A Phase I Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Adults, Children and Infants

Date de début de l'étude : 1 février 2011

For the subjects aged from 18-49 years old adults: Inclusion Criteria: * Healthy subjects (18-49 years old adults) as established by medical history and clinical examination * The subjects oneself or their legal guardian must be aware of this vaccines * Voluntarily participate in the study and signed Informed Consent Form * Subjects with temperature ≤ 37.0℃ * With the ability and objective to comply with the requirements of the protocol * Persist for a 2-month visit and receive blood tests according to program requirements Exclusion Criteria: * Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD) * Allergy or serious side-effects to a vaccine or any ingredient of vaccine * Epilepsy, seizures, convulsions, neurological illness * Congenital or hereditary immunodeficiency * Autoimmune disease * Severe malnutrition or dysgenopathy * Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer * Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy * Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder * Acute illness or acute exacerbation of chronic disease in last 7 days * Any prior administration of immunodepressant or corticosteroids in last 6 months * Any prior administration of blood products in last 3 months * Any prior administration of live-attenuated vaccine in last 28 days or 1 months * Any prior administration of subunit or inactivated vaccines in last 14 days * Under the anti-TB prevention or therapy * Fever before vaccination, axillary temperature ﹥37.0℃ * The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc. * Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg * Breast-feeding, pregnant, planning a pregnancy within 60 days or positive pregnancy test women * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives For the subjects aged from 3-11 years old children: Inclusion Criteria: * Healthy subjects (3-11 years old children) as established by medical history and clinical examination * Full-term (37-42 weeks), weight ≥ 2500 g when it was born * The subjects' legal guardian must be aware of this vaccines * The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form * Subjects with temperature ≤ 37.0℃ * The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol * Persist for a 2-month visit and receive blood tests according to program requirements Exclusion Criteria: * Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD) * ≤37 weeks gestation * weight ≤ 2500 g when it was born * Allergy or serious side-effects to a vaccine or any ingredient of vaccine * Epilepsy, seizures, convulsions, neurological illness * Congenital or hereditary immunodeficiency * Autoimmune disease * Severe malnutrition or dysgenopathy * Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer * Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy * Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder * Acute illness or acute exacerbation of chronic disease in last 7 days * Any prior administration of immunodepressant or corticosteroids in last 6 months * Any prior administration of blood products in last 3 months * Any prior administration of live-attenuated vaccine in last 28 days or 1 months * Any prior administration of subunit or inactivated vaccines in last 14 days * Under the anti-TB prevention or therapy * Fever before vaccination, axillary temperature ﹥37.0℃ * The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc. * Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives For the subjects aged from 6-35 months infants: Inclusion Criteria: * Healthy subjects (6-35 months infants) as established by medical history and clinical examination * Full-term (37-42 weeks), weight ≥ 2500 g when it was born * The subjects' legal guardian must be aware of this vaccines * The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form * Subjects with temperature ≤ 37.0℃ * The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol * Persist for a 2-month visit and receive blood tests according to program requirements Exclusion Criteria: * Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD) * ≤37 weeks gestation * weight ≤ 2500 g when it was born * Allergy or serious side-effects to a vaccine or any ingredient of vaccine * Epilepsy, seizures, convulsions, neurological illness * Congenital or hereditary immunodeficiency * Autoimmune disease * Severe malnutrition or dysgenopathy * Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer * Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy * Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder * Acute illness or acute exacerbation of chronic disease in last 7 days * Any prior administration of immunodepressant or corticosteroids in last 6 months * Any prior administration of blood products in last 3 months * Any prior administration of live-attenuated vaccine in last 28 days or 1 months * Any prior administration of subunit or inactivated vaccines in last 14 days * Under the anti-TB prevention or therapy * Fever before vaccination, axillary temperature ﹥37.0℃ * The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc. * Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives