Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.

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;