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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1336-8817 | Registry Identifier | ICTRP |
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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:
To analyse reasons of parents to decide for or against immunisation of their infant with nirsevimab.
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.
To compare the vaccination coverage rate estimates with data captured via the Australian Immunisation Register.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Infants born in Queensland, Australia from February 1 2024 to 15 April 2025 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus Clinical Research | Recruiting | Brisbane | Queensland | 4006 | Australia |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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