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    EudraCT Number:2021-000062-14
    Sponsor's Protocol Code Number:MN42988
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-23
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-000062-14
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy
    Estudio para Evaluar la Concentración de Linfocitos B En Niños Potencialmente Expuestos al Ocrelizumab Durante el embarazo
    A.4.1Sponsor's protocol code numberMN42988
    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 SponsorF. Hoffmann-La Roche Ltd
    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 supportF. Hoffmann-La Roche Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248196
    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 Yes
    D. name Ocrevus
    D. of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOcrelizumab
    D.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.3Other descriptive nameOCRELIZUMAB
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 Yes
    D. medicinal product typehumanized monoclonal antibody
    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
    Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
    Esclerosis múltiple (EM) o síndrome clínico aislado (SCA) en consonancia con las indicaciones autorizadas en el país
    E.1.1.1Medical condition in easily understood language
    MS is a chronic disease in which the immune system attacks the insulation and support around the nerve cells in the brain, spinal cord and optic nerves, causing inflammation and consequent damage.
    EM: enf crónica en q el sistema inmunológico ataca el aislamiento y el soporte alrededor de células nerviosas del cerebro, médula espinal y nervios ópticos, provocando inflamación y consiguiente daño
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071068
    E.1.2Term Clinically isolated syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate whether infants potentially exposed to ocrelizumab during pregnancy present with postpartum B cell depletion
    Evaluar si los niños potencialmente expuestos al ocrelizumab durante el embarazo presentan depleción posparto de linfocitos B.
    E.2.2Secondary objectives of the trial
    • To evaluate B cell levels in infants potentially exposed to ocrelizumab during pregnancy
    • To evaluate whether there is placental transfer of ocrelizumab from the mother to the infant
    • To evaluate whether infants potentially exposed to ocrelizumab during pregnancy are able to mount humoral immune responses to clinically relevant vaccines
    • To evaluate the levels of ocrelizumab in the mother during pregnancy
    • To evaluate the safety of ocrelizumab in the mother, and the safety of infants potentially exposed to ocrelizumab
    • To evaluate pregnancy and neonatal outcomes
    • Evaluar los niveles de linfocitos B en niños potencialmente expuestos al ocrelizumab durante el embarazo.
    • Evaluar si se produce transferencia placentaria del ocrelizumab de la madre al niño.
    • Evaluar si los niños potencialmente expuestos al ocrelizumab durante el embarazo pueden generar respuestas inmunitarias humorales a vacunas de relevancia clínica.
    • Evaluar los niveles de ocrelizumab en la madre durante el embarazo.
    • Evaluar la seguridad del ocrelizumab en la madre y en los niños potencialmente expuestos al ocrelizumab
    • Evaluar los resultados en el embarazo y neonatales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • An informed consent form (ICF) for participation of the maternal subject and her unborn (for collection of blood samples, infant demographics and AE data) is signed and dated by the subject. Where applicable, the written ICF with respect to the infant is also signed and dated by the holder of parental rights as designated by the maternal subject
    • Able and willing to comply with the study protocol, in the Investigator’s judgment
    • Age 18-40 years, inclusive, at screening
    • Have a diagnosis of MS or CIS (in line with the locally approved indications)
    • Currently pregnant with singleton pregnancy at gestational week <=26 at enrolment
    • Documentation that first (12-week) and second (18 to 20-week) obstetric ultrasound (prenatal screening) has been conducted before enrolment during the screening period
    • Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy (up to gestational week 13 inclusive)
    ● La madre deberá firmar y fechar un formulario de consentimiento informado (FCI) tanto para su participación como para la del hijo que espera (para la extracción de muestras de sangre, datos demográficos y datos de AA del niño). Cuando corresponda, el FCI por escrito también deberá ser firmado y fechado por el titular de los derechos de paternidad designado por la madre.
    ● La paciente deberá poder y querer cumplir el protocolo del estudio, en opinión del investigador.
    ● La edad de la paciente en el momento de la selección deberá ser de 18 40 años, ambos incluidos.
    ● La participante deberá haber sido diagnosticada de EM o SCA (de conformidad con las indicaciones locales autorizadas).
    ● La paciente deberá encontrarse en la semana ≤26 de un embarazo de feto único en el momento de su inscripción.
    ● Deberá documentarse que la primera (semana 12) y la segunda (semana 18 20) ecografía obstétrica (estudio prenatal) se haya llevado a cabo antes de la inscripción, durante el periodo de selección.
    ●Deberá documentarse que la última exposición al ocrelizumab se produjo hasta 6 meses antes de la FUM previa a que la mujer se quedara embarazada O BIEN durante el primer trimestre (hasta la semana 13 de la gestación incluida) de embarazo.
    E.4Principal exclusion criteria
    • Last exposure to ocrelizumab >6 months before the woman’s LMP or later than the first trimester (i.e.after gestational week 13)
    • Gestational age at enrolment >26 weeks
    • Non-singleton pregnancy
    • Received last dose of ocrelizumab at a different posology other than per the local prescribing information
    • Social circumstances that may preclude a woman from participating in the study
    Exclusions related to obstetric and gynecological health
    • Lack of access to ultrasound pre-natal care as part of standard clinical practice
    • Women in whom aneuploid disorders or genetic disorders that cause major congenital malformations have been detected during first trimester prenatal screening (e.g.ultrasound, amniocentesis, genetic testing, nuchal translucency screening, chorionic villus sampling),or in whom any fetal anomalies have been detected during the morphology scan at around or before gestational week 18-20
    • Documented history of disorders associated with adverse pregnancy outcomes, including but not limited to:
    o History of preterm birth (gestational age <37 weeks) for any indication with or without fetal malformations
    o History of spontaneous abortion (miscarriage) after the 1st trimester (i.e. after gestational week 13)
    o History of stillbirth (defined as fetal loss after gestational week 22)
    o History of pre-eclampsia/eclampsia
    o History of a cervical pathology or intervention which may increase the risk of cervical incompetence (e.g. history of cervical cerclage, prior cervical conization or loop electrosurgical excision procedure)
    • Prior or current history of any other gynecological or obstetric disease considered by the investigator to be associated with a high risk of adverse pregnancy outcomes in the current pregnancy
    Exclusions related to general health
    • Lack of peripheral venous access
    • Pre-pregnancy body mass index >35 kilograms per square meter
    • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
    • Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state. The woman may be re-screened and included if condition resolves significant and uncontrolled disease, such as cardiovascular (including cardiac arrhythmia and hypertension), pulmonary (including obstructive pulmonary disease), neurological, psychiatric, renal, hepatic, endocrine (e.g. diabetes, thyroid disorders), or gastrointestinal or any other significant disease that may preclude a woman from participating in the study
    • Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin). Women with in situ carcinoma of the cervix of the uterus, even if excised and resolved with documented clean margins on pathology, are excluded from the study
    • Prior or current history of alcohol or drug abuse, or current use of tobacco
    Exclusions Related to Laboratory Findings
    • Any abnormal screening laboratory value that is clinically relevant will be retested only once in order to rule out any progressive or uncontrolled underlying condition. The last value before study entry must meet study criteria
    • Women with positive screening tests for hepatitis B, determined by a positive HBsAg result (current infection) or positive HBcAb titers (previous infection) will be excluded. Women with documented history of hepatitis B virus vaccination or positive hepatitis B surface antibody titers are eligible
    Exclusions Related to Medications
    Absolute exclusions
    • Drugs known to have teratogenic effects including but not limited to certain anticonvulsants (even if used for pain management), antibiotics such as tetracyclines or fluoroquinolones
    • Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose before enrolment and throughout pregnancy
    Relative exclusions
    • Treatment with one of the following agents prior to the last ocrelizumab dose or prior to the LMP, whichever occurred first:
    − Treatment with siponimod within 10 days
    − Treatment with mycophenolate within 6 weeks
    − Treatment with fingolimod within 2 months
    − Treatment with alemtuzumab within 4 months
    − Treatment with mitoxantrone, methotrexate, rituximab, ofatumumab or cladribine within 6 months
    − Treatment with cyclophosphamide within 12 months
    • Treatment with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/L. If levels are above 0.02 mg/L or not known, an accelerated elimination procedure will be implemented before screening visit
    • Treatment with any investigational agent within 6 months or 5 half-lives of the investigational drug (whichever is longer) prior to the last ocrelizumab dose or prior to the LMP whichever occurred first
    La última exposición al OCRE fue más de 6meses antes de la FUM o fue posterior al primer trimestre de embarazo.
    La edad gestacional en el momento de inscripción es >26semanas.
    El embarazo no es de feto único.
    La posología de la última dosis de OCRE que recibió la paciente era diferente a la info de prescripción local.
    Se dan circunstancias sociales q pueden impedir la participación de la mujer en estudio.
    Exclusiones relacionadas con la salud obstétrica y ginecológica
    No es posible disponer de ecografías prenatales como parte de la práctica clínica habitual.
    Mujeres a las que, durante el estudio prenatal del primer trimestre se les hayan detectado trastornos aneuploides u otros trastornos genéticos q causen malformaciones congénitas importantes, o bien se les hayan detectado anomalías fetales durante la exploración morfológica antes o alrededor de semana 18 20 embarazo.
    Pacientes con antecedentes (Antec) documentados de trastornos asociados con resultados adversos del embarazo, entre los que se incluyen, aunque no exclusiva: Antec de parto prematuro (edad gestacional <37semanas) por cualquier indicación, con o sin malformaciones fetales. De aborto espontáneo después del primer trimestre (es decir, después de la semana13 de la gestación). De mortinatos. De preeclampsia/eclampsia. De una patología o intervención cervicouterina q pueda incrementar el riesgo de insuficiencia cervicouterina
    Antec previos o actuales de cualquier otra enf ginecológica u obstétrica que el investigador considere asociada con un mayor riesgo de resultados adversos para el embarazo en curso.
    Exclusiones relacionadas con el estado de salud general
    Ausencia de acceso venoso periférico.
    Índice de masa corporal (IMC) antes del embarazo >35 kg/m2.
    Cualquier enf concomitante q pueda requerir tto crónico con corticoesteroides sistémicos o inmunodepresores durante el estudio.
    Antec previos o actuales de inmunodeficiencia primaria o secundaria o cualquier otro estado de inmunodepresión grave. Enf importante y no controlada, como enfes cardiovasculares (incluida la arritmia cardíaca y la hipertensión), pulmonares (incluida la enf pulmonar obstructiva), neurológicas, psiquiátricas, renales, hepáticas, endocrinas o gastrointestinales, o cualquier otra enf significativa q pueda impedir a la mujer participar en el estudio.
    Mujeres con neoplasias malignas activas conocidas o a las que se les esté realizando un seguimiento activo para controlar la reaparición de cánceres, incluyendo tumores sólidos y neoplasias malignas hematológicas (excepto carcinomas basocelulares y carcinoma escamocelular in situ de la piel). Las mujeres con carcinoma en cuello uterino in situ, incluso aunque se haya extirpado y resuelto con márgenes patológicos claros documentados, no podrán participar.
    Antec previos o actuales de abuso de drogas o alcohol, o tabaquismo actual
    Exclusiones relacionadas con resultados de laboratorio
    Todos los valores analíticos de selección que resulten anómalos y de importancia clínica deben repetirse una única vez para descartar cualquier enf subyacente progresiva o no controlada. El último valor previo a la incorporación en el estudio debe cumplir los criterios de este.
    Las mujeres con pruebas de detección positivas para hepatitis B, determinadas por un resultado positivo en antígeno de superficie del virus de la hepatitis B (HBsAg), q indica la presencia de infección, o niveles positivos de antígeno nuclear del virus de la hepatitis B (HBcAb), indicativos de una infección previa, no podrán participar
    Exclusiones relacionadas con la medicación
    Exclusiones absolutas
    Medicamentos con efectos teratogénicos conocidos, incluidos, entre otros, ciertos anticonvulsivos (incluso si se usan para el tto del dolor) y antibióticos, como las tetraciclinas o las fluoroquinolonas.
    Tto previsto con interferones, acetato de glatiramer o pulsos de corticoesteroides como terapia puente después de la última dosis de OCRE, antes de la inscripción y durante el embarazo.
    Exclusiones relativas
    Tto con uno de los siguientes agentes antes de la última dosis de OCRE o antes de la FUM, lo que sucediera antes: Tto con siponimod en los últimos 10días, Tto con micofenolato en las últimas 6 emanas, Tto con fingolimod en los últimos 2meses, Tto con alemtuzumab en los últimos 4meses, Tto con mitoxandrona, metotrexato, rituximab, ofatumumab o cladribina en los últimos 6meses, Tto con ciclofosfamida en los últimos 12meses
    Tto con teriflunomida en los últimos dos años, a menos que las concentraciones plasmáticas detectadas sean inferiores a 0,02 mg/l. Si los niveles son superiores a 0,02 mg/l o no se conocen, se llevará a cabo un procedimiento de eliminación acelerada antes de la visita de selección
    Tto con cualquier agente en investigación en los últimos 6meses o 5 semividas del medicamento en investigación (el período que sea más extenso) antes de la última dosis de OCRE o antes de la FUM, lo que sucediera antes.
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of infants with B cell levels (CD19+ cells, absolute counts) below the lower limit of normal (LLN), measured at week 6 (±7 days) post-partum
    1. Proporción de niños con niveles de linfocitos B (células CD19+, recuento absoluto) por debajo del límite inferior de la normalidad (LIN) determinados en la semana 6 (±7 días) posterior al parto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 6
    1. En semana 6
    E.5.2Secondary end point(s)
    1. B cell levels (CD19+ cells, absolute counts and percentage of lymphocytes) measured at week 6 (±7 days) post-partum
    2. Serum concentration of ocrelizumab in the umbilical cord blood at birth
    3. Serum concentration of ocrelizumab in the infant at week 6 (±7 days) post-partum
    4. Mean titers of antibody immune response(s) to vaccination to common childhood immunizations with full or partial doses given prior to 1 year, measured 1 month after the first dose of MMR vaccine or at month 13 (±14 days) in case MMR vaccine is not planned to be administered
    5. Proportion of infants with positive humoral response (seroprotective titers; as defined for the individual vaccine) to vaccines measured 1 month after the first dose of MMR vaccine, or at month 13 (±14 days) in case MMR vaccine is not planned to be administered
    6. Serum concentration of ocrelizumab in the mother during the second trimester, the third trimester, and at delivery
    7. Rate and nature of adverse events (AEs) in the mother throughout the study, including changes in clinical and laboratory results
    8. Rate and nature of AEs in the infant throughout the study, including infections and hospitalizations
    9. Proportion of pregnancies resulting in live births (term and preterm, with and without congenital anomalies), therapeutic abortions, or stillbirths
    10. Infant characteristics at birth, including but not limited to body weight, head circumference and length
    1. Niveles de linfocitos B (células CD19+, recuento absoluto y porcentaje de linfocitos) determinados en la semana 6 (±7 días) posterior al parto.
    2. Concentración sérica de ocrelizumab en la sangre del cordón umbilical en el momento del nacimiento.
    3. Concentración sérica de ocrelizumab en el niño en la semana 6 (±7 días) posterior al parto.
    4. Niveles medios de respuestas inmunitarias de anticuerpos a vacunas comunes en la infancia, cuyas dosis, totales o parciales, se suministran antes de cumplir 1 año, determinados 1 mes después de la primera dosis de MMR o en el mes 13 (±14 días) en caso de que no esté previsto administrarse la vacuna MMR.
    5. Proporción de niños con respuestas humorales positivas (niveles de anticuerpos seroprotectores, tal y como son definidos para cada vacuna particular) a las vacunas cuantificada 1 mes después de la primera dosis de la MMR o en el mes 13 (±14 días) en caso de que no esté previsto administrarse la vacuna MMR.
    6. Concentración sérica de ocrelizumab en la madre durante el segundo trimestre, el tercer trimestre y en el parto
    7. Tasa y naturaleza de los acontecimientos adversos (AA) en la madre a lo largo del estudio, incluidos los cambios en los resultados clínicos y de laboratorio.
    8. Tasa y naturaleza de los AA en el niño a lo largo del estudio, incluidas las infecciones y hospitalizaciones.
    9. Proporción de embarazos con recién nacidos vivos (a término completo y prematuros, con y sin anomalías congénitas), abortos terapéuticos o muerte fetal.
    10. Características de los niños al nacer, incluidas, entre otras, el peso corporal, el perímetro cefálico y la estatura.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Week 6
    2. Within 1 hour after delivery
    3. At Week 6
    4-5. 1 month after the first dose of MMR vaccine, or at month 13 in case MMR vaccine is not planned to be administered
    6. At Weeks 26, 36, and within 24 hours after delivery
    7.-8. Throughout the study
    9.-10. At birth
    1. En la semana 6
    2. Dentro de 1 hora después del parto
    3.En la semana 6
    4-5. 1 mes después de la primera dosis de la vacuna MMR, o en el mes 13 en caso de que no se planee administrar la vacuna MMR
    6. En las semanas 26, 36 y dentro de las 24 horas posteriores al parto
    7-8. Durante todo el estudio
    9. Al nacer
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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
    exposure effects
    Efectos de Exposición
    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. 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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    United States
    United Kingdom
    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
    The end of the study is defined as the date of the last assessment (vaccine response titers measured 1 month after the first dose of MMR vaccine, or at month 13 (±14 days) if MMR is not planned to be administered) for the last infant. The total length of the study, from screening of the first woman to the end of the study, is expected to be approximately 25 months. This includes an enrolment period of approximately 8 months and subject participation period of approximately 17 months.
    Final del estudio: fecha de la última evaluación (niveles de respuesta a las vacunas determinados 1 mes después de la primera dosis de la MMR o en el mes 13 [±14 días] en caso de no estar previsto administrarse la vacuna MMR) del último niño. La duración total prevista del estudio, desde la selección de la primera mujer hasta el final del estudio, es de unos 25 meses. Esto incluye un periodo de inscripción de aproximadamente 8 meses y la participación de los sujetos durante aprox 17 meses
    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 months1
    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 months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 44
    F.1.1.1In Utero Yes
    F. of subjects for this age range: 44
    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: 44
    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 Yes
    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 Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    44 in utero/newborns
    44 en el útero/recién nacidos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 44
    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)
    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 Decision2021-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
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