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
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:
- Assessing nirsevimab immunization rates among eligible infants (according to ČVS recommendation) in their first RSV-season in Czechia (i.e. across all geographies)
- Assessing nirsevimab immunisation rates among the "catch-up cohort", i.e. all infants born between April and September.
- 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:
- To analyze reasons of parents to decide for or against immunization of their infant with nirsevimab.
- 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)
- 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
- 是
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
研究点 (2)
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