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    Summary
    EudraCT Number:2022-001638-12
    Sponsor's Protocol Code Number:mRNA-1010-P302
    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:2022-07-19
    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 number2022-001638-12
    A.3Full title of the trial
    A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older.
    Estudio de fase 3, aleatorizado, enmascarado para el observador y comparado con producto activo, para evaluar la seguridad y la eficacia de mRNA-1010, una vacuna experimental frente a la gripe estacional en adultos de 50 o más años.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older
    Estudio de fase 3 para evaluar la seguridad y la eficacia de mRNA-1010, una vacuna experimental frente a la gripe estacional en adultos de 50 o más años
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    A.4.1Sponsor's protocol code numbermRNA-1010-P302
    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 SponsorModernaTX, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportModernaTX, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationModernaTX, Inc.
    B.5.2Functional name of contact pointSenior Director
    B.5.3 Address:
    B.5.3.1Street Address200 Technology Square
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617949-0868
    B.5.6E-mailclinicaltrials@modernatx.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 namemRNA-1010
    D.3.2Product code mRNA-1010
    D.3.4Pharmaceutical form Dispersion 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 INNInfluenza A (H3N2) Variant Virus
    D.3.9.2Current sponsor codeCX-029931
    D.3.9.3Other descriptive nameA/Darwin/6/2021 (A/H3N2)
    D.3.9.4EV Substance CodeSUB266934
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.018
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza A, H1N1. HA, mRNA
    D.3.9.2Current sponsor codeCX-029581
    D.3.9.3Other descriptive nameA/Wisconsin/588/2019 (A/H1N1)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.018
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza B, Victoria. HA, mRNA
    D.3.9.2Current sponsor codeCX-029678
    D.3.9.3Other descriptive nameB/Michigan/01/2021 (B/Victoria lineage)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.018
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza B, Yamagata. HA, mRNA
    D.3.9.2Current sponsor codeCX-029582
    D.3.9.3Other descriptive nameB/Phuket/3073/2013 (B/Yamagata lineage)
    D.3.9.4EV Substance CodeSUB198407
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.018
    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 Fluarix Quadrivalent/Influsplit Tetra
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameFluarix Quadrivalent/Influsplit Tetra
    D.3.4Pharmaceutical form Solution 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 INNInfluenza A (H1N1)
    D.3.9.3Other descriptive nameA/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019, IVR-215)
    D.3.9.4EV Substance CodeSUB223932
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza A (H3N2)
    D.3.9.3Other descriptive nameInfluenza A virus, A/Cambodia/e0826360/2020 (H3N2) - like strain (A/Tasmania/503/2020, IVR-221), Inactivated
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza B
    D.3.9.3Other descriptive nameB/Washington/02/2019 - like virus (B/Washington/02/2019, wild type)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfluenza B
    D.3.9.3Other descriptive nameB/PHUKET/3073/2013-LIKE STRAIN
    D.3.9.4EV Substance CodeSUB177659
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    Influenza
    Gripe
    E.1.1.1Medical condition in easily understood language
    Influenza
    Gripe
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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 evaluate the safety and reactogenicity of mRNA-1010 during the treatment period (28 days after study intervention) and follow-up period (period following the treatment period).
    - To evaluate relative vaccine efficacy of mRNA-1010 as compared to an active comparator against influenza caused by any influenza A or B virus strains using protocol-defined ILI definition.
    - Evaluar la seguridad y la reactogenia del mRNA-1010 durante el periodo de tratamiento (28 días después de la intervención del estudio) y el periodo de seguimiento (posterior al periodo de tratamiento).
    - Evaluar la eficacia relativa de la vacuna mRNA-1010 respecto a un comparador activo contra la gripe causada por cualquier cepa del virus A o B, según la definición de enfermedad seudogripal (ILI) establecida en el protocolo.
    E.2.2Secondary objectives of the trial
    To evaluate:
    - relative vaccine efficacy of mRNA-1010 vaccine as compared to an active comparator against influenza caused by influenza A or B strains with similarity to the vaccine strains, using protocol defined ILI definition.
    - relative vaccine efficacy of mRNA-1010 vaccine as compared to an active comparator against influenza caused by influenza A or B strains antigenically matched to the vaccine strains using protocol-defined ILI definition.
    - relative vaccine efficacy of mRNA-1010 vaccine as compared to an active comparator against influenza caused by influenza A or B strains using CDC-defined ILI definition.
    - relative vaccine efficacy of mRNA-1010 vaccine as compared to an active comparator against the first episode of culture-confirmed influenza caused by influenza A or B strains.
    - relative vaccine efficacy of mRNA-1010 as compared to an active comparator to prevent hospitalizations associated with influenza illness.
