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    Summary
    EudraCT Number:2022-001981-36
    Sponsor's Protocol Code Number:219238
    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:2022-08-17
    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 number2022-001981-36
    A.3Full title of the trial
    A Phase 3, observer-blind, randomized, placebo controlled study to evaluate the non inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults ≥60 years of age.
    Estudio Fase III, observador ciego, aleatorizado, controlado con placebo, para evaluar la no inferioridad de la respuesta inmune y la seguridad de la vacuna candidata de GSK (RSVPreF3 OA) en adultos de 50 a 59 años de edad, incluyendo adultos con mayor riesgo de enfermedad del tracto respiratorio inferior causada por el virus respiratorio sincitial, comparado con adultos de 60 años de edad o más.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the immune response and safety of a vaccine against respiratory syncytial virus given to adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults 60 years of age and above.
    Estudio para evaluar la respuesta inmune y la seguridad de la vacuna frente al virus respiratorio sincitial (VRS) administrada a adultos de 50 a 59 años de edad, incluyendo aquellos con mayor riesgo de enfermedades del tracto respiratorio inferior causadas por el VRS, en comparación con adultos de 60 años de edad o más.
    A.3.2Name or abbreviated title of the trial where available
    RSV OA=ADJ-018
    RSV OA=ADJ-018
    A.4.1Sponsor's protocol code number219238
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline Biologicals SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 902202700
    B.5.5Fax number+34 918070479
    B.5.6E-mailes-ci@gsk.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 nameRSVPreF3/adjuvanted
    D.3.4Pharmaceutical form Powder and suspension for 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 INNNA
    D.3.9.2Current sponsor codeGSKVx000000017064
    D.3.9.3Other descriptive nameRecombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
    D.3.9.4EV Substance CodeSUB217714
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 120
    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 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
    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
    Respiratory syncytial virus infection
    Infección por virus sincitial respiratorio
    E.1.1.1Medical condition in easily understood language
    Respiratory syncytial virus infection is caused by RSV, which causes respiratory tract infections in people of all ages.
    La infección por el virus sincitial respiratorio es causada por el VSR, que causa infecciones del tracto respiratorio en personas de todas las edades.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035732
    E.1.2Term Pneumonia respiratory syncytial viral
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10038718
    E.1.2Term Respiratory syncytial virus bronchiolitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10069811
    E.1.2Term Respiratory syncytial virus bronchitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10035692
    E.1.2Term Pneumonia due to respiratory syncytial virus
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067384
    E.1.2Term Respiratory syncytial virus pneumonitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10052200
    E.1.2Term Respiratory syncytial virus infection NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066741
    E.1.2Term Respiratory syncytial virus infection recurrent
    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 demonstrate the NI of the humoral immune response in healthy participants 50-59 YOA compared to OA (≥60 YOA) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.
    • To demonstrate the NI of the humoral immune response in healthy participants 50-59 YOA compared to OA (≥60 YOA) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.
    • To demonstrate the NI of the humoral immune response in participants 50-59 YOA at increased risk of RSV-LRTD compared to OA (≥60 YOA) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.
    • To demonstrate the NI of the humoral immune response in participants 50-59 YOA at increased risk of RSV-LRTD compared to OA (≥60 YOA) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.
    .Demostrar la NI** de la respuesta inmune humoral en participantes sanos de 50-59 años en comparación con adultos de edad avanzada (≥60 años) para la cepa VRS-A tras la administración de la vacuna en investigación RSVPreF3 OA.
    .Demostrar la NI** de la respuesta inmune humoral en participantes sanos de 50-59 años en comparación con adultos de edad avanzada (≥60 años) para la cepa VRS-B tras la administración de la vacuna en investigación RSVPreF3 OA.
    .Demostrar la NI** de la respuesta inmune humoral en participantes de 50-59 años con mayor riesgo de EVRB-VRS en comparación con adultos de edad avanzada (≥60 años) para la cepa VRS-A tras la administración de la vacuna en investigación RSVPreF3 OA.
    .Demostrar la NI** de la respuesta inmune humoral en participantes de 50-59 años con mayor riesgo de EVRB-VRS en comparación con adultos de edad avanzada (≥60 años) para la cepa VRS-B tras la administración de la vacuna en investigación RSVPreF3 OA.
