RSV Immunisation Status in Queensland (Australia)

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.

Recruiting

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Key information

Conditions

RSV Immunization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paratus Clinical Research

Brisbane, Queensland, 4006, Australia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

The proportion of immunised infants among all enrolled infants

Time frame: March 2026-May 2026

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

Time frame: March 2026-May 2026

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

Time frame: March 2026-May 2026

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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 29, 2026
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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