This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.
This study is a randomized, placebo-controlled and opened, phase 4 clinical trial to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy population aged 18 years and older . The experimental vaccine is manufactured by Sinovac Research and Development Co.,Ltd. A total of 270 healthy subjects will be enrolled, including 135 adults aged 18-59 years and 135 elderly elderly aged 60 years and older. Subjects in each age group will be divided into two groups in a ratio of 1:1. Subjects in the experimental group will receive two doses of CoronaVac on day 0 and day 28. Subjects in the control group will receive one dose of 23-valent Pneumococcal Polysaccharide Vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
270
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.
Rushan City Center for Disease Control and Prevention
Weihai, Shandong, China
Seroconversion rate of the neutralizing antibody to SARS-CoV-2
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at day 28 after the second dose of inactivated COVID-19 vaccine
Time frame: Day 28 after the second dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Time frame: Day 4, 14, 32,42 and 56 after the first dose
Seropositivity rate of the neutralizing antibody to SARS-CoV-2
Seropositivity rate of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Time frame: Day 4, 14, 28, 32,42 and 56 after the first dose
GMT of the neutralizing antibody to SARS-CoV-2
GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Time frame: Day 4, 14, 28, 32,42 and 56 after the first dose
GMI of the neutralizing antibody to SARS-CoV-2
GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Time frame: Day 4, 14, 28, 32,42 and 56 after the first dose
Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA)
Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Time frame: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA)
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Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Time frame: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Seroconversion rate of the hepatitis A antibody by Electrochemiluminescence
Seroconversion rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Time frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
Seropositivity rate of the hepatitis A antibody by Electrochemiluminescence
Seropositivity rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Time frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
GMT of the hepatitis A antibody by Electrochemiluminescence
GMT of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Time frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
GMI of the hepatitis A antibody by Electrochemiluminescence
GMI of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Time frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
Occurrence of abnormal changes of laboratory safety examinations
Occurrence of abnormal changes of laboratory safety examinations (Platelet factor 4 HIT, blood sugar, ESR, White blood cell count, hemoglobin, platelet count and Coagulation function index)
Time frame: Day 4, 14, 28, 32,42 and 56 after the first dose