- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06180993
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization (NIRSE-GAL)
Study Overview
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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A Coruña
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Santiago de Compostela, A Coruña, Spain, 15707
- Recruiting
- Hospital Clínico Universitario de Santiago de Compostela
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Contact:
- Federico Martinón Torres, PhD, MD
- Phone Number: +34981955373
- Email: federico.martinon.torres@sergas.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects born in Galicia from April 1st, 2023 and March 1st, 2026
Exclusion Criteria:
- No specific criteria has been reported
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
At birth cohort
Subjects born from September 25, 2023 to March 31 in each of the 3 RSV seasons under study 2023/2024, 2024/2025, 2025/2026
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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
Other Names:
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Risk Cohort
Subjects with risk factors born between 1 October 2021 and 31 March 2023
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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
Other Names:
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Catch-up cohort
Subjects born between 1 April and 24 September 2023
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of RSV LRTI hospitalization through the RSV season
Time Frame: 8 months (from October to May)
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8 months (from October to May)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIRSE-GAL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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