Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Merck Sharp & Dohme LLC1,003 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,003

Conditions

RSV Infection

Interventions

ClesrovimabBIOLOGICAL

IM injection

PalivizumabBIOLOGICAL

IM injection

PlaceboBIOLOGICAL

IM injection

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

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 and meet defined criteria for the Early or Moderate Pre-term Group or the chronic lung disease (CLD)/congenital heart disease (CHD) Group. * Is available to complete the follow-up period. Additional inclusion criteria for participation in RSV Season 2: * RSV Season 2 participants enrolled in the CLD/CHD Group in RSV Season 1. Participants with CHD must also have the following: * Hemodynamically significant CHD at the beginning of RSV Season 2, or * If the participant has had surgically repaired hemodynamically significant CHD that did not include extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass: 1) continues to require medications to manage CHD, or 2) any additional medical intervention related to their CHD. * RSV Season 2 participants enrolled in the Early or Moderate Pre-term Group in RSV Season 1, with the following: * Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough * Down Syndrome (trisomy of chromosome 21) * Cystic fibrosis with nutritional compromise * Native Americans and Alaskan Indians or other indigenous populations at high risk for severe RSV disease 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. Additional exclusion criteria for participation in RSV Season 2: * Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.

Locations (146)

Outcomes

Primary Outcomes

Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1

An AE is 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 erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.

Time frame: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)

Number of Participants With Solicited Daily Body Temperatures With Fever in RSV Season 1

Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F. The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.

Time frame: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)

Number of Participants With Solicited Systemic AEs in RSV Season 1

An AE is 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 decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 1 is reported.

Time frame: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)

Number of Participants With Anaphylaxis/Hypersensitivity AEs of Special Interest (AESI) in RSV Season 1

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. The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.

Time frame: Up to 42 days in RSV Season 1

Number of Participants With Rash AESI in RSV Season 1

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 urticaria and drug eruption. The number of participants with rash AESI in RSV Season 1 is reported.

Data from ClinicalTrials.gov

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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

...and 136 more locations

Secondary Outcomes

Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1

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 (NP) sample. The number of cases of outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1. For each participant, only the first occurrence of the case is counted for the analysis.

Time frame: Up to 150 days in RSV Season 1

Number of Cases of RSV-associated Hospitalization in RSV Season 1

RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR NP sample. The number of cases of RSV-associated hospitalization in RSV Season 1 is reported. For each participant, only the first occurrence of the case is counted for the analysis.

Time frame: Up to 150 days in RSV Season 1

Number of Participants With Solicited Injection-site AEs in RSV Season 2

Time frame: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)

Number of Participants With Solicited Daily Body Temperature With Fever in RSV Season 2

Time frame: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)

Number of Participants With Solicited Systemic AEs in RSV Season 2

An AE is 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 decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 2 is reported.

Time frame: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)

Number of Participants With Anaphylaxis/Hypersensitivity AESI in RSV Season 2

Time frame: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)

Number of Participants With Rash AESI in RSV Season 2

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 urticaria and drug eruption. The number of participants with rash AESI in RSV Season 2 is reported.

Time frame: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)

Number of Participants With Nonserious AEs in RSV Season 2

Time frame: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)

Number of Participants With SAEs in RSV Season 2

An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The number of participants with SAEs in RSV Season 2 is reported.

Time frame: Up 180 days postdose in RSV Season 2 (Up to ~575 days)

Concentration of Clesrovimab in RSV Season 1

Blood samples were collected to determine the serum concentration of clesrovimab at Days 7, 150, and 240 in RSV Season 1.

Time frame: At Day 7, Day 150, and Day 240 in RSV Season 1

Concentration of Clesrovimab in RSV Season 2

Blood samples were collected to determine the serum concentration of clesrovimab at Days 7 and 150 in RSV Season 2. RSV Season 2 began 246-393 days after RSV Season 1 dose 1.

Time frame: At Day 7 and Day 150 postdose in RSV Season 2