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RECRUITINGOBSERVATIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - No specific criteria has been reported Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * No specific criteria has been reported

Treatments Being Tested

BIOLOGICAL

Nirsevimab

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