Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT05534035
Status:
UNKNOWN
Last Update Posted:
2022-09-09
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Booster Superiority Study of PTX-COVID19-B Compared to Vaxzevria® in Adults Aged 18 Years and Older
Sponsor:
Everest Medicines (Singapore) Pte. Ltd.
Organization:
Study Overview
Official Title:
A Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated With Vaxzevria®
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
NOT_YET_RECRUITING
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:
This is a Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated with Vaxzevria®.
This study will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
This study will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
Detailed Description:
None
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?: