BridgeMD
A study to test the safety of MK-1654 and how well MK-1654 works in healthy infants
EU CTIS ID: 2022-500350-42-01
What this study is testing
1. To evaluate the efficacy of MK-1654 compared to placebo as assessed by the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) [outpatient and inpatient] from Days 1 through 150 postdose. 2. To evaluate the safety and tolerability of MK-1654 compared to placebo as assessed by the proportion of participants experiencing adverse events (AEs)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Japan
- Korea, Democratic People's Republic of
- China
- South Africa
- Israel
- Colombia
- Chile
- United Kingdom
- Malaysia
- Turkey
- Peru
- Philippines
- Thailand
- United States
- Canada
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Japan; Korea, Democratic People's Republic of; China; South Africa; Israel and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.