| Registry | NCT07615192 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 1113 (Actual) |
| Sponsor | Sanofi (Industry) |
| Conditions | RSV Immunization |
| Interventions | Nirsevimab Respiratory Syncytial Virus monoclonal antibody (Biological) |
| Dates | start 2026-05-29, primary completion 2026-09-30, completion 2026-09-30, first posted 2026-05-29, last updated 2026-10-14 |
| Locations | 1 site in Australia |
Related Papers Related Patents Related Grants Related Experts
All trials for RSV Immunization All trials of Nirsevimab Respiratory Syncytial Virus monoclonal antibody
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1 | Biological: Nirsevimab Respiratory Syncytial Virus monoclonal antibody | Infants born in Queensland, Australia from February 1 2024 to 15 April 2025 |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Paratus Clinical Research | Brisbane, Queensland | Australia |