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

NCT04824391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-08-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • TC Erciyes University

    collaborator OTHER

  • Health Institutes of Turkey

    lead OTHER_GOV

Principal Investigators

  • Zafer Sezer, Assoc.Prof. · Co-Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2022-03-11
Completion
2022-03-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT04824391 on ClinicalTrials.gov