RSV Immunisation Status in Queensland (Australia)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 1,200
- 试验地点
- 1
研究概览
简要总结
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:
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To analyse reasons of parents to decide for or against immunisation of their infant with nirsevimab.
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This objective aims to assess potential influencing factors and evaluate the changes in acceptance across the three cohorts prior and post recommendation.
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In this regard, demographic factors (e.g. education, income) will be included in the analysis where applicable to gain insights on their potential impact.
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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.
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To compare the vaccination coverage rate estimates with data captured via the Australian Immunisation Register.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •- 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.
研究组 & 干预措施
Cohort 1
Infants born in Queensland, Australia from February 1 2024 to 15 April 2025
干预措施: Nirsevimab Respiratory Syncytial Virus monoclonal antibody (Biological)