A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

Inclusion Criteria:

1. Healthy infants aged 2 months (42-89 days); Healthy children aged 2-5 years.

2. Proven vaccination certificate, birth certificate and legal identification documents

3. The participants' guardians can understand and voluntarily sign the informed consentform.

4. Participants and their guardians can obey requirements of the protocol.

Exclusion Criteria:

1. Received any pneumococcal vaccine prior to enrollment.

2. History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.

3. History of allergy to the vaccine or vaccine components, including pneumococcalpolysaccharide for each serotype, diphtheria CRM197, aluminum phosphate, succinicacid, polysorbate 80 and sodium chloride; or serious adverse reactions to thevaccine, such as urticaria, dyspnea, angioedema and asthma.

4. History of dystocia, asphyxia rescue, nervous system damage at birth (onlyapplicable to infants aged 2 months (42-89 days))

5. Congenital malformations or developmental disorders, genetic defects, severemalnutrition, asthma etc.

6. Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/immunosuppression (such as HIV, organ transplantation)

7. Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases,malignant tumors.

8. Family history of mental illness, severe neurological disease (epilepsy orconvulsions) or mental illness.

9. History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomyresulting from any condition.

10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulationfactors, blood coagulopathy, abnormal platelets), history of obvious bleeding orbruising after intramuscular injection or venipuncture.

11. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years ofage 6 months prior to enrollment had been treated with corticosteroids, otherimmunosuppressive agents (excluding corticosteroid spray therapy for allergicrhinitis, superficial corticosteroid therapy for acute non-concurrent dermatitis) orcytotoxic therapy for ≥14 days

12. Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years ofage 3 months prior to enrollment received blood products within the past 3 months (excluding hepatitis B immunoglobulin within 1 month).

13. Receipt of other investigational drugs in the past 60 days or have the plan toparticipate in other clinical trials during this study.

14. Receipt of attenuated live vaccines in the past 14 days.

15. Receipt of inactivated or subunit vaccines in the past 7 days.

16. Acute diseases or acute exacerbation of chronic diseases in the past 7 days.

17. Axillary temperature ≥37.3 °C.

18. According to the investigator's judgment, the subject has any other factors that arenot suitable for participating in the clinical trial.