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    Summary
    EudraCT Number:2020-003643-29
    Sponsor's Protocol Code Number:VAC31518COV3009
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2020-11-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-003643-29
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
    Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de Ad26.COV2.S para la prevención de COVID-19 mediada por SARS-CoV-2 en Adultos mayores de 18 años.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S vaccine for the Prevention of COVID-19 disease in Adults Aged 18 Years and Older
    Estudio de fase 3 para evaluar la eficacia y la seguridad de Ad26.COV2.S para la prevención de la enfermedad COVID-19 en Adultos mayores de 18 años.
    A.3.2Name or abbreviated title of the trial where available
    ENSEMBLE 2
    ENSEMBLE 2
    A.4.1Sponsor's protocol code numberVAC31518COV3009
    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 organisationDr. Arribas Lopez (UCICEC)
    B.5.2Functional name of contact pointDr. Arribas Lopez
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number0034912071466
    B.5.6E-maildrarribas.vaccov@gmail.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 (also known as Ad26COVS1)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy Volunteers, with or without comorbidities (Prevention of SARS-CoV-2-mediated COVID-19)
    Voluntarios sanos, con o sin comorbilidades (Prevención de la COVID-19 mediada por SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    Healthy Volunteers, some of which may have an underlying medical condition (Prevention of COVID-19)
    Voluntarios sanos, algunos de los cuales pueden tener una afección médica subyacente (Prevención de la 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
    To demonstrate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed, moderate to severe/critical COVID-19, as compared to placebo, in SARS-CoV-2 seronegative adults
    Demostrar la eficacia del Ad26.COV2.S en la prevención de la COVID-19 de moderada a grave/crítica, confirmada molecularmente en comparación con el placebo, en adultos seronegativos al SARS-CoV-2
    E.2.2Secondary objectives of the trial
    - To demonstrate the efficacy of Ad26.COV2.S in the prevention of moderate to severe/critical COVID-19 in adults regardless of their serostatus
    - To evaluate the efficacy of Ad26.COV2.S in the prevention of moderate to severe/critical COVID-19
    - To assess the effect of Ad26.COV2.S on:
    1. COVID-19 requiring medical intervention
    2. SARS-CoV-2 viral RNA load for moderate to severe/critical COVID-19
    3. Mild COVID-19
    4. COVID-19 as defined by the US FDA harmonized case definition
    5. All molecularly confirmed symptomatic COVID-19
    6. Occurrence of confirmed asymptomatic or undetected infections with SARS-CoV-2
    - To assess the efficacy of Ad26.COV2.S in the prevention of SARS-CoV-2 infection
    - To evaluate safety in terms of SAEs, MAAEs, and MAAEs leading to study discontinuation
    - In a subset of participants, to evaluate the safety and reactogenicity (local & systemic AEs, unsolicited AEs), and immunogenicity of Ad26.COV2.S as compared to placebo
    Demostrar la eficacia de Ad26.COV2.S en la prevención de la COVID-19 de moderada a grave/crítica en adultos independientemente de su estado serológico
    Evaluar la eficacia de Ad26.COV2.S en la prevención de la COVID-19 de moderada a grave/crítica
    Evaluar el efecto de Ad26.COV2.S en:
    1.COVID-19 que requiera intervención médica
    2.Carga de ARN viral SARS-CoV-2 para la COVID-19 de moderada a grave/crítica
    3.COVID-19 leve
    4.COVID-19 según la definición armonizada de casos de la FDA de EE.UU.
    5.Todos los casos confirmados molecularmente de COVID-19 sintomática
    6.Presencia de infecciones por SARS-CoV-2 asintomáticas confirmadas o no detectadas
    Evaluar la eficacia de Ad26.COV2.S en la prevención de infección por SARS-CoV-2
    Evaluar la seguridad en términos de AAG, AAAM y AAAM que provoquen la interrupción del estudio
    En un subconjunto de participantes, evaluar la seguridad y reactogenia (AA locales y sistémicos, AA inesperados) e inmunogenia de Ad26.COV2.S en comparación con placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Stages 1a and 2a: Participant is ≥18 to <60 years of age on the day of signing the ICF.
    Stages 1b and 2b: Participant is ≥60 years of age on the day of signing the ICF
    2. Stage 1: In the investigator’s clinical judgement, participant must be either in good or stable health, including a BMI <30 kg/m2.
    Participants may have underlying illnesses (not associated with increased risk of progression to severe COVID-19 as specified in Exclusion Criteria), as long as their symptoms and signs are stable and well-controlled. If participants are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding the 1st vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of relevant medical history and BMI at screening.
    As of Stage 2: In the investigator’s clinical judgement, participant may have a stable and well-controlled comorbidity associated with an increased risk of progression to severe COVID-19 (eg, stable/well-controlled HIV infection). If participants are on medication for comorbidity associated with an increased risk of progression to severe COVID-19, the medication dose must have been stable for at least 12 weeks preceding the 1st vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of relevant medical history and BMI at screening.
    3. Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
    4. Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last dose of the study vaccine.
    1. Etapas 1a y 2a: el participante tiene entre 18 y 60 años de edad el día de la firma del FCI.
    Etapas 1b y 2b: el participante tiene 60 años o más el día de la firma del FCI.
    2. Etapa 1: según el criterio clínico del investigador, el participante debe presentar un estado de salud bueno o estable, incluido un IMC menor de 30 kg/m2.
    Los participantes pueden tener enfermedades subyacentes (no asociadas a un aumento del riesgo de progresión a COVID-19 grave, según se especifica en los criterios de exclusión), siempre que sus síntomas y signos se mantengan estables y bien controlados. Si los participantes reciben medicación para una afección, la dosis de la medicación debe haber permanecido estable durante al menos 12 semanas antes de la primera vacunación y se debe prever que se mantenga estable durante todo el estudio. Los participantes se incluirán según antecedentes médicos relevantes y el IMC en el momento de la selección.
    A partir de la etapa 2: según el criterio clínico del investigador, el participante puede presentar una comorbilidad estable y bien controlada asociada a un aumento del riesgo de progresión a COVID-19 grave (p. ej., infección por VIH estable/bien controlada). Si los participantes reciben medicación para una comorbilidad asociada a un aumento del riesgo de progresión a COVID-19 grave, la dosis de la medicación debe haber permanecido estable durante al menos 12 semanas antes de la primera vacunación y se debe prever que se mantenga estable durante todo el estudio. Los participantes se incluirán según antecedentes médicos relevantes y el IMC en el momento de la selección.
    3. El uso de anticonceptivos debe ser coherente con las normativas locales relativas a los métodos anticonceptivos aceptables para los participantes en estudios clínicos.
    4. El participante acepta no donar médula ósea, sangre ni hemoderivados desde la primera administración de la vacuna del estudio hasta 3 meses después de la última dosis de la vacuna del estudio.
    E.4Principal exclusion criteria
    1. 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 1st dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor.
    2. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine).
    3. 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 of 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 within 6 months before administration of the 1st dose of study vaccine and during the study. A substantially immunosuppressive steroid dose is considered to be ≥2 weeks of daily receipt of 20 mg of prednisone or equivalent. Ocular, topical or inhaled steroids are allowed.
    c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of the 1st dose of study vaccine and during the study.
    4. Participant received treatment with Ig in the 3 months or blood products in the 4 months before the planned administration of the 1st dose of study vaccine or has any plans to receive such treatment during the study.
    5. Participant received or plans to receive:
    a. Licensed live attenuated vaccines – within 28 days before or after planned administration of the 1st or subsequent study vaccinations.
    b. Other licensed (not live) vaccines – within 14 days before or after planned administration of the 1st or subsequent study vaccinations.
    6. Participant previously received a coronavirus vaccine.
    7. Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the 1st dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study.
    8. Participant is pregnant or planning to become pregnant within 3 months after the last dose of study vaccine.
    9. 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.
    10. Stage 1: Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19
    11. Stage 1: Participant has a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or other malignancies with minimal risk of recurrence).
    12. Stage 1: Participant has a history of acute polyneuropathy (eg, Guillain-Barré syndrome).
    13. Stage 1: Participant had surgery requiring hospitalization (defined as inpatient stay for longer than 24 hours or overnight stay), within 12 weeks before 1st vaccination, or will not have fully recovered from surgery requiring hospitalization, or has surgery requiring hospitalization planned during the time the participant is expected to participate in the study or within 6 months after the last study vaccine administration.
