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    Summary
    EudraCT Number:2011-002313-11
    Sponsor's Protocol Code Number:V212-009
    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:2012-03-01
    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 number2011-002313-11
    A.3Full title of the trial
    A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease
    Ensayo clínico en fase II, aleatorizado y controlado con placebo para estudiar la seguridad y la inmunogenicidad de V212 en pacientes adultos con enfermedades autoinmunitarias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease
    Ensayo clínico en fase II, aleatorizado y controlado con placebo para estudiar la seguridad y la inmunogenicidad de V212 en pacientes adultos con enfermedades autoinmunitarias
    A.4.1Sponsor's protocol code numberV212-009
    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.
    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.
    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.
    B.5.2Functional name of contact pointMerck Sharp & Dohme Corp.
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, PO Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305-1214
    B.5.5Fax number+1267305-6431
    B.5.6E-mailjanie.parrino@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.3.1Product nameInactivated Varicella Zoster Virus Vaccine
    D.3.2Product code V212
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeV212
    D.3.10 Strength
    D.3.10.1Concentration unit AgU/ml antigen unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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.3.1Product nameInactivated Varicella Zoster Virus Vaccine
    D.3.2Product code V212
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeV212
    D.3.10 Strength
    D.3.10.1Concentration unit AgU/ml antigen unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number93.6
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of herpes zoster in adults with autoimmune disease
    Prevención del herpes zóster (HZ) en adultos que padecen una enfermedad autoinmunitaria.
    E.1.1.1Medical condition in easily understood language
    Prevention of herpes zoster in adults with autoimmune disease
    Prevención del herpes zóster (HZ) en adultos que padecen una enfermedad autoinmunitaria.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019974
    E.1.2Term Herpes zoster
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 determine whether V212 is immunogenic when administered to adult patients with autoimmune disease.
    2) To assess the safety and tolerability of V212 in adult patients with autoimmune disease.
    1) Determinar si V212 es inmunógena cuando se administra a pacientes adultos con enfermedades autoinmunitarias.
    2 ) Evaluar la seguridad y la tolerabilidad de V212 en pacientes adultos con enfermedades autoinmunitarias.
    E.2.2Secondary objectives of the trial
    None
    Ninguno
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ICF genetic (version 00- Genetic y Future Samples 12 Dic 2011)
    HIP y IC genetico ( version 00- Genetico y Muestras Futuras 12 Dic 2011)

    E.3Principal inclusion criteria
    1. Patient is > or = to 18 years of age on the day of signing informed consent.
    2. Patient has been diagnosed with an autoimmune disease, including but not limited to RA, PSA, PSO, IBD, SLE, MS, or other similar diseases (see Appendix 6.1 of protocol).
    3. Patient is not likely to undergo HCT during the study period (through 28 days Postdose 4).
    4. Patient must be on at least one biologic agent, such as a TNF alpha inhibitor, or a non-biologic therapy, at a stable dose for > or = to 3 months, with no planned or anticipated changes in treatment regimen at the time of enrollment. Treatment route of administration must be parenteral or oral; topical administration alone is not sufficient
    (See Appendix 6.2 of protocol).
    5. Minimum doses are required for the following treatments if taken as monotherapy:
    5.1 methotrexate, >0.4 mg/Kg/week;
    5.2 sulfasalazine, or mycophenolate mofetil: > or = to 2g/day;
    5.3 azathioprine, >3.0 mg/Kg/day;
    5.4 6-mercaptopurine, >1.5 mg/Kg/day;
    5.5 prednisone or equivalent of >20 mg/day.
    No minimum doses are required for patients receiving combination therapy including two or more non-biologic agents.
    6. Patient has clinically stable disease for > or = to 30 days prior to enrollment. (Note: MS patient who has experienced a serious relapse [exacerbation] that affects their ability to carry out activities of daily living, should not be enrolled into the study until 4 to 6 weeks after the onset of the relapse.)
    7. Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. The patient may also provide consent for future biomedical research. However, the patient may participate in the main trial without participating in future biomedical research.
    8. Patient has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence (for > or = to 30 years) in a country with endemic VZV infection, or if participant is < 30 years old, attended primary or secondary school in a country with endemic VZV infection (See Section 3.2.8 for more details).
    9. Patient is able to read, understand and complete questionnaires and diaries.

    Read the rest inclusion criteria in the study protocol.

