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The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 | Experimental | 3 to 6 years |
|
| Group A2 | Experimental | 3 to 6 years |
|
| Group A3 | Experimental | 3 to 6 years |
|
| Group A4 | Experimental | 3 to 6 years |
|
| Group B2 | Experimental | 6 to 35 months |
|
| Group B3 | Experimental | 6 to 35 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose) | Biological | Two vaccinations at 28 days apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited adverse events | 7 days after each vaccination | |
| Unsolicited adverse events | 28 days after each vaccination | |
| The occurrence of overall adverse events (AEs) and serious adverse event (SAEs) | Day 0 to Day 196 |
| Measure | Description | Time Frame |
|---|---|---|
| immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA) | Day 28, Day 56, Day 196 | |
| serum neutralizing antibody titers (NT) induced by the EV71 vaccine | Day 28, Day 56, Day 196 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan | ||||
| National Taiwan University Hospital |
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| Group B4 | Experimental | 6 to 35 months |
|
| EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose) | Biological | Two vaccinations at 28 days apart |
|
| EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose) | Biological | Two vaccinations at 28 days apart |
|
| EV71 vaccine (2 μg total protein per dose) | Biological | Two vaccinations at 28 days apart |
|
| EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose) | Biological | Two vaccinations at 28 days apart |
|
| EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose) | Biological | Two vaccinations at 28 days apart |
|
| EV71 vaccine (1 μg total protein per dose) | Biological | Two vaccinations at 28 days apart |
|
| Seroconversion rate (SCR) based on neutralizing antibody titers | Day 28, Day 56, Day 196 |
| change in the laboratory results based on hematology tests in each visit | Day 28, Day 56, Day 196 |
| change in the laboratory results based on biochemistry tests in each visit | Day 28, Day 56, Day 196 |
| change in heart rates at each visit (for the 3 to 6 years old group only) | Day 28, Day 56, Day 196 |
| change in blood pressures at each visit (for the 3 to 6 years old group only) | Day 28, Day 56, Day 196 |
| Taipei |
| Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| ID | Term |
|---|---|
| D004769 | Enterovirus Infections |
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D003384 | Coxsackievirus Infections |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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