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Clinical Trials in Spain / NCT06180993
Recruiting Observational

Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization

NCT06180993 · tracked via the Priya Life Science Spain tracker
Sponsor
Federico Martinón Torres
Phase
Observational
Started
2023-09-25
Last updated
2023-12-26

Condition(s) studied

RSV Infection

Investigational drug(s) / intervention(s)

Nirsevimab →

Nirsevimab: Nirsevimab will be administered administered in a single dose at birth for birth cohort and at the beginning of the campaign for the other cohorts under study

Study summary

A longitudinal observational study based on routinely collected data on hospital and health care use for RSV infections will be undertaken. The Galician public health registries will be used for data collection including baseline information and follow-up data. Historical data will be retrieved for comparison purposes. The study aims to observe and analyze data from all the eligible children in Galicia for nirsevimab treatment. The number of eligible children is expected to be approximately 14,000 per each RSV season.

Eligibility

Sex
ALL
Min age
1 Day
Max age
24 Months
Healthy volunteers
No
Inclusion Criteria: * Subjects born in Galicia from April 1st, 2023 and March 1st, 2026 Exclusion Criteria: * No specific criteria has been reported

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela A Coruña Recruiting

On this site

📄 Beyfortus (nirsevimab) drug profile →
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06180993 on ClinicalTrials.gov ↗ ← All trials in Spain