Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113490
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2005-06-08
Brief Title:
A Study to Evaluate the Safety Tolerability and Immunogenicity of Motavizumab MEDI-524 After Dosing for a Second Season in Children
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase 12 Study to Evaluate the Safety Tolerability and Immunogenicity of MEDI-524 a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus RSV After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104
Status:
COMPLETED
Status Verified Date:
2013-04
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 determine the effect on immune reactivity to motavizumab MEDI-524 of monthly intramuscular IM doses of motavizumab MEDI-524 administered for a second season in children
Detailed Description:
This was a Phase 12 randomized double-blind study in which motavizumab MEDI-524 or palivizumab was administered to children who previously participated in MI-CP104 Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment Subjects were randomized 11 to receive motavizumab or palivizumab at 15 mgkg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104 All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations one at 30 days and the other at 90-120 days after the last dose
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