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Study identifier: NCT06881953 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France

Condition: RSV Infection  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhaseN/A
Planned participants400
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV). Although generally mild, RSV bronchiolitis remains the leading cause of infant hospitalizations for acute respiratory distress in Europe. In France, nearly 30% of children under two years of age are affected annually, representing approximately 480,000 cases. RSV bronchiolitis accounts for 2 to 3% of hospital admissions among infants under one year each winter. These situations place a significant burden on pediatric intensive care units and emergency departments, impacting the delivery of care for other pediatric patients and raising concerns among parent and families. Until September 2023, RSV lower respiratory tract infection prevention strategies in infants in France were limited to non-pharmacological barrier measures, with a monthly injection of the monoclonal antibody palivizumab (Synagis®) recommended among high-risk infants, particularly those born preterm before 35 weeks of gestation. At the end of 2023, a new monoclonal antibody, nirsevimab (Beyfortus®), indicated for passive immunization in the general infant population, received marketing authorization. Administered as a single dose to neonates (from birth) and infants during their first RSV season, nirsevimab demonstrated an estimated efficacy of 76% to 83% in preventing severe RSV bronchiolitis during the 2023-2024 epidemic in France. At the same time, the RSV vaccine Abrysvo® (P…

This description comes directly from the study's public registry record.

Talk to the study team

Bénédicte COULM, RM,PhD  ·  01 84 82 85 34  ·  benedicte.coulm@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Public health department, Hôpital Pitié SalpêtrièreParis, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06881953