This study is a randomized and controlled phase Ⅳ clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine
This study is a randomized and controlled phase Ⅳ clinical trial in children aged 3-5 years old. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine.The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 520 subjects aged 3-5 years old will be enrolled.Subjects will be randomly divided into 2 groups in a ratio of 1:1.The experimental group is the combined immunization group, which will receive the first dose of COVID-19 vaccine and the second dose of COVID-19 vaccine and EV71 vaccine on day 28;Control group is the Non-combined immunization group , which will receive the first dose of COVID-19 vaccine on day 0 ,the first dose of EV71 vaccine on day 14 ,the second dose of COVID-19 vaccine on day 28 and the second dose of EV71 vaccine on day 42.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
520
The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
Yangchun Center for Disease Control and Prevention
Yangchun, Guangdong, China
Zhanjiang Center for Disease Control and Prevention
Zhanjiang, Guangdong, China
Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine
Time frame: Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71
Seroconversion rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71 vaccine
Time frame: Day 28 after the second dose of EV71 vaccine
Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine.
Time frame: Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2
GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after after the second dose of COVID-19 vaccine.
Time frame: Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2
GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after after the second dose of COVID-19 vaccine.
Time frame: Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71
Seropositive rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71
Time frame: Day 28 after the second dose of EV71
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Immunogenicity index-GMT of the neutralizing antibody to EV71
GMT of the neutralizing antibody to EV71 at day 28 after the second dose of EV71
Time frame: Day 28 after the second dose of EV71
Immunogenicity index-GMI of the neutralizing antibody to EV71
GMI of the neutralizing antibody to EV71 at day 28 after the second dose of EV71
Time frame: Day 28 after the second dose of EV71
Safety index-Incidence of the adverse reactions
Incidence of the adverse reactions from day 0 to day 7 after each dose
Time frame: From day 0 to day 7 after each dose
Safety index-Incidence of the adverse reactions
Incidence of the adverse reactions from day 0 to 28 days after the last dose
Time frame: From day 0 to 28 days after the last dose
Safety index-Incidence of the serious adverse events and the adverse events of special interest
Incidence of the serious adverse events and the adverse events of special interest from the beginning vaccination to 6 months after the last dose
Time frame: From the beginning vaccination to 6 months after the last dose