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Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults in Turkey

NCT05150496 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2022-08-11

No results posted yet for this study

Summary

This is a randomized, double-blinded, and positive-controlled Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the immunogenicity of using the high (1200SU) or medium (600SU) dose of CoronaVac® as the booster dose.

Conditions

Interventions

BIOLOGICAL

Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated

Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

High-dose COVID-19 Vaccine(Vero Cell),Inactivated

High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Sponsors & Collaborators

  • Sinovac Research and Development Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Enes Seyda Şahiner, Doctor · Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-01-15
Completion
2023-01-15

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 NCT05150496 on ClinicalTrials.gov