About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
N/A
Trial population
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.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Nirsevimab Respiratory Syncytial Virus monoclonal antibody
Biological/VaccineThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
Treatment groups
Trial outcomes
Primary outcomes
The proportion of immunised infants among all enrolled infants
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Type of immunisation
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
Location of immunization
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
This trial is not recruiting at the moment. You can still explore other options: