Clinical Trial

RSV Immunisation Status in Queensland (Australia)

Recruiting
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Summary
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.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2026-07-20 -> 2026-08-20 2026-08-01
minor Completion pushed: 2026-07-20 -> 2026-08-20 2026-08-01
critical Recruitment opened 2026-06-24
Trial Details
NCT Number NCT07615192
Lead Sponsor Sanofi
Conditions RSV Immunization
Enrollment 1,200 participants
Start Date 2026-05-29
Primary Completion 2026-08-20 (estimated)
Study Completion 2026-08-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-31