Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691947
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2020-11-14
Brief Title:
Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC
Sponsor:
Health Institutes of Turkey
Organization:
Health Institutes of Turkey
Study Overview
Official Title:
Phase 1 Study for the Determination of Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC Given Twice Intramuscularly to Healthy Volunteers in a Placebo Controlled Study Design
Status:
COMPLETED
Status Verified Date:
2023-02
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:
ERUCOV-VAC
Brief Summary:
The objective is to determine the safety and immunogenicity of two different strengths 3 µg and 6 µg of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19
Detailed Description:
This is a double-blind double dose parallel randomized vaccination study Each subject will receive in random order a double intramuscular dose of ERUCOV-VAC 3 µg05 ml Vaccine ERUCOV-VAC 6 µg05 ml Vaccine or 05 ml of placebo Vaccine according to a sequence determined by randomization on Day 0 1st vaccination and Day 21 2nd vaccinationIn total 34 healthy subjects of both genders will be monitored for one year in total after Day 43 the study will be unblinded and the volunteers who took placebo vaccine will be released from the study The most important evaluation will be performed on Day 43 after the first vaccine 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