Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine
Pneumococcal Infections
About this trial
This is an interventional prevention trial for Pneumococcal Infections
Eligibility Criteria
Inclusion Criteria: Adults aged 40-65 years in stable health; The subjects can understand and voluntarily sign the informed consent form; 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; Autoimmune disease or immune deficiency/immunosuppression; 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 7 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.
Sites / Locations
- The First People's Hospital of Yuanping Medical Group
- Salt Lake District Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Experimental Vaccine-lot 1
Experimental Vaccine-lot 2
Experimental Vaccine-lot 3
Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 1.
Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 2.
Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 3.