safety and immunogenicity study of 23-valent pneumococcal polysaccharide vaccine in healthy children, adults and elderly

Conditions: Pneumococcal Infections

Summary: the purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (ppv) in healthy children, adults and elderly. the control vaccine is a commercialized 23-valent ppv.

this study is a randomized, double-blind, single-center, controlled phase iii clinical trial. the purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (ppv) manufactured by sinovac biotech co., ltd. the primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent ppv manufactured by chengdu institute of biological products co., ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). in each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.

Eligibility criteria:
inclusion criteria: * healthy volunteer ≥ 2 years old; * proven legal identity; * written consent of the guardian of participants \< 18 years old, and written consent of the participant ≥ 12 years old; * complying with the requirement of the study protocol; exclusion criteria: * prior vaccination with pneumococcal vaccine; * history of bacterial pneumonia within 3 years prior to this study; * pregnant, breast feeding, or women expected to conceive within 60 days after vaccination; * history of allergy to any vaccine or vaccine ingredient; * receipt of any of the following products: 1. blood product within 3 months prior to study entry; 2. any live attenuated vaccine within 28 days prior to study entry; 3. any subunit vaccine or inactivated vaccine within 14 days prior to study entry; 4. any immunosuppressant within 6 month prior to study entry; * congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor; * history of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders; * acute disease or acute stage of chronic disease within 7 days prior to study entry; * axillaty temperature \> 37.0 °c; * any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study; * participants with the following conditions from day 0 - 28 would be included in the full analysis set (fas), but would be excluded from the per protocol set (pps): 1. receipt of any other investigational or unregistered product (drug or vaccine); 2. receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for \> 14 days, except for inhalant or locally administrated corticosteroid; 3. receipt of immunoglobulin and/or blood product; 4. newly diagnosed autoimmune disease or immunodeficiency (e.g., hiv infection);