An Observational Study to Assess Nirsevimab Immunization Rates in Eligible Infants During Their First RSV Season in the Czechia
Study on Nirsevimab Immunization Rates in Infants During RSV Season in Czechia
Study Overview
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: RSV Immunization
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Age: 18 years or above
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Gender: All
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.
This study investigates the immunization rates of nirsevimab in infants during their first RSV season in Czechia. It looks at how many eligible infants receive the immunization across different times of the year.
The study evaluates the overall rates of nirsevimab immunization and considers various factors, such as the timing of birth and parental decision-making. This study investigates patterns and influences on immunization rates.
- Who can participate: Parents of infants born between April 2025 and March 2027 who live in Czechia and speak Czech can participate if they are at least 18 years old and agree to the study's privacy policy.
- Study details: Participants will complete a survey about their infant's immunization to assess nirsevimab rates. An inactive substance called placebo is not part of this study.
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