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RSV Immunisation Status in Queensland (Australia)

StatusCompleted
PhaseNot specified
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial completed
    • Enrollment target: estimated 1200 to confirmed 1113
    • Site details revised
  2. Primary and study completion pushed from Aug 20, 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 5 words
  3. Primary and study completion pushed from Jul 20, 2026 to Aug 20, 2026v3
  4. Recruitment opened
    • Start date changed from estimate of May 26, 2026 to May 29, 2026
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT07615192
Lead Sponsor Sanofi
Conditions
(from sponsor)		 RSV Immunization
Enrollment 1,113 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov