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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSanofi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

N/A

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Nirsevimab Respiratory Syncytial Virus monoclonal antibody

    Biological/Vaccine

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention

Trial outcomes

Primary outcomes

1

The proportion of immunised infants among all enrolled infants

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

Time frame
June 2026 - July 2026
2

Type of immunisation

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

Time frame
June 2026 - July 2026
3

Location of immunization

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

Time frame
June 2026 - July 2026

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: