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

Purpose

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.

Condition

  • Respiratory Syncytial Virus Infection

Eligibility

Eligible Ages
Under 1 Year
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Clesrovimab
Participants receive a single intramuscular (IM) administration of clesrovimab on Day 1.
  • Biological: Clesrovimab
    Clesrovimab solution
    Other names:
    • MK-1654
Placebo Comparator
Placebo
Participants receive a single IM administration of placebo on Day 1.
  • Drug: Placebo
    Placebo (0.9% sodium chloride [NaCL]) solution

Recruiting Locations

MedStar Georgetown Pediatrics ( Site 0047)
Washington, District of Columbia 20016
Contact:
Study Coordinator
202-713-8849

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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