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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06180993
Other study ID # NIRSE-GAL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2023
Est. completion date October 31, 2026

Study information

Verified date December 2023
Source Hospital Clinico Universitario de Santiago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The purpose of this study is to evaluate the impact of nirsevimab in preventing RSV in healthy infants and high-risk children less than 24 months of age at the start of RSV season in Galicia. The target population to receive nirsevimab is around 14,000 subjects including all healthy newborns during the RSV season, those < 6 months at the start of the season, as well as those < 24 months with comorbidities at the start of the season. Nirsevimab will be administered as part of the immunization program of Galicia and following the implementation plan designed by the Public Health authorities, using the vaccination facilities of the Galician system, i.e., hospitals and primary care centres. Appointments for administration and registration of administered doses will be performed as per usual immunization protocols. The expected coverage with nirsevimab in the target population is expected to be high (>80%). RSV testing is routinely performed in the hospital and emergency department settings. The Galician Regional Surveillance Information System will retrieve all the existing information of the different electronic databases for new RSV cases detected in Galicia, including hospitalization, primary care, drug administration and immunization. RSV case ascertainment and classification will be per- formed by a specialized clinical team according to pre-established definitions.


Recruitment information / eligibility

Status Recruiting
Enrollment 42000
Est. completion date October 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers
Gender All
Age group 1 Day to 24 Months
Eligibility Inclusion Criteria: - Subjects born in Galicia from April 1st, 2023 and March 1st, 2026 Exclusion Criteria: - No specific criteria has been reported

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela A Coruña

Sponsors (1)

Lead Sponsor Collaborator
Federico Martinón Torres

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of RSV LRTI hospitalization through the RSV season 8 months (from October to May)
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