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    Summary
    EudraCT Number:2020-005330-14
    Sponsor's Protocol Code Number:VAC31518COV2004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-18
    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 number2020-005330-14
    A.3Full title of the trial
    An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants.
    Estudio en fase II, abierto para evaluar la seguridad, la reactogenicidad y la inmunogenicidad de Ad26.COV.S.2 en participantes embarazadas sanas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants
    Estudio de fase 2 para evaluar la seguridad, la reactogenicidad y la inmunogenicidad de Ad26.COV2.S en participantes embarazadas sanas.
    A.3.2Name or abbreviated title of the trial where available
    HORIZON 1
    HORIZON 1
    A.4.1Sponsor's protocol code numberVAC31518COV2004
    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 SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    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 supportJanssen Vaccines & Prevention B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG, S.A.
    B.5.2Functional name of contact pointGLOBAL CLINICAL OPERATIONS
    B.5.3 Address:
    B.5.3.1Street AddressPº de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917226174
    B.5.5Fax number003491 722 86 28
    B.5.6E-mailbpiney1@its.jnj.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 nameAd26.COV2.S
    D.3.2Product code VAC31518
    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 INNNot available
    D.3.9.2Current sponsor codeVAC31518
    D.3.9.3Other descriptive nameAd26.COV2.S
    D.3.9.4EV Substance CodeSUB208328
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    Healthy Pregnant Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)
    Voluntarias embarazadas sanas (prevención de la COVID-19 mediada por el SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    Healthy Pregnant Volunteers (Prevention of COVID-19)
    Voluntarias embarazadas sanas (prevención de COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 100000004865
    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 assess the safety and reactogenicity of Ad26.COV2.S (5x10^10 vp) administered intramuscularly (IM) as a 2-dose schedule, in adult participants during the 2nd and/or 3rd trimester of pregnancy, and (potentially) post-partum.
    2.To assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S (5x10^10 vp), administered IM as a 2-dose schedule during the 2nd and/or 3rd trimester of pregnancy, 28 days after the first vaccination.
    3.To assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S (5x10^10 vp), administered IM as a 2-dose schedule during the 2nd and/or 3rd trimester of pregnancy, 28 days after the 2nd vaccination.
    1. Evaluar la seguridad y la reactogenicidad de Ad26.COV2.S (5x10^10 vp) administrado por vía intramuscular (IM) en un esquema de 2 dosis, en participantes adultas durante el segundo y/o tercer trimestre del embarazo, y (potencialmente) después del parto.
    2. Evaluar la respuesta inmunitaria humoral en la sangre periférica de las participantes adultas a Ad26.COV2.S (5x10^10 vp), administrada por vía IM en un esquema de 2 dosis durante el segundo y/o tercer trimestre de embarazo, 28 días después de la primera vacunación.
    3.Evaluar la respuesta inmunitaria humoral en sangre periférica de las participantes adultas a Ad26.COV2.S (5x10^10 vp), administrada por vía IM en un esquema de 2 dosis durante el 2º y/o 3º trimestre de embarazo, 28 días después de la 2ª vacunación.
    E.2.2Secondary objectives of the trial
    1.To assess pregnancy outcomes in adult participants who have received Ad26.COV2.S during the 2nd and/or 3rd trimester of pregnancy.
    2.To assess pregnancy-related AEs in adult participants who have received Ad26.COV2.S during the 2nd and/or 3rd trimester of pregnancy.
    3.To assess outcomes in neonates and infants up to approximately 12 months of age born to participants who have received Ad26.COV2.S, during the 2nd and/or 3rd trimester of pregnancy.
    4.To assess safety in neonates and infants born to adult participants who have received Ad26.COV2.S, during the 2nd and/or 3rd trimester of pregnancy.
    5.To assess antibody levels against SARS-CoV-2 in neonates and infants, born to adult participants who have received Ad26.COV2.S during the 2nd and/or 3rd trimester of pregnancy, at birth (ie, in cord blood) and at approximately 2 months, 6 months, and 12 months of age.
    1. Evaluar los resultados del embarazo en participantes adultas que hayan recibido Ad26.COV2.S durante el 2º y/o 3º trimestre de embarazo.
    2. Evaluar los EA relacionados con el embarazo en participantes adultas que hayan recibido Ad26.COV2.S durante el 2º y/o 3º trimestre del embarazo.
    3. Evaluar los resultados en neonatos y bebés de hasta aproximadamente 12 meses de edad nacidos de participantes que hayan recibido Ad26.COV2.S, durante el 2º y/o 3º trimestre del embarazo.
    4. Evaluar la seguridad en neonatos y lactantes nacidos de participantes adultos que hayan recibido Ad26.COV2.S, durante el 2º y/o 3º trimestre del embarazo.
    5.Evaluar los niveles de anticuerpos contra el SARS-CoV-2 en neonatos y lactantes nacidos de participantes adultos que hayan recibido Ad26.COV2.S durante el 2º y/o 3º trimestre de embarazo, al nacer (es decir, en la sangre del cordón umbilical) y aproximadamente a los 2, 6 y 12 meses de edad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 45 years of age, inclusive, on the day of signing the ICF.
    2. Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening, and must not have comorbidities related to an increased risk of severe COVID-19 or high-risk pregnancy. Participant may have underlying illnesses (eg,
    stable/well-controlled HIV infection)*, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 or high-risk pregnancy.
    * Stable/well-controlled HIV infection includes:
    a. CD4 cell count ≥300 cells/μL.
    b. HIV viral load <50 copies/mL.
    c. Participant must be on a stable anti-retroviral treatment (ART) for 6 months (unless the change is due to tolerability, in which case the regimen can be for only the previous 3 months; changes in formulation are allowed) and the participant must be willing to continue his/her ART throughout the study as directed by his/her local physician.
    3. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study.
    4. Participant will be at 2nd or 3rd trimester of pregnancy, ie, Week 16 to Week 38 of gestation, at the time of vaccination, based on ultrasound at the time of screening (unless performed elsewhere within 28-days prior to vaccination).
    5. Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
    1. Participantes entre 18 años (o la edad legal de consentimiento en la jurisdicción en la que se realiza el estudio) y 45 años, inclusive, el día de la firma del CI.
    2. La participante debe estar sana, tal y como confirman la historia clínica, la exploración física, las constantes vitales y los antecedentes obstétricos realizados en el momento del cribado, y no debe tener comorbilidades relacionadas con un mayor riesgo de COVID-19 grave o de embarazo de alto riesgo. La participante puede tener enfermedades subyacentes (p. ej,infección por VIH estable/bien controlada)*, siempre que los síntomas y signos estén controlados médicamente y no se consideren comorbilidades relacionadas con un mayor riesgo de COVID-19 grave o de embarazo de alto riesgo.
    * La infección por VIH estable/bien controlada incluye:
    a. Recuento de células CD4 ≥300 células/μL.
    b. Carga viral del VIH <50 copias/mL.
    c. La participante debe estar en un tto. antirretroviral (TAR) estable durante 6 meses (a menos que el cambio se deba a la tolerabilidad, en cuyo caso el régimen puede ser sólo para los 3 meses anteriores; se permiten cambios en la formulación) y el participante debe estar dispuesto a continuar su TAR durante todo el estudio según las indicaciones de su médico local.
    3. Si está medicada por una enfermedad, la dosis de la medicación debe haber sido estable durante al menos 12 semanas antes de la vacunación y se espera que permanezca estable durante la duración del estudio.
    4. La participante estará en el 2º o 3º trimestre de embarazo, es decir, entre la semana 16 y la 38 de gestación, en el momento de la vacunación, según la ecografía realizada en el momento de la selección (a menos que se realice en otro lugar dentro de los 28 días anteriores a la vacunación).
    5. La participante acepta no donar médula ósea, sangre y productos sanguíneos desde la 1ª administración de la vacuna del estudio hasta 3 meses después de recibir la última dosis de la vacuna del estudio.
