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

ClinicalTrials.gov Identifier: NCT04938830 (view full study on clinicaltrials.gov)
Condition:  RSV infection
Status:  Recruiting


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

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
Study Phase:
Phase 3
Estimated Enrollment:
1000
Study Start Date:
November 2021
Estimated Study Completion Date:
January 2026
Estimated Primary Completion Date:
June 2025
Ages Eligible for Study:
up to 1 years
Genders 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.

United States     Toll Free Number     1-800-770-4674   

  • San Juan, 00935
  • Washington, District of Columbia, 20010
  • Orlando, Florida, 32806
  • Tampa, Florida, 33606
  • Atlanta, Georgia, 30310
  • Rochester, New York, 14642
  • Greenville, South Carolina, 29607
  • Corpus Christi, Texas, 78411
  • Edinburg, Texas, 78539
  • San Antonio, Texas, 78207
  • San Antonio, Texas, 78229
  • San Antonio, Texas, 78249

Canada     Study Coordinator     9024708141   

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