Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults (NCT NCT02480998)
NCT ID: NCT02480998
Last Updated: 2020-08-11
Results Overview
Percentage of subjects achieving seroconversion\* for HI antibody after vaccination
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
84 participants
Primary outcome timeframe
28 days
Results posted on
2020-08-11
Participant Flow
Participant milestones
| Measure |
IL-YANG Flu Vaccine QIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine QIV 0.5mL
|
IL-YANG Flu Vaccine TIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine TIV 0.5mL
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
28
|
|
Overall Study
COMPLETED
|
56
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults
Baseline characteristics by cohort
| Measure |
IL-YANG Flu Vaccine QIV 0.5mL
n=56 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine QIV 0.5mL
|
IL-YANG Flu Vaccine TIV 0.5mL
n=28 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine TIV 0.5mL
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.77 years
STANDARD_DEVIATION 7.01 • n=5 Participants
|
27.75 years
STANDARD_DEVIATION 8.48 • n=7 Participants
|
27.10 years
STANDARD_DEVIATION 7.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPercentage of subjects achieving seroconversion\* for HI antibody after vaccination
Outcome measures
| Measure |
IL-YANG Flu Vaccine QIV 0.5mL
n=56 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine QIV 0.5mL
|
IL-YANG Flu Vaccine TIV 0.5mL
n=28 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine TIV 0.5mL
|
|---|---|---|
|
Seroconversion Rate
H1N1
|
58.93 percentage of participants
Interval 46.04 to 71.81
|
64.29 percentage of participants
Interval 46.54 to 82.03
|
|
Seroconversion Rate
H3N2
|
64.29 percentage of participants
Interval 51.74 to 76.84
|
53.57 percentage of participants
Interval 35.1 to 72.04
|
|
Seroconversion Rate
B/Yamagata
|
55.36 percentage of participants
Interval 42.34 to 68.38
|
35.71 percentage of participants
Interval 17.97 to 53.46
|
|
Seroconversion Rate
B/Victoria
|
46.43 percentage of participants
Interval 33.37 to 59.49
|
14.29 percentage of participants
Interval 1.32 to 27.25
|
PRIMARY outcome
Timeframe: 28 daysPercentage of subjects achieving seroprotection\* for HI antibody after vaccination
Outcome measures
| Measure |
IL-YANG Flu Vaccine QIV 0.5mL
n=56 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine QIV 0.5mL
|
IL-YANG Flu Vaccine TIV 0.5mL
n=28 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine TIV 0.5mL
|
|---|---|---|
|
Seroprotection Rate
H1N1
|
94.64 percentage of participants
Interval 88.75 to 100.0
|
85.71 percentage of participants
Interval 72.75 to 98.68
|
|
Seroprotection Rate
H3N2
|
96.43 percentage of participants
Interval 91.57 to 100.0
|
82.14 percentage of participants
Interval 67.96 to 96.33
|
|
Seroprotection Rate
B/Yamagata
|
87.50 percentage of participants
Interval 78.84 to 96.16
|
78.57 percentage of participants
Interval 63.37 to 93.77
|
|
Seroprotection Rate
B/Victoria
|
78.57 percentage of participants
Interval 67.82 to 89.32
|
64.29 percentage of participants
Interval 46.54 to 82.03
|
SECONDARY outcome
Timeframe: 28 daysGeometric Mean Ratio of post vaccination HI geometric mean titers
Outcome measures
| Measure |
IL-YANG Flu Vaccine QIV 0.5mL
n=56 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine QIV 0.5mL
|
IL-YANG Flu Vaccine TIV 0.5mL
n=28 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine TIV 0.5mL
|
|---|---|---|
|
GMR
H1N1
|
5.32 Ratio of GMT titer
Interval 3.39 to 8.35
|
8.41 Ratio of GMT titer
Interval 4.71 to 15.01
|
|
GMR
H3N2
|
6.90 Ratio of GMT titer
Interval 4.25 to 11.19
|
6.73 Ratio of GMT titer
Interval 3.411 to 14.57
|
|
GMR
B/Massachusetts
|
3.85 Ratio of GMT titer
Interval 2.82 to 5.27
|
2.90 Ratio of GMT titer
Interval 1.67 to 5.03
|
|
GMR
B/Brisbane
|
3.20 Ratio of GMT titer
Interval 2.52 to 4.06
|
2.00 Ratio of GMT titer
Interval 1.4 to 2.85
|
SECONDARY outcome
Timeframe: 28 daysGeometric Mean Titer of post vaccination HI geometric mean titers
Outcome measures
| Measure |
IL-YANG Flu Vaccine QIV 0.5mL
n=56 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine QIV 0.5mL
|
IL-YANG Flu Vaccine TIV 0.5mL
n=28 Participants
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine TIV 0.5mL
|
|---|---|---|
|
GMT
H1N1
|
128 HI titer of post vaccination
Interval 97.31 to 168.5
|
110.40 HI titer of post vaccination
Interval 69.3 to 175.8
|
|
GMT
H3N2
|
176.70 HI titer of post vaccination
Interval 132.1 to 234.2
|
128.00 HI titer of post vaccination
Interval 69.42 to 236.2
|
|
GMT
B/Massachusetts
|
73.36 HI titer of post vaccination
Interval 58.97 to 91.27
|
51.24 HI titer of post vaccination
Interval 32.99 to 79.57
|
|
GMT
B/Brisbane
|
52.52 HI titer of post vaccination
Interval 44.21 to 62.39
|
36.23 HI titer of post vaccination
Interval 28.51 to 46.03
|
Adverse Events
IL-YANG Flu Vaccine QIV 0.5mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IL-YANG Flu Vaccine TIV 0.5mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr.Dong-suck Lim, CI
The catholic university of Korea, Seoul ST. Marry's Hospital
Phone: +82-2-2258-7327
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place