Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004) (NCT04767373) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
United States, Argentina, Belgium3,632 participantsStarted 2021-04-07
Plain-language summary
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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 respiratory syncytial virus (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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)
Timeframe: From Day 1 (postdose) to Day 150
2
RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Timeframe: From Day 1 (postdose) to Day 5
3
RSV Season 1: Percentage of Participants With Fever
Timeframe: From Day 1 (postdose) to Day 5
4
RSV Season 1: Percentage of Participants With Solicited Systemic AEs
Timeframe: From Day 1 (postdose) to Day 5
5
RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)
Timeframe: From Day 1 (postdose) to Day 42
6
RSV Season 1: Percentage of Participants With Rash AESI
Timeframe: From Day 1 (postdose) to Day 42
7
RSV Season 1: Percentage of Participants With ≥1 Nonserious AE