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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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RSV Infection

Intervention / Treatment
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* Biological: Nirsevimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects born in Galicia from April 1st, 2023 and March 1st, 2026 Exclusion Criteria: No specific criteria has been reported

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| At birth cohort<br>Subjects born from September 25, 2023 to March 31 in each of the 3 RSV seasons under study 2023/2024, 2024/2025, 2025/2026 | Biological: Nirsevimab<br>* 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<br>* Other names: Beyfortus;|
| Risk Cohort<br>Subjects with risk factors born between 1 October 2021 and 31 March 2023 | Biological: Nirsevimab<br>* 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<br>* Other names: Beyfortus;|
| Catch-up cohort<br>Subjects born between 1 April and 24 September 2023 | Biological: Nirsevimab<br>* 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<br>* Other names: Beyfortus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of RSV LRTI hospitalization through the RSV season |  | 8 months (from October to May) |