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Palivizumab-Controlled Evaluation of Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
EU CTIS ID: 2022-500752-39-00
What this study is testing
To evaluate the safety and tolerability of clesrovimab (MK-1654) compared to palivizumab in respiratory syncytial virus (RSV) Season 1 as assessed by the proportion of participants experiencing AEs.
- Therapeutic confirmatory (Phase III)
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
- Participants at increased risk for severe respiratory syncytial virus (RSV) infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
- Is available to complete the follow-up period.
- Is male or female and has a chronological age from birth up to 1 year and is entering their first RSV season.
You likely can't join if
- Requires mechanical ventilation at time of enrollment.
- Has a life expectancy <6 months.
- Has known hepatic or renal dysfunction, or chronic seizure disorder.
- Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- Has severe immunodeficiency or is severely immunocompromised.
- Has known hypersensitivity to any component of clesrovimab or palivizumab.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Malaysia
- Mexico
- Turkey
- Canada
- Chile
- Puerto Rico
- Thailand
- Australia
- Japan
- Taiwan
- United Kingdom
- Colombia
- United States
- South Africa
- Singapore
- Peru
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 New Zealand; Malaysia; Mexico; Turkey; Canada; Chile 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.