A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

Study Overview
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Brief Summary
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This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers

Detailed Description
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This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.

Official Title
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A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers

Conditions
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Enterovirus Infection

Intervention / Treatment
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* Biological: EV71 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who is free of obvious health problems Able and willing to comply with the study procedure adn give written informed consent Exclusion Criteria: Female who is pregnant/lactating or planning to be pregnant Body mass index(BMI) > 35 Oral temperature > 37.5 Celsius at the time of planned vaccination Subject with any abnormal laboratory results at screening With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder With a history of hypersensitivity to vaccine or allergic disease Use of any investigational/non-registered product within 30 days prior to vaccination Use of immunoglobulins or any blood products within 3 months prior to vaccination Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EV 71 vaccine 5ug<br>EV71 Vaccine 5ug | Biological: EV71 vaccine<br>* Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.<br>* Other names: EV71 vac;|
| Experimental: EV 71 vaccine 10ug<br>EV71 vaccine 10ug | Biological: EV71 vaccine<br>* Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.<br>* Other names: EV71 vac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint | The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose | 210 Days |