Clinical trial NCT06180993: Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
Official title: Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: RSV Infection
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 42000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children born between April 1st, 2023 and March 1st, 2026, both dates included, in Galicia (North- west Spain)

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.

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.

Eligibility criteria: Inclusion Criteria:

* Subjects born in Galicia from April 1st, 2023 and March 1st, 2026

Exclusion Criteria:

* No specific criteria has been reported

Primary outcomes:
measure: Incidence of RSV LRTI hospitalization through the RSV season
timeFrame: 8 months (from October to May)
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
Study officials:
References: