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    Summary
    EudraCT Number:2011-005617-36
    Sponsor's Protocol Code Number:TESEC-06
    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:2012-03-14
    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 number2011-005617-36
    A.3Full title of the trial
    A phase III contact tracing trial comparing the diagnostic performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in combination with a double blind randomized split body safety assessment of C-Tb versus 2 T.U. Tuberculin PPD RT23 SSI
    Ensayo de fase III de seguimiento de contactos comparando el funcionamiento diagnóstico de C-Tb frente a ?QuantiFERON®-TB Gold In-Tube?, en combinación con un análisis de seguridad aleatorizado y doble ciego en diferentes partes del cuerpo de C-Tb frente a 2 UT de Tuberculina PPD RT23SSI (PPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigational research (clinical trial) to compare CT-b, which is a new test to diagnose tuberculosis, with 2 standard tests (PPD and QuantiFERON)
    Estudio de investigación (ensayo clínico) para comparar CT-b, una nueva prueba para el diagnóstico de la tuberculosis, con 2 pruebas estándar en el diagnóstico de la tuberculosis (PPD y QuantiFERON)
    A.4.1Sponsor's protocol code numberTESEC-06
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/012/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorStatens Serum Institut
    B.1.3.4CountryDenmark
    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 supportStatens Serum Institut
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStatens Serum Institut
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street Address5 Artillerivej
    B.5.3.2Town/ cityCopenhagen S
    B.5.3.3Post codeDK-2300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+453268 3416
    B.5.5Fax number+453268 3872
    B.5.6E-mailbtg@ssi.dk
    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 nameC-Tb
    D.3.2Product code C-Tb
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrdESAT-6
    D.3.9.2Current sponsor coderdESAT-6
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrCPF-10
    D.3.9.2Current sponsor coderCPF-10
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 2 T.U. Tuberculin PPD RT23 SSI
    D.2.1.1.2Name of the Marketing Authorisation holderStatens Serum Institute
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 name2 T.U. Tuberculin PPD RT23 SSI
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTuberculin
    D.3.9.2Current sponsor codePPD
    D.3.9.3Other descriptive nameTUBERCULIN PPD RT 23
    D.3.9.4EV Substance CodeSUB22072
    D.3.10 Strength
    D.3.10.1Concentration unit tuberculin unit tuberculin unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Tuberculosis diagnostic tool
    Prueba diagnóstica para la tuberculosis
    E.1.1.1Medical condition in easily understood language
    Tuberculosis diagnosis
    Diagnóstico de la tuberculosis
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10044755
    E.1.2Term Tuberculosis
    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
    -To compare the diagnostic performance of C-Tb to that of QuantiFERON®-TB Gold In-Tube
    -To compare the diagnostic performance of C-Tb to that of Tuberculin PPD RT23 SSI
    -To assess the safety of C-Tb
    -Comparar la utilidad diagnóstica de C-Tb con la de QuantiFERON®-TB Gold In-Tube
    -Comparar la utilidad diagnóstica de C-Tb con la de Tuberculina PPD RT23 SSI
    -Evaluar la eficacia de C-Tb
    E.2.2Secondary objectives of the trial
    To asses the diagnostic outcome of C-Tb, QuantiFERON®-TB Gold In-Tube and Tuberculin PPD RT23 SSI between and within 4 groups defined by estimated risk of infection with M. tuberculosis (MTb).
    Evaluar el resultado diagnóstico de C-Tb, QuantiFERON®-TB Gold In-Tube y Tuberculina PPD RT23 SSI en y entre 4 grupos definidos en función del riesgo estimado de infección por M. tuberculosis (MTb).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Can comply with one of the following groups:
    a) Negative control group: Must have no history of exposure to a TB
    index case, and have no signs or symptoms of TB
    b) Positive control group: Confirmed TB disease within the last 3 years
    by sputum smear microscopy and/or Culture, Gene Xpert
    or PCR
    c) Close contact group: Must be in close contact with a pulmonary
    smear positive TB index case for more than 6 hours/day for at least five
    days
    d) Occasional contact group: Must be in contact with a pulmonary
    sputum smear positive TB index case between 6 hours/week and 6
    hours/day
    2.Is between 6 weeks - 65 years of age
    3.Participant, parent or legal guardian has provided signed informed consent
    4.Is willing and likely to comply with the trial procedures
    5.Is prepared to grant authorized persons access to their medical record
    1.Deberán cumplir los criterios para ser incluidos en uno de los siguientes grupos:
    a)Grupo de control negativo No deben presentar antecedentes de exposición a un caso inicial de TB, y tampoco deben mostrar signos o síntomas de TB.
    b)Grupo de control positivo: Deben haber padecido TB en el transcurso de los 3 años previos, confirmada mediante microscopia y/o cultivo de frotis de esputo, PCR o el sistema Gene Xpert.
    c) Grupo de contacto estrecho: Deben haber mantenido contacto estrecho con un caso inicial de TB pulmonar (resultados positivos en la prueba de frotis de esputo), durante más de 6 horas/día, al menos durante cinco días.
    d) Grupo de contacto ocasional: Deben haber mantenido contacto estrecho con un caso inicial de TB pulmonar (resultados positivos en la prueba de frotis de esputo) (entre 6 horas/semana y 6 horas/día).
    2.Deben tener entre 6 semanas y 65 años de edad.
    3.Deben haber proporcionado el consentimiento informado por escrito (también podrán proporcionarlo los padres o el representante legal, según corresponda).
    4.Deben estar dispuestos a realizar los procedimientos del estudio.
