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 COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and the commercialized scale in workshop 1 in healthy children aged 3-17 years.
This study is a double-blind, randomized phase Ⅳ clinical trial in healthy children aged 3-17 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy children aged 3-17 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 2520 healthy subjects aged 3 to 17 years old will be enrolled.The subjects will be randomly divided into 7 groups of 360 participants per group with an equal probability to received 7 batches of commercial-scale vaccine.All subjects received two doses of vaccine on day 0 and day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,520
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Yaliang county Center for Disease Control and Prevention
Xi’an, Shanxi, China
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
Time frame: 28 days after the full immunization
Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2
Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
Time frame: 28 days after the full immunization
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
Time frame: 28 days after the full immunization
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
Time frame: 28 days after the full immunization
Incidence of adverse reactions 0-7 days after vaccination
The incidence of adverse reactions of each lot of COVID-19 vaccine 0-7 days after vaccination
Time frame: 0-7 days after vaccination
Incidence of adverse reactions 0-28 days after vaccination
The incidence of adverse reactions of each lot of COVID-19 vaccine 0-28 days after vaccination
Time frame: 0-28 days after vaccination
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600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection