Lead Sponsor

Merck Sharp & Dohme LLC

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

•Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
•For the phase 2b cohort only: Has a chronological age \>2 weeks of age up to 1 year and is entering their first respiratory syncytial virus (RSV) season at the time of obtaining documented informed consent.
•For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
•For participants in South Korea only: Weighs ≥2 kg

•Is recommended to receive palivizumab per local guidelines or professional society recommendations.
•Has known hypersensitivity to any component of clesrovimab
•Has a bleeding disorder contraindicating IM administration
•Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
•Has received any vaccine or monoclonal antibody for the prevention of RSV
•Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study

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