RSV ImmunizationNCT07615192
RSV Immunisation Status in Queensland (Australia)
An observational study of RSV Immunization, run by Sanofi at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RSV Immunization
- What is being tested?
- Nirsevimab Respiratory Syncytial Virus monoclonal antibody
- How many people
- 1,113 participants
- Where
- 1 siteAustralia
- Study dates
- 29 May 2026to 30 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- This objective aims to assess potential influencing factors and evaluate the changes in acceptance across the three cohorts prior and post recommendation.
- In this regard, demographic factors (e.g. education, income) will be included in the analysis where applicable to gain insights on their potential impact.
- 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.
- Conditions
- RSV Immunization
- Being tested
- Nirsevimab Respiratory Syncytial Virus monoclonal antibody
- Keywords
- nirsevimab; nirsevimab immunization rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirsevimab Respiratory Syncytial Virus monoclonal antibodyBiological
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Infants born in Queensland, Australia from February 1 2024 to 15 April 2025 Receives: Biological: Nirsevimab Respiratory Syncytial Virus monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of immunised infants among all enrolled infants
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Measured: March 2026-May 2026
Type of immunisation
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Measured: March 2026-May 2026
Location of immunization
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Measured: March 2026-May 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start29 May 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615192
- Sponsor's protocol ID
- RSV24171
- Other IDs
- U1111-1336-8817
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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