Trial Outcomes & Findings for Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children (NCT NCT02263131)
NCT ID: NCT02263131
Last Updated: 2020-07-09
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
416 participants
Primary outcome timeframe
up to Day28(+7)
Results posted on
2020-07-09
Participant Flow
Participant milestones
| Measure |
IL-YANG PFS
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Overall Study
STARTED
|
347
|
69
|
|
Overall Study
COMPLETED
|
337
|
68
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children
Baseline characteristics by cohort
| Measure |
IL-YANG PFS
n=347 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=69 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.83 years
STANDARD_DEVIATION 4.87 • n=5 Participants
|
7.45 years
STANDARD_DEVIATION 5.01 • n=7 Participants
|
7.77 years
STANDARD_DEVIATION 4.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to Day28(+7)Population: Whole participant
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 PFS
n=337 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=68 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion
Strain H1N1
|
62.02 percentage of paticipants
|
76.81 percentage of paticipants
|
|
Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion
Strain H3N2
|
53.41 percentage of paticipants
|
57.35 percentage of paticipants
|
|
Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion
Strain B
|
54.90 percentage of paticipants
|
66.18 percentage of paticipants
|
PRIMARY outcome
Timeframe: up to Day28(+7)Population: This is because the results showed that the seroconversion rate of HI antibody varies depending on the number of vaccination.
Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2),
Outcome measures
| Measure |
IL-YANG PFS
n=337 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=68 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination
Strain H1N1(1st)
|
60.06 percentage of participants
|
54.84 percentage of participants
|
|
Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination
Strain H1N1(2nd)
|
82.76 percentage of participants
|
66.67 percentage of participants
|
|
Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination
Strain H3N2(1st)
|
53.41 percentage of participants
|
56.45 percentage of participants
|
|
Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination
Strain H3N2(2nd)
|
75.86 percentage of participants
|
66.67 percentage of participants
|
|
Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination
Strain B(1st)
|
54.22 percentage of participants
|
66.13 percentage of participants
|
|
Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination
Strain B(2nd)
|
62.07 percentage of participants
|
66.67 percentage of participants
|
PRIMARY outcome
Timeframe: up to Day28(+7)Population: Whole participant
Percentage of Participants With Healthy Children Aged From 6 Months to \<18 Years With Seroprotection
Outcome measures
| Measure |
IL-YANG PFS
n=337 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=68 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Seroprotection Rate for HI Antibody
Strain H1N1
|
94.96 percentage of paticipants
|
89.71 percentage of paticipants
|
|
Seroprotection Rate for HI Antibody
Strain H3N2
|
93.77 percentage of paticipants
|
91.18 percentage of paticipants
|
|
Seroprotection Rate for HI Antibody
Strain B
|
95.25 percentage of paticipants
|
95.59 percentage of paticipants
|
PRIMARY outcome
Timeframe: up to Day28(+7)Population: This is because the results showed that the seroconversion rate of HI antibody varies depending on the number of vaccination.
Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination
Outcome measures
| Measure |
IL-YANG PFS
n=337 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=68 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Seroprotection Rate of HI Antibody
Strain H1N1(1st)
|
96.10 percentage of participants
|
91.94 percentage of participants
|
|
Seroprotection Rate of HI Antibody
Strain H1N1(2nd)
|
82.76 percentage of participants
|
66.67 percentage of participants
|
|
Seroprotection Rate of HI Antibody
Strain H3N2(1st)
|
95.45 percentage of participants
|
93.55 percentage of participants
|
|
Seroprotection Rate of HI Antibody
Strain H3N2(2nd)
|
75.86 percentage of participants
|
66.67 percentage of participants
|
|
Seroprotection Rate of HI Antibody
Strain B(1st)
|
96.75 percentage of participants
|
96.77 percentage of participants
|
|
Seroprotection Rate of HI Antibody
Strain B(2nd)
|
79.31 percentage of participants
|
83.33 percentage of participants
|
SECONDARY outcome
Timeframe: Day28(+7)Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.
