Идёт набор NCT07634692

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

— Наблюдательное RSV Immunization

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Nirsevimab Respiratory Syncytial Virus monoclonal antibody.
Кому может быть актуально: Состояния в реестре: RSV Immunization. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Чехия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Биопрепарат Nirsevimab Respiratory Syncytial Virus monoclonal antibody
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

Первичные конечные точки

The proportion of immunised infants among all enrolled infants [Срок оценки: June 2026 - July 2026]
Type of immunisation [Срок оценки: June 2026 - July 2026]
Location of immunization [Срок оценки: June 2026 - July 2026]

Критерии участия

Критерии включения

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