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 hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.
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RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)
Timeframe: From Day 1 (postdose) to Day 150
RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Timeframe: From Day 1 (postdose) to Day 5
RSV Season 1: Percentage of Participants With Fever
Timeframe: From Day 1 (postdose) to Day 5
RSV Season 1: Percentage of Participants With Solicited Systemic AEs
Timeframe: From Day 1 (postdose) to Day 5
RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)
Timeframe: From Day 1 (postdose) to Day 42
RSV Season 1: Percentage of Participants With Rash AESI
Timeframe: From Day 1 (postdose) to Day 42
RSV Season 1: Percentage of Participants With ≥1 Nonserious AE
Timeframe: From Day 1 (postdose) to Day 42
Percentage of Participants With Serious Adverse Events (SAEs)
Timeframe: RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515