Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129766
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2005-08-10
Brief Title:
Study of MEDI-524 Motavizumab for the Prophylaxis of Serious Respiratory Syncytial Virus RSV Disease in High-Risk Children
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Pivotal Phase 3 Study of MEDI-524 Numax Motavizumab an Enhanced Potency Humanized RSV Monoclonal Antibody for the Prophylaxis of Serious RSV Disease in High-Risk Children
Status:
COMPLETED
Status Verified Date:
2013-06
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:
None
Brief Summary:
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular IM injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease A secondary objective was to compare the incidence of medically-attended lower respiratory infections LRIs between treatment groups
Detailed Description:
A randomized double-blind palivizumab-controlled multi-center multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere Each child only participated during a single RSV season Approximately 6600 children at risk for serious RSV disease were to be randomized in a 11 ratio to receive either 15 mgkg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses
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