Efficacy, Immunogenicity and Safety of Inactivated ERUCOV-VAC Compared With Placebo in COVID-19

Summary

The objective is to determine the efficacy, immunogenicity and safety of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the efficacy and safety in prophylaxis of COVID-19. A 3rd application will be performed to approximately the half of the volunteers who were administered 3 μg/0.5 ml and who accept to be vaccinated for a 3rd time, on their month 4 visit.

Timeline

Start

2021-02-10

Primary completion

2022-03-11

Completion

2022-03-30

Publications

• Results Ozdarendeli A, Sezer Z, Pavel STI, Inal A, Yetiskin H, Kaplan B, Uygut MA, Bayram A, Mazicioglu M, Unuvar GK, Yuce ZT, Aydin G, Aslan AF, Kaya RK, Koc RC, Ates I, Kara A. Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials. Vaccine. 2023 Jan 9;41(2):380-390. doi: 10.1016/j.vaccine.2022.10.093. Epub 2022 Nov 22.

Drugs

Indications