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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 : Not yet recruiting
First Posted : June 24, 2021
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study aims to evaluate the safety and tolerability of MK-1654 compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

Condition or disease Intervention/treatment Phase
RSV Infection Biological: MK-1654 Biological: Palivizumab Phase 3

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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
Estimated Study Start Date : February 7, 2022
Estimated Primary Completion Date : November 12, 2025
Estimated Study Completion Date : July 17, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab

Arm Intervention/treatment
Experimental: MK-1654
Participants will receive an intramuscular (IM) injection.
Biological: MK-1654
IM injection

Active Comparator: Palivizumab
Participants will receive an IM injection.
Biological: Palivizumab
IM injection




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 MK-1654 in RSV Season 1 [ Time Frame: Up to 240 days ]
    Serum concentration of MK-1654 after dose of MK-1654 in RSV Season 1

  11. Concentration of MK-1654 in RSV Season 2 [ Time Frame: From approximately 393 days up to 550 days ]
    Serum concentration of MK-1654 after dose of MK-1654 in RSV Season 2



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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 MK-1654 or palivizumab.

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04938830    
Other Study ID Numbers: 1654-007
2020-005996-11 ( EudraCT Number )
MK-1654-007 ( Other Identifier: Merck )
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
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
Palivizumab
Antiviral Agents
Anti-Infective Agents