This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.
Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Incidence rate of solicited local adverse events(AEs)
All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Time frame: 7 days after vaccination
Incidence rate of solicited systemic AEs
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Time frame: 7 days after vaccination
Incidence rate of unsolicited AEs
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Time frame: 21 days after vaccination
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]
The proportion of subjects with post-vaccination HI titers of ≥1:40
Time frame: 21-28 days after vaccination
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were \<1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
Time frame: 21-28 days after vaccination
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9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
The mean increase in geometric mean HI titer
Time frame: 21-28 days after vaccination