Trials / Completed
CompletedNCT02878330
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
A Phase 2b 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 Preterm Infants
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,453 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 365 Days
- Healthy volunteers
- Accepted
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.
Detailed description
This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MEDI8897 | A single IM dose of 50 mg on Day 1 of the study. |
| DRUG | Placebo | A single IM dose of placebo matched to MEDI8897 on Day 1 of the study. |
Timeline
- Start date
- 2016-11-03
- Primary completion
- 2018-07-17
- Completion
- 2018-12-06
- First posted
- 2016-08-25
- Last updated
- 2019-10-14
- Results posted
- 2019-10-14
Locations
161 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Estonia, Finland, France, Hungary, Italy, Latvia, Lithuania, New Zealand, Poland, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02878330. Inclusion in this directory is not an endorsement.