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days30
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 140
    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)
    Subjects will be contacted by telephone at 6 months after Day 395, then annually for the next 4 years for long-term safety related to the DNA vaccine. Items to be assessed by questionnaire and available patient records include mortality, development of any new cancer, development of infection requiring hospitalization or resulting in death, graft survival, creatinine and erythema and/or induration at the sites of immunizations.
    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 Decision2014-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
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