Evaluation of the Efficacy, Safety and Immunogenicity of Inactivated COVID 19 Vaccine(TURKOVAC) in Healthy Population of 18 and 64 Years of Age (Both Inclusive):a Randomized, Double-blind, Phase IIb Clinical Trial

1. clinically significant infection or other acute illness not due to SARS-CoV-2, including fever ≥ 37.4°C within 24 hours prior to the planned study vaccination.

2. had close contact to persons with confirmed SARS-CoV-2 infection within 14 days prior to screening Visit 1.

3. has participated in a clinical study involving an investigational SARS-CoV-2 vaccine.

4. has a history of SARS-CoV-1 or MERS infection (self-reported).

5. positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

6. has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination.

7. has abnormal findings in any required study investigations (including medical history, vital signs, physical examination, and clinical laboratory) considered clinically relevant by the Investigator.

8. with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation or completion of the study, based on Investigator's clinical judgement.

9. with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected.

10. has a history of malignancy in the past five years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than five years ago that is considered to have achieved a cure, the subject may be enrolled. A history of hematologic malignancy is a permanent exclusion. Subjects with a history of skin cancer must not be vaccinated at the previous tumor site.

11. has a known or suspected defect of the immune system, such as subjects with congenital or acquired immune deficiency.

12. received immuno-suppressive therapy within four weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study.

13. has a history of any vaccine related contraindicating event.

14. presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

15. has donated blood, blood fractions or plasma within four weeks prior to Visit 1 or received blood-derived products (e.g., plasma) within 12 weeks prior to Visit 1 in this study or plans to donate blood or use blood products during the study.

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

17. has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating.

18. has a known or suspected problem with alcohol, caffeine or drug abuse as determined by the Investigator.

19. has any condition that, in the opinion of the Investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study.

20. has participated in another clinical study involving an investigational medicinal product (IMP) or device within 4 weeks prior to Visit 1 or is scheduled to participate in another clinical study involving an IMP, or device during this study.

21. blood pressure, after resting for five min, higher than 140/90 or lower than 100/60 mm Hg.

22. pulse rate outside the range of 50 - 100 beats/min OR respiratory rate outside the range of 15 - 18 breathings /min, after resting for five min.

23. laboratory values (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, BUN, total bilirubin, AST, ALT, GGT, ALP, hemoglobin, hematocrit, erythrocytes, leukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab, urinalysis if requested) outside normal range with clinical relevance at entry.

24. intake or administration of OTC medication (including herbal remedies) which may have an effect on the study according to the investigator within 2 weeks prior to the start of the study.

25. legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study.

26. is a member of the team conducting the study or in a dependent relationship with one of the study team members.

What this study is about