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This study is designed to evaluate the long-term antibody titers of Envacgen® approximately 6 years after the first vaccination dose in participants who were aged 2 months to <6 years at the time of enrollment in the CT-EV-31s study.
This is an extension study of protocol CT-EV-31s, to evaluate the long-term immunogenicity of EV71 Enterovirus Vaccine (Envacgen®).
The study will consist of a single visit approximately 6 years after the first vaccination of the EV71 vaccine or Placebo in participants aged 2 months to < 6 years when participating in the CT-EV-31s study. Immunogenicity response against EV71 virus antigen at the visit will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EV71 Vaccine with Adjuvant AlPO4 | EV71 Vaccine Produced in Vero Cells with Adjuvant AlPO4 |
| |
| Adjuvant AlPO4 | Placebo (Adjuvant AlPO4 only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 vaccine | Biological | EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-31s study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum neutralizing antibody titer | Geometric mean titer (GMT) of EV71 neutralizing antibody at approximately 6 years after first dose of EV71 vaccination or Placebo for participants. | Approximately 6 years after first dose of vaccination. |
| Seroprotection rate | Seroprotection rate (defined as neutralizing antibody titer ≥1:32) at approximately 6 years after first dose of EV71 vaccination or Placebo for participants. | Approximately 6 years after first dose of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have completed participation in study CT-EV-31s.
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| Name | Affiliation | Role |
|---|---|---|
| Li-Min Huang, M.D., Ph.D. | National Taiwan University Hospital | Principal Investigator |
| Nan-Chang Chiu, M.D. | Mackay Memorial Hospital | Principal Investigator |
| Cheng-Hsun Chiu, M.D., Ph.D. | Chang Gang Memorial Hospital, LinKou | Principal Investigator |
| Chien-Yu Lin, M.D., Ph.D. | Mackay Memorial Hospital, HsinChu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital, HsincChu | Hsinchu | Taiwan | ||||
| Mackay Memorial Hospital, Taipei |
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Serum
| Taipei |
| Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Chang Gung Medical Hospital Linkou | Taoyuan | Taiwan |