    Evaluar la eficacia relativa de la vacuna mRNA-1010 respecto:
    - a un comparador activo contra la gripe causada por cepas de gripe A o B con similituda a las cepas vacunales, según la definición de ILI establecida en el protocolo.
    - a un comparador activo contra la gripe causada por cepas de gripe A o B con correspondencia antigénica con las cepas vacunalesb, según la definición de ILI establecida en el protocolo.
    - a un comparador activo contra la gripe causada por cepas de gripe A o B (cualquier cepa o cepas similares o cepas con correspondencia antigénica), según la definición de ILI establecida por los CDC.
    - a un comparador activo contra la gripe, confirmada por cultivo, causada por cepas de gripe A o B (cualquier cepa o cepas con correspondencia antigénica).
    - a un comparador activo para prevenir hospitalizaciones por enfermedad gripal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all the following criteria apply:
    1. At least 50 years of age at the time of consent (Screening visit).
    2. Investigator has assessed that the participant understands and is willing and physically able to comply with protocol-mandated follow up, including all procedures.
    3. Provide written informed consent for participation in this study, including all evaluations and procedures as specified by this protocol.
    4. Females of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as postmenopausal or permanently sterilized. Follicle-stimulating hormone may be measured at the discretion of the Investigator to confirm postmenopausal status.
    5. Females of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
    - Has a negative pregnancy test at the Screening visit and on the day of vaccination prior to study vaccine dose being administered on Day 1.
    - Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
    Adequate female contraception is defined as consistent and correct use of a local health authority-approved contraceptive method in accordance with the product label.
    - Has agreed to continue adequate contraception through 90 days following study vaccine administration.
    Solo podrán participar en este estudio los pacientes que cumplan todos los criterios siguientes:
    1. Tener una edad mínima de 50 años en el momento del consentimiento (visita de selección).
    2. El investigador ha constatado que el participante entiende el seguimiento exigido por el protocolo, incluidos todos los procedimientos, y que está dispuesto a cumplirlo y es físicamente capaz de hacerlo.
    3. Otorgar el consentimiento informado por escrito para participar en este estudio, incluidas todas las evaluaciones y procedimientos especificados en el protocolo.
    4. Podrán participar en el estudio las mujeres sin capacidad de procrear, lo que se define como las que sean posmenopáusicas o hayan sido esterilizadas permanentemente. Podrá medirse la hormona foliculoestimulante, a criterio del investigador, para confirmar la posmenopausia.
    5. Podrán participar en el estudio las mujeres potencialmente fértiles que cumplan todos los criterios siguientes:
    - Presentar una prueba de embarazo negativa en la visita de selección y el día de la vacunación antes de la administración de la dosis de la vacuna del estudio el día 1.
    - Haber utilizado métodos anticonceptivos adecuados o haberse abstenido de toda actividad que pueda provocar un embarazo durante como mínimo 28 días antes de la primera dosis (día 1).
    La anticoncepción femenina adecuada se define como el uso constante y correcto, de acuerdo con el prospecto del producto, de un método anticonceptivo aprobado por las autoridades sanitarias locales.
    - Haber aceptado continuar con la anticoncepción adecuada hasta 90 días después de la administración de la vacuna del estudio.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1. Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza within the past 5 days prior to the screening visit.
    2. Close contact with someone with SARS-CoV-2 infection or COVID-19 as defined by the US CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening visit.
    3. Acutely ill or febrile (temperature >/= 38.0°C [100.4°F]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.
    4. History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 60 days prior to the Screening visit and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
    5. Reported history of congenital or acquired immunodeficiency, immunocompromising/ immunosuppressive condition, asplenia, or recurrent severe infections.
    The following conditions are permitted at the discretion of the Investigator:
    - Human immunodeficiency virus [HIV] positive participants on antiretroviral therapy with cluster of differentiation 4 count >/= 350 cells/mm3 and HIV RNA </= 500 copies/mL within the past 12 months.
    - Immune-mediated diseases that are stable, for example, Hashimoto's thyroiditis and type 1 diabetes mellitus or conditions such as asthma, psoriasis, vitiligo, gout, areata, autoimmune ovarian failure that do not require systemic immunosuppressants per Exclusion Criterion 10.
    6. Dermatologic conditions that could affect local solicited AR assessment of the injection site.
    7. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
    8. Reported history of coagulopathy or bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
    9. Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, may pose additional risk due to participation in the study or that could interfere with the interpretation of study results.
    10. Received systemic immunosuppressants for > 14 days in total within 180 days prior to the Screening visit (for glucocorticosteroids, ≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during
    participation in the study. Inhaled, nasal, intra-articular, and topical steroids are allowed.
    11. Received any vaccine authorized or approved by local health agency </= 28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
    12. Plans to receive a non-study influenza vaccine during the study from Day 1 to Day 181.
    13. Is unaware whether they received an influenza vaccine in the previous influenza season.
    14. Received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to the Randomization Visit.
    15. Tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Randomization Visit.
    16. Has been treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to the Randomization Visit.
    17. History of myocarditis, pericarditis, or myopericarditis within 60 days prior to the Screening visit. Participants who have not returned to baseline after their convalescent period will also be excluded.
    18. History of Guillain-Barre syndrome.
    19. Received systemic immunoglobulins and long-acting biological therapies that affect immune responses (eg infliximab) or blood products within 90 days prior to the Screening visit or plans to receive them during the study.
    20. Donated >/= 450 mL of blood products within 28 days prior to the Screening visit or plans to donate blood products during the study.
    21. Participated in an interventional clinical study within 28 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.
    Note: interventions such as counseling, biofeedback, and cognitive therapy are not exclusionary.
    22. Participant is working or has worked as study personnel or is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel.
    No podrán participar en el estudio los sujetos que cumplan cualquiera de los siguientes criterios:
    1. Contacto estrecho con una persona con infección por virus de la gripe confirmada en laboratorio o con una persona que haya recibido tratamiento antivírico para la gripe en los últimos 5 días antes de la visita de selección.
    2. Contacto estrecho con una persona con infección por SARS-CoV-2 o con COVID-19 según la definición de los CDC de Estados Unidos o que haya dado positivo en una prueba de SARS-CoV-2 en los últimos 10 días antes de la visita de selección.
    3. Enfermedad aguda o fiebre (temperatura >/= 38,0 °C [100,4 °F]) 72 horas antes de la visita de selección, en dicha visita o el día 1. A los participantes que cumplan este criterio se les podrá reprogramar dentro del margen para la selección de 28 días y conservarán el número de participante asignado inicialmente.
    4. Diagnóstico o afección anterior que, a juicio del investigador, sea clínicamente inestable o pueda afectar a la seguridad del participante, a la evaluación de los criterios de valoración de la seguridad, a la evaluación de la respuesta inmunitaria o al cumplimiento de los procedimientos del estudio. Se define como clínicamente inestable un diagnóstico o afección que requiera cambios considerables en su manejo o medicación en el plazo de los 60 días anteriores a la visita de selección e incluye el estudio en curso de una enfermedad no diagnosticada que podría conllevar un nuevo diagnóstico o afección.
    5. Antecedentes registrados de inmunodeficiencia congénita o adquirida, trastorno causante de inmunocompromiso/ inmunosupresión, asplenia o infecciones graves recurrentes.
    Se permiten los siguientes trastornos, a criterio del investigador:
    - Participantes infectados por el virus de la inmunodeficiencia humana (human immunodeficiency virus, HIV) en tratamiento antirretroviral y con una cifra de antígeno CD4 >/= 350 células/mm3 y ácido ribonucleico (ribonucleic acid, RNA) del HIV </= 500 copias/ml en los últimos 12 meses.
    - Enfermedades de origen inmunitario que permanezcan estables, por ejemplo, tiroiditis de Hashimoto y diabetes mellitus de tipo 1 o dolencias como asma, psoriasis, vitíligo, gota, alopecia areata o insuficiencia ovárica autoinmunitaria que no requieran inmunosupresores sistémicos conforme al criterio de exclusión 10.
    6. Trastornos cutáneos que puedan afectar a la evaluación de las reacciones adversas (adverse reactions, AR) locales en el lugar de la inyección de recogida solicitada (solicited).
    7. Antecedentes registrados de anafilaxia o reacción de hipersensibilidad severa tras la recepción de cualquier vacuna de mRNA o antigripal o de cualquier componente de dichas vacunas, incluida la proteína del huevo.
    8. Historial registrado de coagulopatía o trastorno hemorrágico que se considere una contraindicación para inyecciones intramusculares (IM) o flebotomía.
    9. Cualquier proceso médico o psiquiátrico o situación laboral, incluidos los antecedentes registrados de abuso de sustancias, que, en opinión del investigador, pueda suponer un riesgo adicional debido a la participación en el estudio o que pueda interferir en la interpretación de los resultados del estudio.
    10. Haber recibido inmunosupresores sistémicos durante > 14 días en total en el plazo de los 180 días anteriores a la visita de selección (en el caso de los glucocorticosteroides, ≥ 10 mg/día de prednisona o equivalente) o previsión de que precise tratamiento inmunosupresor sistémico en cualquier momento durante la participación en el estudio. Se permiten corticosteroides inhalados, nasales, intraarticulares y tópicos.