    E.2.2Secondary objectives of the trial
    Safety:
    • To evaluate the safety and reactogenicity after the RSVPreF3 OA investigational vaccine administration.
    Immunogenicity:
    • To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine until 12 months post-study intervention administration.
    • To evaluate the cell-mediated immunity (CMI) response after RSVPreF3 OA investigational vaccine administration until 12 months post-study intervention administration.
    Seguridad:
    Evaluar la seguridad y la reactogenicidad después de la administración de la vacuna en investigación RSVPreF3 OA.
    Inmunogenicidad:
    Evaluar la respuesta inmune humoral a la vacuna en investigación RSVPreF3 OA hasta 12 meses después de la administración de la intervención del estudio.
    Evaluar la respuesta inmune celular después de la administración de la vacuna en investigación RSVPreF3 OA hasta 12 meses después de la administración de la intervención del estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
    • Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
    1. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group)
    • A male or female participant 50-59 YOA at the time of the study intervention administration.
    • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
    • Female participants of childbearing potential may be enrolled in the study, if the participant:
    - has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and
    - has a negative pregnancy test on the day of study intervention administration.
    Specific inclusion criteria for participants in the Adults-HA Sub-cohort
    • Healthy participants as established by medical history and clinical examination before entering into the study.
    • Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
    Specific inclusion criteria for participants in the Adults-AIR Sub cohort
    Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):
    • Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
    • Chronic cardiovascular disease
    • Diabetes mellitus: types 1 and 2
    • Other diseases at increased risk for RSV-LRTD disease
    - Chronic kidney disease
    - Chronic liver disease
    2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)
    • A male or female participant ≥60 YOA at the time of the study intervention administration.
    • Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
    • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
    .Participantes que, en opinión del investigador, puedan y vayan a cumplir los requisitos del protocolo
    .Obtención del consentimiento informado del paciente por escrito o con la presencia de un testigo antes de realizar cualquiera de los procedimientos específicos del estudio
    Criterios de inclusión específicos para todos los participantes de la cohorte 1
    .Participante varón o mujer de 50-59 años en el momento de la primera administración de la intervención del estudio
    .Las mujeres participantes sin capacidad de procrear pueden incluirse en el estudio. La incapacidad de procrear se define como histerectomía, ovariectomía bilateral, salpingectomía bilateral o posmenopausia
    .Las mujeres participantes con capacidad de procrear pueden incluirse en el estudio, si la participante:
    • Ha practicado una anticoncepción adecuada desde 1 mes antes de la administración de la vacuna del estudio hasta el final del estudio, y
    • Tiene un test de embarazo negativo del día de la administración de la vacuna del estudio
    Criterios de inclusión específicos para los participantes de la subcohorte de adultos-AS
    .Participantes sanos, según lo determinado a partir de la historia clínica y la exploración física antes de incorporarse al estudio
    .Los participantes con enfermedades estables crónicas, con o sin tratamiento específico, como hipertensión arterial, hipercolesterolemia o hipotiroidismo, y que no tengan mayor riesgo de EVRB-VRS (véase la sección 5.1.1.2) podrán participar en este estudio si el investigador considera que están médicamente estables (sin cambios en el tratamiento ni en la gravedad de la enfermedad en los últimos 3 meses)
    Criterios de inclusión específicos para los participantes de la subcohorte de adultos-CMR, Los participantes deben tener un diagnóstico de al menos una de las siguientes enfermedades y presentar una situación estable (sin cambios en el tratamiento ni en la gravedad de la enfermedad en los últimos 3 meses):
    .Enfermedad pulmonar crónica causante de síntomas que limiten sus actividades diarias o uso prolongado de medicación
    .Enfermedad cardiovascular crónica
    .Diabetes mellitus: tipos 1 y 2
    .Otras enfermedades con mayor riesgo de EVRB-VRS
    .Insuficiencia renal crónica
    .Enfermedad hepática crónica
    Criterios de inclusión específicos de la cohorte 2 (grupo de AEA-VRS)
    .Participante varón o mujer de ≥60 años en el momento de la primera administración de la intervención del estudio.
    .Los participantes con enfermedades crónicas estables, con o sin tratamiento específico, como diabetes, hipertensión o cardiopatía, pueden participar en este estudio si el investigador considera que están médicamente estables (sin cambios en el tratamiento o en la gravedad de la enfermedad en los últimos 3 meses).
    .Participantes que viven en la comunidad general o en un centro de residencia asistida que proporciona asistencia mínima, de modo que el participante sea el principal responsable de su cuidado personal y sus actividades de la vida diaria
    E.4Principal exclusion criteria
    Medical conditions
    • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy , based on medical history and physical examination (no laboratory testing required).
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
    • Hypersensitivity to latex.
    • Unstable chronic illness.
    • Any history of dementia or any medical condition that moderately or severely impairs cognition.
    • Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.
    • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
    • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
    Prior/Concomitant therapy
    • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 4, Month 12).
    • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration.
    Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
    • Previous vaccination with an RSV vaccine, including investigational RSV vaccines.
    • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune modifying treatments or planned administration at any time up to the end of the study.
    - Up to 3 months prior to the study intervention administration:
    o For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
    o Administration of immunoglobulins and/or any blood products or plasma derivatives.
    - Up to 6 months prior to study intervention administration: long-acting immune modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
    Prior/Concurrent clinical study experience
    • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device).
    Other exclusions
    Other exclusions for all participants
    • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
    • Bedridden participants.
    • Planned move during the study period that will prohibit participating in the study until study end.
    • Participation of any study personnel or their immediate dependents, family, or household members.
    Other exclusions for Cohort 1
    • Pregnant or lactating female.
    • Female planning to become pregnant or planning to discontinue contraceptive precautions.
    Procesos médicos
    .Cualquier estado de inmunodepresión o inmunodeficiencia confirmada o supuesta como consecuencia de una enfermedad o tratamiento inmunosupresor/citotóxico, según la historia clínica y la exploración física (no se precisan pruebas analíticas)
    .Antecedentes de cualquier reacción o hipersensibilidad que pueda verse agravada probablemente por alguno de los componentes de la intervención del estudio
    .Hipersensibilidad al látex
    .Enfermedad crónica inestable
    .Antecedentes de demencia o cualquier proceso médico que altere moderada o gravemente la capacidad cognitiva
    .Trastornos neurológicos o crisis comiciales recurrentes o no controlados. Los participantes con enfermedades neurológicas activas o crónicas controladas médicamente pueden incluirse en el estudio según la valoración del investigador, siempre que su estado les permita cumplir los requisitos del protocolo. Los participantes en el estudio pueden decidir designar un cuidador para que les ayude a realizar los procedimientos del estudio
    .Enfermedad subyacente importante que, en opinión del investigador, impediría la finalización del estudio
    .Cualquier proceso médico que, en opinión del investigador, haría que la inyección intramuscular no fuera segura
    Tratamiento previo/concomitante
    .Uso de cualquier producto (fármaco, vacuna o producto sanitario) en investigación o no autorizado distinto de la intervención del estudio durante el periodo que comienza 30 días antes de la primera dosis de la intervención del estudio (del día -29 al día 1) o uso previsto durante el período del estudio (hasta la visita 4, mes 12)
    .Administración programada o real de una vacuna no prevista en el protocolo del estudio en el período comprendido entre 30 días antes y 30 días después de la administración de la intervención del estudio, a excepción de las vacunas antigripales inactivadas o de subunidades o vacunas para la COVID-19 (completamente autorizada o con autorización de uso de emergencia), que podrán administrarse hasta 14 días antes o desde 14 días después de la administración del estudio
