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

Inclusion Criteria:

1. Healthy children aged from 2 months to 6 years old (i.e. >= 2 months old and < 7years old) at the time of first vaccination.

2. Subject's guardians are able and willing to comply with study procedures and providethe signed informed consent.

3. Subject is able and can comply with the requirements of the protocol.

4. Subject with body temperature <= 38℃.

Exclusion Criteria:

1. Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71vaccination.

2. Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagicconjunctivitis associated with enterovirus infection in the past 30 days.

3. Subject with a history of hypersensitivity to vaccines, or a history of allergicdisease 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 subjectparticipation 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 braindamage at the screening visit.

8. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type Idiabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathicarthritis (JIA), immune (or idiopathic) thrombocytopenia purpura) that may affectsubject participation in the study in the opinion of the investigator.

9. Bleeding disorder diagnosed by a doctor or significant bruising or hemostaticdifficulties 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 tovaccination 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 systemicimmunosuppressants, other systemic immunomodulators, or systemic corticosteroidswithin 6 months prior to vaccination.

15. Any condition that in the opinion of the investigator may interfere with theevaluation of study objectives.

16. Subject with any confirmed or suspected immunodeficiency.