NCT04824391

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

Phase 2 Study for the Determination of Efficacy, Immunogenicity and Safety of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, in a Placebo Controlled, Randomized, Double Blind Study Design.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	ERUCOV-VAC 3 µg/0.5 ml Vaccine	Two IM applications on Days 1 and 28
BIOLOGICAL	ERUCOV-VAC 6 µg/0.5 ml Vaccine	Two IM applications on Days 1 and 28
OTHER	Placebo	Two IM applications on Days 1 and 28

Timeline

• Start date: 2021-02-10
• Primary completion: 2022-03-11
• Completion: 2022-03-30
• First posted: 2021-04-01
• Last updated: 2023-08-03

Locations

1 site across 1 country: Turkey (Türkiye)