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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 Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 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 B1 | Experimental | 2 to 35 months |
|
| Group B2 | Experimental | 2 to 35 months |
|
| Group B3 | Experimental | 2 to 35 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose) | Biological | Two vaccinations at 28 days apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum neutralizing antibody titers (NT) induced by the EV71 vaccine | Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 56 | Day 56 |
| Seroconversion rate (SCR) based on neutralizing antibody titers | Evaluate the immunogenicity change of SCR from baseline on Day 56 | Day 56 |
| Serum neutralizing antibody titers (NT) induced by the EV71 vaccine | Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 28 | Day 28 |
| Serum neutralizing antibody titers (NT) induced by the EV71 vaccine | Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196 | Day 196 |
| Seroconversion rate (SCR) based on neutralizing antibody titers | Evaluate the immunogenicity change of SCR from baseline on Day 28 | Day 28 |
| Seroconversion rate (SCR) based on neutralizing antibody titers | Evaluate the immunogenicity change of SCR from baseline on Day 196 | Day 196 |
| 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) |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31399275 | Derived | Hung MC, Cho CY, Chen CJ, Lai CC, Wu KG. Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial. Vaccine. 2019 Sep 3;37(37):5559-5566. doi: 10.1016/j.vaccine.2019.07.096. Epub 2019 Aug 6. |
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| EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) | Biological | Two vaccinations at 28 days apart |
|
| EV71 vaccine ([1 μg total protein ] per dose) | Biological | Two vaccinations at 28 days apart |
|
| Day 0 to Day 196 |
| The occurrence of EV 71 breakthrough infection after Visit 3 | Day 57 to Day 364 |
| Serum neutralizing antibody titers (NT) induced by the EV71 vaccine | Evaluate the immunogenicity of serum neutralization antibody titer induced by the EV 71 vaccine on Day 364 | Day 364 |
| Taipei |
| Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| ID | Term |
|---|---|
| D004769 | Enterovirus Infections |
| D005536 | Foot-and-Mouth Disease |
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D000820 | Animal Diseases |
| 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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