Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 8:32 PM
Study NCT ID:
NCT05239806
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
Sponsor:
Sinocelltech Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind Phase II 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 ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
Status:
UNKNOWN
Status Verified Date:
2022-02
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 objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.
Detailed Description:
The study is a randomized, double-blind, and approved vaccine-controlled Phase II booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with one dose of Sinopharm inactivated COVID-19 vaccine or one dose of Commirnaty as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations (1-dose of SCTV01C and 1-dose of SCTV01E, or 2-dose of SCTV01E, or 1-dose of Sinopharm inactivated COVID-19 vaccine and 1-dose of SCTV01E, 1-dose of Comirnaty and 1-dose of SCTV01E).
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?: