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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,632
Clesrovimab solution
Placebo (0.9% sodium chloride \[NaCL\]) solution
RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)
Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
Time frame: From Day 1 (postdose) to Day 150
RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included redness/erythema, swelling, and pain/tenderness. Per protocol, the percentage of RSV season 1 participants with solicited injection-site AEs were reported.
Time frame: From Day 1 (postdose) to Day 5
RSV Season 1: Percentage of Participants With Fever
Fever was defined as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). Per protocol, the percentage of RSV season 1 participants with fever were reported.
Time frame: From Day 1 (postdose) to Day 5
RSV Season 1: Percentage of Participants With Solicited Systemic AEs
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included irritability, somnolence/drowsiness, and appetite lost. Per protocol, the percentage of RSV season 1 participants with solicited systemic AEs were reported.
Time frame: From Day 1 (postdose) to Day 5
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Southeastern Pediatric Associates, P.A. ( Site 0008)
Dothan, Alabama, United States
Northwest Arkansas Pediatric Clinic ( Site 0050)
Fayetteville, Arkansas, United States
Children's Clinic of Jonesboro, PA ( Site 0058)
Jonesboro, Arkansas, United States
Long Beach Memorial Medical Center ( Site 0014)
Long Beach, California, United States
Madera Family Medical Group ( Site 0046)
Madera, California, United States
Orange County Research Institute ( Site 0057)
Ontario, California, United States
Children's Hospital Colorado ( Site 0066)
Aurora, Colorado, United States
Optumcare Colorado Springs, LLC ( Site 0022)
Colorado Springs, Colorado, United States
Children's National Hospital ( Site 0076)
Washington D.C., District of Columbia, United States
MedStar Georgetown Pediatrics ( Site 0047)
Washington D.C., District of Columbia, United States
...and 207 more locations
RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Anaphylaxis/Hypersensitivity AESI included anaphylaxis, angioedema, bronchospasm, drug hypersensitivity, dyspnea, hypersensitivity, dysphonia, and wheezing. Per protocol, the percentage of RSV season 1 participants with anaphylaxis/hypersensitivity AESI were reported.
Time frame: From Day 1 (postdose) to Day 42
RSV Season 1: Percentage of Participants With Rash AESI
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included acute generalized exanthematous pustulosis, drug eruption, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, generalized rash of exfoliative nature, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Per protocol, the percentage of RSV season 1 participants with rash AESI were reported.
Time frame: From Day 1 (postdose) to Day 42
RSV Season 1: Percentage of Participants With ≥1 Nonserious AE
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of RSV season 1 participants with ≥1 nonserious AE were reported.
Time frame: From Day 1 (postdose) to Day 42
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE was any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. Per protocol, the percentage of participants in RSV season 1 and RSV season 2 with SAEs were reported.
Time frame: RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
RSV Season 1: Number of Participants With RSV-Associated Hospitalization
RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR nasopharyngeal sample. Per protocol, the number of participants with RSV-associated hospitalization were reported for RSV season 1.
Time frame: From Day 1 (postdose) to Day 150
RSV Season 1: Number of Participants With RSV-Associated MALRI
Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive RT-PCR nasopharyngeal sample. Per protocol, participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
Time frame: From Day 1 (postdose) to Day 180