RecruitingNCT06180993

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


Sponsor

Federico Martinón Torres

Enrollment

42,000 participants

Start Date

Sep 25, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 DayMax Age: 24 Months

Inclusion Criteria1

  • Subjects born in Galicia from April 1st, 2023 and March 1st, 2026

Exclusion Criteria1

  • No specific criteria has been reported

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Interventions

BIOLOGICALNirsevimab

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


Locations(1)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

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NCT06180993


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