    E.4Principal exclusion criteria
    1. Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (eg, preeclampsia, premature birth during previous pregnancy).
    2. Participants with risk factors (eg, multiple pregnancies [twins or higher order multiples], diabetes, high blood pressure, obesity [before pregnancy], epilepsy, thyroid disease, heart or blood disorders, poorly controlled asthma, or infections) or complications (eg, abnormal placenta position, fetal growth less than the 10th percentile for gestational age [fetal growth restriction], and rhesus [Rh] sensitization) for a high-risk pregnancy.
    3. Participants with a family health history of congenital disorders or anomalies.
    4. Participant with abnormal pregnancy screening testa (eg, ultrasound fetal abnormalities, maternal blood screen)
    5. Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned first dose of study vaccine; vaccination at a later date is permitted at the discretion of the investigator and after consultation with the sponsor.
    6. Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence.
    7. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients.
    8. Participant has abnormal function of the immune system resulting from:
    a. Clinical conditions (eg, autoimmune disease, potential immune mediated disease or known or suspected immunodeficiency, chronic kidney disease [with dialysis]) expected to have an impact on the immune response elicited by the study vaccine. Participants with clinical conditions stable under non-immunomodulator treatment (eg, autoimmune thyroiditis, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed as well as steroids at a non-immunosuppressive dose or route of administration.
    b. Chronic (>10 days) or recurrent use of systemic corticosteroids at immunosuppressive doses within 6 months before administration of study vaccine and during the study.
    Note: Ocular, topical or inhaled steroids are allowed.
    c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of study vaccine and during the study
    9. Participant received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.
    10. Participant received or plans to receive:
    a. Licensed live attenuated vaccines – within 28 days before or after planned administration of the 1st and 2nd study vaccinations
    b. Other licensed (not live) vaccines – within 14 days before or after planned administration of the 1st and 2nd study vaccinations.
    11. Participant received an investigational drug or used an invasive investigational medical device within 30 days, or received investigational immunoglobulin or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months, before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study.
    12. Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.
    13. Participant had major surgery as per the investigator’s judgment within 12 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery (with the exception of Cesarean Section) planned during the time the participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
    14. Participant has chronic active hepatitis B or hepatitis C infection per medical history.
    1. Participantes con antecedentes médicos u obstétricos que las pongan en mayor riesgo de complicaciones maternas o fetales (por ejemplo, preeclampsia, parto prematuro durante un embarazo anterior).
    2. Participantes con factores de riesgo (p. ej., embarazos múltiples [gemelos o múltiplos de orden superior], diabetes, hipertensión arterial, obesidad [antes del embarazo], epilepsia, enfermedad tiroidea, trastornos cardíacos o sanguíneos, asma mal controlada o infecciones) o complicaciones (p. ej., posición anormal de la placenta, crecimiento fetal inferior al percentil 10 para la edad gestacional [restricción del crecimiento fetal] y sensibilización al Rh) para un embarazo de alto riesgo.
    3. Participantes con antecedentes sanitarios familiares de trastornos o anomalías congénitas.
    4. Participante con una prueba de detección de embarazo anormal (por ejemplo, anomalías fetales en la ecografía, análisis de sangre materna).
    5. Participante con enfermedad aguda clínicamente significativa (esto no incluye enfermedades menores como la diarrea o una infección leve del tracto respiratorio superior) o una temperatura ≥38,0ºC (100,4°F) dentro de las 24 horas anteriores a la 1ª dosis prevista de la vacuna del estudio; se permite la vacunación en una fecha posterior a discreción del investigador y previa consulta con el promotor.
    6. Participante con antecedentes de neoplasia en los 5 años anteriores a la selección (las excepciones son los carcinomas de células escamosas y basales de la piel y el carcinoma in situ del cuello uterino, o la neoplasia, que se considera curada con un riesgo mínimo de recidiva.
    7. Participante con alergia conocida o sospechada o antecedentes de anafilaxia u otras reacciones adversas graves a las vacunas o sus excipientes.
