| Eligibility |
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.
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