NCT04838080

Safety and Immunogenicity of the Inactivated Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine Compared to Placebo

Phase 1 Study for the Determination of Safety and Immunogenicity of Different Strengths of Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Kocak Farma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the safety and immunogenicity of two different strengths (4 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

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine	Two applications on Days 0 and 21
BIOLOGICAL	Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine	Two applications on Days 0 and 21
BIOLOGICAL	Placebo	Two applications on Days 0 and 21

Timeline

• Start date: 2021-03-19
• Primary completion: 2021-06-01
• Completion: 2021-10-20
• First posted: 2021-04-08
• Last updated: 2021-04-13

Locations

1 site across 1 country: Turkey (Türkiye)