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This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to < 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to < 2 years
This is an extension study of protocol CT-EV-21, to evaluate the long-term immunogenicity of EV71vaccine.
The first study visit will be approximately 3 or 4 years after the administration of first vaccination of EV71 vaccine or placebo in CT-EV-21 study; 4 years after the first vaccination for subjects 2 to < 6 years of age (2b), and 3 years after first dose for subjects 2 months to < 2 years of age (2c and 2d).
Subjects of 2b will remain in the study for approximately 12 months and will have 2 clinic visits; subjects of 2c and 2d will remain in the study for approximately 24 months and will have 3 clinic visits. Immunogenicity response against EV71 virus antigen at each 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-21 study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum neutralizing antibody titer | Geometric mean titer (GMT) of EV71 neutralizing antibody titers at 4 and 5 years after first dose of EV71 vaccination for subjects of 2b; and 3 to 5 years after first dose of EV71 vaccination for subjects of 2c and 2d. | Up to 5 years after first dose of EV71 vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have completed participation in study CT-EV-21
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| Name | Affiliation | Role |
|---|---|---|
| Li-Min Huang, M.D., Ph.D. | National Taiwan University 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 |
| Nan-Chang Chiu, M.D. | Mackay Memorial Hospital | 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 Hosptial | Taipei | Taiwan |
| Chang Gung Memorial Hospital, LinKou | Taoyuan | Taiwan |