    8. Participante con una función anormal del sistema inmunitario como consecuencia de:
    a. Condiciones clínicas (por ejemplo, enfermedad autoinmune, enfermedad potencialmente inmunomediada o inmunodeficiencia conocida o sospechada, enfermedad renal crónica [con diálisis]) que se espera tengan un impacto en la respuesta inmune provocada por la vacuna del estudio. Los participantes con condiciones clínicas estables bajo tratamiento no inmunomodulador (p.e., tiroiditis autoinmune, enfermedad reumática inflamatoria autoinmune como la artritis reumatoide) pueden ser inscritos a discreción del investigador. Se permite el tratamiento no inmunomodulador así como los esteroides a una dosis o vía de administración no inmunosupresora.
    b. Uso crónico (>10 días) o recurrente de corticoides sistémicos a dosis inmunosupresoras en los 6 meses anteriores a la administración de la vacuna del estudio y durante el mismo. Nota: Se permiten los esteroides oculares, tópicos o inhalados.
    c. Admón de agentes antineoplásicos e inmunomoduladores o radioterapia en los 6 meses anteriores a la administración de la vacuna del estudio y durante el estudio
    9. La participante recibió tto con inmunoglobulinas en los 3 meses anteriores o productos sanguíneos en los 4 meses anteriores a la administración prevista de la primera dosis de la vacuna del estudio o tiene previsto recibir dicho tratamiento durante el estudio.
    10. La participante recibió o tiene previsto recibir
    a. Vacunas vivas atenuadas autorizadas - dentro de los 28 días anteriores o posteriores a la administración prevista de la 1ª y 2ª vacuna del estudio
    b. Otras vacunas autorizadas (no vivas) - dentro de los 14 días anteriores o posteriores a la administración prevista de la 1ª y 2ª vacuna del estudio.
    11. La participante recibió un fármaco en investigación o utilizó un dispositivo médico invasivo en investigación en un plazo de 30 días, o recibió inmunoglobulina o anticuerpos monoclonales en investigación en un plazo de 3 meses, o recibió suero de convalecencia para el tto de COVID-19 en un plazo de 4 meses o recibió una vacuna en investigación (incluidas las vacunas investigadas vectorizadas por adenovirus) en un plazo de 6 meses, antes de la administración planificada de la primera dosis de la vacuna del estudio o está actualmente inscrito o tiene previsto participar en otro estudio en investigación durante el curso de este estudio.
    12. La participante tiene antecedentes de una condición médica aguda o crónica subyacente o hallazgos en el examen físico para los cuales, en opinión del investigador, la participación no sería en el mejor interés del participante (p.e., comprometer el bienestar) o que podría impedir, limitar o confundir las evaluaciones especificadas en el protocolo.

    Se han eliminado los criterios nº 15 y 18 de la página 79 del protocolo en inglés, por exceder el número de caracteres permitidos.
    E.5 End points
    E.5.1Primary end point(s)
    - Solicited local and systemic adverse events (AEs) for 7 days after (each) vaccination.
    - Unsolicited AEs for 28 days after (each) vaccination.
    - Serious adverse events (SAEs) throughout the study (from first vaccination until end of the study, ie, at least 12 months after delivery).
    - Medically-attended adverse events (MAAEs) until 6 months after the last vaccination, and MAAEs leading to study discontinuation (during the entire study).
    - Serological response to vaccination as measured by enzyme-linked immunosorbent assay (ELISA; [S-ELISA, EU/mL]), 28 days after first and second vaccination.
    - Antibody geometric mean concentration (GMCs, S-ELISA), 28 days after first and second vaccination.
    - Efectos adversos (EA) locales y sistémicos solicitados durante los 7 días posteriores a (cada) vacunación.
    - Efectos adversos no solicitados durante los 28 días posteriores a (cada) vacunación.
    - Acontecimientos adversos graves (EAS) durante todo el estudio (desde la primera vacunación hasta el final del estudio, es decir, al menos 12 meses después del parto).
