Efficacy and Safety of 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 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.
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 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
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MK-1654 |
Participants receive a single intramuscular (IM) administration of MK-1654 on Day 1. |
|
|
Placebo Comparator Placebo |
Participants receive a single IM administration of placebo on Day 1. |
|
Recruiting Locations
Children's National and nearby locations
Children's National Hospital ( Site 0076)
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Contact:
Study Coordinator
202-476-4293
Study Coordinator
202-476-4293
More Details
- NCT ID
- NCT04767373
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC