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

NCT07634692 | Not Yet Recruiting

• 1 other identifier: RSV25849
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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. 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. 2.Assessing nirsevimab immunisation rates among the "catch-up cohort", i.e. all infants born between April and September.
3. 3.Assessing nirsevimab immunization rate among the "in-season cohort", i.e. all infants born during the RSV season between October and March.
4. 4.To analyze reasons of parents to decide for or against immunization of their infant with nirsevimab.
5. 5.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)
6. 6.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

Keywords

nirsevimab;; nirsevimab immunization rates

Outcome Measures

Primary Outcomes (3)

• The proportion of immunised infants among all enrolled infants

  A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.

  June 2026 - July 2026

• Type of immunisation

  A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.

  June 2026 - July 2026

• Location of immunization

  A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.

  June 2026 - July 2026

Study Arms (2)

Cohort 1

"Catch-up cohort", i.e. all infants born between April and September in Czechia.

Biological: Nirsevimab Respiratory Syncytial Virus monoclonal antibody

Cohort 2

"In-season cohort", i.e. all infants born during the RSV season between October and March in Czechia.

Biological: Nirsevimab Respiratory Syncytial Virus monoclonal antibody

Interventions

Nirsevimab Respiratory Syncytial Virus monoclonal antibody BIOLOGICAL

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• N/A
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi s.r.o.

Prague, 160 00, Czechia

Location

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)