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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-30

Study Completion Date

2025-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hand, Foot and Mouth Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental Group aged 6~23 months

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.

Group Type EXPERIMENTAL

Experimental Vaccine

Intervention Type BIOLOGICAL

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.

Experimental Group aged 24~35 months

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 .

Group Type EXPERIMENTAL

Experimental Vaccine

Intervention Type BIOLOGICAL

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.

Experimental Group aged 36~71 months

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 .

Group Type EXPERIMENTAL

Experimental Vaccine

Intervention Type BIOLOGICAL

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 Group aged 36~71 months

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 .

Group Type ACTIVE_COMPARATOR

Control Vaccine

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Enterovirus Type 71 Vaccine（Vero Cell）, Inactivated Enterovirus Type 71 Vaccine, Inactivated（Human Diploid Cell）

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes