The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
230
LG chem
Seoul, Gangseo-Gu, South Korea
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
Time frame: 4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
Time frame: 4 weeks after 3rd(last) vaccination
Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
Time frame: 4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
Time frame: 4 weeks after 3rd(last) vaccination
Solicited adverse events
Time frame: Baseline(pre-vaccination) up to 7 days after each vaccination
Unsolicited adverse events
Time frame: Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination
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