A Clinical Study for Inactivated Vaccine Against EV71

Study Overview
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Brief Summary
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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.

Conditions
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Enterovirus 71 Human

Intervention / Treatment
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* Biological: EV71 with adjuvant aluminium phosphate
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination The subjects' guardians are able to understand and sign the informed consent Main Exclusion Criteria: Subject with previous known exposure to EV71. Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months. Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder. Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period. Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Phosphate Buffer Saline with adjuvant aluminium phosphate | Biological: Placebo<br>* Phosphate Buffer Saline with adjuvant aluminium phosphate<br>|
| Experimental: EV71 with adjuvant aluminium phosphate<br>Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml | Biological: EV71 with adjuvant aluminium phosphate<br>* Two arms, EV71 with aluminium phosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 Geometric mean titer (GMT) of EV71 neutralizing antibody titers Post-vaccination-to-pre-vaccination GMT ratio of EV 71 neutralizing antibody titers Seropositivity rate | 2 years from study initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EV71 Vaccine