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

3. juni 2026 opdateret af: Sanofi

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefonnummer: option 6 800-633-1610
  • E-mail: Contact-US@sanofi.com

Studiesteder

  • Tjekkiet
      • Prague, Tjekkiet, 160 00
        • Sanofi s.r.o.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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:

  • N/A

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Cohort 1
"Catch-up cohort", i.e. all infants born between April and September in Czechia.
Biologisk: Nirsevimab Respiratory Syncytial Virus monoclonal antibody
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
Cohort 2
"In-season cohort", i.e. all infants born during the RSV season between October and March in Czechia.
Biologisk: Nirsevimab Respiratory Syncytial Virus monoclonal antibody
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The proportion of immunised infants among all enrolled infants
Tidsramme: June 2026 - July 2026
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
June 2026 - July 2026
Type of immunisation
Tidsramme: June 2026 - July 2026
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
June 2026 - July 2026
Location of immunization
Tidsramme: June 2026 - July 2026
A descriptive analysis of immunisation status (yes/no) will be performed using summary statistics.
June 2026 - July 2026

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

17. juli 2026

Studieafslutning (Anslået)

17. juli 2026

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RSV25849

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med RSV-immunisering

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner