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THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness (THRIVE)

5 de mayo de 2026 actualizado por: Menzies School of Health Research

Passive Immunisation With RSV-specific Monoclonal Antibody (RSV-SMA) to Prevent RSV Respiratory Infections Among Aboriginal and Torres Strait Islander Children in the Northern Territory: a Pragmatic Randomised Controlled Trial.

RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. The goal of this clinical trial is to evaluate whether routinely administering a single dose of respiratory syncytial virus (RSV)-specific monoclonal antibody, nirsevimab, from 6 months old, provides protection against RSV infections for Aboriginal and Torres Strait Islander children throughout in the first and second year of life.

In this study, participants will be randomly assigned to receive either a single dose of intra-muscular RSV-specific monoclonal antibody, nirsevimab, or standard care (no RSV-specific monoclonal antibody). The primary objective is to determine whether administration ofRSV-specific monoclonal antibody, nirsevimab reduces the occurrence of RSV infection over the subsequent 12 months. Secondary objectives include assessing whether nirsevimab reduces RSV-related hospital attendances, as well as respiratory and all-cause hospitalisations, over the following 6 and 12 months. An assessment of cost-effectiveness will also be undertaken.

Participants will receive the study intervention at 6 months of age (+90 days). Follow-up will be conducted through passive surveillance using electronic medical records and public health notification systems to capture relevant health outcomes.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is a pragmatic, parallel-group, randomised controlled trial conducted in the Northern Territory to evaluate an RSV prevention strategy in Aboriginal and Torres Strait Islander infants under real-world conditions.

Eligible infants aged approximately 6 months (+90 days) will be randomised in a 1:1 ratio to receive either a single intramuscular dose of RSV-specific monoclonal antibody (nirsevimab) or standard care. Randomisation will be stratified by geographic region (e.g. Top End and Central Australia), remoteness classification and prior nirsevimab dose status.

At enrolment, baseline data is collected to confirm eligibility and characterise the study population. This includes review of immunisation and birth records and collection of simple clinical measurements such as weight and temperature, consistent with routine care.

The study is designed to minimise participant burden and reflect routine clinical practice. Apart from the study intervention and a brief follow-up contact approximately 7 days after enrolment to assess early safety, no additional procedures or scheduled study visits are required. Participants will otherwise continue to receive standard healthcare through existing services.

Outcome ascertainment will be undertaken using passive follow-up through routinely collected health data. This includes review of hospital medical records and linkage with RSV notifications reported through the Northern Territory notifiable disease surveillance system. These data sources will be used to identify laboratory-confirmed RSV infection, healthcare presentations, and hospital admissions during the follow-up period.

The study incorporates a Bayesian adaptive design, allowing for interim analyses at predefined enrolment milestones. This enables potential early stopping for superiority or futility, ensuring efficient use of resources and minimising unnecessary exposure of participants.

An economic evaluation will be conducted alongside the trial to assess the cost-effectiveness of the intervention using observed healthcare utilisation and outcome data.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1000

Fase

  • Fase 4

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Australia
    • Northern Territory
      • Darwin, Northern Territory, Australia, 0810
        • Menzies School of Health Research
        • Contacto:

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

Inclusion Criteria:

  1. Aboriginal and/or Torres Strait Islander infant ≥ 6 calendar months old and < 9 calendar months old.
  2. Parent/caregiver is willing for their infant to participate in the study and informed consent for the infant's participation in the study has been given.
  3. Parent/caregiver is willing to comply with all study procedures outlined in the protocol, including review of maternal/ infant immunisation records, electronic medical records and public health notifications, for the duration of the study.

Exclusion Criteria:

  1. Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).
  2. Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.
  3. Previously enrolled in this trial.

Temporary Exclusion Criteria

  1. Infants who have received a prior dose of RSV-SMA between ≥ 1 calendar months old and < 3 calendar months old will be excluded until at least 150 days have passed since their most recent dose. Randomisation can be delayed until participants meet this criterion.
  2. Acute illness at the time of assessment (e.g. fever ≥ 38.5°C, acute respiratory or other infection as determined by trained and delegated study staff) is temporarily excluded until they are recovered and/or symptom-free for ≥ 24 hours.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Nirsevimab (RSV-specific monoclonal antibody)
Participants in the experimental arm will receive a single dose of RSV-specific monoclonal antibody - nirsevimab, administered from 6 months old (+ 90 days) in accordance with the licensed indication for RSV prevention. Dosing will be weight-based (50mg for infants < 5kg, and 100mg for infants ≥5 kg) and administered by unblinded study staff. Participants will continue to receive routine health care and additional immunisations in accordance with the National Immunisation Program and local guidelines.
Biológico: Nirsevimab (RSV-specific monoclonal antibody)
A single intramuscular dose of RSV-specific monoclonal antibody (RSV-SMA) - nirsevimab, will be administered from 6 months old (+ 90 days) to prevent RSV respiratory infections among Aboriginal and Torres Strait Islander children in the first and second year of life. Our randomised clinical trial will be among the first to evaluate the health and economic impact of routinely administering a dose of RSV-SMA from 6 months old in a year-round program for this high-risk population with less distinct RSV infection seasons.
Sin intervención: Standard Care
Participants in the standard care arm will NOT receive a dose of RSV-specific monoclonal antibody - nirsevimab. Participants will continue to receive routine health care and immunisations in accordance with the National Immunisation Program and local guidelines.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
RSV infection
Periodo de tiempo: Before 6-months and 12-months post randomisation date
RSV respiratory infection detected by reverse transcription polymerase chain reaction (RT-PCR) on a respiratory specimen from time of randomisation to before 6-months and before 12-months post-randomisation AND notified to the NT Notifiable Disease System. RSV infection before 12 months post-randomisation is the primary endpoint.
Before 6-months and 12-months post randomisation date

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
RSV hospital attendance
Periodo de tiempo: Before 6-months and 12-months post randomisation date
Any emergency department presentation or hospital admission at any time from time of randomisation to before 6-months and before 12- months post-randomisation, AND for which RSV is detected by RT-PCR of a respiratory specimen (regardless of notification) collected at any time from 120 hours before hospital presentation to 72 hours afterwards.
Before 6-months and 12-months post randomisation date
RSV hospitalisation
Periodo de tiempo: Before 6-months and 12-months post randomisation date
Subset of RSV hospital attendances resulting in admission to an inpatient service.
Before 6-months and 12-months post randomisation date
RSV hospitalisation - severe
Periodo de tiempo: Before 6-months and 12-months post randomisation date.
Subset of RSV hospitalisations WITH any documented oxygen saturation <90% at any point during the clinical presentation in accordance with the World Health Organization case definition, AND WITH documented receipt of supplemental oxygen.
Before 6-months and 12-months post randomisation date.
Respiratory hospitalisation
Periodo de tiempo: Before 6-months and 12-months post randomisation date
Any admission to an inpatient service from time of randomisation to before 6 -months and before 12-months post randomisation AND receiving a primary diagnosis consistent with any acute respiratory infection, including bronchiolitis, bronchitis, pneumonia, influenza, whooping cough, or chest/respiratory infection, OR RSV hospitalisation.
Before 6-months and 12-months post randomisation date
Any hospitalisation
Periodo de tiempo: Before 6-months and 12-months post randomisation date
Hospital admission to an inpatient service at any time after time of randomisation to before 6-month and before 12-months post randomisation regardless of primary diagnosis.
Before 6-months and 12-months post randomisation date

Colaboradores e Investigadores

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

Patrocinador

Menzies School of Health Research

Colaboradores

University of Sydney
Murdoch Childrens Research Institute

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 (Estimado)

15 de mayo de 2026

Finalización primaria (Estimado)

31 de julio de 2030

Finalización del estudio (Estimado)

31 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

5 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

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

5 de mayo de 2026

Última verificación

1 de enero de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GNT2043738

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

De-identified individual data may be shared following consultation with the Australian First Nations Reference Group for Maternal and Child Health, First Nations researchers and Cultural Advisors, and in compliance with Indigenous Data Sovereignty principles.

Información sobre medicamentos y dispositivos, documentos del estudio

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

No

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

No

producto fabricado y exportado desde los 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. .

Ensayos clínicos sobre Virus Respiratorio Sincitial (RSV)

Ensayos clínicos sobre Nirsevimab (RSV-specific monoclonal antibody)

  • Duke University
    Columbia University; Emory University; Centers for Disease Control and Prevention; Children's Hospital Medical Center, Cincinnati y otros colaboradores
    Reclutamiento
    Seguridad del anticuerpo monoclonal preventivo de RSV
    Fiebre | Evento adverso después de la vacunación
    Estados Unidos

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