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The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014.
On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EV71 vaccine group | The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial. | ||
| Placebo group | The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| The seropositive rate of EV71 neutralizing antibody-1 | Calculated based on the cutoff value of 1:8 | 5 years (64 months) |
| Measure | Description | Time Frame |
|---|---|---|
| The seropositive rate of EV71 neutralizing antibody-2 | Calculated based on the cutoff value of 1:16 | 5 years (64 months) |
| The seropositive rate of EV71 neutralizing antibody-3 | Calculated based on the cutoff value of 1:32 |
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Inclusion Criteria:
In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).
The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:
Exclusion Criteria:
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The studied subjects are infants aged 6-35 months old infants when enrolled into the phase III clinical trial, and they are children aged 6-8 years old five years after the EV71 vaccine /placebo injection.
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| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu | Jiangsu Provicial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheyang Center for Disease Control and Prevention | Yancheng | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29482422 | Derived | Hu Y, Zeng G, Chu K, Zhang J, Han W, Zhang Y, Li J, Zhu F. Five-year immunity persistence following immunization with inactivated enterovirus 71 type (EV71) vaccine in healthy children: A further observation. Hum Vaccin Immunother. 2018 Jun 3;14(6):1517-1523. doi: 10.1080/21645515.2018.1442997. Epub 2018 Apr 11. |
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| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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The venous blood was collected for EV71 neutralizing antibody detection
| 5 years (64 months) |
| The GMT of EV71 neutralizing antibody | The GMT of EV71 neutralizing antibody 64 months after the first dose injection | 5 years (64 months) |
| D014777 | Virus Diseases |
| D007239 | Infections |