A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects

Exclusion Criteria

• •1. Subject with previous known exposure to Enterovirus 71 (EV71).
• •2. Subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
• •3. Subject with gestation \< 37 weeks.
• •4. Subject with birth weight \<2.5 kg.
• •5. 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.
• •6. Family history of seizures or progressive neurological disease.
• •7. Family history of congenital or hereditary immunodeficiency.
• •8. Severe malnutrition or dysgenopathy.
• •9. Major congenital defects or serious chronic illness, including perinatal brain damage.
• •10. 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).
• •11. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
• •12. Any acute infections 7 days prior to administrating the first vaccination.
• •13. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
• •14. Administration of any vaccines within 14 days prior to randomization.
• •15. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
• •16. Chronic administration (defined as \> 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination or planned use during the study period.
• •17. Subjects who had ever received investigational EV-71 vaccine prior to randomization.
• •18. Under anti-tuberculosis prevention or therapy.
• •19. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.