    1.El paciente tiene una edad mínima de 18 años el día de la firma del consentimiento informado.
    2.El paciente ha sido diagnosticado de una enfermedad autoinmunitaria, como por ejemplo AR, APs, PSO, EII, LES, EM u otras enfermedades similares (véase el apéndice 6.1 del protocolo).
    3.No es probable que el paciente se someta a un TCH durante el período del estudio (hasta 28 días después de la dosis 4).
    4.El pacientes debe estar en tratamiento con al menos un producto biológico, como un inhibidor del TNF α, o un tratamiento no biológico, a una dosis estable durante ≥ 3 meses, sin modificaciones planificadas o previstas del régimen de tratamiento en el momento de la inclusión. La vía de administración debe ser parenteral u oral; la administración tópica no es suficiente por sí sola (véase el apéndice 6.2 del protocolo).
    5.Se exigen unas dosis mínimas de los siguientes tratamientos en caso de administrarse en monoterapia:
    5.1 Metotrexato, > 0,4 mg/kg/semana.
    5.2 Sulfasalazina o micofenolato mofetilo: ≥ 2 g/día.
    5.3 Azatioprina, > 3,0 mg/kg/día.
    5.4 6 mercaptopurina, > 1,5 mg/kg/día.
    5.5 Prednisona o equivalente, > 20 mg/día.
    No se exigen dosis mínimas en los pacientes tratados con una combinación de dos o más fármacos no biológicos.
    6.El paciente presenta una enfermedad clínicamente estable durante ≥ 30 días antes de la inclusión. (Nota: un paciente con EM que haya presentado una recidiva [exacerbación] grave que afecte a su capacidad para realizar las actividades cotidianas no podrá ser incluido en el estudio hasta 4 a 6 semanas después del inicio de la recidiva.)
    7.El paciente comprende los procedimientos del estudio, los tratamientos alternativos disponibles y los riesgos asociados y acepta voluntariamente participar en él otorgando su consentimiento informado por escrito. El paciente también podrá otorgar su consentimiento para la investigación biomédica futura. No obstante, el paciente podrá participar en el ensayo principal sin participar en la investigación biomédica futura.
    8.El paciente tiene antecedentes de varicela, anticuerpos contra el VVZ (confirmados antes de recibir hemoderivados) o residencia (durante ≥ 30 años) en un país con infección endémica por el VVZ o el participante tiene menos de 30 años de edad y ha cursado la educación primaria o secundaria en un país con infección endémica por el VVZ (consulte más detalles en el apartado 3.2.2.7 del protocolo).
    9.El paciente sabe leer y es capaz de comprender y cumplimentar los cuestionarios y diarios.
    Leer el resto de criterios de inclusión en el protocolo del estudio.
    E.4Principal exclusion criteria
    1. A history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin (a history of contact dermatitis to neomycin is not a criterion for study exclusion).
    2. Prior history of HZ within 1 year of enrollment.
    3. Prior receipt of any varicella or zoster vaccine.
    4. Patient has active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebritis or CNS vasculitis) requiring therapeutic intervention within 90 days of enrollment.
    5. Patient is receiving or expected to receive therapy containing rituximab or any other anti-CD20 monoclonal antibodies at any time during the time period beginning
    3 months prior to enrollment through 28 days Postdose 4.
    6. Patient is receiving systemic corticosteroid therapy, prednisone or prednisone equivalent >40 mg/day at the time of enrollment.
    7. Patient has received systemic prednisone or prednisone equivalent > or = to 50 mg/day for > or = to 0 days within 6 months of enrollment.
    8. Patient has participated in a study of investigational drug or vaccine or received investigational products within 30 days prior to enrollment or is expected to receive an investigational product (other than the study vaccine) throughout the duration of the study.
    9. Patient is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months after last vaccination dose.
    10. Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.
    11. Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.

    Read the rest exclusion criteria in the study protocol.
    1.Antecedentes de reacción alérgica a cualquier componente de la vacuna (incluida la gelatina) o de reacciones anafilácticas/anafilactoides a neomicina (el antecedente de dermatitis de contacto a neomicina no es un criterio de exclusión del estudio).
    2.Antecedentes de HZ en el año previo a la inclusión en el estudio.
    3.Administración previa de cualquier vacuna contra la varicela o el herpes zóster.
    4.El pacientes presenta un lupus del sistema nervioso central (SNC) activo (incluidas crisis convulsivas, psicosis, síndrome cerebral orgánico, encefalitis o vasculitis del SNC) que precisa intervención terapéutica en los 90 días previos a la inclusión en el estudio.
    5.El paciente está recibiendo o cabe esperar que reciba tratamiento con rituximab u otros anticuerpos monoclonales anti CD20 en cualquier momento durante el período comprendido entre 3 meses antes de la inclusión y 28 días después de la dosis 4.
    6.El paciente está recibiendo corticoides sistémicos, prednisona o equivalente de prednisona > 40 mg/día, en el momento de la inclusión.
    7.El paciente ha recibido prednisona o equivalente de prednisona por vía sistémica ≥ 50 mg/día durante ≥ 30 días en los 6 meses previos a la inclusión en el estudio.
    8.El paciente ha participado en un estudio de un fármaco o vacuna en investigación o ha recibido un producto en investigación en los 30 días previos a la inclusión en el estudio o cabe prever que reciba un producto en investigación (diferente de la vacuna del estudio) durante el estudio.
    9.La paciente está embarazada, en período de lactancia o espera concebir durante el período comprendido entre 2 semanas antes de la inclusión y 6 meses después de la última dosis de la vacuna.
    10.Administración o programación de una vacuna de virus vivos durante el período comprendido entre 4 semanas antes de la dosis 1 y 28 días después de dosis 4.
    11.Administración o programación de cualquier vacuna de virus inactivados durante el período comprendido entre 7 días antes y 7 días después de cualquier dosis de la vacuna del estudio.

    Leer el resto de criterios de exclusión en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary immunogenicity endpoint is the GMFR of the VZV-specific immune responses from prevaccination to ~28 days Postdose 4.
    El criterio de valoración principal de la inmunogenicidad es el IMG de las respuestas inmunitarias específicas contra el VVZ entre antes y 28 días después de la dosis 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 (prior to Dose 1) and Visit 5 (28 days Postdose 4 [+7 days])
    Día 1 ( Antes de la dosis 1) y visita 5 (28 días tras la dosis 4 ( + 7 días))
    E.5.2Secondary end point(s)
    None
    Ninguno
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    Ninguno
    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
    Immunologic response to vaccine
    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 trial3
    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 EEA27
    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
    Belgium
    Canada
    Colombia
    Denmark
    Estonia
    Israel
    Netherlands
    New Zealand
    Peru
    Romania
    Spain
    Sweden
    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
    LPLV
    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 months5
    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 months4
    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 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: 204
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 136
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Immunocompromised individuals with autoimmune disease
    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 184
    F.4.2.2In the whole clinical trial 340
    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)
    No change is planned to the standard of care for the patient
    No aplica
    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 Decision2012-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-26
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