Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants

Exclusion Criteria

• •Primary immunization phase:
• •1. The baby is born in abnormal labor (dystocia, instrumental delivery) or has a history of asphyxia and nervous system damage, and is now suffering from pathologic jaundice, perianal abscess and severe eczema;
• •2. Have been vaccinated against pneumococcus in the past or have a history of invasive diseases caused by pneumococcus in the past (confirmed by either clinical, serological or microbiological methods);
• •3. Previous history of severe allergy to any vaccine or drug, such as anaphylactic shock, allergic laryngeal edema, allergic purpura and local allergic necrosis reaction (Arthus reaction);
• •4. Suffering from congenital or acquired immunodeficiency, or receiving immunosuppressant treatment, such as systemic glucocorticoid treatment for more than 2 weeks one month before vaccination, such as prednisone or similar drugs \> 5mg/day (use of local and inhaled/atomized steroids is eligible for enrollment);
• •5. Have received blood or blood-related products or immunoglobulin treatment before joining the group (hepatitis B immunoglobulin is acceptable);
• •6. Suffering from severe congenital malformation, severe developmental disorders, serious genetic diseases (such as severe thalassemia), severe malnutrition, etc.;
• •7. Suffering from infectious diseases such as tuberculosis and viral hepatitis, or parents infected with human immunodeficiency virus;
• •8. Having contraindications to intramuscular injections such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
• •9. Those with a history or family history of convulsions, epilepsy, encephalopathy and psychosis;
• •10. Asplenia, functional asplenia, and asplenia or splenectomy for any reason;
• •11. Subjects with other safety risks or conditions that, in the opinion of the investigator, may interfere with the assessment of the purpose of the study.
• •Booster immunization phase:
• •1. Subject received any other pneumonia vaccine after primary immunization and before booster immunization;
• •2. Subject has received blood or blood-related products or immunoglobulin treatment within 3 months before booster immunization;
• •3. The subjects have known or suspected immunological functional defects since they participated in this clinical trial, including receiving immunosuppressant treatment (such as systemic glucocorticoid treatment for more than 2 weeks in one month before vaccination, such as prednisone or similar drugs \> 5mg/day) and their parents are HIV-infected;
• •4. According to the researcher's judgment, the subjects have any other factors that are not suitable for clinical trials.