Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns

NCT07251972 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: 2025PI033
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiolitis

Keywords

immunoprophylaxis RSV

Outcome Measures

Primary Outcomes (1)

• Bronchiolitis incidence

  Number of emergency room visits for bronchiolitis

  8 months

Interventions

to compare vaccine and monoclonal antibody BIOLOGICAL

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

Eligibility Criteria

• Age: 4 Days - 8 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

term born neonate

You may qualify if:

• all term born neonates

You may not qualify if:

• postnatal transfert
• born at home or in birthing center

Sponsors & Collaborators

• Jean-Michel HASCOET: lead

Study Sites (1)

Chru Nancy

Nancy, France

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: September 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)