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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1342-0595 | Registry Identifier | ICTRP |
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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:
Secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | "Catch-up cohort", i.e. all infants born between April and September in Czechia. |
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| Cohort 2 | "In-season cohort", i.e. all infants born during the RSV season between October and March in Czechia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi s.r.o. | Recruiting | Prague | 160 00 | Czechia |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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