RSV Infection
Conditions
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).
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 solicited systemic AEs in RSV Season 1 | Up to 5 days | Percentage of participants with solicited systemic AEs 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Participants with SAEs in RSV Season 2 | From approximately 393 days up to 575 days | Percentage of participants with SAEs 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 |
| 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 |
| 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 RSV-associated hospitalization in RSV Season 1 | Up to 150 days | Percentage of participants with RSV-associated hospitalization in RSV Season 1 |
| 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 |
| 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 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 rash AESI in RSV Season 2 | From approximately 393 days up to 440 days | Percentage of participants with rash AESI in RSV Season 2 |
Countries
Australia, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Peru, Puerto Rico, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed