Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02878330
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2016-08-22
Brief Title:
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
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
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDI8897 Ph2b
Brief 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 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None