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

ClinicalTrials.gov Identifier: NCT04767373 (view full study on clinicaltrials.gov)
Condition:  Respiratory syncytial virus infection
Status:  Active, not recruiting


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

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.

Study Type:
Interventional
Study Phase:
Phase 2/Phase 3
Estimated Enrollment:
3300
Study Start Date:
April 2021
Estimated Study Completion Date:
August 2024
Estimated Primary Completion Date:
August 2024
Ages Eligible for Study:
up to 1 years
Genders 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

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