This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of CoronaVac in healthy adults aged 26-45 years.
This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 1080 healthy subjects aged 26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,080
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Jingliang Wu
Huai'an, Jiangsu, China
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population
GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
Time frame: Day 28 after the second dose
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
Time frame: Day 28 after the second dose
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
Time frame: Day 28 after the second dose
GMT of the neutralizing antibody to live SARS-CoV-2 in total population
GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
Time frame: Day 28 after the second dose
Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population
GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
Time frame: Day 28 after the second dose
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
Time frame: Day 28 after the second dose
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Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population
Seropositive rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
Time frame: Day 28 after the second dose
GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population
GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
Time frame: Day 28 after the second dose
Seropositivity rate of anti-SARS-CoV-2 S antibody
Seropositivity rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
Time frame: Day 28 after the second dose
Seroconversion rate of anti-SARS-CoV-2 S antibody
Seroconversion rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
Time frame: Day 28 after the second dose
Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody
GMC of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
Time frame: Day 28 after the second dose
GMI of anti-SARS-CoV-2 S antibody
GMI of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
Time frame: Day 28 after the second dose
Incidence of adverse reactions after vaccination
Incidence of adverse reactions from the beginning of the vaccination to 28 days after the second dose
Time frame: From the beginning of the vaccination to 28 days after the second dose