    Nota: En el caso de que las autoridades sanitarias recomienden u organicen una vacunación masiva de urgencia ante una amenaza para la salud pública imprevista (p. ej., una pandemia) al margen del programa de vacunación habitual, el período descrito anteriormente podrá reducirse en caso necesario para esa vacuna, siempre que se utilice conforme a las recomendaciones oficiales locales y se notifique al promotor en consecuencia
    .Vacunación previa con una vacuna frente al VRS, incluidas vacunas en investigación frente al VRS
    .Administración crónica de fármacos inmunomoduladores (definida como más de 14 días consecutivos en total) o administración de tratamientos inmunomoduladores de acción prolongada o administración prevista en cualquier momento hasta el final del estudio:
    Hasta 3 meses antes de la administración de la intervención del estudio:
    -En cuanto a los corticosteroides, eso significará una dosis de prednisona ≥20 mg/día o equivalente. Se permite el uso de esteroides inhalados y tópicos
    -Administración de inmunoglobulinas o de cualquier hemoderivado o derivados del plasma
    -Hasta 6 meses antes de la administración de la intervención del estudio: fármacos inmunomoduladores de acción prolongada, incluidos entre otros, inmunoterapia (p. ej., inhibidores del TNF), anticuerpos monoclonales o medicación antitumoral
    Participación previa o simultánea en estudios clínicos
    .Participación simultánea, en cualquier momento del período del estudio, en otro estudio clínico en el que el participante haya estado o vaya a estar expuesto a una vacuna o producto (fármaco o producto sanitario invasivo) en investigación o no
    Otros motivos de exclusión
    Otros motivos de exclusiones para todos los participantes
    .Antecedentes de consumo crónico de alcohol o toxicomanía que, en opinión del investigador, impida o haga improbable que el posible participante facilite informes de seguridad exactos o cumpla los procedimientos del estudio
    .Participantes postrados en cama
    .Traslado previsto durante el período del estudio que impida la participación en el ensayo hasta el final del estudio
    .Participación de cualquier miembro del personal del estudio o sus subordinados inmediatos, familiares o convivientes
    Otros motivos de exclusiones para la Cohorte 1
    .Mujeres embarazadas o en lactancia
    .Mujeres que planeen quedarse embarazadas o dejar de utilizar métodos anticonceptivos
    E.5 End points
    E.5.1Primary end point(s)
    1. RSV-A neutralization antibody titers expressed as group geometric mean titer (GMT) ratio in healthy participants compared to OA
    2. RSV-A neutralization antibody titers expressed as group seroresponse rate (SRR) difference in healthy participants compared to OA
    3. RSV-B neutralization antibody titers expressed as group GMT ratio in healthy participants compared to OA
    4. RSV-B neutralization antibody titers expressed as group SRR difference in healthy participants compared to OA
    5. RSV-A neutralization antibody titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA
    6. RSV-A neutralization antibody titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA
    7. RSV-B neutralization antibody titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA
    8. RSV-B neutralization antibody titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA
    1.Títulos de anticuerpos neutralizantes frente al RSV-A expresados como cociente de la media geométrica (GMT) en participantes sanos comparados con adultos mayores (OA)
    2.Títulos de anticuerpos neutralizantes frente al RSV-A expresados como la diferencia de tasa de serorrespuesta en participantes sanos comparados con adultos mayores (OA).
    3.Títulos de anticuerpos neutralizantes frente al RSV-B expresados como cociente de la media geométrica (GMT) en participantes sanos comparados con adultos mayores (OA)
    4.Títulos de anticuerpos neutralizantes frente al RSV-B expresados como la diferencia de tasa de serorrespuesta en participantes sanos comparados con adultos mayores (OA).
    5.Títulos de anticuerpos neutralizantes frente al RSV-A expresados como cociente de la media geométrica (GMT) en participantes con mayor riesgo de RSV-LRTD comparados con adultos mayores (OA).
    6.Títulos de anticuerpos neutralizantes frente al RSV-A expresados como la diferencia de tasa de serorrespuesta en participantes con mayor riesgo de RSV-LRTD comparados con adultos mayores (OA).
    7.Títulos de anticuerpos neutralizantes frente al RSV-B expresados como cociente de la media geométrica (GMT) en participantes con mayor riesgo de RSV-LRTD comparados con adultos mayores (OA).
