A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered with Hexavalent Vaccine At 2, 4 and 12-15 Months of Age to Healthy Infants in Indonesia
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.).
• Infant's parent(s) or legal guardian must be able and willing to provide voluntary written/thumb-printed informed consent for the infant to participate in the study.
• Infant's parent(s) or legal guardian must be willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
• The infant's mother must provide related medical certificate(s) for the negative results for HIV, HBV and syphilis infection within 1 year prior to screening.
• Infant's parent(s) or legal guardian must have a readily identifiable place of residence in the study area, be available for the duration of trial participation, and have a means of telephone contact.
⁃ Note: For items with an asterisk (\*), If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.