Trial Outcomes & Findings for Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants (NCT NCT02555618)
NCT ID: NCT02555618
Last Updated: 2016-12-29
Results Overview
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
400 participants
Primary outcome timeframe
Baseline and Day 22
Results posted on
2016-12-29
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 24 September 2015 to 18 November 2015.
Healthy Volunteers were enrolled equally in 1 of 2 groups, TAK-850 subcutaneous (SC) or Influenza hemagglutinin (HA) vaccine SC.
Participant milestones
| Measure |
TAK-850
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
COMPLETED
|
199
|
200
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
TAK-850
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Overall Study
Sponsor's Circumstances
|
1
|
0
|
Baseline Characteristics
Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
TAK-850
n=200 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 9.46 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Age, Customized
20 to 29 years
|
102 participants
n=5 Participants
|
98 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
Age, Customized
30 to 39 years
|
46 participants
n=5 Participants
|
47 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Age, Customized
40 to 49 years
|
52 participants
n=5 Participants
|
55 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Gender
Female
|
94 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Gender
Male
|
106 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
200 participants
n=5 Participants
|
200 participants
n=7 Participants
|
400 participants
n=5 Participants
|
|
Height
|
166.3 cm
STANDARD_DEVIATION 8.41 • n=5 Participants
|
166.0 cm
STANDARD_DEVIATION 8.32 • n=7 Participants
|
166.2 cm
STANDARD_DEVIATION 8.35 • n=5 Participants
|
|
Weight
|
58.67 kg
STANDARD_DEVIATION 8.918 • n=5 Participants
|
57.69 kg
STANDARD_DEVIATION 7.937 • n=7 Participants
|
58.18 kg
STANDARD_DEVIATION 8.445 • n=5 Participants
|
|
Body Mass Index (BMI)
|
21.10 kg/m^2
STANDARD_DEVIATION 1.912 • n=5 Participants
|
20.86 kg/m^2
STANDARD_DEVIATION 1.752 • n=7 Participants
|
20.98 kg/m^2
STANDARD_DEVIATION 1.835 • n=5 Participants
|
|
Influenza Infection within 1 Year
Yes
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Influenza Infection within 1 Year
No
|
186 participants
n=5 Participants
|
189 participants
n=7 Participants
|
375 participants
n=5 Participants
|
|
Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived)-A/H1N1 Strain
Titer <40
|
74 participants
n=5 Participants
|
65 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived)-A/H1N1 Strain
Titer ≥40
|
125 participants
n=5 Participants
|
135 participants
n=7 Participants
|
260 participants
n=5 Participants
|
|
HI Antibody Titer (Egg-derived)-A/H3N2 Strain
Titer <40
|
106 participants
n=5 Participants
|
105 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
HI Antibody Titer (Egg-derived)-A/H3N2 Strain
Titer ≥40
|
93 participants
n=5 Participants
|
95 participants
n=7 Participants
|
188 participants
n=5 Participants
|
|
HI Antibody Titer (Egg-derived)-B Strain
Titer <40
|
93 participants
n=5 Participants
|
98 participants
n=7 Participants
|
191 participants
n=5 Participants
|
|
HI Antibody Titer (Egg-derived)-B Strain
Titer ≥40
|
106 participants
n=5 Participants
|
102 participants
n=7 Participants
|
208 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 22Population: Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain
|
47.7 percentage of participants
Interval 40.627 to 54.918
|
46.0 percentage of participants
Interval 38.948 to 53.172
|
|
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain
|
31.2 percentage of participants
Interval 24.795 to 38.088
|
36.0 percentage of participants
Interval 29.35 to 43.071
|
|
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
B Strain
|
28.6 percentage of participants
Interval 22.472 to 35.463
|
26.0 percentage of participants
Interval 20.068 to 32.658
|
PRIMARY outcome
Timeframe: Days 1 and 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 1
|
39.04 titer
95% Confidence Interval 5.256 • Interval 30.955 to 49.228
|
43.77 titer
95% Confidence Interval 4.794 • Interval 35.178 to 54.463
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 22
|
239.24 titer
