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

NCT07634692 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 257

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • RSV Immunization

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2026-06-26
Completion
2026-06-26

Countries

  • Czechia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634692 on ClinicalTrials.gov