The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT) as compared to Pfizer's 13-valent pneumococcal conjugate vaccine (PCV13) when co-administered with local EPI 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-TT as compared to PCV13 one month after the booster dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
630
PCV13-TT is supplied as 0.5 mL prefill syringe (PFS), with 0.5 mL suspension for intramuscular injection. After shaking, the vaccine is a homogenous, white suspension. Each dose (0.5 mL) of PCV13-TT contains pneumococcal polysaccharide serotypes 1, 3 4, 5, 6A 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F which are conjugated to TT carrier protein individually. The vaccine is formulated in phosphate-buffered saline containing 4.25 mg/dose sodium chloride (NaCl), 44.35 μg/dose sodium dihydrogen phosphate (NaH2PO4), 19.0 μg/dose disodium hydrogen phosphate (Na2HPO4), and contains 0.5 mg/dose of aluminum phosphate as an adjuvant; no preservatives added.
PCV13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes. Each 0.5 mL dose of PCV13 is formulated to contain approximately 2.2 μg of each of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F polysaccharides, 4.4 μg of 6B polysaccharides, 34 μg 26 CRM197 carrier protein, 100 μg polysorbate 80, 295 μg succinate buffer and 125 μg aluminum as aluminum phosphate adjuvant.
RSUP Prof. Dr. I.G.N.G Ngoerah
Denpasar, Bali, Indonesia
Ilmu Kesehatan anak FKUI RSCM
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Immunogenicity and non-inferiority as measured by serotype-specific IgG
Percentage of infants with serotype-specific IgG concentrations ≥0.35 μg/mL
Time frame: 1 month after the booster dose
Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
Serotype-specific IgG GMCs
Time frame: 1 month after the booster dose
Solicited local and systemic adverse events after each dose
Frequency and severity of solicited local and systemic adverse events (AEs)
Time frame: within 30 min and 7 days after each dose
Unsolicited adverse events after each dose
Frequency and severity of unsolicited AEs
Time frame: within 30 days after each dose
Serious adverse events throughout the study
Frequency of serious AEs (SAEs)
Time frame: from dose 1 until 6 months after booster dose
Immune response to primary series as measured by serotype-specific IgG
Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL
Time frame: 1 month after the 2nd dose
Immune response to primary series as measured by serotype-specific IgG GMC
Serotype-specific IgG GMCs
Time frame: 1 month after the 2nd dose
Functional antibody responses as measured by serotype-specific OPA titer
Percentage of infants with serotype-specific OPA titer ≥1:8
Time frame: baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose
Functional antibody responses as measured by serotype-specific OPA geometric mean titers (GMTs)
Serotype-specific OPA geometric mean titers (GMTs)
Time frame: baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose
Immune persistence as measured by serotype-specific IgG
Percentage of infants with pneumococcal serotype-specific IgG concentrations ≥0.35 µg/mL
Time frame: 12-15 months of age, before the booster dose
Immune persistence as measured by serotype-specific IgG GMC
Serotype-specific IgG GMCs
Time frame: 12-15 months of age, before the booster dose
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