Outcome measures
| Measure |
IL-YANG PFS
n=337 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=68 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Geometric Mean Titer* (GMT) of HI Antibody
Strain H1N1(pre)
|
24.40 Titer
Interval 21.99 to 27.07
|
24.80 Titer
Interval 19.76 to 31.12
|
|
Geometric Mean Titer* (GMT) of HI Antibody
Strain H1N1(post)
|
111.40 Titer
Interval 101.52 to 122.25
|
88.45 Titer
Interval 70.33 to 111.24
|
|
Geometric Mean Titer* (GMT) of HI Antibody
Strain H3N2(pre)
|
31.85 Titer
Interval 28.47 to 35.63
|
30.00 Titer
Interval 22.59 to 39.84
|
|
Geometric Mean Titer* (GMT) of HI Antibody
Strain H3N2(post)
|
110.60 Titer
Interval 100.93 to 121.19
|
104.92 Titer
Interval 82.25 to 133.84
|
|
Geometric Mean Titer* (GMT) of HI Antibody
Strain B(pre)
|
36.22 Titer
Interval 32.63 to 40.21
|
39.44 Titer
Interval 31.96 to 48.66
|
|
Geometric Mean Titer* (GMT) of HI Antibody
Strain B(post)
|
130.53 Titer
Interval 117.98 to 144.41
|
151.70 Titer
Interval 119.0 to 192.9
|
SECONDARY outcome
Timeframe: Day28(+7)Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.
Outcome measures
| Measure |
IL-YANG PFS
n=337 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=68 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
GMR of HI Antibody Titer Before Vaccination and After Vaccination
Strain H1N1
|
4.57 Ratio of GMT titer
Interval 4.11 to 5.08
|
3.57 Ratio of GMT titer
Interval 2.79 to 4.57
|
|
GMR of HI Antibody Titer Before Vaccination and After Vaccination
Strain H3N2
|
3.47 Ratio of GMT titer
Interval 3.16 to 3.82
|
3.50 Ratio of GMT titer
Interval 2.77 to 4.42
|
|
GMR of HI Antibody Titer Before Vaccination and After Vaccination
Strain B
|
3.60 Ratio of GMT titer
Interval 3.26 to 3.98
|
3.85 Ratio of GMT titer
Interval 3.01 to 4.92
|
SECONDARY outcome
Timeframe: Day28(+7)Population: Number of subjects whose HI antibody titer increased minimum four-fold on day 28 after vaccination
Outcome measures
| Measure |
IL-YANG PFS
n=54 Participants
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=16 Participants
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer
Strain B
|
18.75 percentage of participants
|
0.00 percentage of participants
|
|
Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer
Strain H1N1
|
35.29 percentage of participants
|
28.57 percentage of participants
|
|
Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer
Strain H3N2
|
61.90 percentage of participants
|
50.00 percentage of participants
|
Adverse Events
IL-YANG PFS
Serious events: 8 serious events
Other events: 185 other events
Deaths: 0 deaths
TIV PFS
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IL-YANG PFS
n=347 participants at risk
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=69 participants at risk
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Nervous system disorders
Febrile convulsion
|
0.29%
1/347
|
0.00%
0/69
|
|
Vascular disorders
Kawasaki's disease
|
0.29%
1/347
|
0.00%
0/69
|
|
Infections and infestations
Bronchopneumonia
|
0.58%
2/347
|
0.00%
0/69
|
|
Renal and urinary disorders
Haematuria
|
0.29%
1/347
|
0.00%
0/69
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/347
|
0.00%
0/69
|
|
Infections and infestations
Otitis media acute
|
0.29%
1/347
|
0.00%
0/69
|
|
Infections and infestations
Bronchiolitis
|
0.29%
1/347
|
0.00%
0/69
|
|
Infections and infestations
Otitis media
|
0.29%
1/347
|
0.00%
0/69
|
Other adverse events
| Measure |
IL-YANG PFS
n=347 participants at risk
IL-YANG FLU Vaccine Prefilled Syringe INJ.
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
|
TIV PFS
n=69 participants at risk
VAXIGRIP Prefilled Syringe INJ.
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain
|
34.6%
120/347
|
36.2%
25/69
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
48.4%
168/347
|
50.7%
35/69
|
|
Skin and subcutaneous tissue disorders
Redness
|
13.8%
48/347
|
7.2%
5/69
|
|
Skin and subcutaneous tissue disorders
Swelling
|
5.5%
19/347
|
2.9%
2/69
|
Additional Information
Dr. Kang Jin Han
The Catholic University of Korea, Seoul St. Mary's Hospital
Phone: +82-10-4251-8375
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place