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Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults

NCT04866069 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-18

No results posted yet for this study

Summary

This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm.

Conditions

  • Covid19

Interventions

BIOLOGICAL

SARS-CoV-2 vaccine

Adjuvanted inactivated vaccine

BIOLOGICAL

Placebo

0.9% NaCl

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • VETAL Inc.

    collaborator UNKNOWN

  • MonitorCRO

    collaborator INDUSTRY

  • Osman ERGANIS, PhD, Prof

    lead OTHER

Principal Investigators

  • Oguz Akbas, MD · MonitorCRO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-25
Primary Completion
2021-09-05
Completion
2021-09-05

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 NCT04866069 on ClinicalTrials.gov