    5.Deben otorgar su permiso para que las personas autorizadas tengan acceso a su historia clínica.
    E.4Principal exclusion criteria
    1.Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. Mumps Measles Rubella (MMR), yellow fever, oral typhoid vaccines)
    2.Has been tuberculin tested less than 12 months prior to the day of inclusion
    3.Is pregnant, breastfeeding or intending to get pregnant within the trial period
    4.Is a female of child bearing potential (12 years of age or older having had their first menstruation) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures within the trial period
    5.Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin?s disease, lymphoma, leukaemia, sarcoidosis)
    6.Has a current skin condition which interferes with the reading of the C-Tb and Tuberculin PPD RT23 SSI e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
    7.Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders, or significantly impaired venous access
    8.Current participation in another clinical trial with an investigational or non investigational drug or device, which in the opinion of investigator may interfere with this trial drug
    9.Has participated in previous clinical trials investigating injections with ESAT-6 and/or CFP-10 antigens
    10.Has a condition which in the opinion of the investigator is not suitable for participation in the trial
    1.Haber recibido una vacuna viva en el transcurso de las 6 semanas previas al día de inclusión en el estudio (por ejemplo, paperas, sarampión, rubeola, fiebre amarilla, vacunas orales frente a la fiebre tifoidea)
    2.Haberse sometido a la prueba de tuberculina menos de 12 meses antes del día de la inclusión en el estudio.
    3.Estar embarazada o en período de lactancia, o tener intención de quedarse embarazada durante el estudio.
    4.En el caso de las mujeres en edad fértil (? 12 años de edad, que hayan tenido la primera menstruación), no estar dispuestas a utilizar un método anticonceptivo eficaz (hormonal, intrauterino o de barrera [incluido el gel espermicida]) durante el estudio.
    5.Padecer una enfermedad activa que afecte a los órganos linfáticos (con la excepción de VIH) ?por ejemplo, enfermedad de Hodgkin, linfoma, leucemia, sarcoidosis?.
    6.Presentar alguna enfermedad cutánea que interfiera con la lectura de las pruebas de C-Tb y Tuberculina PPD RT23 SSI (por ejemplo, tatuajes, cicatrizaciones graves, quemazón / quemadura solar, exantema, eccema, psoriasis o cualquier otra enfermedad cutánea en la zona de inyección o cerca de esta).
    7.Padecer alguna enfermedad por la que las extracciones de sangre representen más que un riesgo mínimo para el participante, como hemofilia, otros trastornos de la coagulación o acceso venoso significativamente deteriorado.
    8.Estar participando en la actualidad en otro ensayo clínico con un fármaco o dispositivo autorizados o en fase de investigación que, en opinión del investigador, podrían interferir con el fármaco de este estudio.
    9.Haber participado previamente en ensayos clínicos en los que se evaluara la administración de inyecciones con antígenos ESAT-6 y/o CFP-10.
    10.Padecer una enfermedad que en opinión del investigador haga que el participante no se considere idóneo para ser incluido en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    -The specificity of C-Tb compared to that of QuantiFERON®-TB Gold In-Tube
    -The specificity of C-Tb compared to that of Tuberculin PPD RT23 SSI
    -The sensitivity of C-Tb compared to that of QuantiFERON®-TB Gold In-Tube
    -The sensitivity of C-Tb compared to that of Tuberculin PPD RT23 SSI
    -Especificidad de C-Tb en comparación con la de QuantiFERON®-TB Gold In-Tube
    -Especificidad de C-Tb en comparación con la de Tuberculina PPD RT23 SSI
    -Sensibilidad de C-Tb en comparación con la de QuantiFERON®-TB Gold In-Tube
    -Sensibilidad de C-Tb en comparación con la de Tuberculina PPD RT23 SSI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Reading of indurantion at 48-72 hours
    Quantiferon results: when available
    Lectura de la induración a las 48-72 horas
    Resultados del Quantiferon: cuando estén disponibles
    E.5.2Secondary end point(s)
    -Response ratios for C-Tb, QuantiFERON®-TB Gold In-Tube and Tuberculin PPD RT23 SSI in 4 groups defined by estimated risk of infection with MTb.
    -The diameter of induration at the C-Tb injection site measured transversely to the long axis of the forearm at 2 to 3 days after intradermal administration of C-Tb
    -The diameter of induration at the Tuberculin PPD RT23 SSI injection site measured transversely to the long axis of the forearm at 2 to 3 days after intradermal administration of Tuberculin PPD RT23 SSI
    -Cocientes de respuesta para C-Tb, QuantiFERON®-TB Gold In-Tube y Tuberculina PPD RT23 en 4 grupos definidos en función del riesgo estimado de infección por MTb.
    -Diámetro de la induración en la zona de inyección de C-Tb, medido transversalmente al eje mayor del antebrazo, 2-3 días después de la administración intradérmica de C-Tb.
    -Diámetro de la induración en la zona de inyección de Tuberculina PPD RT23 SSI, medido transversalmente al eje mayor del antebrazo, 2-3 días después de la administración intradérmica de Tuberculina PPD RT23 SSI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Reading of indurantion at 48-72 hours
    Quantiferon results: when available
    Lectura de la induración a las 48-72 horas
    Resultados del Quantiferon: cuando estén disponibles
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Other diagnostic test
    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 concerned12
    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 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
    Last Patient Last Visit
    Ultima Visita del Último Paciente
    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 months6
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days28
    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: 120
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 780
    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 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 state900
    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)
    Standard of care
    Tratamiento normal
    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 Decision2012-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-02
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