    - Eventos Adversos Atendidos Medicamente (EAAM) hasta 6 meses después de la última vacunación, y Eventos Adversos Atendidos Medicamente (EAAM) que provocaron la interrupción del estudio (durante todo el estudio).
    - Respuesta serológica a la vacunación medida por ensayo inmunoenzimático (ELISA; [S-ELISA, EU/mL]), 28 días después de la primera y segunda vacunación.
    - Concentración media geométrica de anticuerpos (GMC, S-ELISA), 28 días después de la primera y segunda vacunación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after (each) vaccination
    SAEs throughout the study
    MAAEs until 6 months after the last vaccination
    28 días después de (cada) vacunación
    EAS durante todo el estudio
    Eventos Adversos Atendidos Medicamente (EAAM) hasta 6 meses después de la última vacunación
    E.5.2Secondary end point(s)
    - Pregnancy outcomes (including, live term birth, live preterm birth, stillbirth, and abortion).
    - Pregnancy-related AEs including: gestational diabetes, gestational hypertension, premature rupture of membranes, premature labor, premature uterine contractions, poor or restricted fetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine hemorrhage (nonexhaustive).
    - Outcomes in neonates and infants (including, normal neonate, term neonate with complications, preterm neonate with complications, neonatal infection, respiratory distress, congenital anomalies, neonatal death, low birth weight, and small for estational age measured from birth until approximately 12 months of age (non-exhaustive).
    - SAEs (including Multisystem Inflammatory Syndrome in Children [MIS-C]) in neonates and infants from birth approximately 12 months of age.
    - MAAEs in neonates and infants from birth until 6 months of age.
    - MAAEs in neonates/infants leading to study discontinuation from birth until discontinuation.
    - Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) at birth and at approximately 2 months, 6 months, and 12 months of age.
    - Antibody GMCs (S-ELISA) at birth and at approximately 2 months, 6 months, and 12 months of age.
    - Resultados del embarazo (incluidos los nacimientos vivos a término, los nacimientos vivos prematuros, los mortinatos y los abortos).
    - Los EA relacionados con el embarazo incluyen: diabetes gestacional, hipertensión gestacional, rotura prematura de membranas, parto prematuro, contracciones uterinas prematuras, crecimiento fetal deficiente o restringido, preeclampsia, eclampsia, hemorragia vaginal o intrauterina (no exhaustivo).
    - Resultados en neonatos y lactantes (incluyendo, neonato normal, neonato a término con complicaciones, neonato prematuro con complicaciones, infección neonatal, dificultad respiratoria, anomalías congénitas, muerte neonatal, bajo peso al nacer y pequeño para la edad estacional medido desde el nacimiento hasta aproximadamente los 12 meses de edad (no exhaustivo).
    - EAS (incluyendo el Síndrome Inflamatorio Multisistémico en Niños [SMI-C]) en neonatos y lactantes desde el nacimiento hasta aproximadamente los 12 meses de edad.
    - Eventos Adversos Atendidos Medicamente (EAAM) en neonatos y lactantes desde el nacimiento hasta los 6 meses de edad.
    - Eventos Adversos Atendidos Medicamente (EAAM) en neonatos/bebés que conducen a la interrupción del estudio desde el nacimiento hasta la interrupción.
    - Respuesta serológica a la vacunación medida por ELISA (S-ELISA, EU/mL) al nacimiento y aproximadamente a los 2 meses, 6 meses y 12 meses de edad.
    - Anticuerpos GMC (S-ELISA) al nacimiento y aproximadamente a los 2 meses, 6 meses y 12 meses de edad.

    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 12 months of age
    Hasta los 12 meses de edad
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Reactogenicity and Immunogenicity
    Reactogenicidad e inmunogenicidad
    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 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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Brazil
    Canada
    South Africa
    United States
    Finland
    Spain
    United Kingdom
    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
    LVLS
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 400
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 400
    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)
    NA
    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 Decision2021-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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