The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent Vaccines at 2,4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-DT/TT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).
Healthy infants based on medical history and clinical assessment.
Infants age of 6-8 weeks at enrolment. Infants will be eligible since the day they reach 6 weeks of age and until 8 weeks of age included.
*Body weight at enrollment ≥3.0 kg (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).
*On the day of vaccination and within 3 days prior to 1st dose of vaccination, axillary temperatures <37.5°C/99.1°F (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).
Use of any investigational product other than that used in the study prior to randomization or planned use of such a product during the period of study participation.
History of S. pneumoniae infection as confirmed by laboratory testing if available.
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).
History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine. And/or all components of the hexavalent vaccine.