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Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months to < 2 years of age. The last study visit is on Day 422 when subjects will be contacted via telephone / home visit system to assess for adverse events and concomitant medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EV71vac | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71vac | Biological | Subjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Laboratory Confirmed EV71-Associated Disease | The primary outcome is the number of Laboratory confirmed EV71-associated disease by viral isolation or CODEHOP assay. | Approximately 14 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Min Huang, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital, HsincChu | Hsinchu | Taiwan | ||||
| Taichung Veteran General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35427481 | Derived | Nguyen TT, Chiu CH, Lin CY, Chiu NC, Chen PY, Le TTV, Le DN, Duong AH, Nguyen VL, Huynh TN, Truong HK, Phan TL, Nguyen TTT, Shih SR, Huang CG, Weng YJ, Hsieh EF, Chang S, Chen C, Tai IC, Huang LM. Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1708-1717. doi: 10.1016/S0140-6736(22)00313-0. Epub 2022 Apr 12. |
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| Placebo | Biological | Subjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366. |
|
| Taichung |
| Taiwan |
| Mackay Memorial Hospital, Taipei | Taipei | Taiwan |
| National Taiwan Univeristy Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital, LinKou | Taoyuan | Taiwan |
| Pasteur Institute of HCMC | Ho Chi Minh City | Vietnam |