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

A Clinical Trial With an Open-label Phase to Evaluate the Safety of Five-dose Sabin Inactivated Poliovirus Vaccine (Vero Cell)（ msIPV） in Adults, Children and Infants, and a Blinded,Randomized and Controlled Phase to Evaluate the Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants

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.

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.