SKYCellflu Quadrivalent Prefilled Syringe Mechanism of Action

Pharmacotherapeutic group: Influenza vaccine. ATC code: J07BB02.
Pharmacology: Pharmacodynamics: The efficacy of SKYCellflu Quadrivalent is supported by the immunogenicity data from a Phase I/II clinical trial and three Phase III clinical trials. The immunogenicity was assessed based on the seroprotection rate, seroconversion rate, GMR (Geometric Mean Ratio) and GMT (Geometric Mean Titer), in which were calculated using pre-vaccination and post-vaccination of HI (Hemagglutination inhibition) antibody titers. Throughout the Phase III clinical trials, the immunogenicity was evaluated in total of 1,435 subjects who completed the clinical trial without any major protocol violations. Data obtained from 1,435 subjects administered with SKYCellflu Quadrivalent were as follows.
Adults and elderly aged 19 years or older: Immunogenicity was assessed on 1,495 subjects (Test group: 748 subjects, Control group 1: 371 subjects, Control group 2: 376 subjects) included in the per protocol study (PPS), and the pre-determined efficacy criteria for this vaccine were met and the criteria for non-inferiority and superiority were also met. (See Table 1.)

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Children and adolescents aged 3 to 18 years: Immunogenicity was assessed on 314 subjects (Test group: 253 subjects, Control group: 61 subjects) included in the PPS, and the pre-determined efficacy criteria for this drug were met. (See Table 2.)

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Children aged 6 months to 35 months of age: Immunogenicity was assessed on 653 subjects (Test group: 434 subjects, Control group: 219 subjects) included in the PPS, and the pre-determined efficacy criteria for this drug were met and the criteria for non-inferiority and superiority were also met. (See Table 3.)

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In conclusion, the immunogenicity results of four clinical trials suggest that SKYCellflu Quadrivalent has a satisfactory immunogenicity profile for all four strains (A/H1N1, A/H3N2, B/Yamagata and B/Victoria).
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Nonclinical data reveal no special hazard based on conventional repeat dose toxicity studies. SKYCellflu Quadrivalent was well tolerated and immunogenic in mice. In a repeat-dose toxicity study in rabbits and mice, there was no evidence of systemic toxicity and the vaccine was locally well tolerated.
No evidence of reproductive or developmental toxicity was seen in a study where the human dose was administered prior to and during gestation to female rabbits.