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:
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-post: contact-us@sanofi.com
Studieorter
-
-
Queensland
-
Brisbane, Queensland, Australien, 4006
- Rekrytering
- Paratus Clinical Research
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Cohort 1
Infants born in Queensland, Australia from February 1 2024 to 15 April 2025
|
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The proportion of immunised infants among all enrolled infants
Tidsram: March 2026-May 2026
|
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
|
March 2026-May 2026
|
|
Type of immunisation
Tidsram: March 2026-May 2026
|
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
|
March 2026-May 2026
|
|
Location of immunization
Tidsram: March 2026-May 2026
|
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
|
March 2026-May 2026
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- RSV24171
- U1111-1336-8817 (Registeridentifierare: ICTRP)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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