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

5 de maio de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

1000

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Austrália
    • Northern Territory
      • Darwin, Northern Territory, Austrália, 0810
        • Menzies School of Health Research
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
RSV infection
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
RSV hospital attendance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Menzies School of Health Research

Colaboradores

University of Sydney
Murdoch Childrens Research Institute

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de maio de 2026

Conclusão Primária (Estimado)

31 de julho de 2030

Conclusão do estudo (Estimado)

31 de dezembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

5 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de maio de 2026

Primeira postagem (Real)

11 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de maio de 2026

Última verificação

1 de janeiro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GNT2043738

Plano para dados de participantes individuais (IPD)

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INDECISO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

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produto fabricado e exportado dos EUA

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