Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.
Polio and Post-Polio Syndrome
About this trial
This is an interventional prevention trial for Polio and Post-Polio Syndrome
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteer aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;
- Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
- Axillary temperature ≤ 37.0 °C;
Exclusion Criteria:
- Preterm or low birth weight infants;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- History of polio;
- Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
- Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
- Mother of the participant has HIV infection;
- Acute illness or acute exacerbation of chronic disease within the past 7 days;
- Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
- Receipt of any subunit or inactivated vaccine within the past 7 day;
- Receipt of any live attenuated vaccine within the past 14 days;
- Receipt of any blood product within the past 3 months;
- Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Sites / Locations
- Jiangsu Provincial Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Experimental Group - High dosage
Experimental Group - Medium dosage
Experimental Group - Low dosage
Control Group -commercialized sIPV
Control Group -commercialized IPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV