Prevention of RSV infection in infants by administering nirsevimab to infants, with or without maternal RSV vaccination: a randomised controlled trial in France as part of the Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)

Respiratory syncytial virus infection, Bronchiolitis, Respiratory tract infection

Symptomatic RSV respiratory tract infection (RTI) by 12 months of age, confirmed by an approved positive RSV test: RSV reverse transcription polymerase chain reaction (RT-PCR) or a positive RSV antigen test on nasal swabs (fitting for infants) performed in a protocol-approved central or local laboratory. Parents will be encouraged to carry out an RT-PCR test in the event of running or blocked nose, cough, wheeze, or difficulty breathing.

RSV RTI by 3 and 6 months of age, Medically-attended (MA)-RSV RTI by 3, 6 and 12 months of age, RSV RTI-associated hospitalisations by 3, 6 and 12 months of age, RSV RTI with SpO2 <90% and/or with need for supplemental O2, RSV RTI-associated deaths by 12 months of age, All-cause RTI by 3, 6 and 12 months of age, All-cause medically attended respiratory tract infections (MA-RTI) by 3, 6 and 12 months of age, All-cause RTI-associated hospitalisations by 3, 6 and 12 months of age, All-cause RTI with SpO2 <90% and/or with need for supplemental O2 by 3, 6 and 12 months of age, All-cause RTI-associated deaths by 12 months of age, MA wheezing with 1 or more episodes by 12 months, RT-PCR Cycle threshold (Ct) value overall and by RSV subtype (RSV-A or RSV-B) for RSV-infection confirmed by RT-PCR by 12 months of age, Serious adverse events (SAEs), grade ≥3 AEs by 12 months of age, All-cause MA-RTI by 12 months post-delivery, SAEs by 12 months post-delivery, Pregnancy loss (miscarriage and stillbirth), Preterm (<37 weeks’ gestation) delivery, Infant low birth weight (<2500g), Acceptability of trial interventions and procedures

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France