A Phase 4 interventional study of Experimental Vaccine and Control Vaccine in Hand, Foot and Mouth Disease, sponsored by Sinovac Biotech Co., Ltd. Status unknown at 1 site in China. Open to participants aged 6 Months to 71 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention
This is an open，observational and follow-up clinical trial based on the clinical trial of EV71 vaccine extended age group.The purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6 \~71 months after full immunization of two doses of vaccine.
This study is an open,observational and follow-up clinical trial of EV71 vaccine based on the clinical trial of EV71 vaccine extended age group.The main purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6\~71 months after full immunization of two doses of vaccine.In this study, a total of 474 subjects from the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set，including 274 subjects aged 6\~35 months (the maximum number of subjects aged 6-23 months is 146, and the maximum number of subjects aged 24-35 months is 128),100 subjects aged 36\~71 months and were enrolled in experimental group(EV71 vaccine developed by Sinovac Biotech Co., Ltd) and 100 subjects aged 36\~71 months and were enrolled in control group(EV71 vaccine developed by Institute of Medical Biology,Chinese Academy of Medical Sciences) will be enrolled .Blood samples will be collected from subjects aged 6-23 months at 36 months after full immunization and at the age of 72 months.Blood samples will be collected from subjects aged 24 to 35 months at 36 months after full immunization.Blood samples will be collected from subjects aged 36-71 months at 36 months after the full immunization.
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 11 are open to participants now.
This study's planned enrollment of 474 is close to the median of 445 across 50 interventional studies indexed under Hand, Foot and Mouth Disease.
Browse Hand, Foot and Mouth Disease studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Up to 146 subjects aged 6\~23 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization and at the age of 72 months.
Biological: Experimental Vaccine
Up to 128 subjects aged 24\~35 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization .
Biological: Experimental Vaccine
100 subjects aged 36\~71 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization .
Biological: Experimental Vaccine
100 subjects aged 36\~71 months and have received EV71 vaccine developed by Institute of Medical Biology,Chinese Academy of Medical Sciences will be collected blood samples at 36 months after full immunization .
Biological: Control Vaccine
The EV71 vaccine was manufactured by Sinovac Biotech Co., Ltd and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
Also known as: Enterovirus Type 71 Vaccine（Vero Cell）, Inactivated
The EV71 vaccine was manufactured by Institute of Medical Biology,Chinese Academy of Medical Sciences ,and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
Also known as: Enterovirus Type 71 Vaccine, Inactivated（Human Diploid Cell）
The seroconversion rates (SCR) of EV71 neutralizing antibody of all enrolled subjects
The seroconversion rates (SCR) of EV71 neutralizing antibody of all subjects at 36 months after full immunization.
Time frame: At 36 months after full immunization
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
Time frame: At the age of 72 months
GMT of the EV71 neutralizing antibody of all enrolled subjects
GMT of the EV71 neutralizing antibody of all enrolled subjects at 36 months after full immunization.
Time frame: At 36 months after full immunization
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
Time frame: At the age of 72 months
Start is estimated for Jul 2022; primary completion for Jul 2025, 36 months later.
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Hand, Foot and Mouth Disease →