This is a randomized, Open, control phase Ⅳ clinical trial of inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co., Ltd,Beijing institute of Biological Products Co.,Ltd and Wuhan Institute of Biological Products Co.,Ltd.The purpose of this study is to explore booster Immunization of SARS-CoV-2 Inactivated Vaccine from different manufactures in adults aged 18-45 years old Previously Vaccinated with inactivated COVID-19 vaccine
This study a randomized, Open, control phase Ⅳclinical trial of inactivated COVID-19 vaccine .The purpose of this study is to explore booster Immunization of SARS-CoV-2 inactivated vaccine from different manufactures in adults aged 18-45 years old previously vaccinated with inactivated COVID-19 vaccine.A total of 480 subjects who have completed vaccination of two doses of inactivated COVID-19 vaccine for 6 to 8 months will be enrolled.In this study ,96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd.(experimental group 1).192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will be randomly divided into two groups (experimental group 2 and experimental group 3) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. and Beijing institute of Biological Products Co., Ltd,respectively.192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.will be randomly divided into two groups(experimental group 4 and experimental group 5) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. and Wuhan Institute of Biological Products Co.,Ltd.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
480
Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Inactivated COVID-19 vaccine manufactured by Beijing Institute of Biological Products Co.,Ltd.4ug inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.200WU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Yanhe Tujia Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, China
Immunogenicity index-GMT of neutralizing antibodies
GMT of neutralizing antibody 28 days after booster dose.
Time frame: 28 days after booster dose
Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies
Seroconversion rate (4-fold and above increase)of neutralizing antibodies 28 days after booster dose.
Time frame: 28 days after booster dose
Immunogenicity index-seropositive rate of neutralizing antibody
Seropositive rate of neutralizing antibody 28 days after booster dose.
Time frame: 28 days after booster dose
Safety index-Incidence of adverse reactions
Incidence of adverse reactions occured 0-28 days after booster
Time frame: 0-28 days after booster
Safety index-Incidence of adverse reactions
Incidence of adverse reactions occurred 0-7 days after booster dose.
Time frame: 0-7 days after booster dose
Safety index-Incidence of SAEs and AESIs
Incidence of SAEs and AESIs occured 0-28 days after booster.
Time frame: 0-28 days after booster
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