Status:
COMPLETED
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Respiratory Syncytial Virus Infection
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hyp...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2024
Estimated Enrollment :
3632 Patients enrolled
Trial Details
Trial ID
NCT04767373
Start Date
April 7 2021
End Date
July 9 2024
Last Update
May 6 2025
Active Locations (217)
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1
Southeastern Pediatric Associates, P.A. ( Site 0008)
Dothan, Alabama, United States, 36303
2
Northwest Arkansas Pediatric Clinic ( Site 0050)
Fayetteville, Arkansas, United States, 72703
3
Children's Clinic of Jonesboro, PA ( Site 0058)
Jonesboro, Arkansas, United States, 72401
4
Long Beach Memorial Medical Center ( Site 0014)
Long Beach, California, United States, 90806