RSV Immunisation Status in Queensland (Australia)

NCT07615192 | Not Yet Recruiting

• 1 other identifier: RSV24171
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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. 1.To analyse reasons of parents to decide for or against immunisation of their infant with nirsevimab.
2. 2.This objective aims to assess potential influencing factors and evaluate the changes in acceptance across the three cohorts prior and post recommendation.
3. 3.In this regard, demographic factors (e.g. education, income) will be included in the analysis where applicable to gain insights on their potential impact.
4. 4.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.
5. 5.To compare the vaccination coverage rate estimates with data captured via the Australian Immunisation Register.

Conditions

RSV Immunization

Keywords

nirsevimab; nirsevimab immunization rates

Outcome Measures

Primary Outcomes (3)

• The proportion of immunised infants among all enrolled infants

  A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.

  March 2026-May 2026

• Type of immunisation

  A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.

  March 2026-May 2026

• Location of immunization

  A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.

  March 2026-May 2026

Study Arms (1)

Cohort 1

Infants born in Queensland, Australia from February 1 2024 to 15 April 2025

Biological: Nirsevimab Respiratory Syncytial Virus monoclonal antibody

Interventions

Nirsevimab Respiratory Syncytial Virus monoclonal antibody BIOLOGICAL

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Paratus Clinical Research

Brisbane, Queensland, 4006, Australia

Location

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)