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NCT Number: NCT07251972

Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns

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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This study is active but is not currently recruiting participants.

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Key information

Age range

4 day–8 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Chru Nancy

Nancy, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all term born neonates

Exclusion criteria

  • postnatal transfert
  • born at home or in birthing center

Treatment and study plan

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

Primary outcomes

  1. Bronchiolitis incidence

    Time frame: 8 months

    Number of emergency room visits for bronchiolitis

Sponsors and collaborators

Lead sponsor

Jean-Michel HASCOET

Other

Registry information

Official study title

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

Acronym: Abrystus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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