This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.
This study is a single-center, open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine.The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.This study (PRO-nCOV-3002-1) will be used as a sub-trial of the Phase Ⅲ global multi-center clinical trial in children and adolescents(PRO-nCOV-3002) to provide safety and immunogenicity data.A total of 1000 healthy children aged 3-11 years will be enrolled ,including 500 children aged 3-5 years and 500 children aged 6-11 years.All subjects will receive 2 doses of experimental vaccine (600SU) with an interval of 28 days,and adverse reactions/events will be collected from all subjects after each dose and SAE and AESI monitoring will be completed from the beginning of vaccination to 6 and 12 months after full vaccination to evaluate the safety of the vaccine.About 3.0-3.5ml of venous blood will be collected from all subjects before immunization, 28 days after the whole immunization, 6 months after the whole immunization and 12 months after the whole immunization. Neutralizing antibody and S antibody will be detected to evaluate the immunogenicity and immune persistence of the vaccine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection
Sheyang County Center for Disease Control and Prevention
Yancheng, Jiangsu, China
Immunogenicity index-the GMT of neutralizing antibodies
The GMT of neutralizing antibodies 28 days after the second vaccination.
Time frame: 28 days after the second vaccination
Immunogenicity index-the seroconversion rate of neutralizing antibodies
The seroconversion rate of neutralizing antibodies 28 days after the second vaccination
Time frame: 28 days after the second vaccination
Immunogenicity index-the seropositive rate of neutralizing antibodies 28 days after the second vaccination
The seropositive rate of neutralizing antibodies 28 days after the second vaccination
Time frame: 28 days after the second vaccination
Immunogenicity index-GMI of neutralizing antibodies
GMI of neutralizing antibodies 28 days after the second vaccination
Time frame: 28 days after the second vaccination
Immunogenicity index-The seroconversion rate of the S antibody to SARS-CoV-2
The seroconversion rate of the S antibody to SARS-CoV-2 28 days after the second vaccination
Time frame: 28 days after the second vaccination
Immunogenicity index-The seropositivity rate of the S antibody to SARS-CoV-2
The seropositivity rate of the S antibody to SARS-CoV-2 28 days after the second vaccination
Time frame: 28 days after the second vaccination
Immunogenicity index-GMC of the S antibody to SARS-CoV-2
GMC of the S antibody to SARS-CoV-2 28 days after the second vaccination
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Time frame: 28 days after the second vaccination
Immunogenicity index-GMI of the S antibody to SARS-CoV-2
GMI of the S antibody to SARS-CoV-2 28 days after the second vaccination
Time frame: 28 days after the second vaccination
Immunogenicity index-The seropositive rate of neutralizing antibodies
The seropositive rate of neutralizing antibodies 6 months/12 months days after the second vaccination
Time frame: 6 months/12 months days after the second vaccination
Immunogenicity index-GMT of neutralizing antibodies
GMT of neutralizing antibodies 6 months/12 months days after the second vaccination
Time frame: 6 months/12 months days after the second vaccination
Immunogenicity index-The seropositivity rate of the S antibody to SARS-CoV-2
The seropositivity rate of the S antibody to SARS-CoV-2 6 months/12 months days after the second vaccination
Time frame: 6 months/12 months days after the second vaccination
Immunogenicity index-GMC of the S antibody to SARS-CoV-2
GMC of the S antibody to SARS-CoV-2 6 months/12 months days after the second vaccination
Time frame: 6 months/12 months days after the second vaccination
Safety index-Incidence rate of adverse reactions
Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose vaccination
Time frame: From the beginning of the vaccination to 28 days after the second dose vaccination
Safety index-Incidence rate of SAEs
Incidence rate of SAEs from the beginning of the vaccination to 6 months after the second dose vaccination.
Time frame: From the beginning of the vaccination to 6 months after the second dose vaccination
Safety index-Incidence rate of AESIs
Incidence rate of AESIs from the beginning of the vaccination to 6 months after the second dose vaccination
Time frame: From the beginning of the vaccination to 6 months after the second dose vaccination