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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-002368-18
    Sponsor's Protocol Code Number:HEPB-VAC-01
    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:2018-07-25
    Trial 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 number2018-002368-18
    A.3Full title of the trial
    Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity in
    immunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis B
    vaccine with increased antigenic load
    Ensayo clínico de bajo nivel de intervención, de fase IV, para comparar la inmunogenicidad
    en pacientes inmunosupresores de una vacuna adyuvada contra hepatitis B con una
    vacuna de elevada carga antigénica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity in
    immunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis B
    vaccine with increased antigenic load
    Ensayo clínico de bajo nivel de intervención, de fase IV, para comparar la inmunogenicidad
    en pacientes inmunosupresores de una vacuna adyuvada contra hepatitis B con una
    vacuna de elevada carga antigénica
    A.4.1Sponsor's protocol code numberHEPB-VAC-01
    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 SponsorFUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)
    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 supportBeca La Marató 2017 de TV3 (26ª edición)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)
    B.5.2Functional name of contact pointARO
    B.5.3 Address:
    B.5.3.1Street AddressPl. Vall D'hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number349348930002701
    B.5.6E-mailaro@vhir.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals, S.A., Rixensart, Bélgica
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product nameFendrix
    D.3.2Product code Fendrix
    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 INNFendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
    D.3.9.3Other descriptive nameHEPATITIS B VACCINE (RDNA)
    D.3.9.4EV Substance CodeSUB12020MIG
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
    D.2.1.1.2Name of the Marketing Authorisation holderHBVAXPRO® 40 micrograms
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product nameHBVAXPRO® 40 micrograms
    D.3.2Product code HBVAXPRO® 40 micrograms
    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 INNHBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
    D.3.9.3Other descriptive nameHEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)
    D.3.9.4EV Substance CodeSUB128542
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.
    2. breast and lung cancer undertreated by chemotherapy
    3. HIV
    4. Haematopoietic progenitor cell transplantation (TCPH).
    1. Enfermedades reumatológicas autoinmunes en tratamiento con rituximab o
    infliximab.
    2. cáncer de mama y de pulmón en tratamiento con quimioterapia
    3. VIH
    4. Trasplantes de células progenitoras hematopoyéticas (TCPH).
    E.1.1.1Medical condition in easily understood language
    1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.
    2. breast and lung cancer undertreated by chemotherapy
    3. HIV
    4. Haematopoietic progenitor cell transplantation (TCPH).
    1. Enfermedades reumatológicas autoinmunes, cáncer de mama y de pulmón, VIH y trasplantes de células progenitoras hematopoyéticas (TCPH).
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10058467
    E.1.2Term Lung neoplasm malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063581
    E.1.2Term Stem cell transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the proportion of patients with protective levels of antibodies against HBV at 3 months after the first
    dose, in immunosuppressed patients, between those vaccinated with an anti-hepatitis B vaccine adjuvanted with
    AS04C versus those vaccinated with anti-hepatitis B vaccine with increased antigenic load.
    Comparar la proporción de pacientes con niveles protectores de anticuerpos anti-HBV a los 3 meses después de recibir la primera dosis (en pacientes inmunodeprimidos). Esta comparación se realizará entre: pacientes vacunados con la vacuna anti-Hepatitis B con AS04C de adjuvante frente a los vacunados con la vacuna contra la hepatitis B con un incremento de la carga antigénica.
    E.2.2Secondary objectives of the trial
    To compare the proportion of patients with protective levels of antibodies against HBV at 3 months after the first
    dose, in immunosuppressed patients, between those vaccinated with an anti-hepatitis B vaccine adjuvanted with
    1. To compare the proportion of patients with protective levels of antibodies against HBV at 7 and 12 months
    after the first dose, in immunosuppressed patients, between those vaccinated with anti-hepatitis B vaccine
    adjuvanted with AS04C and those vaccinated with an increased antigenic load.
    2. To compare the levels of antibodies against HBV at 3, 7 and 12 months of the first dose, in
    immunosuppressed patients, between patients vaccinated with anti-hepatitis B vaccine adjuvanted with
    AS04C and those vaccinated with an increased antigenic load vaccine.
    3. To describe all adverse events that could appear during research.
    1. Comparar la proporción de pacientes con niveles protectores de anticuerpos contra HBV a los 7 y 12 meses después de la primera dosis, en pacientes inmunodeprimidos, entre pacientes vacunados con la vacuna anti-Hepatitis B con AS04C de adjuvante frente a los vacunados con la vacuna contra la hepatitis B con un incremento de la carga antigénica.

    2. Comparar niveles de anticuerpos contra HBV a los 3, 7 y 12 meses después de la primera dosis, en pacientes inmunodeprimidos, entre pacientes vacunados con la vacuna anti-Hepatitis B con AS04C de adjuvante frente a los vacunados con la vacuna contra la hepatitis B con un incremento de la carga antigénica.

