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

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.

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Key information

Conditions

RSV Immunization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi s.r.o.

Prague, 160 00, Czechia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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

Primary outcomes

The proportion of immunised infants among all enrolled infants

Time frame: June 2026 - July 2026

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

Time frame: June 2026 - July 2026

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

Time frame: June 2026 - July 2026

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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 9, 2026
Registry last updated: Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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