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Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization (NIRSE-GAL)

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ClinicalTrials.gov Identifier: NCT06180993
Recruitment Status : Recruiting
First Posted : December 26, 2023
Last Update Posted : December 26, 2023
Sponsor:
Information provided by (Responsible Party):
Federico Martinón Torres, Hospital Clinico Universitario de Santiago

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.

Condition or disease Intervention/treatment
RSV Infection Biological: Nirsevimab

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.

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Study Type : Observational
Estimated Enrollment : 42000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
Actual Study Start Date : September 25, 2023
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : October 31, 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
At birth cohort
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
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
Other Name: Beyfortus

Risk Cohort
Subjects with risk factors born between 1 October 2021 and 31 March 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
Other Name: Beyfortus

Catch-up cohort
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
Other Name: Beyfortus




Primary Outcome Measures :
  1. Incidence of RSV LRTI hospitalization through the RSV season [ Time Frame: 8 months (from October to May) ]


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Ages Eligible for Study:   1 Day to 24 Months   (Child)
Sexes Eligible for Study:   All
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No specific criteria has been reported

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06180993


Locations
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Spain
Hospital Clínico Universitario de Santiago de Compostela Recruiting
Santiago de Compostela, A Coruña, Spain, 15707
Contact: Federico Martinón Torres, PhD, MD    +34981955373    federico.martinon.torres@sergas.es   
Sponsors and Collaborators
Federico Martinón Torres
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Responsible Party: Federico Martinón Torres, Principal investigator, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier: NCT06180993    
Other Study ID Numbers: NIRSE-GAL
First Posted: December 26, 2023    Key Record Dates
Last Update Posted: December 26, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Infections