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

Inclusion Criteria:

Primary immunization phase:

1. The subject's legal guardian voluntarily agreed to allow his child to participate inthe study and signed an informed consent form.

2. The subject's legal guardian has the ability to understand the study procedures andto participate in all planned follow-up visits.

3. Full-term pregnancy (37 weeks to 42 weeks gestation) and the birth weight was 2500g~4000g.

4. On the day of the first dose of vaccination, it meets the observation age of thisclinical trial (2~3 months of age, with a minimum of 6 weeks) and be able to providelegal identification;

5. Not having received a non-live vaccine within 7 days prior to enrollment and nothaving received a live vaccine within 14 days;

6. The body temperature <37.5°C (axillary body temperature) on the day of enrollment.

Booster immunization phase:

1. Infants and children who have completed the full process of basic immunization inthis clinical trial and are 12 to 15 months of age;

2. According to the opinion of the investigator, the subject's legal guardians andtheir families can comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

Primary immunization phase:

1. The baby is born in abnormal labor (dystocia, instrumental delivery) or has ahistory of asphyxia and nervous system damage, and is now suffering from pathologicjaundice, perianal abscess and severe eczema;

2. Have been vaccinated against pneumococcus in the past or have a history of invasivediseases 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 anaphylacticshock, allergic laryngeal edema, allergic purpura and local allergic necrosisreaction (Arthus reaction);

4. Suffering from congenital or acquired immunodeficiency, or receivingimmunosuppressant 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 beforejoining 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, orparents infected with human immunodeficiency virus;

8. Having contraindications to intramuscular injections such as thrombocytopenia, anycoagulation disorder or receiving anticoagulant therapy;

9. Those with a history or family history of convulsions, epilepsy, encephalopathy andpsychosis;

10. Asplenia, functional asplenia, and asplenia or splenectomy for any reason;

11. Subjects with other safety risks or conditions that, in the opinion of theinvestigator, 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 beforebooster immunization;

2. Subject has received blood or blood-related products or immunoglobulin treatmentwithin 3 months before booster immunization;

3. The subjects have known or suspected immunological functional defects since theyparticipated in this clinical trial, including receiving immunosuppressant treatment (such as systemic glucocorticoid treatment for more than 2 weeks in one month beforevaccination, such as prednisone or similar drugs > 5mg/day) and their parents areHIV-infected;

4. According to the researcher's judgment, the subjects have any other factors that arenot suitable for clinical trials.