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RECRUITING
NCT06180993

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

Sponsor: Federico Martinón Torres

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Day - 24 Months

Study Type

OBSERVATIONAL

Enrollment

42000

Start Date

2023-09-25

Completion Date

2026-10-31

Last Updated

2023-12-26

Healthy Volunteers

Not specified

Conditions

Interventions

BIOLOGICAL

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

Locations (1)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain