Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
NIRSE-GAL
1 other identifier
observational
42,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2023
CompletedFirst Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
ExpectedDecember 26, 2023
December 1, 2023
2.5 years
December 8, 2023
December 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of RSV LRTI hospitalization through the RSV season
8 months (from October to May)
Study Arms (3)
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
Risk Cohort
Subjects with risk factors born between 1 October 2021 and 31 March 2023
Catch-up cohort
Subjects born between 1 April and 24 September 2023
Interventions
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
Eligibility Criteria
All children born between April 1st, 2023 and March 1st, 2026, both dates included, in Galicia (North- west Spain)
You may qualify if:
- Subjects born in Galicia from April 1st, 2023 and March 1st, 2026
You may not qualify if:
- No specific criteria has been reported
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15707, Spain
Related Publications (4)
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. Impact of universal nirsevimab prophylaxis in infants on hospital and primary care outcomes across two respiratory syncytial virus seasons in Galicia, Spain (NIRSE-GAL): a population-based prospective observational study. Lancet Infect Dis. 2026 Jan 12:S1473-3099(25)00742-X. doi: 10.1016/S1473-3099(25)00742-X. Online ahead of print.
PMID: 41539320DERIVEDManzanares 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.
PMID: 40314706DERIVEDMallah 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.
PMID: 38738683DERIVEDAres-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.
PMID: 38701823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 8, 2023
First Posted
December 26, 2023
Study Start
September 25, 2023
Primary Completion
March 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
December 26, 2023
Record last verified: 2023-12