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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Trial Transparency email recommended (Toll free for US & Canada)
- 电话号码:option 6 800-633-1610
- 邮箱:contact-us@sanofi.com
学习地点
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Queensland
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Brisbane、Queensland、澳大利亚、4006
- 招聘中
- Paratus Clinical Research
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cohort 1
Infants born in Queensland, Australia from February 1 2024 to 15 April 2025
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This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The proportion of immunised infants among all enrolled infants
大体时间:March 2026-May 2026
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A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
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March 2026-May 2026
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Type of immunisation
大体时间:March 2026-May 2026
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A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
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March 2026-May 2026
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Location of immunization
大体时间:March 2026-May 2026
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A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
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March 2026-May 2026
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RSV24171
- U1111-1336-8817 (注册表标识符:ICTRP)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.