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

Sinovac

Status and phase: Not yet enrolling; Phase 4

Conditions: Hand, Foot and Mouth Disease

Treatments: Biological: Experimental Vaccine; Biological: Control Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05397587

PRO-EV71-3003-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 474 estimated patients

Sex: All

Ages: 6 to 71 months old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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474 participants in 4 patient groups

Experimental Group aged 6~23 months

Experimental group

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.

Treatment:

Biological: Experimental Vaccine

Experimental Group aged 24~35 months

Experimental group

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 .

Treatment:

Biological: Experimental Vaccine

Experimental Group aged 36~71 months

Experimental group

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 .

Treatment:

Biological: Experimental Vaccine

Control Group aged 36~71 months

Active Comparator group

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 .

Treatment:

Biological: Control Vaccine