studies of the safety and immunogenicity of a sabin inactivated poliovirus vaccine

Conditions: Poliomyelitis

Summary: 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.

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: 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;

Keywords: sabin strain inactivated poliovirus vaccine poliomyelitis safety immunogenicity infant