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NCT07634692

An Observational Study to Assess Nirsevimab Immunization Rates in Eligible Infants During Their First RSV Season in the Czechia

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2026-06-15

Completion Date

2026-07-17

Last Updated

2026-06-09

Healthy Volunteers

Yes

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

Locations (1)

Sanofi s.r.o.

Prague, Czechia