RecruitingNCT06511687

Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)

Effectiveness And Impact of Nirsevimab In A Nationwide Immunization Program During The 2024 Winter Campaign In Chile (Nirse-CL)


Sponsor

Instituto Sistemas Complejos de Ingeniería

Enrollment

160,000 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The Nirse-CL study is a collaborative effort between the Ministry of Health of Chile, Instituto Sistemas Complejos de Ingeniería (ISCI), and the Faculty of Medicine of the University of Chile. The primary aim is to determine the effectiveness of the monoclonal antibody nirsevimab in preventing RSV infection in infants based on the integrated analysis of several national databases before, during, and after the implementation of a universal immunization program. The impact of the program on RSV-related health outcomes will also be determined.


Eligibility

Max Age: 4 Years

Inclusion Criteria3

  • Subjects born between October 1st, 2023, to September 31st, 2024.
  • Subjects born with 29 weeks of gestational age (wga) or less who were born between July 1st, 2023 and October 1st, 2023
  • Subjects born with Bronchopulmonary Dysplasia (BPD), 32 or less wga and/or a birth weight less than 1·5 kgs born between April 1st, 2023 and October 1st, 2023.

Exclusion Criteria1

  • No specific criteria has been reported

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Interventions

BIOLOGICALNirsevimab

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


Locations(1)

ISCI

Santiago, Chile

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NCT06511687


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