A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfizer's PCV13

Exclusion Criteria

• •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
• •1. Use of any investigational medicinal product prior to randomization or planned use of such a product during the period of study participation.
• •2. History of S. pneumoniae infection as confirmed by medical enquiry or as confirmed by laboratory testing if available.
• •3. Participant has fever (axillary temperature ≥ 37.5℃) within 24 hours prior to the 1st dose of vaccination; (If the subject does not meet the criteria, the visit may be rescheduled when the criteria are met.)
• •4. The infant who are children in care, preterm and low-birth-weight(Preterm infants have a gestational age below 37 weeks at birth and low-birth-weight infants have a birth weight below 2.5 kg).
• •5. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the 2 study vaccines. This includes all components of the EPI vaccines.
• •6. History of anaphylactic shock.
• •7. Any abnormal vital sign.
• •8. Any moderate or severe acute illness.
• •9. History of administration of a non-study vaccine within 30 days prior to administration of study vaccine, other than EPI vaccinations (Note: EPI vaccines other than that stipulated in the study must be given at least 14 days prior to the investigational vaccine.)
• •10. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for 14 days at a dose of 20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids within indicated dosage are permitted.
• •11. Administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
• •12. History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia at birth).
• •13. History of suspected primary immunodeficiency.
• •14. History of meningitis, seizures or any neurological disorder.
• •15. A family history of congenital or hereditary immunodeficiency.
• •16. The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel.
• •17. Any medical or social condition that in the opinion of the investigator may compromise the well-being of the study participant, interfere with the study objectives, pose a risk to the study participant, or prevent the study participant from completing the study follow-up.