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

NCT04838080 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-04-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Kocak Farma

    lead INDUSTRY

Principal Investigators

  • Aydin Erenmemisoglu, Prof. · Legal representative

  • Turgay Celik, Prof. · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-19
Primary Completion
2021-06-01
Completion
2021-10-20

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838080 on ClinicalTrials.gov