Status:
COMPLETED
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
Lead Sponsor:
MedImmune LLC
Conditions:
Respiratory Syncytial Virus
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when admi...
Detailed Description
This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and...
Eligibility Criteria
Inclusion
- Key
- Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
- Infants who are entering their first RSV season at the time of screening
- Key
Exclusion
- Gestational age \< 32 weeks 0 days and \>34 weeks 6 days
- Meets 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 any RSV vaccine, including maternal RSV vaccination
Key Trial Info
Start Date :
January 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2016
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT02290340
Start Date
January 13 2015
End Date
September 28 2016
Last Update
September 19 2018
Active Locations (13)
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1
Research Site
Anaheim, California, United States
2
Research Site
Ontario, California, United States
3
Research Site
Syracuse, New York, United States
4
Research Site
Cleveland, Ohio, United States