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Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04767373
Recruitment Status : Active, not recruiting
First Posted : February 23, 2021
Last Update Posted : July 17, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infection Biological: Clesrovimab Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
Actual Study Start Date : April 7, 2021
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : August 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Clesrovimab
Participants receive a single intramuscular (IM) administration of clesrovimab on Day 1.
 Biological: Clesrovimab
Clesrovimab solution
Other Name: MK-1654
Placebo Comparator: Placebo
Participants receive a single IM administration of placebo on Day 1.
 Drug: Placebo
Placebo (0.9% sodium chloride [NaCL]) solution


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with RSV-associated MALRI [ Time Frame: From Day 1 (postdose) to Day 150 ]
    Outpatient and inpatient MALRI is 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; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample.

  2. Percentage of participants with solicited injection-site adverse events (AEs) [ Time Frame: From Day 1 (postdose) to Day 5 ]
    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. The percentage of participants with solicited injection-site AEs (i.e., redness/erythema, swelling, and pain/tenderness) will be reported.

  3. Percentage of participants with fever [ Time Frame: From Day 1 (postdose) to Day 5 ]
    Fever is defined as as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). The percentage of participants with fever will be reported.

  4. Percentage of participants with solicited systemic AEs [ Time Frame: From Day 1 (postdose) to Day 5 ]
    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. The percentage of participants with solicited systemic AEs (i.e., irritability, drowsiness, and appetite lost) will be reported.

  5. Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI) [ Time Frame: From Day 1 (postdose) to Day 42 ]
    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. The percentage of participants with anaphylaxis/hypersensitivity will be reported.

  6. Percentage of participants with rash AESI [ Time Frame: From Day 1 (postdose) to Day 42 ]
    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. The percentage of participants with rash will be reported.

  7. Percentage of participants with ≥1 nonserious AE [ Time Frame: From Day 1 (postdose) to Day 42 ]
    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.

  8. Percentage of participants with serious adverse events (SAEs) [ Time Frame: Up to Day 515 ]
    An SAE is 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. The percentage of participants with SAEs will be reported.


Secondary Outcome Measures :
  1. Percentage of participants with RSV-associated hospitalization [ Time Frame: From Day 1 (postdose) to Day 150 ]
    RSV-associated hospitalization is defined as a hospital admission for respiratory illness AND RSV-positive RT-PCR nasopharyngeal sample.

  2. Percentage of participants with RSV-associated MALRI [ Time Frame: From Day 1 (postdose) to Day 180 ]
    Outpatient and inpatient MALRI is 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; AND 3) RSV-positive RT-PCR nasopharyngeal sample.


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
  • For the phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
  • For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
  • For participants in South Korea only: Weighs ≥2 kg

Key Exclusion Criteria:

  • Is recommended to receive palivizumab per local guidelines or professional society recommendations.
  • Has known hypersensitivity to any component of clesrovimab
  • Has a bleeding disorder contraindicating IM administration
  • Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
  • Has received any vaccine or monoclonal antibody for the prevention of RSV
  • Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04767373


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT04767373    
Other Study ID Numbers: 1654-004
MK-1654-004 ( Other Grant/Funding Number: Merck )
jRCT2051210019 ( Registry Identifier: jRCT )
PHRR210706-003684 ( Registry Identifier: PHRR )
2022-500350-42-00 ( Registry Identifier: EU CT Number )
2020-002405-26 ( EudraCT Number )
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections