safety of sabin inactivated poliovirus vaccine in adults, children and infants and lot consistency immunogenicity, and safety of the msipv in 2 months old infants

Conditions: Poliomyelitis

Summary: this study includes two parts.a clinical trial with a open-label to evaluate the safety of sabin inactivated poliovirus vaccine (vero cell) (2.5ml-5 doses)(hereinafter referred to as "msipv")manufactured by sinovac biotech co., ltd. in adults, children and infants in partⅰ and a blinded,randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msipv in 2 months old infants in partⅱ.

this study includes two stages. a clinical trial with an open-label to evaluate the safety of sabin inactivated poliovirus vaccine (vero cell) (2.5ml-5 doses) (hereinafter referred to as "msipv") in adults, children and infants in stageⅰ and a blinded, randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msipv in 2 months old infants in stage ⅱ. a total of 1572 subjects including 24 adults aged 18-49 years,24 children aged 4 years,1524 infants aged 2 months will be enrolled. stagesⅰ:72 healthy subjects, including 24 adults,24 children and 24 infants will be enrolled. 24 adults and 24 children will receive one dose of vaccine and 24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. stagesⅱ:1500 infants aged 2 months will be randomly divided into 5 groups (experimental vaccine-lot 1, experimental vaccine-lot 2, experimental vaccine-lot 3,ipv control group and single-dose sipv control group) according to the ratio of 1:1:1:1:1. subjects in 3 experimental groups will receive 5-dose sipv produced by sinovac for three lots, subjects in ipv control group will receive ipv produced by pasteur, and subjects in single-dose sipv control group will receive single-dose sipv produced by sinovac. all subjects will receive 4 doses of experimental or control vaccine according to the primary immunization schedule of 0,1,2 months, one dose of booster at 18 months of age.

Eligibility criteria:
inclusion criteria: inclusion criteria for adult subjects : * healthy adults aged 18-49 days; * proven legal identification; * the subject can understand and voluntarily sign the informed consent form. inclusion criteria for children subjects : * healthy children aged 4 years old; * subjects who have completed primary immunization with 3 doses of sipv vaccine; * proven legal identification and vaccination certificate; * the subject and/or guardian can understand and voluntarily sign the informed consent form. inclusion criteria for infant subjects: * healthy infants aged 2 months (60\~89 days) * proven legal identification and vaccination certificate; * the subject and/or guardian can understand and voluntarily sign the informed consent form. exclusion criteria: exclusion criteria for adult subjects: * women aged 18 to 49 years, positive urine pregnancy test, pregnant women, breastfeeding women, or planning to become pregnant within 3 months; * previous history of vaccination of sipv vaccine; * allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc; * congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.; * autoimmune disease or immunodeficiency/immunosuppression; * thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy; * serious chronic diseases, serious cardiovascular diseases, hypertension that cannot be controlled by drugs (systolic blood pressure \> 140mmhg, diastolic blood pressure \> 90mmhg), diabetes, liver and kidney diseases, malignant tumors, etc; * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders; * immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; * history of alcohol or drug abuse; * receipt of blood products within in the past 3 months; * receipt of other investigational drugs in the past 30 days; * receipt of attenuated live vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days; * acute diseases or acute exacerbation of chronic diseases in the past 7 days; * axillary temperature \>37.0°c; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. exclusion criteria for children subjects: * have received 4 doses of sipv vaccine; * history of polio; * allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc; * congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.; * autoimmune disease or immunodeficiency/immunosuppression; * thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy; * suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc; * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders; * immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; * history of alcohol or drug abuse; * receipt of blood products within in the past 3 months; * receipt of other investigational drugs in the past 30 days; * receipt of attenuated live vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days; * acute diseases or acute exacerbation of chronic diseases in the past 7 days; * axillary temperature \>37.0°c; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. exclusion criteria for infant subjects: * previous history of vaccination of sipv vaccine; * history of polio; * allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc; * preterm birth babies (delivered before 37 weeks gestation), low birth weight (girls with birth weight \<2300g, boy with birth weight\<2500 g); * history of dystocia, asphyxia and nervous system damage at birth; * congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.; * autoimmune disease or immunodeficiency/immunosuppression; * thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy; * -suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc; * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders; * have received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy); * receipt of blood products ; * receipt of other investigational drugs in the past 30 days; * receipt of attenuated live vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days; * acute diseases or acute exacerbation of chronic diseases in the past 7 days; * axillary temperature \>37.0°c; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.