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

• Status: Recruiting
• Trial end date: 2025-01-08
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants. It is hypothesized that MK-1654 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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 MK-1654

• 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