The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. These children have Lower Respiratory Tract Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection to the lower airways such as lungs. This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children. This study is seeking for participants who: * Are 1 day to less than or equal to 60 months of age * weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms. * Have been tested to have RSV by medical tests. * show signs of LRTI. All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it. Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home. The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
10
Kaiser Permanente Los Angeles Medical center
Los Angeles, California, United States
Kaiser Permanente
Los Angeles, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Kojunkai Daido Hospital
Nagoya, Aichi-ken, Japan
Nintenkai Kagoshima Children's Hospital
Hioki, Kagoshima-ken, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Osaka City General Hospital
Osaka, Japan
Monti Clinical Research Centre
Mdantsane, Eastern Cape, South Africa
University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
Johannesburg, Gauteng, South Africa
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. All AEs were included for evaluation.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)
Number of Participants Who Discontinued From Study Due to TEAEs
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)
Number of Participants Who Discontinued From Study Due to Serious TEAEs
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. A serious AE (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation if existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important event or situation as pre-specified in protocol.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)
Number of Participants With Clinically Significant Laboratory Abnormalities
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, mean cell volume, mean cell hemoglobin \& concentration); chemistry: urea and creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyl transferase (GGT), calcium, sodium, potassium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, albumin, total protein, cystatin C; urinalysis: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, albumin, creatinine (urine), urine albumin to creatinine ratio. Clinically significant laboratory abnormalities findings were based on investigator discretion.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)
Number of Participants With Clinically Significant Vital Signs
Vital signs included systolic and diastolic blood pressure, pulse rate/heart rate, temperature, respiratory rate, and oxygen saturation. Clinically significance vital signs findings were based on investigator discretion.
Time frame: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (maximum up to 33 days)
Plasma Concentrations Versus Time Summary of Sisunatovir
Time frame: Day 3: Pre-dose, T1 and T2 hours post-dose; Day 5: Pre-dose; where T1 is the first analysis time point post-dose while T2 is the second analysis time point post-dose
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