immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine

Conditions: Pneumococcal Infections

Summary: this is a randomized, double-blind, positive-controlled phase ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by sinovac biotech co., ltd.the purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.

this study is a randomized, double-blind, positive-controlled phase ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.the experimental vaccine was manufactured by sinovac biotech co., ltd,the control vaccine was manufactured by merck sharp \& dohme.a total of 1800 subjects including 900 subjects aged 2\~17 years,360 subjects aged 18\~59 years and 540 subjects aged 60 years and above will be enrolled.subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.

Eligibility criteria:
inclusion criteria: * children aged 2 years and above in stable health; * the subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form.if the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself); * proven legal identity. exclusion criteria: * have received any pneumococcal vaccine; * history bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture. * women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month; * history of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema; * severe chronic diseases,such as severe cardiovascular diseases, hypertension(systolic blood pressure ≥140mmhg and/or diastolic blood pressure ≥90mmhg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.; * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; * immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; * a long history of alcohol or drug abuse; * receipt of blood products within in the past 3 months; * receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine; * receipt of attenuated live vaccines or covid-19 vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days; * onset of various acute or chronic diseases within 3 days prior to the study; * underarm body temperature before vaccination\>37.0°c; * the subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.