| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03979313 | 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) | PHASE3 | COMPLETED | 3,012 | — | — | Jul 23, 2019 | Mar 21, 2023 | Feb 28, 2024 | 198 | United States, Argentina +29 |
| NCT03959488 | A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children | PHASE2 | COMPLETED | 925 | — | — | Jul 30, 2019 | Jan 20, 2023 | Sep 21, 2023 | 128 | United States, Austria +24 |
| NCT02878330 | A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. | PHASE2 | COMPLETED | 1,453 | — | — | Nov 3, 2016 | Dec 6, 2018 | Oct 14, 2019 | 161 | United States, Argentina +21 |
| NCT02114268 | A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults | PHASE1 | COMPLETED | 342 | — | — | Apr 1, 2014 | Jun 1, 2015 | Nov 28, 2016 | 1 | United States |
Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Safety and tolerability of MEDI8897 will be assessed by the occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) , adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs)
The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (\<) 2 months: greater than or equal to (\>=) 60 breaths/min; 2-6 months: \>= 50 breaths/min; and for \> 6 months - 2 years, \>= 40 breaths/min), or hypoxemia (in room air - oxygen saturation \< 95% at altitudes less than or equal to (\<=) 1800 meters or \< 92% at altitudes \> 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| MEDI8897 | EXPERIMENTAL | Anti-RSV monoclonal antibody with an extended half-life |
| Placebo | PLACEBO_COMPARATOR | Commercially available 0.9% (w/v) saline |
| Palivizumab | ACTIVE_COMPARATOR | anti-RSV monoclonal antibody |
| MEDI8897 50 mg | EXPERIMENTAL | Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study. |
| MEDI8897 300 milligram (mg) Intravenous (IV) | EXPERIMENTAL | Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
| MEDI8897 1000 mg IV | EXPERIMENTAL | Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. |
| MEDI8897 3000 mg IV | EXPERIMENTAL | Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
| MEDI8897 100 mg Intramuscular (IM) | EXPERIMENTAL | Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
| MEDI8897 300 mg IM | EXPERIMENTAL | Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| MEDI8897 | DRUG | Anti-RSV monoclonal antibody with an extended half-life |
| Placebo | DRUG | Commercially available 0.9% (w/v) saline |
| Palivizumab | DRUG | Approved anti-RSV monoclonal antibody |
| MEDI8897 Intravenous | DRUG | Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
| MEDI8897 Intramuscular | DRUG | Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
Key Inclusion Criteria: * Healthy infants in their first year of life and born at or after 35 weeks 0 days GA * Infants who are entering their first RSV season at the time of screening Key Exclusion Criteria: * Meets national or other local criteria to receive commercial palivizumab * Any fever (...