Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
- Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- Proven legal identity;
- Participants (≥ 18 years old), or guardians of the participants (< 18 years old) 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:
- Breast feeding, pregnant, or expected to conceive in the next 60 days;
- 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;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
- severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
- Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
- Long term history of alcoholism or drug abuse;
Receipt of any of the following products:
- Any subunit or inactivated vaccine within the past 7 day;
- Any live attenuated vaccine within the past 14 days;
- Any other investigational medicine(s) within the past 30 days;
- Any blood product within the past 3 months;
- Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
- Acute illness or acute exacerbation of chronic disease within the past 7 days;
- Axillary temperature > 37.0 °C;
- Infant participants with prior vaccination of poliovirus;
- Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Sites / Locations
- Pizhou City Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Phase I Adult Group - High dosage
Phase I Adult Group - Medium dosage
Phase I Child Group - High dosage
Phase I Child Group - Medium dosage
Phase I Infant Group - High dosage
Phase I Infant Group - Medium dosage
Phase I Infant Group - Low dosage
PhaseⅡExperimental Group - High dosage
PhaseⅡExperimental Group - Medium dosage
PhaseⅡExperimental Group - Low dosage
PhaseⅡControl Group -commercialized sIPV
PhaseⅡ Control Group -commercialized IPV
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of high dosage investigational sIPV
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of medium dosage investigational sIPV
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-dose regimen of high dosage investigational sIPV
Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; Intervention: Single-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 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 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