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

A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants

The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

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:

  1. Any subunit or inactivated vaccine within the past 7 day;
  2. Any live attenuated vaccine within the past 14 days;
  3. Any other investigational medicine(s) within the past 30 days;
  4. Any blood product within the past 3 months;
  5. 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;