NCT04582344

Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)

Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine (Vero Cell), Inactivated

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,214 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18\~59 Years.

Detailed description

This study is a randomized, double-blinded, multi-center, placebo-controlled phase III clinical trial in adults aged 18\~59 years. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 13.000 subjects will be enrolled. Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14. It is planned that the study will be conducted with two separate cohorts. The first cohort will be healthcare workers in the high risk group (K-1) and the second cohort will be people at normal risk (K-2). After 2 doses of vaccination of 1300 volunteers are completed, safety data will be evaluated by the data safety monitoring board without breaking the blinding, and if there is no safety issue, the K2 cohort will continue to be vaccinated.1.300 volunteers, including 650 volunteers SARS-CoV-2 vaccine and placebo arms, will be included in the K-1 cohort. In the K-2 cohort (normal risk group for COVID-19), 7.650 volunteers were planned to be included in the SARS-CoV-2 vaccine group, and 3.500 volunteers in the placebo group.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	CoronaVac	Two doses at 14-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (each prefilled syringe of the vaccine contains 600 SU of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,14
BIOLOGICAL	Placebo	Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, two doses given 14 days apart.

Timeline

• Start date: 2020-09-14
• Primary completion: 2022-06-30
• Completion: 2022-07-27
• First posted: 2020-10-09
• Last updated: 2024-05-24

Locations

25 sites across 1 country: Turkey (Türkiye)