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Immunogenicity results: Immunogenicity of SKYVaricella was assessed with a multi-national, randomized, double-blind, active controlled, parallel clinical trial in healthy children 12 months to 12 years of age. The primary immunogenicity analysis was performed for 458 subjects in per protocol set (PPS) and non-inferiority in seroconversion rate was proven by fluorescent antibody to membrane antigen (FAMA) assay. FAMA assay results in phase III clinical trial are presented in table as follows. (See Table 1.)
Click on icon to see table/diagram/imagePharmacokinetics: Not applicable.
Toxicology: Preclinical Safety Data: The results from safety pharmacology studies (cardiovascular, respiratory and central nervous systems), single and repeated dose toxicity studies, and reproductive and developmental toxicity studies showed no potential adverse effects in humans.
