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临床试验/NCT07634692
NCT07634692已完成不适用

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

Sanofi2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2026年6月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Sanofi
入组人数
257
试验地点
2

研究概览

简要总结

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

入选标准

  • 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

排除标准

  • 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

"Catch-up cohort", i.e. all infants born between April and September in Czechia.

干预措施: Nirsevimab Respiratory Syncytial Virus monoclonal antibody (Biological)

Cohort 2

"In-season cohort", i.e. all infants born during the RSV season between October and March in Czechia.

干预措施: Nirsevimab Respiratory Syncytial Virus monoclonal antibody (Biological)

研究者

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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