    14. Stage 1: Participant has chronic active hepatitis B or hepatitis C infection per medical history
    1. El participante tiene una enfermedad aguda clínicamente significativa (no se incluyen enfermedades de menor importancia, como diarrea o infección leve de las vías respiratorias superiores) o una temperatura mayor o igual 38,0 ºC (100,4 °F) en el plazo de 24 horas antes de la primera dosis prevista de la vacuna del estudio; la aleatorización en una fecha posterior está permitida a criterio del investigador y tras consultarlo con el promotor.
    2. El participante tiene una alergia conocida o sospechada o antecedentes de anafilaxia u otras reacciones adversas graves a vacunas o sus excipientes (incluidos específicamente los excipientes de la vacuna del estudio).
    3. El participante tiene una función anómala del sistema inmunitario a consecuencia de:
    a. Afecciones clínicas (p. ej., enfermedad autoinmune, posible enfermedad mediada por el sistema inmunitario o inmunodeficiencia conocida o sospechada, enfermedad renal crónica [con diálisis]) que se prevé que afecten a la respuesta inmunitaria de la vacuna del estudio. Los participantes con afecciones clínicas estables en tratamiento no inmunomodulador (p. ej., tiroiditis autoinmune, enfermedad reumática inflamatoria autoinmune, como artritis reumatoide) pueden inscribirse a criterio del investigador. Se permite el tratamiento no inmunomodulador, así como corticoesteroides a una dosis o vía de administración no inmunodepresora.
    b. Uso crónico (>10 días) o recurrente de corticoesteroides sistémicos en un plazo de 6 meses antes de la administración de la primera dosis de la vacuna del estudio y durante el estudio. Una dosis de corticoesteroides con suficiente acción inmunodepresora se considera mayor o igual a 2 semanas de administración diaria de 20 mg de prednisona o equivalente. Se permiten los corticoesteroides oculares, tópicos o inhalados.
    c. Administración de antineoplásicos e inmunomoduladores o radioterapia en el plazo de 6 meses antes de la administración de la primera dosis de la vacuna del estudio y durante el estudio.
    4. El participante recibió tratamiento con Ig en el plazo de 3 meses o hemoderivados en el plazo de 4 meses antes de la administración prevista de la primera dosis de la vacuna del estudio o tiene previsto recibir dicho tratamiento durante el estudio.
    5. El participante recibió o tiene previsto recibir:
    a. Vacunas vivas atenuadas autorizadas: en los 28 días antes o después de la administración prevista de la primera vacunación del estudio o las vacunaciones posteriores.
    b. Otras vacunas (no vivas) autorizadas: en los 14 días antes o después de la administración prevista de la primera vacunación del estudio o las vacunaciones posteriores.
    6. El participante recibió anteriormente una vacuna contra el coronavirus.
    7. El participante recibió un fármaco en investigación (incluidos los fármacos en investigación para la profilaxis de la COVID-19) o usó un dispositivo médico invasivo en investigación en el plazo de 30 días o recibió una vacuna en investigación (incluidas las vacunas con vector de adenovirus en investigación) en el plazo de 6 meses antes de la administración prevista de la primera dosis de la vacuna del estudio o está inscrito actualmente o planea participar en otro estudio de investigación durante el transcurso de este estudio.
    8. La participante está embarazada o planea quedarse embarazada en el plazo de 3 meses después de la última dosis de la vacuna del estudio.
    9. El participante tiene antecedentes de una afección médica aguda o crónica subyacente clínicamente significativa o presenta hallazgos de la exploración física para los cuales, en opinión del investigador, la participación no sería lo mejor para el participante (p. ej., compromete el bienestar) o que podría impedir, limitar o confundir las evaluaciones especificadas en el protocolo.
    10. Etapa 1: participantes con comorbilidades que están o podrían estar asociadas a un aumento del riesgo de progresión a COVID-19 grave.
