Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above
Pneumonia
About this trial
This is an interventional prevention trial for Pneumonia
Eligibility Criteria
Inclusion Criteria: ≥2 years old healthy population; Subjects and/or guardians or trustees voluntarily signed informed consent forms and could comply with the requirements of the clinical trial protocol; Had not received any pneumonia vaccine in the last 5 years; Note: Healthy people do not include the following conditions: ① congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ② History of epilepsy and mental illness; ③ Patients with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases; ⑤ serious liver and kidney diseases, malignant tumors, all kinds of acute diseases or in the acute phase of chronic disease; Adults have diabetes, severe cardiovascular disease, and high blood pressure (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) that cannot be controlled by medication. Exclusion Criteria: Armpit temperature >37.0℃ before inoculation; Family history of seizures or convulsions, epilepsy, and mental illness; People with a progressive neurological disorder or a history of Guillain-Barre syndrome; The patients with clinically significant abnormalities in blood biochemistry and routine blood tests were tested before vaccination; People who received immunoenhancement or suppressant therapy within 3 months (continuous oral or intravenous infusion for more than 14 days); History of abnormal coagulation function (such as deficiency of coagulation factor, coagulation disease); Primary and secondary immunocompromised individuals (thyroid, pancreas, liver, spleen excision history, or need treatment for thyroid disease within the last 12 months); History of severe allergic reactions to vaccinations; Allergy to any component of the investigational vaccine; Have received live attenuated vaccine within 14 days; Other vaccines received within 7 days; Participating in or planning to participate in other clinical trials; Women of childbearing age are lactating, pregnant or planning to become pregnant in the near future; The investigator determined that other conditions were not suitable for participation in the clinical trial.
Sites / Locations
- Ab&b Biotechnology Co., Ltd.JS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Experimental group aged 18-59 years
Control group aged 18-59 years
Experimental group aged ≥60 years
Control group aged ≥60 years
Experimental group aged 2-17 years
Control group aged 2-17 years
Subjects in the age group 18-59 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Subjects in the age group 18-59 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Subjects in the age group ≥60 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Subjects in the age group ≥60 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Subjects in the age group 2-17 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Subjects in the age group 2-17 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent