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.
Parallel
pneumococcal disease prevention
Biological/Vaccine2P+1 programme of PCV13
Immugenocity
1\. To evaluate the serotype-specific IgG responses 30 days after booster dose of the investigational vaccine.
Safety
1.To assess the solicited AEs (local and systemic) occurring 0-7 days after each dose of the investigational vaccine.
Safety
2\. To assess the unsolicited AEs occurring 0-30 days after each dose of the investigational vaccine.
Safety
3\. To assess SAE from 1st dose to 6 months after booster dose of the investigational vaccine.
Immugenocity
1. To evaluate the serotype-specific IgG responses 30 days after 2nd dose of the investigational vaccine. 2. To evaluate the serotype-specific Opsonophagocytic Activicity (OPA) 30 days after the 2nd dose, before the booster dose, and 30 days after the booster dose of the investigational vaccine in OPA subgroup. 3. To evaluate the immune responses induced by hexavalent vaccine 30 days after the 2nd dose of the investigational vaccine in different subsets.
Click on the lead sponsor to view all of their trials.
