Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-05-31

Brief Summary

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Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases annually worldwide. Each year, 2 to 3% of infants under 1 year old are hospitalized for bronchiolitis. The virus primarily found worldwide and in France is RSV. Given the scale, frequency, and potential severity of the illness, several immunoprophylaxis methods have been developed.

Currently, there are two methods: the ABRYSVO vaccine, administered to pregnant women during the last month of pregnancy for immunization via the placenta through the transplacental passage of anti-RSV-A and RSV-B antibodies; or neonatal immunoprophylaxis with BEYFORTUS, which involves an intramuscular injection of the monoclonal antibody nirvesimab directly into the newborn immediately before discharge from the maternity ward during the epidemic period.

Currently, no superiority or difference has been described for either immunoprophylaxis method.

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Detailed Description

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Conditions

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Bronchiolitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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to compare vaccine and monoclonal antibody

collect the details at birth of chosen immunoprophylaxis and collect if later there will be any hospitalisation for bronchiolitis or consultation emergencies

Intervention Type BIOLOGICAL