Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-04-14 @ 4:31 PM
Study NCT ID:
NCT05323461
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2022-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines
Sponsor:
Sinocelltech Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, and Positive-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
ACTIVE_NOT_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, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).
Detailed Description:
Approximately 1,800 participants aged 18 years old and above will be enrolled in this study. 1,350 participants who previously received Sinopharm inactivated COVID-19 vaccine will be enrolled to Cohort 1. 450 participants who previously received mRNA COVID-19 vaccine or previously diagnosed with COVID-19 will be enrolled to Cohort 2.
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?: