Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
NCT ID: NCT06180993
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
42000 participants
OBSERVATIONAL
2023-09-25
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
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
Risk Cohort
Subjects with risk factors born between 1 October 2021 and 31 March 2023
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
Catch-up cohort
Subjects born between 1 April and 24 September 2023
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
24 Months
ALL
No
Sponsors
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Federico Martinón Torres
OTHER
Responsible Party
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Federico Martinón Torres
Principal investigator
Locations
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Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Countries
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Facility Contacts
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Federico Martinón Torres, PhD, MD
Role: primary
References
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Manzanares A, Pardo-Seco J, Rivero-Calle I, Dacosta-Urbieta A, Mallah N, Santiago-Perez MI, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, Jin J, Platero-Alonso L, Alvarez-Gil RM, Ces-Ozores OM, Nartallo-Penas V, Miras-Carballal S, Pineiro-Sotelo M, Gonzalez-Perez JM, Rodriguez-Tenreiro-Sanchez C, Salas A, Duran-Parrondo C, Martinon-Torres F. Respiratory syncytial virus-related lower respiratory tract infection hospitalizations in infants receiving nirsevimab in Galicia (Spain): the NIRSE-GAL study. Eur J Pediatr. 2025 May 2;184(5):321. doi: 10.1007/s00431-025-06151-3.
Mallah N, Ares-Gomez S, Pardo-Seco J, Malvar-Pintos A, Santiago-Perez MI, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, Jin J, Platero-Alonso L, Alvarez-Gil RM, Ces-Ozores OM, Nartallo-Penas V, Miras-Carballal S, Pineiro-Sotelo M, Gonzalez-Perez JM, Rodriguez-Tenreiro C, Rivero-Calle I, Salas A, Duran-Parrondo C, Martinon-Torres F. Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol. Hum Vaccin Immunother. 2024 Dec 31;20(1):2348135. doi: 10.1080/21645515.2024.2348135. Epub 2024 May 13.
Ares-Gomez S, Mallah N, Santiago-Perez MI, Pardo-Seco J, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, Jin J, Platero-Alonso L, Alvarez-Gil RM, Ces-Ozores OM, Nartallo-Penas V, Miras-Carballal S, Pineiro-Sotelo M, Malvar-Pintos A, Gonzalez-Perez JM, Rodriguez-Tenreiro-Sanchez C, Rivero-Calle I, Salas A, Duran-Parrondo C, Martinon-Torres F; NIRSE-GAL study group. Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study. Lancet Infect Dis. 2024 Aug;24(8):817-828. doi: 10.1016/S1473-3099(24)00215-9. Epub 2024 Apr 30.
Other Identifiers
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NIRSE-GAL
Identifier Type: -
Identifier Source: org_study_id