Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04938830
Recruitment Status : Not yet recruiting
First Posted : June 24, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE June 22, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date July 30, 2021
Estimated Study Start Date  ICMJE November 1, 2021
Estimated Primary Completion Date August 21, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
  • 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
  • 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
  • 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
  • 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
  • Participants with rash AESI in RSV Season 1 [ Time Frame: Up to 42 days ]
    Percentage of participants with rash AESI in RSV Season 1
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MK-1654 in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE RSV Infection
Intervention  ICMJE
  • Biological: MK-1654
    IM injection
  • Biological: Palivizumab
    IM injection
Study Arms  ICMJE
  • Experimental: MK-1654
    Participants will receive an intramuscular (IM) injection.
    Intervention: Biological: MK-1654
  • Active Comparator: Palivizumab
    Participants will receive an IM injection.
    Intervention: Biological: Palivizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2021)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 27, 2026
Estimated Primary Completion Date August 21, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938830
Other Study ID Numbers  ICMJE 1654-007
2020-005996-11 ( EudraCT Number )
MK-1654-007 ( Other Identifier: Merck )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP