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Clinical Trial 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.


Clinical Trial 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 µg/0.5 ml Vaccine, ERUCOV-VAC 6 µg/0.5 ml Vaccine or 0.5 ml of placebo Vaccine according to a sequence determined by randomization, on Day 0 (1st vaccination) and Day 21 (2nd vaccination).In 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 Design


Related Conditions & MeSH terms


NCT number NCT04691947
Study type Interventional
Source Health Institutes of Turkey
Contact
Status Completed
Phase Phase 1
Start date November 5, 2020
Completion date November 18, 2021

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