Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-04-07 @ 3:57 PM
Study NCT ID:
NCT05329051
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine in Population Aged ≥18 Years
Sponsor:
Sinocelltech Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years and Previously Fully Vaccinated With mRNA COVID-19
Status:
UNKNOWN
Status Verified Date:
2022-04
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:
The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E compared with Comirnaty.
Detailed Description:
Approximately 400 participants aged ≥18 years old and previously vaccinated with 2 or 3 doses of Comirnaty will be enrolled in this study. They will be randomly assigned to SCTV01E Group and Comirnaty Group in a ratio of 1:1.
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?: