An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)

Hand, Foot and Mouth Disease Clinical Trial

Official title:

An Open, Observational Study to Evaluate the Immunity Persistence of an Inactivated Enterovirus 71 Vaccine (Vero Cell) in Subjects Aged 6 to 71 Months

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05397587
• Other study ID #: PRO-EV71-3003-1
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

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