A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
Public ClinicalTrials.gov record NCT03979313. 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 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
Study identification
- NCT ID
- NCT03979313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,012 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Years 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
- Jul 23, 2019 (Actual)
- Primary completion
- Mar 11, 2021 (Actual)
- Completion
- Mar 21, 2023 (Actual)
- Last update posted
- Feb 28, 2024
2019 – 2023
United States locations
- U.S. sites
- 66
- U.S. states
- 32
- U.S. cities
- 62
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35205 | — |
| Research Site | Fort Defiance | Arizona | 86504 | — |
| Research Site | Fayetteville | Arkansas | 72703 | — |
| Research Site | Anaheim | California | 92804 | — |
| Research Site | Downey | California | 90240 | — |
| Research Site | National City | California | 91950 | — |
| Research Site | Paramount | California | 90723 | — |
| Research Site | West Covina | California | 91790 | — |
| Research Site | Aurora | Colorado | 80015 | — |
| Research Site | Colorado Springs | Colorado | 80922 | — |
| Research Site | Washington D.C. | District of Columbia | 20016 | — |
| Research Site | Gainesville | Florida | 32653 | — |
| Research Site | Hialeah | Florida | 33012 | — |
| Research Site | Miami | Florida | 33142 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Fort Gordon | Georgia | 30905 | — |
| Research Site | Chicago | Illinois | 60611 | — |
| Research Site | Oak Lawn | Illinois | 60453 | — |
| Research Site | Indianapolis | Indiana | 46202 | — |
| Research Site | West Des Moines | Iowa | 50266 | — |
| Research Site | Bardstown | Kentucky | 40004 | — |
| Research Site | Lexington | Kentucky | 40517 | — |
| Research Site | Shreveport | Louisiana | 71105 | — |
| Research Site | Jackson | Mississippi | 39216 | — |
| Research Site | Columbia | Missouri | 65212 | — |
| Research Site | Lincoln | Nebraska | 68504 | — |
| Research Site | Omaha | Nebraska | 68114 | — |
| Research Site | Gallup | New Mexico | 87301 | — |
| Research Site | Shiprock | New Mexico | 87420 | — |
| Research Site | Syracuse | New York | 13210 | — |
| Research Site | Boone | North Carolina | 28607 | — |
| Research Site | Cincinnati | Ohio | 45229 | — |
| Research Site | Cleveland | Ohio | 44109 | — |
| Research Site | Cleveland | Ohio | 44121 | — |
| Research Site | Columbus | Ohio | 43205 | — |
| Research Site | Dayton | Ohio | 45406 | — |
| Research Site | Dayton | Ohio | 45414 | — |
| Research Site | Oklahoma City | Oklahoma | 73104 | — |
| Research Site | Erie | Pennsylvania | 16506 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | Warwick | Rhode Island | 02886 | — |
| Research Site | North Charleston | South Carolina | 29406 | — |
| Research Site | Sioux Falls | South Dakota | 57105 | — |
| Research Site | Kingsport | Tennessee | 37660 | — |
| Research Site | Memphis | Tennessee | 38103 | — |
| Research Site | Tullahoma | Tennessee | 37388 | — |
| Research Site | Baytown | Texas | 77521 | — |
| Research Site | Dallas | Texas | 75251 | — |
| Research Site | Edinburg | Texas | 78539 | — |
| Research Site | League City | Texas | 77573 | — |
| Research Site | Longview | Texas | 75605 | — |
| Research Site | Pearland | Texas | 77584 | — |
| Research Site | San Antonio | Texas | 78240 | — |
| Research Site | San Antonio | Texas | 78249 | — |
| Research Site | Tomball | Texas | 77375 | — |
| Research Site | Layton | Utah | 84041 | — |
| Research Site | Roy | Utah | 84067 | — |
| Research Site | Salt Lake City | Utah | 84107 | — |
| Research Site | Salt Lake City | Utah | 84123 | — |
| Research Site | South Jordan | Utah | 84095 | — |
| Research Site | St. George | Utah | 84790 | — |
| Research Site | Charlottesville | Virginia | 22902 | — |
| Research Site | Richmond | Virginia | 23219 | — |
| Research Site | Seattle | Washington | 98105 | — |
| Research Site | Morgantown | West Virginia | 26506 | — |
| Research Site | 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 132 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03979313, 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 28, 2024 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03979313 live on ClinicalTrials.gov.