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RSV Immunisation Status in Queensland (Australia)

RSV Immunisation Status in Queensland (Australia)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07615192
Enrollment
1200
Registered
2026-05-29
Start date
2026-05-29
Completion date
2026-08-20
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RSV Immunization

Keywords

nirsevimab; nirsevimab immunization rates

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. 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

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

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The proportion of immunised infants among all enrolled infantsMarch 2026-May 2026A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Type of immunisationMarch 2026-May 2026A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Location of immunizationMarch 2026-May 2026A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.

Countries

Australia

Contacts

CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com800-633-1610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026