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Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns

Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns in a Level 3 Maternity Unit During Winter 2025-2026

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07251972
Acronym
Abrystus
Enrollment
1050
Registered
2025-11-26
Start date
2025-09-01
Completion date
2026-05-31
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

immunoprophylaxis RSV

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.

Interventions

BIOLOGICALto 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

Sponsors

Jean-Michel HASCOET
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Days to 8 Months

Inclusion criteria

* all term born neonates

Exclusion criteria

* postnatal transfert * born at home or in birthing center

Design outcomes

Primary

MeasureTime frameDescription
Bronchiolitis incidence8 monthsNumber of emergency room visits for bronchiolitis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026