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

Primary Purpose

Hand, Foot and Mouth Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Experimental Vaccine
Control Vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease

Eligibility Criteria

6 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yun County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Experimental Group aged 6~23 months

Experimental Group aged 24~35 months

Experimental Group aged 36~71 months

Control Group aged 36~71 months

Arm Description

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.

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 .

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 .

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 .

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2022
Last Updated
June 7, 2022
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05397587
Brief Title
An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2022 (Anticipated)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
474 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group aged 6~23 months
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Group aged 24~35 months
Arm Type
Experimental
Arm Description
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 .
Arm Title
Experimental Group aged 36~71 months
Arm Type
Experimental
Arm Description
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 .
Arm Title
Control Group aged 36~71 months
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Biological
Intervention Name(s)
Experimental Vaccine
Other Intervention Name(s)
Enterovirus Type 71 Vaccine(Vero Cell), Inactivated
Intervention Description
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
Intervention Name(s)
Control Vaccine
Other Intervention Name(s)
Enterovirus Type 71 Vaccine, Inactivated(Human Diploid Cell)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The seroconversion rates (SCR) of EV71 neutralizing antibody of all enrolled subjects
Description
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
Title
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months
Description
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
Title
GMT of the EV71 neutralizing antibody of all enrolled subjects
Description
GMT of the EV71 neutralizing antibody of all enrolled subjects at 36 months after full immunization.
Time Frame
At 36 months after full immunization
Title
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zheng, Master
Phone
18987115640
Email
yaqueer_zy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zheng, Master
Organizational Affiliation
Yunnan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yun County Center for Disease Control and Prevention
City
Lincang
State/Province
Yunnan
ZIP/Postal Code
675800
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuncong Li
Phone
18288351142
Email
908038397@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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