RSV Immunization
Conditions
Keywords
nirsevimab;, nirsevimab immunization rates
Brief summary
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.
Interventions
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
Sponsors
Sanofi
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of immunised infants among all enrolled infants | June 2026 - July 2026 | A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics. |
| Type of immunisation | June 2026 - July 2026 | A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics. |
| Location of immunization | June 2026 - July 2026 | A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics. |
Countries
Czechia
Outcome results
None listed