Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06042049
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-07-13
Brief Title:
A Study to Assess Safety Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD CLD Immunocompromise Down Syndrome or Born Pre-Term in Japan
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
JUBILUS
Brief Summary:
The purpose of this study is to measure the safety PK occurrence of ADA to nirsevimab and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged 12 months
Study details include
The study duration is approximately 21 months with a 2-month enrollment period
Study intervention is 2 doses administered 5- 6 months apart
The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval
Study details include
The study duration is approximately 21 months with a 2-month enrollment period
Study intervention is 2 doses administered 5- 6 months apart
The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None