Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
ConditionRSV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-24
SponsorFederico Martinón Torres
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects born in Galicia from April 1st, 2023 and March 1st, 2026
Disqualifiers
No specific criteria has been reported
Trial population
All children born between April 1st, 2023 and March 1st, 2026, both dates included, in Galicia (North- west Spain)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Nirsevimab
Biological/VaccineNirsevimab 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
Treatment groups
42,000 Participants
are divided into 3 treatment groupsGroup A: At birth cohort1 intervention
Group B: Risk Cohort1 intervention
Group C: Catch-up cohort1 intervention
Trial outcomes
Primary outcomes
1
Incidence of RSV LRTI hospitalization through the RSV season
Time frame
8 months (from October to May)Sponsors and contacts
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Federico Martinón Torres
Lead sponsor
Hospital Clinico Universitario de Santiago
Sponsor institution
Source ClinicalTrials.gov