A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants

Inclusion criteria

For children group (aged from 12-36 months):

• Healthy children aged from 12 to 36 months old as established by medical history and clinical examination
• The subjects' guardians are able to understand and sign the informed consent
• Had never received the vaccine against EV71
• Subjects who can and will comply with the requirements of the protocol
• Subjects with temperature <=37.0°C on axillary setting

For infants group (aged from 6-11 months):

• Healthy infants aged from 6 to 11 months old as established by medical history and clinical examination
• The subjects' guardians are able to understand and sign the informed consent
• Had never received the vaccine against EV71
• Subjects who can and will comply with the requirements of the protocol
• Subjects with temperature <=37.0°C on axillary setting

Exclusion criteria

For children group (aged from 12-36 months):

• Subject who has a medical history of HFMD
• <= 37 weeks gestation
• Subjects with a birth weight <2.5 kg
• Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
• Family history of seizures or progressive neurological disease
• Family history of congenital or hereditary immunodeficiency
• Severe malnutrition or dysgenopathy
• Major congenital defects or serious chronic illness, including perinatal brain damage
• Autoimmune disease
• Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
• Any acute infections in last 7 days
• Any prior administration of immunodepressant or corticosteroids in last 6month
• Any prior administration of blood products in last 3 month
• Any prior administration of other research medicines in last 1 month
• Any prior administration of attenuated live vaccine in last 28 days
• Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
• Under the anti-TB prevention or therapy
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

For infants group (aged from 6-11 months):

• Subject who has a medical history of HFMD
• <= 37 weeks gestation
• Subjects with a birth weight <2.5 kg
• Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
• Family history of seizures or progressive neurological disease
• Family history of congenital or hereditary immunodeficiency
• Severe malnutrition or dysgenopathy
• Major congenital defects or serious chronic illness, including perinatal brain damage
• Autoimmune disease
• Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
• Any acute infections in last 7 days
• Any prior administration of immunodepressant or corticosteroids in last 6month
• Any prior administration of blood products in last 3 month
• Any prior administration of other research medicines in last 1 month
• Any prior administration of attenuated live vaccine in last 28 days
• Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
• Under the anti-TB prevention or therapy
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Exclusion criteria

for the second dose:

• Had any Grade 3 or Grade 4 adverse reaction within 7 days after first dose
• Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
• Had any SAE related to first dose during the following-up of first dose
• Any condition that in the opinion of the investigator, or IRB