RSV Immunisation Status in Queensland (Australia)
ConditionRSV Immunization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSanofi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
The study will target a sample of 1,200 parents of infants born between February 2024 and April 2025. Eligible participants must be at least 18, reside in Queensland, and not have been involved in similar research recently.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Nirsevimab Respiratory Syncytial Virus monoclonal antibody
Biological/VaccineThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
Treatment groups
1,200 Participants
are divided into 1 treatment groupGroup A: Cohort 11 intervention
Trial outcomes
Primary outcomes
1
The proportion of immunised infants among all enrolled infants
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Time frame
March 2026-May 20262
Type of immunisation
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Time frame
March 2026-May 20263
Location of immunization
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Time frame
March 2026-May 2026 Source ClinicalTrials.gov