A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

Exclusion Criteria

• •1. Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination.
• •2. Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days.
• •3. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• •4. Subject under 2 years old with gestation \<34weeks or a birth weight \<2200g.
• •5. History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator.
• •6. Severe malnutrition or dysgenopathy at the screening visit.
• •7. Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit.
• •8. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura) that may affect subject participation in the study in the opinion of the investigator.
• •9. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
• •10. Any acute febrile illness 3 days prior to administrating the first vaccination.
• •11. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during Visit 1 to Visit 4 (Day 0 to Day 196).
• •12. Administration of any vaccine within 14 days prior to each study vaccination.
• •13. Use of immunoglobulins or any blood products within 3 months prior to vaccination.
• •14. Chronic administration (defined as \> 14 day of continuous use) of systemic immunosuppressants, other systemic immunomodulators, or systemic corticosteroids within 6 months prior to vaccination.
• •15. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
• •16. Subject with any confirmed or suspected immunodeficiency.