    8.Títulos de anticuerpos neutralizantes frente al RSV-B expresados como la diferencia de tasa de serorrespuesta en participantes con mayor riesgo de RSV-LRTD comparados con adultos mayores (OA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 3, 5, 7. 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
    2, 4, 6, 8. 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
    1, 3, 5, 7. 1 mes después de la administración de la vacuna en investigación RSVPreF3 OA (Día 31)
    2, 4, 6, 8. 1 mes después de la administración de la vacuna en investigación RSVPreF3 OA (Día 31) comparado con el basal (Día 1)
    E.5.2Secondary end point(s)
    1. Percentage of participants reporting each solicited administration site event (pain, redness and swelling)
    2. Percentage of participants reporting each solicited systemic event (fever, headache, muscle pain, joint pain, tiredness)
    3. Percentage of participants reporting unsolicited adverse events (AEs)
    4. Percentage of participants reporting any serious adverse events (SAEs)
    5. Percentage of participants reporting any potential immune mediated diseases (pIMDs)
    6. Percentage of participants reporting SAEs related to study intervention administration
    7. Percentage of participants reporting pIMDs related to study intervention administration
    8. Percentage of participants reporting any fatal SAEs
    9. RSV-A neutralization antibody titers expressed as GMT
    10. RSV-B neutralization antibody titers expressed as GMT
    11. Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers
    12. Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers
    1. Porcentaje de participantes que notifican cada acontecimiento solicitado en el lugar de administración (dolor, enrojecimiento e inflamación)
    2. Porcentaje de participantes que notifican cada acontecimiento solicitado sistémico (fiebre dolor de cabeza, dolor muscular, dolor de articulaciones, cansancio).
    3. Porcentaje de participantes que notifican acontecimientos adversos no solicitados (AEs)
    4. Porcentaje de participantes que notifican cualquier acontecimiento adverso grave (SAEs)
    5. Porcentaje de participantes que notifican cualquier enfermedad potencial mediada inmunológicamente (pIMD)
    6. Porcentaje de participantes que notifican acontecimientos adversos graves (SAEs) relacionados con la administración de la vacuna del estudio.
    7. Porcentaje de participantes que notifican enfermedad potencial mediada inmunológicamente (pIMD) relacionada con la administración de la vacuna del estudio.
    8. Porcentaje de participantes que notifican cualquier acontecimiento adverso grave (SAEs) fatal.
    9. Títulos de anticuerpos neutralizantes frente al RSV-A expresados como media geométrica (GMT).
    10. Títulos de anticuerpos neutralizantes frente al RSV-B expresados como media geométrica (GMT).
    11. Frecuencia de linfocitos T CD4+ específicos de RSVPreF3 que expresan al menos dos marcadores de activación
    12. Frecuencia de linfocitos T CD8+ específicos de RSVPreF3 que expresan al menos dos marcadores de activación
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2. Within 4 days after study intervention administered on Day 1
    3. Within 30 days after study intervention administered at Day 1
    4, 5. After study intervention administration (Day 1) up to Month 6
    6, 7, 8. After study intervention administration (Day 1) up to study end (Month 12)
    9, 10, 11, 12. At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration
    1, 2. Dentro de los 4 días posteriores a la administración de la vacuna del estudio en el Día 1.
    3. Dentro de los 30 días posteriores a la administración de la vacuna del estudio en el Día 1.
    4, 5. Después de la administración de la vacuna del estudio (Día 1) hasta el Mes 6.
    6, 7, 8. Después de la administración de la vacuna del estudio (Día 1) hasta el final del estudio (Mes 12).
    9, 10, 11, 12. Antes de la administración de la intervención del estudio y 1, 6 y 12 meses después de dicha administración.
    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 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
    Immunogenicity
    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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observador ciego para la Cohorte 1 (Día1-Día 31), y simple ciego después, y abierto para la Cohorte
    Observer-blind for Cohort 1 (Day1-Day 31), and single-blind afterwards, and open-label for Cohort 2
    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 trial5
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Argentina
    Canada
    Japan
    Mexico
    United States
    Poland
    Netherlands
    Spain
    Germany
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    EoS: LSLV (Visit 4 at Month 12) or Date of the last testing/reading released of the Human Biological Samples, related to primary and secondary endpoints, whichever occurs later. EoS must be achieved no later than 8 months after LSLV. EoS cannot be before LSLV.
    EoS: LSLV (Visita 4 en el mes 12) o Fecha de la última prueba / lectura publicada de las Muestras Biológicas Humanas, relacionadas con los puntos finales primarios y secundarios, lo que ocurra más tarde. La EoS debe lograrse a más tardar 8 meses después de la LSLV. EoS no puede estar antes de LSLV.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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: 1216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 304
    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 Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception 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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 590
    F.4.2.2In the whole clinical trial 1520
    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)
    After the participant has ended the participation in this trial they will continue with standard care.
    Después de que el participante haya terminado la participación en este ensayo, continuará con la atención estándar.
    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 Decision2022-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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