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

Active, not recruiting
COVID-19

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.

Eligibility Criteria

Inclusion Criteria:

- 18-59 years of age (including 18 and 59 years of ages),

- For only K1 cohort, health care workers such as medical doctor, nurse, ward boy,
cleaner, hospital technician, administrative personnel who work in any department of a
hospital.

- Signed informed consent

Exclusion Criteria:

- Previously PCR positive for COVID-19

- IgG or IgM is positive

- For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent
to engage in sexual relations with reproductive intent without use of birth control
methods in the three months following vaccination

- Known allergy to components of the study vaccine or control

- Use of immunosuppressant therapy regimens within the six months prior to enrollment in
the study or planned use within the two years following enrollment. Immunosuppressant
therapy regimens include: antineoplastic chemotherapy, radiation therapy and
immunosuppressants to induce transplant tolerance, among others

- Use of immunosuppressive doses of corticosteroids within the three months prior to the
enrollment in the study and planned use of immunosuppressive doses of corticoids
within the three months following enrollment in the study. Immunosuppressive doses of
corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for
longer than one week. Continued use of topical or nasal corticosteroids is not
considered an immunosuppressant

- History of asplenia

- History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet
disorder), or prior history of significant bleeding or bruising following IM
injections or venipuncture

- Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has
caused medical, professional or family problems, indicated by clinical history

- Administration of immunoglobulins and/or any blood products within the three months
preceding the planned administration of the vaccine candidate

- Participation in another clinical trial with an investigational product in the six
months prior to enrollment in the study or planned participation in another clinical
trial within the two years following enrollment

- Received live attenuated virus vaccine 14 days prior to enrollment in the study

- Inactivated vaccine or sub unit vaccine 7 days prior to enrollment in the study

- Fever (oral temperature >37.2℃, axillary temperature will not be accepted) within the
past 24 hours

- Any other condition that, in the opinion of the principal investigator or his/her
representative physician, could put the safety/rights of potential participants at
risk or prevent them from complying with this protocol.

- Any confirmed or suspected autoimmune disease or immunodeficiency disease, including
human immunodeficiency virus (HIV) infection.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 59 Years
Countries
Turkey
Locations

T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
Ankara, Turkey Region, Turkey

T.R. Ministry of Health Ankara Provincial Health Directorate Ankara Training and Research Hospital, Infectious Diseases
Ankara, Turkey Region, Turkey

Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Ankara, Turkey Region, Turkey

Çukurova University Faculty of Medicine, Department of Infectious Diseases
Adana, Turkey

Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology
Ankara, Turkey

T.C Ministry of Health Ankara Provincial Health Directorate Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
Ankara, Turkey

Akdeniz University Faculty of Medicine, Department of Infectious Diseases
Antalya, Turkey

Bursa Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Bursa, Turkey

Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Diyarbakır, Turkey

Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Gaziantep, Turkey

Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology
Istanbul, Turkey

Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
Istanbul, Turkey

Istanbul Medipol University Faculty of Medicine, Department of Internal Medicine
Istanbul, Turkey

Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Istanbul, Turkey

T.R. Ministry of Health Istanbul Provincial Health Directorate Marmara Univesity Istanbul Pendik Education and Research Hospital
Istanbul, Turkey

T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic
Istanbul, Turkey

T.R. Ministry of Health Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Turkey

University of Health Sciences İstanbul Ümraniye Training and Research Hospital
Istanbul, Turkey

Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases
İzmir, Turkey

Republic Of Turkey Ministry Of Health Izmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital
İzmir, Turkey

T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases
İzmir, Turkey

T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department
Kayseri, Turkey

Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Kocaeli, Turkey

Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases
Malatya, Turkey

Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology
Trabzon, Turkey

Murat Akova, Prof., Principal Investigator
Faculty Member

Health Institutes of Turkey
NCT Number
Keywords
COVID-19, SARS-CoV-2 Vaccine
MeSH Terms
COVID-19