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Un estudio de mRNA-1345, una vacuna de mRNA dirigida al virus respiratorio sincitial, en niños de 2 a

27 de julio de 2026 actualizado por: ModernaTX, Inc.

Un estudio de fase 2, aleatorizado y ciego al observador para evaluar la seguridad, reactogenicidad e inmunogenicidad del ARNm-1345, una vacuna de ARNm dirigida al virus sincitial respiratorio, en niños de 2 a

El propósito del estudio es evaluar la seguridad, reactogenicidad e inmunogenicidad del ARNm-1345 en niños de 2 a <5 años y en niños con alto riesgo de enfermedad por virus respiratorio sincitial (VSR) de 5 a <18 años. para informar la selección del nivel de dosis para la siguiente fase de desarrollo (Fase 3).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

349

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85006
        • Velocity Clinical Research, Phoenix
      • Scottsdale, Arizona, Estados Unidos, 85260
        • Headlands Research - Scottsdale
    • California
      • Banning, California, Estados Unidos, 92220
        • Velocity Clinical Research - Banning
      • Fullerton, California, Estados Unidos, 92835
        • ASCADA Research, LLC - Family Medicine
      • Long Beach, California, Estados Unidos, 90815
        • ARK Clinical Research
      • Rolling Hills Estates, California, Estados Unidos, 90274
        • Peninsula Research Associates (PRA)
    • Florida
      • Doral, Florida, Estados Unidos, 33122
        • D&H Doral Research Center, LLC
      • Kissimmee, Florida, Estados Unidos, 34741
        • Kissimmee Clinical Research
      • Largo, Florida, Estados Unidos, 33777
        • Accel Clinical
      • Miami, Florida, Estados Unidos, 33125
        • Med-Care Research
      • Orlando, Florida, Estados Unidos, 32829
        • Accel Research Sites - Nona Pediatric Center
      • Pensacola, Florida, Estados Unidos, 32501
        • Sec Clinical Research
      • Tamarac, Florida, Estados Unidos, 33321
        • D&H Tamarac Research Center
    • Georgia
      • Fayetteville, Georgia, Estados Unidos, 30214
        • Javara, Inc.
      • Macon, Georgia, Estados Unidos, 31210
        • Velocity Clinical Research-Primary Pediatrics, Macon
      • Savannah, Georgia, Estados Unidos, 31405
        • CenExel iResearch, LLC
    • Idaho
      • Idaho Falls, Idaho, Estados Unidos, 83404
        • Clinical Research Prime
      • Meridian, Idaho, Estados Unidos, 83642
        • Velocity Clinical Research - Boise
    • Kansas
      • El Dorado, Kansas, Estados Unidos, 67042
        • Alliance for Multispeciality Research, LLC
      • Overland Park, Kansas, Estados Unidos, 66210
        • Velocity Clinical Research-Kansas City
    • Louisiana
      • Lafayette, Louisiana, Estados Unidos, 70508
        • Velocity Clinical Research - Lafayette
      • Metairie, Louisiana, Estados Unidos, 70006
        • Velocity Clinical Research Metairie
    • Michigan
      • Southfield, Michigan, Estados Unidos, 48075
        • Great Lakes Research Institute
      • Southgate, Michigan, Estados Unidos, 48195-1896
        • Pediatric & Adolescent Center
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55402
        • Clinical Research Institute
    • Mississippi
      • Gulfport, Mississippi, Estados Unidos, 39503
        • Velocity Clinical Research, Gulfport
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87107
        • Velocity Clinical Research- Albuquerque
    • New York
      • Binghamton, New York, Estados Unidos, 13905
        • Velocity Clinical Research-Binghamton
      • Rochester, New York, Estados Unidos, 14620
        • University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
    • Ohio
      • South Euclid, Ohio, Estados Unidos, 44121
        • Senders Pediatrics
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • DM Clinical Research - Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19104-4318
        • The Children's Hospital of Philadelphia - Pediatrics
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02886
        • Velocity Clinical Research - Providence
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29414
        • Coastal Pediatric Research
      • Simpsonville, South Carolina, Estados Unidos, 29680
        • TRIBE Clinical Research
    • Texas
      • Austin, Texas, Estados Unidos, 78704
        • Elligo Clinical Research Center
      • Beaumont, Texas, Estados Unidos, 77701
        • REX Clinical Trials, LLC
      • Conroe, Texas, Estados Unidos, 77384
        • Javara Inc (Conroe)
      • Houston, Texas, Estados Unidos, 77055
        • West Houston Clinical Research Service
      • Houston, Texas, Estados Unidos, 77065
        • DM Clinical Research - CyFair
      • Plano, Texas, Estados Unidos, 75024
        • Village Pediatrics
      • Stephenville, Texas, Estados Unidos, 76401
        • Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas
      • Victoria, Texas, Estados Unidos, 77901
        • Victoria Clinical Research Group
    • Utah
      • West Jordan, Utah, Estados Unidos, 84088
        • Velocity Clinical Research - Salt Lake City
    • Virginia
      • Annandale, Virginia, Estados Unidos, 22003
        • PI-Coor Clinical Research, LLC
      • Richmond, Virginia, Estados Unidos, 23294
        • National Clinical Research, Inc.
      • Richmond, Virginia, Estados Unidos, 23226
        • Clinical Research Partners
  • Panamá
      • La Chorrera, Panamá, 07066
        • CEVAXIN Chorrera
      • Panama City, Panamá, 07093
        • CEVAXIN Avenida Mexico
      • Panama City, Panamá, 07114
        • CEVAXIN 24 de Diciembre

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

Criterios clave de inclusión:

Cohorte 1:

  • 2 a <5 años de edad, al momento de la firma del consentimiento informado.
  • Sano o con condiciones crónicas estables que aumenten el riesgo de enfermedad por VRS, según el criterio clínico del Investigador.

Cohorte 2:

  • 5 a <18 años de edad, al momento de la firma del consentimiento informado.
  • Participantes con enfermedades crónicas estables que aumentan el riesgo de enfermedad por VSR.
  • Las participantes femeninas en edad fértil pueden inscribirse en el estudio si la participante: 1) tiene una prueba de embarazo en orina negativa en la selección y el día de la inyección (día 1); 2) ha practicado métodos anticonceptivos adecuados o se ha abstenido de todas las actividades que podrían provocar un embarazo durante los 28 días anteriores al Día 1; 3) ha aceptado continuar con la anticoncepción adecuada durante los 90 días posteriores a la inyección; y 4) actualmente no está amamantando.

Criterios de exclusión clave:

  • Enfermedad aguda o fiebre (temperatura ≥38,0°Celsius [100,4°Fahrenheit]) dentro de las 72 horas anteriores o durante la visita de selección o el día 1.
  • Historial de un diagnóstico o condición que, a juicio del Investigador, pueda afectar la evaluación del estudio o comprometer la seguridad del participante.
  • Ha recibido o planea recibir cualquier vacuna autorizada o autorizada ≤14 días antes de la inyección de la vacuna del estudio (día 1) o planea recibir una vacuna autorizada o autorizada dentro de los 14 días posteriores a la inyección de la vacuna del estudio.
  • Recepción de cualquier inmunosupresor sistémico previo o fármacos modificadores del sistema inmunológico. Se permiten cursos cortos (<7 días) de corticosteroides orales si se completan al menos 3 meses antes de la inscripción.
  • Recepción de anticuerpos monoclonales contra el VRS dentro de los 6 meses anteriores a la inscripción en el estudio.
  • Participó en un estudio clínico intervencionista dentro de los 28 días (6 meses para un estudio que evalúa un producto sin licencia en este grupo de edad) antes del día de la inscripción o planea hacerlo mientras está inscrito en este estudio.

Nota: Pueden aplicarse otros criterios de inclusión y exclusión definidos por el protocolo.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Parte A y Parte B: Cohorte 1 (2 a <5 años de edad)
Parte A: Los participantes de 2 a <5 años de edad recibirán una única inyección intramuscular (IM) de ARNm-1345 o placebo el día 1. Parte B: Los participantes tendrán la opción de volver a inscribirse en un programa de seguridad de 6 meses. -período de seguimiento.
Biológico: Placebo
Inyección de cloruro de sodio al 0,9 % (solución salina normal)
Biológico: ARNm-1345
Líquido estéril para inyección
Experimental: Parte A: Cohorte 2 (5 a <18 años de edad)
Los participantes de 5 a <18 años recibirán una única inyección IM de ARNm-1345 el día 1.
Biológico: ARNm-1345
Líquido estéril para inyección

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part A (Cohorts 1 and 2): Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Periodo de tiempo: Up to 7 days post-injection
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 7 days post-injection
Part A (Cohorts 1 and 2): Number of Participants With Unsolicited Adverse Events (AEs)
Periodo de tiempo: Up to 28 days post-injection
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 28 days post-injection
Part A (Cohorts 1 and 2): Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
Periodo de tiempo: Day 1 through end of Part A (Month 6)
A MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through end of Part A (Month 6)
Part B (Cohort 1): Number of Participants With RSV-RTD, Respiratory Syncytial Virus- Lower Respiratory Tract Disease (RSV-LRTD), Severe RSV-LRTD, Very Severe RSV-LRTD and RSV Hospitalization Classified by Clinical Assessment Team (CAT)
Periodo de tiempo: Day 1 through end of Part B (Month 6)
RSV-RTD: Runny nose or blocked nose or cough and confirmed RSV infection. RSV-LRTD: Cough or difficulty breathing (Based on Investigator's observation; difficulty breathing included signs of wheezing, stridor, tachypnoea, chest in-drawing or subcostal or intercostal retractions) and peripheral oxygen saturation (SpO2) <95%, or respiratory rate (RR) increased and confirmed RSV infection. RSV Severe-LRTD: Meeting the definition of RSV-LRTD and SpO2 <93%, or lower chest wall in-drawing. RSV Very Severe LRTD: Meeting the definition of RSV-LRTD and SpO2 <90%, or failure to respond/unconscious. RSV Hospitalization: Confirmed RSV and hospitalized for acute medical condition.
Day 1 through end of Part B (Month 6)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part A (Cohort 1): Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
Periodo de tiempo: Day 1, Day 29, and Month 6
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) for RSV-A and 10 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 112476 IU/mL for RSV-B. 95% confidence interval (CI) for geometric mean (GM) value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1, Day 29, and Month 6
Part A (Cohort 1): Geometric Mean Concentration (GMC) of Serum RSV Prefusion F (Pre-F) Binding Antibody
Periodo de tiempo: Day 1, Day 29, and Month 6
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 arbitrary units (AU)/mL and ULOQ was 580553 AU/mL for RSV Pre-F immunoglobulin G (IgG) antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1, Day 29, and Month 6
Part A (Cohort 1): Geometric Mean Fold Rise (GMFR) of Post-baseline/Baseline Neutralizing Antibody Titers
Periodo de tiempo: Day 29 and Month 6
Antibody values reported as below lower LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 10 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 112476 IU/mL for RSV-B. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29 and Month 6
Part A (Cohort 1): GMFR of Post-baseline/Baseline Binding Antibody Concentrations
Periodo de tiempo: Day 29 and Month 6
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29 and Month 6
Part A (Cohort 1): Percentage of Participants With Seroresponse in RSV Neutralizing Antibody
Periodo de tiempo: Baseline to Day 29 and Month 6
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29 and Month 6
Part A (Cohort 1): Percentage of Participants With Seroresponse in RSV Pre-F Binding Antibody
Periodo de tiempo: Baseline to Day 29 and Month 6
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29 and Month 6
Part A (Cohort 2): GMT of Serum RSV Neutralizing Antibody
Periodo de tiempo: Day 1 and Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 15 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 162163 IU/mL for RSV-B. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1 and Day 29
Part A (Cohort 2): GMC of Serum RSV Pre-F Binding Antibody
Periodo de tiempo: Day 1 and Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1 and Day 29
Part A (Cohort 2): GMFR of Post-baseline/Baseline Neutralizing Antibody Titers
Periodo de tiempo: Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 15 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 162163 IU/mL for RSV-B. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29
Part A (Cohort 2): GMFR of Post-baseline/Baseline Binding Antibody Concentrations
Periodo de tiempo: Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29
Part A (Cohort 2): Percentage of Participants With Seroresponse in RSV Neutralizing Antibody
Periodo de tiempo: Baseline to Day 29
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29
Part A (Cohort 2): Percentage of Participants With Seroresponse in RSV Pre-F Binding Antibody
Periodo de tiempo: Baseline to Day 29
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29
Part B (Cohort 1): Number of Participants With AESIs and SAEs
Periodo de tiempo: Day 1 through Part B EOS (Month 6)
An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Part B EOS (Month 6)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

ModernaTX, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de octubre de 2023

Finalización primaria (Actual)

27 de junio de 2025

Finalización del estudio (Actual)

27 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

18 de octubre de 2023

Primero enviado que cumplió con los criterios de control de calidad

18 de octubre de 2023

Publicado por primera vez (Actual)

24 de octubre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • mRNA-1345-P202
  • 2024-000502-15 (Número EudraCT)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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