Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192478
Status:
COMPLETED
Last Update Posted:
2008-07-28
First Post:
2005-09-13
Brief Title:
Open-Label Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mgkg or 15 mgkg Children to be Followed for 90 Days After Their Last Dose of MEDI-524
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase 12 Open-Label Repeat-Dose Dose-Escalation Study to Evaluate the Safety Tolerability Immunogenicity and Pharmacokinetics of MEDI-524 a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus RSV in Children at Risk for Serious RSV Disease
Status:
COMPLETED
Status Verified Date:
2008-07
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:
MEDI-524 given for up to 5 doses at 3 and 15 mgkg to high-risk children appeared to be safe and well tolerated
Detailed Description:
This study is designed to describe the safety tolerability immunogenicity and pharmacokinetics of escalating repeated IM injections the intended route of administration for immunoprophylaxis of MEDI-524 initially in children 6 months old with a history of prematurity ³32 to 35 weeks gestation without BPD one of the target populations of infants at high risk for serious RSV disease
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