Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India

Inclusion Criteria: - Neonates and infants aged 0 to 12 months on the day of inclusion and born during or entering their first RSV season OR children up to 24 months of age on the day of inclusion who remain vulnerable to severe RSV disease through their second RSV season

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

• Known systemic hypersensitivity to any of the study intervention components, orhistory of a life-threatening reaction to the study intervention used in the studyor to a product containing any of the same substances

• Known thrombocytopenia, as reported by the parent(s)/legally acceptablerepresentative(s), contraindicating intramuscular injection

• Known bleeding disorder, or receipt of anticoagulants in the 3 weeks precedinginclusion, contraindicating intramuscular injection

• Chronic illness that, in the opinion of the investigator, is at a stage where itmight interfere with study conduct or completion

• Active LRTI on the day of study intervention administration

• Active RSV infection on the day of study intervention administration

• Moderate or severe acute illness/infection (according to investigator judgment) orfebrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study interventionadministration. A prospective participant should not be included in the study untilthe condition has resolved or the febrile event has subsided

• Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine in thesame RSV season than inclusion in the study

• Mother of the participant was administered an RSV vaccine during her pregnancy withthe participant

• Receipt of immune globulins, blood or blood-derived products in the past 3 months

• Receipt of any investigational drug in the last 30 days prior to the inclusion inthe study

• Participation at the time of study enrollment or in the 4 weeks preceding the studyintervention administration or planned participation during the present studyperiod, in another clinical study investigating a vaccine, drug, medical device, ormedical procedure Note: The above information is not intended to contain allconsiderations relevant to a potential participation in a clinical trial.