Phase 2
Completed N=1,453
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
Source: ClinicalTrials.gov NCT02878330 ↗Enrolled (actual)
1,453
Serious AEs
13.1%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) — 46; 25 Participants — p=<0.0001
Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) |
46; 25 | <0.0001 sig |
| SECONDARY Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI) |
20; 8 | 0.0002 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
416; 834; 81; 108 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs) |
3; 5; 4; 4 | — |
| SECONDARY Serum Concentration of MEDI8897 |
35.9; 18.9; 2.1 | — |
| SECONDARY Elimination Half-life (t1/2) of MEDI8897 |
59.3 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies to MEDI8897 |
4; 11; 6; 17; 8; 30 | — |
Eligibility Criteria
Key Inclusion Criteria
- Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
- Infants who are entering their first full RSV season at the time of screening.
Key Exclusion Criteria
- Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
- Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization.
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of 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 (NCT02878330). 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. Informational only — not medical advice.