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An Observational Study to Assess Nirsevimab Immunization Rates in Eligible Infants During Their First RSV Season in the Czechia

2026年8月7日 更新者:Sanofi

The primary objective of this study is to determine the nirsevimab immunization rate in eligible infants in their first RSV-season in Czechia.

The study will focus on:

  1. Assessing nirsevimab immunization rates among eligible infants (according to ČVS recommendation) in their first RSV-season in Czechia (i.e. across all geographies)
  2. Assessing nirsevimab immunisation rates among the "catch-up cohort", i.e. all infants born between April and September.
  3. Assessing nirsevimab immunization rate among the "in-season cohort", i.e. all infants born during the RSV season between October and March.

Secondary objectives are:

  1. To analyze reasons of parents to decide for or against immunization of their infant with nirsevimab.
  2. To assess immunization rates for further subgroups, if sufficient sample for subgroup achieved, e.g. by: risk group (defined chronic condition or pre-term birth status)
  3. To assess concordance of a parent survey results based on randomly sampled parent population using Computer-Assisted Self-Interviewing (CASI) for estimating immunization rates in Czechia with coverage calculated based on pharmacy sales data.

研究概览

研究类型

观察性的

注册 (实际的)

257

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Prague、捷克语、160 00
        • Sanofi s.r.o.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

The study will target a sample of 250 parents of infants born between April 2025 and March 2027.

Eligible participants must be at least 18, reside in Czechia at the time of survey completion and speak Czech.

描述

Inclusion Criteria:

  • Be a parent of an infant born between April 2025/26 and March 2026/27, respectively
  • Permanent residence in Czechia at the time of survey completion and speak Czech
  • Be at least 18 years old at the time of survey completion
  • Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey
  • Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey

Exclusion criteria:

  • N/A

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
Cohort 1
"Catch-up cohort", i.e. all infants born between April and September in Czechia.
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
Cohort 2
"In-season cohort", i.e. all infants born during the RSV season between October and March in Czechia.
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

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
The proportion of immunised infants among all enrolled infants
大体时间:June 2026 - July 2026
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
June 2026 - July 2026
Type of immunisation
大体时间:June 2026 - July 2026
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
June 2026 - July 2026
Location of immunization
大体时间:June 2026 - July 2026
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
June 2026 - July 2026

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月15日

初级完成 (实际的)

2026年6月26日

研究完成 (实际的)

2026年6月26日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月7日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • RSV25849
  • U1111-1342-0595 (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)?

是的

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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