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A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children Group 1: 200U EV71 vaccine | Experimental | 12 children received 3 doses of 200U EV71 vaccine 28 days apart |
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| Children Group 1: Placebo | Placebo Comparator | 6 children received 3 doses of placebo 28 days apart |
|
| Children Group 2: 400U EV71 vaccine | Experimental | 12 children received 3 doses of 400U EV71 vaccine 28 days apart |
|
| Children Group 2: Placebo | Placebo Comparator | 6 children received 3 doses of placebo 28 days apart |
|
| Infants Group 1: 100U EV71 vaccine | Experimental | 24 infants received 3 doses of 100U EV71 vaccine 28 days apart |
|
| Infants Group 1: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100U inactivated Enterovirus Type 71 Vaccine | Biological | Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine | All adverse events were records. Blood cell and biochemistry were performed. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine | virus neutralization assays were performed. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan-pin Li, MD | Guangxi Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GuangXi Center for Diseases Control and Prevention | Nanning | Guangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24260259 | Derived | Mao Q, Cheng T, Zhu F, Li J, Wang Y, Li Y, Gao F, Yang L, Yao X, Shao J, Xia N, Liang Z, Wang J. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy chinese infants and children. PLoS One. 2013 Nov 19;8(11):e79599. doi: 10.1371/journal.pone.0079599. eCollection 2013. | |
| 22426327 | Derived |
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8 infants received 3 doses of placebo 28 days apart |
|
| Infants Group 2: 200U EV71 vaccine | Experimental | 24 infants received 3 doses of 200U EV71 vaccine 28 days apart |
|
| Infants Group 2: Placebo | Placebo Comparator | 8 infants received 3 doses of placebo 28 days apart |
|
| Infants Group 3: 400U EV71 vaccine | Experimental | 24 infants received 3 doses of 400U EV71 vaccine 28 days apart |
|
| Infants Group 3: Placebo | Placebo Comparator | 8 infants received 3 doses of placebo 28 days apart |
|
|
| 200U inactivated Enterovirus Type 71 Vaccine | Biological | Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
|
|
| 400U inactivated Enterovirus Type 71 Vaccine | Biological | Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
|
|
| Placebo | Biological | Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm |
|
| Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15. |
| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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