Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
- Conditions
- RSV Infection
- Interventions
- Registration Number
- NCT04938830
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1003
- Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
- Is available to complete the follow-up period.
- Requires mechanical ventilation at time of enrollment.
- Has a life expectancy <6 months.
- Has known hepatic or renal dysfunction, or chronic seizure disorder.
- Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- Has severe immunodeficiency or is severely immunocompromised.
- Has known hypersensitivity to any component of clesrovimab or palivizumab.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clesrovimab Placebo Participants will receive intramuscular (IM) injections of clesrovimab and placebo Palivizumab Palivizumab Participants will receive IM injections. Clesrovimab Clesrovimab Participants will receive intramuscular (IM) injections of clesrovimab and placebo
- Primary Outcome Measures
Name Time Method Participants with solicited daily body temperature with fever in RSV Season 1 Up to 5 days Percentage of participants with solicited daily body temperature with fever in RSV Season 1
Participants with non-serious AEs in RSV Season 1 Up to 42 days Percentage of participants with non-serious AEs in RSV Season 1
Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1 Up to 365 days Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1 Up to 42 days Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1
Participants with rash AESI in RSV Season 1 Up to 42 days Percentage of participants with rash AESI in RSV Season 1
Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1 Up to 5 days Percentage of participants with solicited injection-site AEs in RSV Season 1
Participants with solicited systemic AEs in RSV Season 1 Up to 5 days Percentage of participants with solicited systemic AEs in RSV Season 1
- Secondary Outcome Measures
Name Time Method Participants with RSV-associated hospitalization in RSV Season 1 Up to 150 days Percentage of participants with RSV-associated hospitalization in RSV Season 1
Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 From approximately 393 days up to 440 days Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1 Up to 150 days Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
Participants with solicited systemic AEs in RSV Season 2 From approximately 393 days up to 400 days Percentage of participants with solicited systemic AEs in RSV Season 2
Participants with rash AESI in RSV Season 2 From approximately 393 days up to 440 days Percentage of participants with rash AESI in RSV Season 2
Participants with non-serious AEs in RSV Season 2 From approximately 393 days up to 440 days Percentage of participants with non-serious AEs in RSV Season 2
Concentration of clesrovimab in RSV Season 1 Up to 240 days Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1
Participants with SAEs in RSV Season 2 From approximately 393 days up to 575 days Percentage of participants with SAEs in RSV Season 2
Concentration of clesrovimab in RSV Season 2 From approximately 393 days up to 550 days Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2
Participants with solicited injection-site AEs in RSV Season 2 From approximately 393 days up to 400 days Percentage of participants with solicited injection-site AEs in RSV Season 2
Participants with solicited daily body temperature with fever in RSV Season 2 From approximately 393 days up to 400 days Percentage of participants with solicited daily body temperature with fever in RSV Season 2
Trial Locations
- Locations (146)
Miller Children's & Women's Hospital Long Beach ( Site 0001)
🇺🇸Long Beach, California, United States
Children's Hospital of Orange County ( Site 0047)
🇺🇸Orange, California, United States
Children's Hospital Colorado ( Site 0011)
🇺🇸Aurora, Colorado, United States
Children's National Medical Center ( Site 0020)
🇺🇸Washington D.C., District of Columbia, United States
Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M ( Site 0022)
🇺🇸Orlando, Florida, United States
Nemours Children's Health, Lake Nona Medical City ( Site 0032)
🇺🇸Orlando, Florida, United States
University of South Florida-Department of Pediatrics ( Site 0045)
🇺🇸Tampa, Florida, United States
Morehouse School Of Medicine ( Site 0049)
🇺🇸Atlanta, Georgia, United States
Clinical Research Prime ( Site 0046)
🇺🇸Idaho Falls, Idaho, United States
University of Kentucky HealthCare - Turfland ( Site 0044)
🇺🇸Lexington, Kentucky, United States
Scroll for more (136 remaining)Miller Children's & Women's Hospital Long Beach ( Site 0001)🇺🇸Long Beach, California, United States