    3. Describir todos los eventos adversos que puedan aparecer durante el desarrollo del ensayo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients over 18 years of age, and diagnosed of:
    - Autoimmune rheumatologic diseases under treatment with Rituximab or Infliximab
    - Primary breast cancer or primary lung cancer
    - Human Immunodeficiency Virus (HIV)
    - Hematopoietic stem cell transplantation patients (HSCT), time since transplantation ≥ 6 months
    • Negative result of markers of hepatitis B virus infection (anti-core HBV antibody, hepatitis B virus surface antigen,
    anti-HBV surface antigen antibody) in the last 3 months
    • Life expectancy exceeding 1 year
    • Written consent of the patient to participate in the study
    • Pacientes mayores a 18 años de edad y diagnosticados para:
    - Enfermedad reumatológica autoinmune bajo tratamiento con Rituximab o Infliximab
    - Cancer de mama o pulmón primarios
    - VIH
    - Trasplantes de células progenitoras hematopoyéticas (TCPH).
    • Resultados negativos para marcadores de la hepatitis B (anticuerpos anti-HBV, antígenos de superficie para el virus de la hepatitis B y anticuerpos anti- HBV para antígenos de superficie) dentro de los 3 últimos meses.
    • Esperanza de vida superior a 1 año
    • Consentimiento informado del paciente para participar en el ensayo por escrito
    E.4Principal exclusion criteria
    • Hypersensitivity to the active ingredients or to any of the excipients of vaccines
    • Documented history of infection or previous vaccination against HBV
    • Infection with HIV (except in the subproject with HIV patients)
    • Rejection of vaccination against HBV
    • Difficulty of the patient to go to the study visits
    • Presence of any other immune disorder different than the primary diagnosis
    • Alergia hacia los compuestos activos o excipientes que contienen las vacunas del tratamiento
    • Historial de infección y/o exposición previa a la vacuna contra la hepatitis B documentadas
    • Infección por HIV (excepto en el subgrupo de estudio para pacientes con HIV)
    • No querer ser vacunado contra la Hepatitis B
    • Dificultad del paciente a ir a las visitas del estudio
    • Existencia de alguna otra enfermedad inmunitaria diferente con respecto al primer diagnostico
    E.5 End points
    E.5.1Primary end point(s)
    Main variable for vaccine response assessment (immunogenicity):
    Level of antibodies against HBV surface antigen (HBsAg) one month after the third dose =10UI, which will be
    determined by enzyme-immunoassay.
    Variable Principal para la evaluación de la respuesta de la vacuna (inmunogenicidad):
    Niveles de anticuerpos contra los antígenos de superficie del virus de la hepatitis B (HBsAg), un mes después de la tercera dosis =10UI (debe de ser determinada por ensayo inmuno-enzimáticos).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the clinical trial.
    Durante el ensayo clínico
    E.5.2Secondary end point(s)
    Secondary endpoints of immunogenicity:
    • Level of antibodies against HBV surface antigen at the end of the vaccination schedule, which will be determined by
    enzyme-immunoassay between 1 and 2 months after the last dose.
    • Level of antibodies against HBV surface antigen one year after the end of the vaccination schedule, which will be
    determined by enzyme-immunoassay
    (Patients will be considered responders to the vaccine when the antibody titer against HBsAg is equal to or greater
    than 10IU/l. In the patients who don’t respond after the last dose of vaccination the determination at 12 months won’t
    be performed. These non-responding patients will receive the usual clinical pattern, revaccination with a second
    complete series, and there would be no more follow-up from the study).
    Descriptive variables of subgroups:
    - HIV patients:
    • Level of CD4 lymphocytes and determination of viral load one month before the first dose, one month after
    the third dose, between one and two months after the last dose, and 12 months after the first dose.
    -HSCT patients:
    • Follow up to detect any evidence of Graft-Versus-Host-Disease (GVHD)
    • Type of transplant, autologous or allogeneic
    • Clinical condition that cause the transplant
    -Rheumatologic patients:
    • Main clinical condition
    • Date of diagnosis
    • Other immunosuppressive treatment (besides Rituximab or Infliximab: type of drug, start and end time)
    -Cancer patients:
    • Stage of cancer
    • Date of diagnosis
    • Histological type of cancer
    • Treatment (chemotherapy): start and end time
    • Niveles de anticuerpos contra antígenos de superficie para el virus de la hepatitis B al final del cronograma de vacunación. Esto deberá de realizarse mediante un ensayo inmuno-enzimático entre el mes 1-2 después de la última dosis.

    • Niveles de anticuerpos contra antígenos de superficie para el virus de la hepatitis B un año después de la finalización del cronograma de vacnación del ensayo. Este deberá de determinarse mediante un ensayo inmuno-enzimático.

    Variables descripctivas de los subgrupos:
    - Pacientes con VIH:
    • Niveles de linfocitos CD4 y determinación de la carga viral un mes antes de la primera dosis, un mes antes de la tercera dosis, entre el mes uno y dos después de la última dosis y 12 meses después de la primera dosis.

    -Pacientes que han sufrido una TCPH:
    • Seguimiento para detectar cualquier evidencia de la enfermedad del injerto contra el huesped (GVHD).
    • Tipo de trasplante, autólogo o alogénico.
    • Condición clínica que causo el trasplante

    -Pacientes reumatológicos:
    • Condición clínica principal
    • Fecha del diagnóstico
    • Otros tratamientos inmunosupresores (a parte de Rituximab or Infliximab: tipo de medicamento, empiece u finalización)

    -Pacientes con cancer:
    • Estadio del cáncer
    • Fecha del dagnóstico
    • Descripción histológica del tipo de cáncer
    • Tratamiento quimioterapéutico: empiece y finalización
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the clinical trial.
    Durante el ensayo clínico
    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 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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenocity of both vaccines mentionated at the clinical trial.
    Inmunogenicidad de las dos vacunas mencionadas a usar en el ensayo clínico.
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States No
    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
    última visita último sujeto
    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
    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: 740
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state740
    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)
    According to hospital-procedure guideline of each centre.
    De acuerdo con el protocolo de cada centro.
    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 Decision2018-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
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