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

NCT06511687 | Recruiting FDA Drug

• 1 other identifier: ISCI00000001
• Study Type: observational
• Target: 160,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

RSV

Keywords

RSV; Nirsevimab

Outcome Measures

Primary Outcomes (1)

• LRTI

  Number and incidence of lower-tract respiratory infections hospitalizations (LRTI) attributed to RSV in the pediatric intensive care units (PICU) at a nationwide and regional level.

  from April 2024 to October 2024

Study Arms (3)

Newborns

Subjects born between April 1st, and September 31st in 2024

Biological: Nirsevimab

Catch-up

Subjects born between October 1st of 2023 and March 31st of 2024

Biological: Nirsevimab

High-risk

High-Risk Cohort: Infants born with 29 weeks of gestational age (wga) or less who were born within nine months of the beginning of the RSV season; those born with Bronchopulmonary Dysplasia (BPD), 32 or less wga and/or a birth weight less than 1·5 kgs born within one year of the beginning of the RSV season, and newborns 34 or less wga and/or weight less than 2·5 kgs born during the RSV season.

Biological: Nirsevimab

Interventions

Nirsevimab BIOLOGICAL

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

Also known as: Beyfortus

Catch-up; High-risk; Newborns

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All infants born in Chile between October 1st, 2023, to September 31st, 2024 (approximately 160.000), and all high-risk infants born between July 1st, 2023, and October 1st, 2023 (approximately \<1.000).

You may qualify if:

• 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.

You may not qualify if:

• No specific criteria has been reported

Sponsors & Collaborators

• Instituto Sistemas Complejos de Ingeniería: lead

Study Sites (1)

ISCI

Santiago, 8370398, Chile

RECRUITING

Related Publications (5)

• Rose S, Laan MJ. Why match? Investigating matched case-control study designs with causal effect estimation. Int J Biostat. 2009 Jan 6;5(1):Article 1. doi: 10.2202/1557-4679.1127.

  PMID: 20231866 BACKGROUND

• Martens L, Leroy R, Jara A, Garcia-Zattera MJ, Lesaffre E, Declerck D. Variables associated with longitudinally registered plaque accumulation in a cohort of Flemish schoolchildren. Quintessence Int. 2007 Jul-Aug;38(7):555-64.

  PMID: 17694211 BACKGROUND

• Bruhn CA, Hetterich S, Schuck-Paim C, Kurum E, Taylor RJ, Lustig R, Shapiro ED, Warren JL, Simonsen L, Weinberger DM. Estimating the population-level impact of vaccines using synthetic controls. Proc Natl Acad Sci U S A. 2017 Feb 14;114(7):1524-1529. doi: 10.1073/pnas.1612833114. Epub 2017 Feb 1.

  PMID: 28154145 BACKGROUND

• Pearce N. Analysis of matched case-control studies. BMJ. 2016 Feb 25;352:i969. doi: 10.1136/bmj.i969.

  PMID: 26916049 BACKGROUND

• Torres JP, Saure D, Goic M, Thraves C, Pacheco J, Burgos J, Trigo N, Del Solar F, Neira I, Diaz G, O'Ryan M, Basso LJ. Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL): a retrospective observational study. Lancet Infect Dis. 2025 Nov;25(11):1189-1198. doi: 10.1016/S1473-3099(25)00233-6. Epub 2025 Jun 10.

  PMID: 40513593 DERIVED

MeSH Terms

Interventions

nirsevimab

Central Study Contacts

Leonardo Basso, PhD in Business Administration

CONTACT

56 962295601; l.basso@isci.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 22, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

CL (1)