An Observational Study to Assess Nirsevimab Immunization Rates in Eligible Infants During Their First RSV Season in the Czechia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nirsevimab Respiratory Syncytial Virus monoclonal antibody.
- Who it may be relevant to
- Registry conditions: RSV Immunization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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: 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
- Biological Nirsevimab Respiratory Syncytial Virus monoclonal antibody
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
Primary outcome measures
- The proportion of immunised infants among all enrolled infants [Time frame: June 2026 - July 2026]
- Type of immunisation [Time frame: June 2026 - July 2026]
- Location of immunization [Time frame: June 2026 - July 2026]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Czechia · 1 center
- Sanofi s.r.o. — Prague
Identifiers
NCT: NCT07634692 · RSV25849 · U1111-1342-0595