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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05397587
Other study ID # PRO-EV71-3003-1
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 30, 2022
Est. completion date October 30, 2025

Study information

Verified date May 2022
Source Sinovac Biotech Co., Ltd
Contact Yan Zheng, Master
Phone 18987115640
Email yaqueer_zy@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 474
Est. completion date October 30, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 71 Months
Eligibility Inclusion Criteria: - Subjects in the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set; - Provide legal identification; - Participants or guardians of the participants should be capable of understanding the written consent form and voluntarily participate in the clinical trial. Exclusion Criteria: - Vaccination history of vaccines containing EV71 antigen components other than the EV71 vaccine expanded age group clinical trial; - History of hand, foot and mouth disease caused EV71; - According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Experimental 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.
Control Vaccine
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.

Locations

Country Name City State
China Yun County Center for Disease Control and Prevention Lincang Yunnan

Sponsors (1)

Lead Sponsor Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At 36 months after full immunization
Primary 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. At the age of 72 months
Primary 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. At 36 months after full immunization
Primary 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. At the age of 72 months
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