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This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Phosphate Buffer Saline with adjuvant aluminium phosphate |
|
| EV71 with adjuvant aluminium phosphate | Experimental | Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 with adjuvant aluminium phosphate | Biological | Two arms, EV71 with aluminium phosphate |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate overall safety of EV71 vaccine in children, throughout the study period | Occurrence of overall adverse events and serious adverse events during the entire period of study. | 2 years after study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine | To evaluate the immunogencity in terms of
| 2 years from study initiation |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Min Huang, M.D., PhD. | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang-Guang Memorial Hospital Lin-Kou | Taipei | Taiwan | ||||
| Far Eastern Memorial Hospital |
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| Placebo | Biological | Phosphate Buffer Saline with adjuvant aluminium phosphate |
|
| Taipei |
| Taiwan |
| MacKay Memorial Hospital | Taipei | Taiwan |
| National Taiwan University Hosptial | Taipei | Taiwan |