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).
A total of approximately 500 infants 6-8 weeks of age (WOA) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 250 participants in each group.The study group will receive study PCV13 vaccine and control group will receive Prevenar13® vaccine at 2, 4 and 12-15 months of age (MOA, as early as 6 weeks of age as per WHO recommendations for administration of PCV to infants). Hexavalent vaccine will be injected at 2, 3 and 4 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
500
2P+1 programme of PCV13
Faculty of Medicine Udayana University
Denpasar, Bali, Indonesia
NOT_YET_RECRUITINGUniversitas Padjadjaran Bandung
Bandung, Bandung, Indonesia
NOT_YET_RECRUITINGFaculty of Medicine, padjadjaran University
Bandung, Bandung, Indonesia
RECRUITINGImmugenocity
1\. To evaluate the serotype-specific IgG responses 30 days after booster dose of the investigational vaccine.
Time frame: 1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after the booster dose of the investigational vaccine. 2. GMC ratio of serotype-specific IgG responses 30 days after the booster dose of the investigat
Safety
1.To assess the solicited AEs (local and systemic) occurring 0-7 days after each dose of the investigational vaccine.
Time frame: 1.Incidence, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of the investigational vaccine in all participants.
Safety
2\. To assess the unsolicited AEs occurring 0-30 days after each dose of the investigational vaccine.
Time frame: 2. Incidence, severity, and causality of unsolicited AEs within 30 days after each dose of the investigational vaccine in all participants.
Safety
3\. To assess SAE from 1st dose to 6 months after booster dose of the investigational vaccine.
Time frame: 3. Incidence, severity, and causality of SAEs 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.
Time frame: 1. Percentage of participants with serotype-specific IgG concentrations ≥ 0.35 μg/mL, measured 30 days after 2nd dose of the investigational vaccine. 2. GMC of serotype-specific IgG responses 30 days after 2nd dose of the investigational vaccine. 3. Pe
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