NIRSEVIMAB for Respiratory syncytial virus infection|Bronchiolitis|Respiratory tract infection

Inclusion criteria

• {"criterion_text":"- Pregnant women\n- Affiliated to social security regime or an equivalent system\n- Live-birth to mother enrolled in the study\n- Informed consent from the mother, and the other legal representative (partner / co-parent) when applicable\n- Provide informed consent prior to study enrolment\n- Willing and able (in the site investigator’s opinion) to comply with all study requirements\n- More than 18 years of age\n- Between 32 and 36 weeks + 6 days of gestation\n- Able to read and complete the eHealth questionnaire in French or English\n- Willing to receive maternal vaccine in pregnancy, if allocated\n- Willing for the baby to receive infant nirsevimab\n- Willing for their data to be re-used as part of the joint analysis with PIPELINE-RSV-International trial"}

Exclusion criteria

• {"criterion_text":"- Major illness of the maternal participant or conditions of the foetus that, in the investigator’s judgment, would substantially increase the risk associated with the maternal or infant participant’s participation in and completion of the study\n- Any suspected or confirmed condition in the foetus that in the opinion of the site investigator would contraindicate participation of the future newborn/infant in the study\n- High risk of prematurity as judged by treating clinician\n- Multiple pregnancy (i.e. twins, triplets or more).\n- Previous participation in the PIPELINE-RSV trial\n- Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial\n- Any contraindication for receipt of intramuscular injection (bleeding diathesis or a condition associated with prolonged bleeding) or of vaccine (history of severe allergic reaction, e.g. anaphylaxis, to any component of the vaccine)\n- History of Guillain Barré Syndrome (GBS)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Confirmed by an approved positive RSV test: RSV RT-PCR or positive RSV antigen test on nasal swabs performed in a protocol-approved central or local laboratory; parents encouraged to carry out RT-PCR in the event of respiratory symptoms."}

Secondary endpoints

• {"endpoint_text":"- RSV RTI by 3 and 6 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- Medically-attended (MA)-RSV RTI by 3, 6 and 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- RSV RTI-associated hospitalisations by 3, 6 and 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- RSV RTI with SpO2 <90% and/or with need for supplemental O2","definition_or_measurement_approach":""}
• {"endpoint_text":"- RSV RTI-associated deaths by 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- All-cause RTI by 3, 6 and 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- All-cause medically attended respiratory tract infections (MA-RTI) by 3, 6 and 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- All-cause RTI-associated hospitalisations by 3, 6 and 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- All-cause RTI with SpO2 <90% and/or with need for supplemental O2 by 3, 6 and 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- All-cause RTI-associated deaths by 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- MA wheezing with 1 or more episodes by 12 months","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serious adverse events (SAEs), grade ≥3 AEs by 12 months of age","definition_or_measurement_approach":""}
• {"endpoint_text":"- All-cause MA-RTI by 12 months post-delivery","definition_or_measurement_approach":""}
• {"endpoint_text":"- SAEs by 12 months post-delivery","definition_or_measurement_approach":""}
• {"endpoint_text":"- Pregnancy loss (miscarriage and stillbirth)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Preterm (<37 weeks’ gestation) delivery","definition_or_measurement_approach":""}
• {"endpoint_text":"- Infant low birth weight (<2500g)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Acceptability of trial interventions and procedures","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

18-09-2025

Latest Decision Or Authorization Date

21-10-2025

Processing Time Days

33

Number Of Sites

17

Number Of Participants

2000

Primary sponsor

Full Name

Centre Hospitalier Annecy Genevois

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France