Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582344
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2020-10-01
Brief Title:
Clinical Trial For SARS-CoV-2 Vaccine COVID-19
Sponsor:
Health Institutes of Turkey
Organization:
Health Institutes of Turkey
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine Vero Cell Inactivated
Status:
COMPLETED
Status Verified Date:
2022-08
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 III 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 efficacy safety and immunogenicity of the experimental vaccine in healthy adults aged 1859 Years
Detailed Description:
This study is a randomized double-blinded multi-center placebo-controlled phase III clinical trial in adults aged 1859 years The purpose of this study is to evaluate the efficacy safety and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine The experimental vaccine and placebo were both manufactured by Sinovac Research Development Co Ltd A total of 13000 subjects will be enrolled Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 014 It is planned that the study will be conducted with two separate cohorts The first cohort will be healthcare workers in the high risk group K-1 and the second cohort will be people at normal risk K-2 After 2 doses of vaccination of 1300 volunteers are completed safety data will be evaluated by the data safety monitoring board without breaking the blinding and if there is no safety issue the K2 cohort will continue to be vaccinated1300 volunteers including 650 volunteers SARS-CoV-2 vaccine and placebo arms will be included in the K-1 cohort In the K-2 cohort normal risk group for COVID-19 7650 volunteers were planned to be included in the SARS-CoV-2 vaccine group and 3500 volunteers in the placebo group
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