An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)
An Open, Observational Study to Evaluate the Immunity Persistence of an Inactivated Enterovirus 71 Vaccine (Vero Cell) in Subjects Aged 6 to 71 Months
1 other identifier
interventional
474
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
July 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedJune 10, 2022
May 1, 2022
3 years
May 25, 2022
June 7, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (4)
Experimental Group aged 6~23 months
EXPERIMENTALUp 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.
Experimental Group aged 24~35 months
EXPERIMENTALUp 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 .
Experimental Group aged 36~71 months
EXPERIMENTAL100 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 .
Control Group aged 36~71 months
ACTIVE COMPARATOR100 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 .
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yun County Center for Disease Control and Prevention
Lincang, Yunnan, 675800, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Zheng, Master
Yunnan Provincial Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
July 30, 2022
Primary Completion
July 30, 2025
Study Completion
October 30, 2025
Last Updated
June 10, 2022
Record last verified: 2022-05