    11. Etapa 1: el participante tiene antecedentes de neoplasia maligna en un plazo de 1 año antes de la selección (son excepciones los carcinomas epidermoide y basocelular de la piel y el carcinoma in situ del cuello uterino, u otras neoplasias malignas con mínimo riesgo de recurrencia).
    12. Etapa 1: el participante tiene antecedentes de polineuropatía aguda (p. ej., síndrome de Guillain-Barré).
    13. Etapa 1: el participante se sometió a cirugía que requirió hospitalización (definida como el ingreso del paciente durante más de 24 horas o estancia de una noche) en el plazo de 12 semanas antes de la primera vacunación, o no se habrá recuperado totalmente de la cirugía que requirió hospitalización, o tiene planificada una cirugía que requiere hospitalización durante el tiempo que está previsto que el participante participe en el estudio o en un plazo de 6 meses después de la última administración de la vacuna del estudio.
    14. Etapa 1: el participante tiene una infección activa crónica por hepatitis B o hepatitis C según antecedentes médicos.
    E.5 End points
    E.5.1Primary end point(s)
    First occurrence of molecularly confirmed, moderate to severe/critical COVID-19, with onset at least 14 days after the 2nd vaccination (Day 71)
    Primera manifestación de la COVID-19 de moderada a grave/crítica, molecularmente confirmada, con inicio al menos 14 días después de la segunda vacunación (día 71)
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 71
    día 71
    E.5.2Secondary end point(s)
    Efficacy:
    First occurrence of molecularly confirmed, moderate to severe/critical COVID-19, with onset
    -1 day after the 1st vaccination
    -at least 14 days after the 2nd vaccination (Day 71)
    -14 days after the 1st vaccination (Day 15)
    Safety: Occurrence and relationship of SAEs (during the entire study), MAAEs (until 6 months after the last vaccination), and MAAEs leading to study discontinuation (during the entire study) for all participants
    Immunogenicity:
    -Analysis of antibodies binding to the SARS-CoV-2 S protein by ELISA
    -SARS-CoV-2 neutralization as measured by virus neutralization assay (VNA; wildtype virus and/or pseudovirion expressing SARS-CoV-2 S protein)
    Eficacia:
    Primera manifestación de la COVID-19 de moderada a grave/crítica, confirmada molecularmente, con inicio
    -1 día después de la primera vacunación
    -como mínimo 14 días después de la segunda vacunación (día 71)
    -14 días después de la primera vacunación (día 15)
    Seguridad: incidencia y relación de los AAG (durante todo el estudio), los AAAM (hasta 6 meses después de la última vacunación) y los AAAM que conlleven la interrupción del estudio (durante todo el estudio) para todos los participantes
    Inmunogenia:
    -Análisis de los anticuerpos de unión a la proteína S del SARS-CoV-2 mediante ELISA
    -Neutralización del SARS-CoV-2 medida por el ensayo de neutralización del virus (VNA; virus natural y/o seudovirión que expresa la proteína S del SARS-CoV-2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: Day 2, day 15, day 71
    Safety: throughout the study
    Eficacia: día 2, día 15, día 71
    Seguridad: a lo largo de todo el estudio
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenia
    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 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 trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    Colombia
    France
    Germany
    Philippines
    South Africa
    Spain
    United Kingdom
    United States
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 21000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9000
    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 Yes
    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
    Subjects with stable and well-controlled comorbidities
    Sujetos con comorbilidades estables y bien controladas
    F.4 Planned number of subjects to be included
    F.4.1In the member state2000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20000
    F.4.2.2In the whole clinical trial 30000
    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)
    At the end of the study, participants who received placebo may be offered the Ad26.COV2.S study vaccine at no cost when the vaccine has been shown to be safe and efficacious, and preferably also after the duration of protection has been determined. This will occur in accordance with local and national regulations and in consultation with the responsible national authorities.
    Al final del estudio, a los participantes que recibieron placebo se les podrá ofrecer la vacuna del estudio Ad26.COV2.S sin coste cuando la vacuna haya demostrado ser segura y eficaz, y preferentemente también después de haber determinado la duración de la protección. Esto se producirá de conformidad con las normativas locales y nacionales y en consulta con las autoridades nacionales responsables.
    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 Decision2020-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-16
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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