Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551547
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2020-09-15
Brief Title:
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19
Sponsor:
Sinovac Research and Development Co Ltd
Organization:
Sinovac Biotech Co Ltd
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Phase ⅠⅡ Clinical Trial to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine Vero Cell in Healthy Population Aged 3-17 Years
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
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 randomized double-blinded and placebo controlled phase 12 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research Development Co Ltd The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years
Detailed Description:
This study is a randomized double-blinded single-center placebo-controlled phase 12 clinical trial in children and adolescents aged 3-17 years The experimental vaccine and placebo were both manufactured by Sinovac Research Development Co Ltd A total of 552 subjects will be enrolled with 72 at phase 1 and 480 at phase 2 Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 028 Subjects in Phase receive the second dose 10 months or 12 months after the second dose
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?:
None