An observational study in RSV Infection, sponsored by Federico Martinón Torres. Recruiting at 1 site in Spain. Open to participants aged 1 Day to 24 Months. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Federico Martinón Torres · Observational
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.
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.
293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.
This study's planned enrollment of 42,000 is above the median of 346 across 73 observational studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Federico Martinón Torres is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All children born between April 1st, 2023 and March 1st, 2026, both dates included, in Galicia (North- west Spain)
Exclusion Criteria:
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
Subjects with risk factors born between 1 October 2021 and 31 March 2023
Biological: Nirsevimab
Subjects born between 1 April and 24 September 2023
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
Also known as: Beyfortus
Incidence of RSV LRTI hospitalization through the RSV season
Time frame: 8 months (from October to May)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Respiratory Syncytial Virus Infections→
Federico Martinón Torres