Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 1:14 PM
Study NCT ID:
NCT06567457
Status:
WITHDRAWN
Last Update Posted:
2024-08-22
First Post:
2023-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
Sponsor:
Clover Biopharmaceuticals AUS Pty
Organization:
Study Overview
Official Title:
Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
varients of COVID-19 has changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
Detailed Description:
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
Study Oversight
Has Oversight DMC:
True
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?: