This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.
Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. 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. The serious adverse events are collected during 6 months post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
454
For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
CHMP criteria
Seroprotection rate \> 70%, Seroconversion rate \> 40%, GMR \> 2.5
Time frame: At Day 28 post-vaccination
Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80
Time frame: At Day 28 post-vaccination
Immunogenicity compared to control group
Time frame: At Day 28 post-vaccination
Incidence rate of Advers Event (AE)
Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE
Time frame: During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE
Incidence rate of Severe Adverse Event (SAE)
Time frame: During 6 months post-vaccination
Vital Sign
Time frame: At Day 0 and at Day 28 post-vaccination
Physical Examination
Time frame: At Day 0 and at Day 28 post-vaccination
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