Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.' (NCT NCT02677493)
NCT ID: NCT02677493
Last Updated: 2023-09-28
Results Overview
Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer \< 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1794 participants
Primary outcome timeframe
Day 28
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1197
|
298
|
299
|
|
Overall Study
COMPLETED
|
1186
|
296
|
296
|
|
Overall Study
NOT COMPLETED
|
11
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.'
Baseline characteristics by cohort
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=1197 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=298 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=299 Participants
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
Total
n=1794 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1015 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
1522 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
182 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
812 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
1224 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
385 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
570 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.
Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer \< 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.
Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=1175 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=293 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=294 Participants
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Rate of Healthy Adults Aged ≥19 Years With Seroconversion
A/H1N1
|
47.7 percentage of subjects
Interval 44.9 to 50.6
|
49.5 percentage of subjects
Interval 43.6 to 55.4
|
49.0 percentage of subjects
Interval 43.1 to 54.8
|
|
Rate of Healthy Adults Aged ≥19 Years With Seroconversion
A/H3N2
|
78.7 percentage of subjects
Interval 76.3 to 81.0
|
81.6 percentage of subjects
Interval 76.6 to 85.8
|
77.9 percentage of subjects
Interval 72.7 to 82.5
|
|
Rate of Healthy Adults Aged ≥19 Years With Seroconversion
B/Yamagata
|
51.8 percentage of subjects
Interval 48.9 to 54.7
|
54.9 percentage of subjects
Interval 49.1 to 60.7
|
23.1 percentage of subjects
Interval 18.4 to 28.4
|
|
Rate of Healthy Adults Aged ≥19 Years With Seroconversion
B/Victoria
|
47.7 percentage of subjects
Interval 44.9 to 50.6
|
24.2 percentage of subjects
Interval 19.4 to 29.6
|
54.8 percentage of subjects
Interval 48.9 to 60.5
|
PRIMARY outcome
Timeframe: Day 28Population: The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.
Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.
Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=1175 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=293 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=294 Participants
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Rate of Healthy Adults Aged ≥19 Years With Seroprotection
A/H3N2
|
90.0 percentage of subjects
Interval 88.1 to 91.6
|
92.5 percentage of subjects
Interval 88.9 to 95.2
|
89.5 percentage of subjects
Interval 85.4 to 92.7
|
|
Rate of Healthy Adults Aged ≥19 Years With Seroprotection
A/H1N1
|
88.2 percentage of subjects
Interval 86.2 to 90.0
|
89.4 percentage of subjects
Interval 85.3 to 92.7
|
87.1 percentage of subjects
Interval 82.7 to 90.7
|
|
Rate of Healthy Adults Aged ≥19 Years With Seroprotection
B/Yamagata
|
86.3 percentage of subjects
Interval 84.2 to 88.2
|
88.4 percentage of subjects
Interval 84.2 to 91.8
|
64.6 percentage of subjects
Interval 58.9 to 70.1
|
|
Rate of Healthy Adults Aged ≥19 Years With Seroprotection
B/Victoria
|
84.9 percentage of subjects
Interval 82.8 to 86.9
|
69.3 percentage of subjects
Interval 63.7 to 74.5
|
85.7 percentage of subjects
Interval 81.2 to 89.5
|
SECONDARY outcome
Timeframe: Day 28Population: Rate of healthy adults aged ≥19 \~ \<65 years
The percentage of subjects with HI antibody SCR on Day 28 after vaccination of the investigational product was calculated and its 95% two-sided CI was presented for each strain by treatment group and by age group. The immunogenicity of the test vaccine was to be demonstrated if the lower limit of the 95% two-sided CI by age group was higher than the above mentioned criteria (40% for \< 65 years of age, 30% for ≥ 65 years of age) in each treatment group.
Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=996 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=251 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=249 Participants
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group
Strain H1N1
|
48.7 percentage of participants
Interval 45.5 to 51.8
|
51.8 percentage of participants
Interval 45.4 to 58.1
|
51.8 percentage of participants
Interval 45.4 to 58.2
|
|
Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group
Strain H3N2
|
80.3 percentage of participants
Interval 77.7 to 82.7
|
83.3 percentage of participants
Interval 78.1 to 87.7
|
78.7 percentage of participants
Interval 73.1 to 83.6
|
|
Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group
Strain B Yamagata
|
52.3 percentage of participants
Interval 49.2 to 55.5
|
54.6 percentage of participants
Interval 48.2 to 60.9
|
24.5 percentage of participants
Interval 19.3 to 30.3
|
|
Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group
Strain B Victoria
|
48.3 percentage of participants
Interval 45.1 to 51.4
|
27.5 percentage of participants
Interval 22.1 to 33.5
|
56.6 percentage of participants
Interval 50.2 to 62.9
|
SECONDARY outcome
Timeframe: Day 28Population: Rate of healthy adults aged ≥65 years
Seroprotection is defined as follows. subjects who have a post-vaccination (Day 28) HI antibody titer ≥ 1: 40
Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=179 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=42 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=45 Participants
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.
Strain B Victoria
|
44.7 percentage of participants
Interval 37.3 to 52.3
|
4.8 percentage of participants
Interval 0.6 to 16.2
|
44.4 percentage of participants
Interval 29.6 to 60.0
|
|
Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.
Strain H3N2
|
69.8 percentage of participants
Interval 62.5 to 76.5
|
71.4 percentage of participants
Interval 55.4 to 84.3
|
73.3 percentage of participants
Interval 58.1 to 85.4
|
|
Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.
Strain B Yamagata
|
49.2 percentage of participants
Interval 41.6 to 56.7
|
57.1 percentage of participants
Interval 41.0 to 72.3
|
15.6 percentage of participants
Interval 6.5 to 29.5
|
|
Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.
