Phase 3
N=1,490
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)
Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT03979313 ↗Enrolled (actual)
1,490
Serious AEs
7.8%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) — 25; 12; 6; 15 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MEDI8897 (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort) |
25; 12; 6; 15; 465; 967 | <0.0001 sig |
| SECONDARY Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort) |
8; 6; 6; 15; 482; 973 | 0.0708 |
| SECONDARY Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group |
89.91; 164.03; 74.09; 105.05; 68.63; 100.54 | — |
| SECONDARY Anti-drug Antibody Results by Visit (As Treated Population) |
4; 4; 2; 14; 1; 21 | — |
Summary
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.
Eligibility Criteria
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 (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination
Data sourced from ClinicalTrials.gov (NCT03979313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.