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

Inclusion criteria

Primary immunization phase:

• The subject's legal guardian voluntarily agreed to allow his child to participate in the study and signed an informed consent form.
• The subject's legal guardian has the ability to understand the study procedures and to participate in all planned follow-up visits.
• Full-term pregnancy (37 weeks to 42 weeks gestation) and the birth weight was 2500g~4000g.
• On the day of the first dose of vaccination, it meets the observation age of this clinical trial (2~3 months of age, with a minimum of 6 weeks) and be able to provide legal identification;
• Not having received a non-live vaccine within 7 days prior to enrollment and not having received a live vaccine within 14 days;
• The body temperature <37.5°C (axillary body temperature) on the day of enrollment.

Booster immunization phase:

• Infants and children who have completed the full process of basic immunization in this clinical trial and are 12 to 15 months of age;
• According to the opinion of the investigator, the subject's legal guardians and their families can comply with the requirements of the clinical trial protocol.

Exclusion criteria

Primary immunization phase:

• 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;
• 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);
• 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);
• 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);
• Have received blood or blood-related products or immunoglobulin treatment before joining the group (hepatitis B immunoglobulin is acceptable);
• Suffering from severe congenital malformation, severe developmental disorders, serious genetic diseases (such as severe thalassemia), severe malnutrition, etc.;
• Suffering from infectious diseases such as tuberculosis and viral hepatitis, or parents infected with human immunodeficiency virus;
• Having contraindications to intramuscular injections such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
• Those with a history or family history of convulsions, epilepsy, encephalopathy and psychosis;
• Asplenia, functional asplenia, and asplenia or splenectomy for any reason;
• 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:

• Subject received any other pneumonia vaccine after primary immunization and before booster immunization;
• Subject has received blood or blood-related products or immunoglobulin treatment within 3 months before booster immunization;
• 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;
• According to the researcher's judgment, the subjects have any other factors that are not suitable for clinical trials.