Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nirsevimab.
- Who it may be relevant to
- Registry conditions: RSV Infection. Basic parameters: 1 Day — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- 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
Primary outcome measures
- Incidence of RSV LRTI hospitalization through the RSV season [Time frame: 8 months (from October to May)]
Eligibility criteria
Inclusion criteria
- Subjects born in Galicia from April 1st, 2023 and March 1st, 2026
Exclusion criteria
- No specific criteria has been reported
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Spain · 1 center
- Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela
Publications
- Razzini JL, Gine-Vazquez I, Jin J, Santiago-Perez MI, Perez-Martinez O, Otero-Barros MT, Suarez-Gaiche N, Kramer R, 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, Manzanares-Casteleiro A, Dacosta-Urbieta A, Alvarez-Smith C, Rivero-Calle I, Salas A, Duran-Parrondo C, Mallah N, Martinon-Torres F PMID 41539320
- 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 lowe PMID 40314706
- 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 universa PMID 38738683
- 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 i PMID 38701823
Identifiers
NCT: NCT06180993 · NIRSE-GAL