The purpose of this study was to evaluate the antibody response to each of the four influenza vaccine strains included in the study vaccine, as measured by hemagglutination inhibition (HAI) at 4 weeks after the last dose of the study vaccine in young subjects aged between 3 years old and 17 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
174
This was an open study to demonstrate the use of AdimFlu-S (QIS) (2016-2017 season) vaccine in young subjects aged between 3 years old to 17 years old. All subjects were divided into two subgroups. That were subjects aged 3 to 8 years old, who received 2 doses of 0.5 mL vaccine separated by 4 weeks, and subjects aged 9 to 17 years old, who received one dose of 0.5 mL vaccine.
Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroconversion rate
The primary endpoint of immunogenicity evaluation was the seroconversion rate
Time frame: Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization
Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by geometric mean folds increase
The primary endpoint of immunogenicity evaluation was the geometric mean folds increase
Time frame: Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization
Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroprotection rate
The secondary endpoint of immunogenicity evaluation was the seroprotection rate
Time frame: Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization
Evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S (QIS)
Evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of QIS. Reactogenicity events were pre-specified adverse events systematically recorded on diary cards during post-vaccination period by all participants for 7 days after each vaccination. Unsolicited adverse events were recorded on the diary card till 28 days post vaccination, while serious adverse events should be recorded throughout the study period
Time frame: In regard to the long term safety of the study vaccine, the significant and/or serious adverse event(s) will be recorded during the 6 months follow up after the scheduled last vaccination
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