Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
Public ClinicalTrials.gov record NCT04767373. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04767373
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 3,632 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 1 Year
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 7, 2021 (Actual)
- Primary completion
- Jul 9, 2024 (Actual)
- Completion
- Jul 9, 2024 (Actual)
- Last update posted
- Feb 11, 2026
2021 – 2024
United States locations
- U.S. sites
- 51
- U.S. states
- 24
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southeastern Pediatric Associates, P.A. ( Site 0008) | Dothan | Alabama | 36303 | — |
| Northwest Arkansas Pediatric Clinic ( Site 0050) | Fayetteville | Arkansas | 72703 | — |
| Children's Clinic of Jonesboro, PA ( Site 0058) | Jonesboro | Arkansas | 72401 | — |
| Long Beach Memorial Medical Center ( Site 0014) | Long Beach | California | 90806 | — |
| Madera Family Medical Group ( Site 0046) | Madera | California | 93637 | — |
| Orange County Research Institute ( Site 0057) | Ontario | California | 91762 | — |
| Children's Hospital Colorado ( Site 0066) | Aurora | Colorado | 80045 | — |
| Optumcare Colorado Springs, LLC ( Site 0022) | Colorado Springs | Colorado | 80922 | — |
| Children's National Hospital ( Site 0076) | Washington D.C. | District of Columbia | 20010 | — |
| MedStar Georgetown Pediatrics ( Site 0047) | Washington D.C. | District of Columbia | 20016 | — |
| Next Phase Research Alliance, LLC ( Site 0071) | Homestead | Florida | 33030 | — |
| Acevedo Clinical Research Associates ( Site 0002) | Miami | Florida | 33142 | — |
| Tekton Research ( Site 0080) | Chamblee | Georgia | 30341 | — |
| Meridian Clinical Research, LLC ( Site 0083) | Macon | Georgia | 31210 | — |
| Clinical Research Prime ( Site 0075) | Idaho Falls | Idaho | 83404 | — |
| Saltzer Medical Group ( Site 0004) | Nampa | Idaho | 83686 | — |
| Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061) | Topeka | Kansas | 66604 | — |
| ACC Pediatric Research ( Site 0067) | Haughton | Louisiana | 71037 | — |
| Meridian Clinical Research, LLC ( Site 0082) | Hastings | Nebraska | 68901 | — |
| Midwest Children's Health Research Institute, LLC ( Site 0044) | Lincoln | Nebraska | 68504 | — |
| Dartmouth-Hitchcock Medical Center ( Site 0031) | Lebanon | New Hampshire | 03756 | — |
| Rutgers University-Pediatric Clinical Research Center ( Site 0055) | New Brunswick | New Jersey | 08901 | — |
| Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093) | Winston-Salem | North Carolina | 27103 | — |
| Senders Pediatrics ( Site 0062) | Cleveland | Ohio | 44121 | — |
| Ohio Pediatric Research Association ( Site 0063) | Dayton | Ohio | 45414 | — |
| CCP- Kid's Way ( Site 0017) | Hermitage | Pennsylvania | 16148 | — |
| UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043) | Pittsburgh | Pennsylvania | 15213 | — |
| Coastal Pediatric Research ( Site 0013) | Charleston | South Carolina | 29414 | — |
| Tribe Clinical Research, LLC ( Site 0015) | Greenville | South Carolina | 29607 | — |
| Holston Medical Group ( Site 0040) | Kingsport | Tennessee | 37660 | — |
| Javara - Privia Medical Group North Texas - Frisco ( Site 0086) | Frisco | Texas | 75035 | — |
| University of Texas Medical Branch at Galveston ( Site 0059) | Galveston | Texas | 77555 | — |
| DM Clinical Research ( Site 0005) | Houston | Texas | 77065 | — |
| FMC Science - Lampasas ( Site 0011) | Lampasas | Texas | 76550 | — |
| DCOL Center for Clinical Research ( Site 0042) | Longview | Texas | 75605 | — |
| University Health System- San Antonio ( Site 0048) | San Antonio | Texas | 78229 | — |
| Private Practice - Dr. Etokhana ( Site 0089) | San Antonio | Texas | 78244 | — |
| Road Runner Research, Ltd ( Site 0049) | San Antonio | Texas | 78249 | — |
| Alliance for Multispecialty Research, LLC ( Site 0092) | Kaysville | Utah | 84037 | — |
| Wee Care Pediatrics ( Site 0077) | Layton | Utah | 84041 | — |
| Cottonwood Pediatrics ( Site 0032) | Murray | Utah | 84107 | — |
| Wee Care Pediatrics-Roy ( Site 0053) | Roy | Utah | 84067 | — |
| University of Utah School of Medicine ( Site 0006) | Salt Lake City | Utah | 84108 | — |
| Copperview Medical Center ( Site 0078) | South Jordan | Utah | 84095 | — |
| Wee Care Pediatrics ( Site 0065) | Syracuse | Utah | 84075 | — |
| Pediatric Research of Charlottesville, LLC ( Site 0073) | Charlottesville | Virginia | 22902 | — |
| MultiCare Rockwood Cheney Clinic ( Site 0068) | Cheney | Washington | 99004 | — |
| Multicare Health System Institute for Research and Innovation ( Site 0025) | Spokane | Washington | 99202 | — |
| Multicare Institute For Research And Innovation ( Site 0045) | Tacoma | Washington | 98405 | — |
| Marshall University School of Medicine and Medical Center ( Site 0064) | Huntington | West Virginia | 25701 | — |
| Marshfield Clinic ( Site 0054) | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 166 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04767373, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 11, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04767373 live on ClinicalTrials.gov.