Strain H1N1
|
42.5 percentage of participants
Interval 35.1 to 50.1
|
35.7 percentage of participants
Interval 21.6 to 52.0
|
33.3 percentage of participants
Interval 20.0 to 49.0
|
SECONDARY outcome
Timeframe: Day 28Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=1175 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=587 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).
Strain H1N1
|
82.2 Titer
Interval 77.8 to 86.9
|
85.1 Titer
Interval 78.4 to 92.3
|
—
|
|
Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).
Strain H3N2
|
127.6 Titer
Interval 119.5 to 136.2
|
130.6 Titer
Interval 119.1 to 143.2
|
—
|
|
Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).
Strain B Yamagata
|
74.3 Titer
Interval 70.5 to 78.3
|
75.9 Titer
Interval 67.9 to 85.0
|
—
|
|
Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).
Strain B Victoria
|
60.1 Titer
Interval 57.5 to 62.9
|
62.0 Titer
Interval 56.5 to 68.1
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: Please see "Outcome Measure Description" and "Arm/Group Description"above.
The IL-YANG Quadrivalent Influenza Vaccine contain two types of B strain, while two kinds of Trivalent Influenza Vaccine contain each type of B strain. Primary outcome was about seroconversion and seroprotection rate of HI antibody, so each results of 3 kinds of vaccine was described. Considering the cross-reaction between two types of B strain, the analysis was designed in a way that the SCR/SPR of the B strains can be compared, respectively. However, secondary outcome, unlike the primary outcome, is expressed as a ratio(difference of seroconversion rate). So, the above factors were not to be consider. All methods of analysis are comply with the request of MFDS, and the result data that may make you confuse will be delete.
Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=587 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=1175 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)
Strain H1N1
|
49.2 percentage of participants
Interval 45.1 to 53.4
|
47.7 percentage of participants
Interval 44.9 to 50.6
|
—
|
|
Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)
Strain H3N2
|
79.7 percentage of participants
Interval 76.2 to 82.9
|
78.7 percentage of participants
Interval 76.3 to 81.0
|
—
|
|
Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)
Strain B Yamagata
|
54.9 percentage of participants
Interval 49.1 to 60.7
|
51.8 percentage of participants
Interval 48.9 to 54.7
|
—
|
|
Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)
Strain B Victoria
|
54.8 percentage of participants
Interval 48.9 to 60.5
|
47.7 percentage of participants
Interval 44.9 to 50.6
|
—
|
SECONDARY outcome
Timeframe: Day 28Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=1175 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=293 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=294 Participants
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain B Victoria
|
60.1 Titer
Interval 57.5 to 62.9
|
41.2 Titer
Interval 37.6 to 45.2
|
62.0 Titer
Interval 56.5 to 68.1
|
|
Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain H1N1
|
82.2 Titer
Interval 77.8 to 86.9
|
89.8 Titer
Interval 79.7 to 101.3
|
80.6 Titer
Interval 72.1 to 90.0
|
|
Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain H3N2
|
127.6 Titer
Interval 119.5 to 136.2
|
135.6 Titer
Interval 118.7 to 154.9
|
125.8 Titer
Interval 110.7 to 143.0
|
|
Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain B Yamagata
|
74.3 Titer
Interval 70.5 to 78.3
|
75.9 Titer
Interval 67.9 to 85.0
|
44.0 Titer
Interval 39.6 to 48.7
|
SECONDARY outcome
Timeframe: Day 28Outcome measures
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=1175 Participants
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=293 Participants
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=294 Participants
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain B Yamagata
|
3.3 Ratio of GMT titer
Interval 3.1 to 3.5
|
3.5 Ratio of GMT titer
Interval 3.1 to 3.9
|
2.0 Ratio of GMT titer
Interval 1.8 to 2.2
|
|
Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain B Victoria
|
2.9 Ratio of GMT titer
Interval 2.8 to 3.1
|
2.1 Ratio of GMT titer
Interval 1.9 to 2.2
|
3.0 Ratio of GMT titer
Interval 2.7 to 3.3
|
|
Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain H1N1
|
3.9 Ratio of GMT titer
Interval 3.6 to 4.2
|
4.1 Ratio of GMT titer
Interval 3.5 to 4.8
|
3.7 Ratio of GMT titer
Interval 3.1 to 4.3
|
|
Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Strain H3N2
|
9.5 Ratio of GMT titer
Interval 8.8 to 10.2
|
10.9 Ratio of GMT titer
Interval 9.5 to 12.6
|
9.8 Ratio of GMT titer
Interval 8.5 to 11.4
|
Adverse Events
IL-YANG Quadrivalent Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IL-YANG Flu Vaccine Prefilled Syringe
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
IL-YANG Trivalent Influenza Vaccine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IL-YANG Quadrivalent Influenza Vaccine
n=1194 participants at risk
The QIV is included both B strain (Yamagata, Victoria).
IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Flu Vaccine Prefilled Syringe
n=298 participants at risk
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection.
|
IL-YANG Trivalent Influenza Vaccine
n=299 participants at risk
This TIV is included the B/Victoria strain.
IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection.
|
|---|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/1194
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
0.34%
1/298 • Number of events 1
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
0.00%
0/299
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
|
Nervous system disorders
Vascular headache
|
0.00%
0/1194
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
0.34%
1/298 • Number of events 1
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
0.00%
0/299
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1194
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
0.00%
0/298
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
0.33%
1/299 • Number of events 1
Safety set consists of all randomized subjects who had at least one dose of the investigational product. A subject who was randomized in this study but was withdrawn prior to vaccination of the investigational product was excluded from the safety set. There was 3-subject withdrawn prior to vaccination from 1197 enrolled subjects.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place