phase-1 study pneumococcal conjugate vaccine study in healthy adults
A Study to Evaluate the Safety and Immunogeneicity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Solicited adverse events
Solicited adverse events
Time frame: Baseline(pre-vaccination) up to 7 days after
Unsolicited adverse events
Unsolicited adverse events
Time frame: Baseline(pre-vaccination) up to 4 weeks after vaccination
Immediate reactions after vaccination
Immediate reactions after vaccination
Time frame: Baseline(pre-vaccination) up to 30 minutes after vaccination
Serotype-Specific Pneumococcal immunoglobulin G antibody Geometric Mean Concentrations (GMCs) 4 weeks After Vaccination
GMC
Time frame: 4 weeks After Vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 4 weeks After Vaccination
GMT
Time frame: 4 weeks After Vaccination
Proportion of subjects achieving 4-fold rise in Pneumococcal Opsonophagocytic Activity (OPA) titer at 4 weeks after vaccination
OPA titer
Time frame: 4 weeks after vaccination
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