    11. Haber recibido cualquier vacuna autorizada o aprobada por las autoridades sanitarias locales </= 28 días antes de la intervención del estudio (día 1) o tener previsto recibir una vacuna autorizada o aprobada por las autoridades sanitarias locales en el plazo de los 28 días anteriores o posteriores a la intervención del estudio.
    12. Previsión de recibir una vacuna antigripal distinta a la del estudio desde el día 1 hasta el día 181.
    13. No saber si recibió una vacuna antigripal en la temporada de gripe anterior.
    14. Haber recibido una vacuna antigripal estacional o cualquier otra vacuna antigripal en investigación en el plazo de los 180 días anteriores a la visita de aleatorización.
    15. Resultado positivo en una prueba de la gripe efectuada por métodos aprobados por las autoridades sanitarias locales en el plazo de los 180 días anteriores a la visita de aleatorización.
    16. Haber recibido tratamiento antivírico para la gripe (p. ej., Tamiflu) en el plazo de los 180 días anteriores a la visita de aleatorización.
    17. Antecedentes de miocarditis, pericarditis o miopericarditis en el plazo de los 60 días anteriores a la visita de selección. También se excluirá a los participantes que no hayan vuelto a la situación basal tras su periodo de convalecencia.
    Por favor Consulte el protocolo para obtener más detalles
    E.5 End points
    E.5.1Primary end point(s)
    - Solicited local and systemic ARs through 7 days after study injection.
    - Unsolicited AEs through 28 days after study injection.
    - MAAEs from Day 1 to Day 361 (Month 12)/EoS.
    - AESIs from Day 1 to Day 361 (Month 12)/EoS.
    - SAEs from Day 1 to Day 361 (Month 12)/EoS.
    - AEs leading to discontinuation from Day 1 to Day 361 (Month 12)/EoS.
    - Reacciones adversas (AR) locales y sistémicas de recogida solicitada en el diario (solicited) hasta 7 días después de la inyección del estudio.
    - Acontecimientos adversos (adverse events, AE) comunicados espontáneamente (unsolicited) hasta 28 días después de la inyección del estudio.
    - AE atendidos médicamente (medically attended adverse events, MAAE) desde el día 1 hasta el día 361 (mes 12)/fin del estudio (end of study, EoS).
    - AE de especial interés (adverse events of special interest, AESI) desde el día 1 hasta el día 361 (mes 12)/EoS.
    - AE graves (serious adverse events, SAE) desde el día 1 hasta el día 361 (mes 12)/EoS.
    - AE que lleven a la retirada desde el día 1 hasta el día 361 (mes 12)/EoS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7-28 days; 1-12 months
    7-28 días; 1-12 meses
    E.5.2Secondary end point(s)
    - First episode of RT-PCR-confirmed ILI that begins at least 14 days post vaccination through Day 181 (Month 6)/end of influenza season caused by influenza A or B strains with similarity to those selected for the seasonal vaccine.
    - First episode of RT-PCR confirmed ILI that begins at least 14 days after vaccination through Day 181 (Month 6)/end of influenza season caused by influenza A or B strains antigenically matched to the vaccine strains selected for the seasonal vaccine.
    - Primer episodio de enfermedad seudogripal (influenza-like illness, ILI) confirmada mediante reacción en cadena de la polimerasa con retrotranscriptasa (reverse transcriptase-polymerase chain reaction, RT-PCR que comienza por lo menos 14 días después de la vacunación, hasta el día 181 (mes 6)/fin de la temporada de gripe, causada por cepas de gripe A o B con similitud a las seleccionadas para la vacuna estacional.
    - Primer episodio de ILI confirmada por RT-PCR que comienza por lo menos 14 días después de la vacunación, hasta el día 181 (mes 6)/fin de la temporada de gripe, causada por cepas de gripe A o B con correspondencia antigénica con las cepas vacunales seleccionadas para la vacuna estacional.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    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 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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Reactogenicity
    Reactogenicidad
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Con enmascaramiento para el observador
    Observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Canada
    Taiwan
    United States
    Estonia
    Poland
    Bulgaria
    Netherlands
    Spain
    Germany
    Denmark
    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 or last scheduled procedure for the last participant in the trial globally.
    Última visita del último sujeto (last visit of the last subject, LVLS) o el último procedimiento programado para el último participante en el ensayo, en todos los países.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11500
    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 state564
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12745
    F.4.2.2In the whole clinical trial 23000
    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)
    There will be no post trial treatment following the end of the study.
    No habrá tratamiento posterior al ensayo tras la finalización del estudio.
    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 Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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