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Trial record 1 of 1 for:    MK1654-007
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Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

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ClinicalTrials.gov Identifier: NCT04938830
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
RSV Infection Biological: Clesrovimab Biological: Palivizumab Biological: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : August 21, 2025
Estimated Study Completion Date : April 27, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Clesrovimab
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
 Biological: Clesrovimab
IM injection
Other Name: MK-1654

Biological: Placebo
IM injection
Active Comparator: Palivizumab
Participants will receive IM injections.
 Biological: Palivizumab
IM injection


Outcome Measures
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Primary Outcome Measures :
  1. Participants with solicited injection-site Adverse Events (AEs) in RSV Season 1 [ Time Frame: Up to 5 days ]
    Percentage of participants with solicited injection-site AEs in RSV Season 1

  2. Participants with solicited daily body temperature with fever in RSV Season 1 [ Time Frame: Up to 5 days ]
    Percentage of participants with solicited daily body temperature with fever in RSV Season 1

  3. Participants with solicited systemic AEs in RSV Season 1 [ Time Frame: Up to 5 days ]
    Percentage of participants with solicited systemic AEs in RSV Season 1

  4. Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1 [ Time Frame: Up to 42 days ]
    Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1

  5. Participants with rash AESI in RSV Season 1 [ Time Frame: Up to 42 days ]
    Percentage of participants with rash AESI in RSV Season 1

  6. Participants with non-serious AEs in RSV Season 1 [ Time Frame: Up to 42 days ]
    Percentage of participants with non-serious AEs in RSV Season 1

  7. Participants with serious AEs (SAEs) through the duration of participation in RSV Season 1 [ Time Frame: Up to 365 days ]
    Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1


Secondary Outcome Measures :
  1. Participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1 [ Time Frame: Up to 150 days ]
    Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1

  2. Participants with RSV-associated hospitalization in RSV Season 1 [ Time Frame: Up to 150 days ]
    Percentage of participants with RSV-associated hospitalization in RSV Season 1

  3. Participants with solicited injection-site AEs in RSV Season 2 [ Time Frame: From approximately 393 days up to 400 days ]
    Percentage of participants with solicited injection-site AEs in RSV Season 2

  4. Participants with solicited daily body temperature with fever in RSV Season 2 [ Time Frame: From approximately 393 days up to 400 days ]
    Percentage of participants with solicited daily body temperature with fever in RSV Season 2

  5. Participants with solicited systemic AEs in RSV Season 2 [ Time Frame: From approximately 393 days up to 400 days ]
    Percentage of participants with solicited systemic AEs in RSV Season 2

  6. Participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 [ Time Frame: From approximately 393 days up to 440 days ]
    Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2

  7. Participants with rash AESI in RSV Season 2 [ Time Frame: From approximately 393 days up to 440 days ]
    Percentage of participants with rash AESI in RSV Season 2

  8. Participants with non-serious AEs in RSV Season 2 [ Time Frame: From approximately 393 days up to 440 days ]
    Percentage of participants with non-serious AEs in RSV Season 2

  9. Participants with SAEs in RSV Season 2 [ Time Frame: From approximately 393 days up to 575 days ]
    Percentage of participants with SAEs in RSV Season 2

  10. Concentration of clesrovimab in RSV Season 1 [ Time Frame: Up to 240 days ]
    Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 1

  11. Concentration of clesrovimab in RSV Season 2 [ Time Frame: From approximately 393 days up to 550 days ]
    Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Is available to complete the follow-up period.

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.
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): NCT04938830


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

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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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT04938830    
Other Study ID Numbers: 1654-007
MK-1654-007 ( Other Identifier: Merck )
jRCT2031210664 ( Registry Identifier: jRCT )
2020-005996-11 ( EudraCT Number )
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 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
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
 Virus Diseases
Infections
Palivizumab
Antiviral Agents
Anti-Infective Agents