Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121108
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2005-07-13
Brief Title:
MEDI-524 Motavizumab for the Prevention of Respiratory Sycytial Virus RSV Disease Among Native American Indian Infants in the Southwestern United States
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase 3 Study of MEDI-524 Motavizumab an Enhanced Potency Humanized Respiratory Syncytial Virus RSV Monoclonal Antibody for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
Status:
COMPLETED
Status Verified Date:
2021-12
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:
MI-CP117 was a Phase 3 randomized double-blind placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season
Detailed Description:
MI-CP117 was a Phase 3 randomized double-blind placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American infants during their first RSV season
Participants were randomized in a 21 ratio to receive either 15 mgkg motavizumab or placebo by intramuscular IM injection every 30 days during the RSV season for a maximum of 5 injections
During their first RSV season participants were evaluated monthly just prior to each injection of study drug for adverse events AEs including medically attended otitis media with a final post-dosing follow up evaluation at Study Day 150 During Seasons 1 2 and 3 blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations motavizumab serum concentrations and anti-motavizumab antibodies Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday
Participants were randomized in a 21 ratio to receive either 15 mgkg motavizumab or placebo by intramuscular IM injection every 30 days during the RSV season for a maximum of 5 injections
During their first RSV season participants were evaluated monthly just prior to each injection of study drug for adverse events AEs including medically attended otitis media with a final post-dosing follow up evaluation at Study Day 150 During Seasons 1 2 and 3 blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations motavizumab serum concentrations and anti-motavizumab antibodies Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday
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