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Recruiting NCT07615192

RSV Immunisation Status in Queensland (Australia)

Observational RSV Immunization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nirsevimab Respiratory Syncytial Virus monoclonal antibody.
Who it may be relevant to
Registry conditions: RSV Immunization. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The primary objective of this study is to determine the nirsevimab immunisation rate in eligible infants (according to Queensland Paediatric Respiratory Syncytial Virus Prevention Program recommendation) in Queensland, Australia. The study will focus on: 1\. Assessing the immunisation rates among eligible infants (born from 1 February 2024 to 15 April 2025) in their first Respiratory Syncytial Virus (RSV)-season in Queensland. Secondary objectives of this study are as follows: 1. To analyse reasons of parents to decide for or against immunisation of their infant with nirsevimab. 1. This objective aims to assess potential influencing factors and evaluate the changes in acceptance across the three cohorts prior and post recommendation. 2. In this regard, demographic factors (e.g. education, income) will be included in the analysis where applicable to gain insights on their potential impact. 2. To assess immunisation rates for further subgroups, e.g. by: a) risk group (defined chronic condition or pre-term birth status), b) regional areas of Queensland. 3. To compare the vaccination coverage rate estimates with data captured via the Australian Immunisation Register.

Interventions

  • Biological Nirsevimab Respiratory Syncytial Virus monoclonal antibody
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

Primary outcome measures

  • The proportion of immunised infants among all enrolled infants [Time frame: March 2026-May 2026]
  • Type of immunisation [Time frame: March 2026-May 2026]
  • Location of immunization [Time frame: March 2026-May 2026]

Eligibility criteria

Inclusion criteria

  • Be a parent of an infant born between 1 February 2024 and 15 April 2025
  • Be at least 18 years of age
  • Reside in Queensland, Australia
  • Read and agree to the Participant Information and Consent Form (PICF) before proceeding to the survey
  • Agree with Adverse Event (AE) reporting requirements before proceeding to the survey

Exclusion criteria

\- Have participated in any studies on infant respiratory diseases in the past 4 months

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Australia · 1 center
  • Paratus Clinical Research — Brisbane

Identifiers

NCT: NCT07615192 · RSV24171 · U1111-1336-8817

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