Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization

RSV Infection Clinical Trial

— NIRSE-GAL  

Official title:

Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180993
• Other study ID #: NIRSE-GAL
• Status: Recruiting
• Start date: September 25, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: December 2023
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42000
• Est. completion date: October 31, 2026
• Est. primary completion date: March 31, 2026
• Gender: All
• Age group: 1 Day to 24 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No specific criteria has been reported

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Federico Martinón Torres

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of RSV LRTI hospitalization through the RSV season		8 months (from October to May)