Evaluating the effectiveness of nirsevimab for RSV prevention in infants
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
This study is testing if nirsevimab can help prevent RSV infections in healthy infants and high-risk children under 24 months in Galicia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 42000 (estimated) |
| Ages | 1 Day to 24 Months |
| Sex | All |
| Sponsor | Hospital Clinico Universitario de Santiago Academic / other |
| Drugs / interventions | nirsevimab |
| Locations | 1 site (Santiago de Compostela, A Coruña) |
| Trial ID | NCT06180993 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of nirsevimab in preventing respiratory syncytial virus (RSV) infections among healthy infants and high-risk children under 24 months in Galicia. Utilizing data from public health registries, the study will analyze hospital and healthcare usage related to RSV infections over multiple seasons. Approximately 14,000 eligible children will be monitored, with nirsevimab administered as part of the routine immunization program. The study will also compare historical data to evaluate the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy newborns and children under 24 months of age, particularly those under 6 months or with comorbidities.
Not a fit: Patients older than 24 months or those not residing in Galicia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of RSV infections in infants and high-risk children.
How similar studies have performed: Other studies have shown promising results with similar immunization approaches for RSV prevention, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects born in Galicia from April 1st, 2023 and March 1st, 2026 Exclusion Criteria: * No specific criteria has been reported
Where this trial is running
Santiago de Compostela, A Coruña
- Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.