An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)
Hand, Foot and Mouth Disease
About this trial
This is an interventional prevention trial for Hand, Foot and Mouth Disease
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.
Sites / Locations
- Yun County Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Experimental Group aged 6~23 months
Experimental Group aged 24~35 months
Experimental Group aged 36~71 months
Control Group aged 36~71 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.
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 .