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

NCT06180993 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 42000

Last updated 2023-12-26

No results posted yet for this 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.

Conditions

  • RSV Infection

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

Sponsors & Collaborators

  • Federico Martinón Torres

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-03-31
Completion
2026-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180993 on ClinicalTrials.gov