Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05933512
Status:
UNKNOWN
Last Update Posted:
2023-07-06
First Post:
2023-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines
Sponsor:
Sinocelltech Ltd.
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-2 (COVID-19 Beta/Omicron (BA.1/BQ.1.1/XBB.1) Variants S-Trimer Vaccine) in Population Previously Vaccinated With mRNA COVID-19 Vaccine
Status:
UNKNOWN
Status Verified Date:
2023-07
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 study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
Detailed Description:
For participants in Group A, they will be randomized to receive SCTV01E or SCTV01E-2 in a ratio of 1:1. For participants in Group B, they will all receive SCTV01E-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?: