Inclusion Criteria:

• Born at ≥ 29 weeks gestational age and aged 0 to 12 months (calendar age), who are entering their first RSV season on the day of inclusion in the study (D01)
• Informed consent form has been signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by local regulations)
• Participant and parent/LAR are able to attend the scheduled visit and to comply with all study procedures

Exclusion Criteria:

Participants are not eligible for the study if any of the following criteria are met:

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Active confirmed RSV infection at the time of dosing/randomization
• Active LRTI at the time of dosing/randomization
• Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
• Laboratory confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular injection
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
• Any condition that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
• Mother of the infant participant was administered an RSV vaccine during her pregnancy with the infant participant
• Receipt of any monoclonal antibody by the infant participant
• Receipt of immune globulins, blood or blood-derived products in the past 3 months by the infant participant
• Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
• Eligible to receive palivizumab at time of inclusion (as per local guidelines)
• In an emergency setting or hospitalized involuntarily
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

        The above information is not intended to contain all considerations relevant to a potential
        participation in a clinical trial.