Actively Recruiting

Age: 1Day - 24Months
All Genders
NCT06180993

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

Led by Federico Martinón Torres · Updated on 2023-12-26

42000

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Day - 24Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects born in Galicia from April 1st, 2023 to March 1st, 2026
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15707

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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