Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above

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.