95% Confidence Interval 3.098 • Interval 204.264 to 280.206
|
241.88 titer
95% Confidence Interval 2.839 • Interval 209.128 to 279.763
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 1
|
21.39 titer
95% Confidence Interval 4.558 • Interval 17.3 to 26.439
|
22.62 titer
95% Confidence Interval 4.823 • Interval 18.163 to 28.168
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 22
|
64.80 titer
95% Confidence Interval 4.643 • Interval 52.282 to 80.314
|
84.93 titer
95% Confidence Interval 5.496 • Interval 66.967 to 107.707
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
B Strain-Day 1
|
24.65 titer
95% Confidence Interval 3.898 • Interval 20.38 to 29.812
|
25.34 titer
95% Confidence Interval 4.211 • Interval 20.734 to 30.96
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
B Strain-Day 22
|
70.14 titer
95% Confidence Interval 3.652 • Interval 58.523 to 84.063
|
65.89 titer
95% Confidence Interval 4.197 • Interval 53.945 to 80.475
|
SECONDARY outcome
Timeframe: Days 1 and 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 1
|
62.8 percentage of participants
Interval 55.697 to 69.543
|
67.5 percentage of participants
Interval 60.535 to 73.937
|
|
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 22
|
95.5 percentage of participants
Interval 91.589 to 97.911
|
97.0 percentage of participants
Interval 93.585 to 98.891
|
|
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 1
|
46.7 percentage of participants
Interval 39.645 to 53.921
|
47.5 percentage of participants
Interval 40.412 to 54.663
|
|
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 22
|
77.9 percentage of participants
Interval 71.477 to 83.451
|
78.0 percentage of participants
Interval 71.614 to 83.536
|
|
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
B Strain-Day 1
|
53.3 percentage of participants
Interval 46.079 to 60.355
|
51.0 percentage of participants
Interval 43.852 to 58.118
|
|
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
B Strain-Day 22
|
81.4 percentage of participants
Interval 75.295 to 86.558
|
76.0 percentage of participants
Interval 69.469 to 81.743
|
SECONDARY outcome
Timeframe: Baseline and Day 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain
|
6.13 fold increase
95% Confidence Interval 5.496 • Interval 4.83 to 7.777
|
5.53 fold increase
95% Confidence Interval 5.353 • Interval 4.373 to 6.982
|
|
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain
|
3.03 fold increase
95% Confidence Interval 4.268 • Interval 2.474 to 3.711
|
3.75 fold increase
95% Confidence Interval 4.861 • Interval 3.012 to 4.681
|
|
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
B Strain
|
2.85 fold increase
95% Confidence Interval 3.399 • Interval 2.398 to 3.376
|
2.60 fold increase
95% Confidence Interval 3.356 • Interval 2.196 to 3.079
|
SECONDARY outcome
Timeframe: Baseline and Day 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain
|
50.8 percentage of participants
Interval 43.591 to 57.894
|
44.0 percentage of participants
Interval 37.006 to 51.175
|
|
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain
|
38.7 percentage of participants
Interval 31.89 to 45.839
|
47.5 percentage of participants
Interval 40.412 to 54.663
|
|
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
B Strain
|
31.7 percentage of participants
Interval 25.262 to 38.611
|
34.0 percentage of participants
Interval 27.467 to 41.016
|
SECONDARY outcome
Timeframe: Days 1 and 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 1
|
32.4939 mm^2
95% Confidence Interval 2.98861 • Interval 27.88271 to 37.86773
|
33.7752 mm^2
95% Confidence Interval 2.85080 • Interval 29.18491 to 39.08753
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 22
|
83.6792 mm^2
95% Confidence Interval 1.70398 • Interval 77.67132 to 90.15189
|
79.9046 mm^2
95% Confidence Interval 1.46596 • Interval 75.75435 to 84.28212
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 1
|
23.6364 mm^2
95% Confidence Interval 2.99866 • Interval 20.27267 to 27.55832
|
24.8424 mm^2
95% Confidence Interval 2.79368 • Interval 21.52683 to 28.66874
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 22
|
48.0742 mm^2
95% Confidence Interval 2.03848 • Interval 43.51841 to 53.10687
|
53.5757 mm^2
95% Confidence Interval 1.87521 • Interval 49.07889 to 58.48463
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
B Strain-Day 1
|
45.6214 mm^2
95% Confidence Interval 2.00064 • Interval 41.40641 to 50.26551
|
46.3984 mm^2
95% Confidence Interval 1.89520 • Interval 42.44118 to 50.72466
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
B Strain-Day 22
|
74.3848 mm^2
95% Confidence Interval 1.32537 • Interval 71.5126 to 77.37238
|
75.8772 mm^2
95% Confidence Interval 1.32751 • Interval 72.9382 to 78.93464
|
SECONDARY outcome
Timeframe: Days 1 and 22Population: FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 1
|
70.4 percentage of participants
Interval 63.484 to 76.601
|
73.0 percentage of participants
Interval 66.285 to 79.02
|
|
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain-Day 22
|
97.0 percentage of participants
Interval 93.553 to 98.886
|
98.5 percentage of participants
Interval 95.679 to 99.69
|
|
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 1
|
63.8 percentage of participants
Interval 56.725 to 70.495
|
67.0 percentage of participants
Interval 60.017 to 73.47
|
|
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain-Day 22
|
89.4 percentage of participants
Interval 84.322 to 93.348
|
93.5 percentage of participants
Interval 89.141 to 96.494
|
|
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
B Strain-Day 1
|
87.9 percentage of participants
Interval 82.588 to 92.118
|
88.5 percentage of participants
Interval 83.245 to 92.569
|
|
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
B Strain-Day 22
|
99.5 percentage of participants
Interval 97.232 to 99.987
|
99.0 percentage of participants
Interval 96.435 to 99.879
|
SECONDARY outcome
Timeframe: Baseline and Day 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1 Strain
|
2.5752 fold increase
95% Confidence Interval 2.83602 • Interval 2.22603 to 2.97921
|
2.3658 fold increase
95% Confidence Interval 2.88645 • Interval 2.04071 to 2.74262
|
|
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2 Strain
|
2.0339 fold increase
95% Confidence Interval 2.54780 • Interval 1.78464 to 2.31798
|
2.1566 fold increase
95% Confidence Interval 2.44635 • Interval 1.9037 to 2.44314
|
|
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
B Strain
|
1.6305 fold increase
95% Confidence Interval 1.81614 • Interval 1.49999 to 1.77232
|
1.6353 fold increase
95% Confidence Interval 1.77973 • Interval 1.50903 to 1.77222
|
SECONDARY outcome
Timeframe: Baseline and Day 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of \<10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain
|
40.2 percentage of participants
Interval 33.33 to 47.369
|
25.5 percentage of participants
Interval 19.614 to 32.128
|
|
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain
|
27.1 percentage of participants
Interval 21.09 to 33.877
|
29.0 percentage of participants
Interval 22.816 to 35.819
|
|
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
B Strain
|
19.6 percentage of participants
Interval 14.323 to 25.803
|
22.0 percentage of participants
Interval 16.464 to 28.386
|
SECONDARY outcome
Timeframe: Days 1 and 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
GMT of HI Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 1
|
7.41 titer
95% Confidence Interval 2.395 • Interval 6.554 to 8.367
|
7.74 titer
95% Confidence Interval 2.346 • Interval 6.876 to 8.723
|
|
GMT of HI Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 22
|
25.88 titer
95% Confidence Interval 4.297 • Interval 21.109 to 31.731
|
17.44 titer
95% Confidence Interval 3.978 • Interval 14.387 to 21.144
|
|
GMT of HI Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 1
|
15.93 titer
95% Confidence Interval 3.549 • Interval 13.349 to 19.021
|
14.67 titer
95% Confidence Interval 3.722 • Interval 12.211 to 17.616
|
|
GMT of HI Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 22
|
39.65 titer
95% Confidence Interval 4.449 • Interval 32.185 to 48.856
|
37.19 titer
95% Confidence Interval 5.313 • Interval 29.465 to 46.944
|
|
GMT of HI Antibody Titer (Vero-Derived Antigen)
B Strain-Day 1
|
10.74 titer
95% Confidence Interval 2.826 • Interval 9.289 to 12.419
|
10.13 titer
95% Confidence Interval 2.721 • Interval 8.811 to 11.649
|
|
GMT of HI Antibody Titer (Vero-Derived Antigen)
B Strain-Day 22
|
21.65 titer
95% Confidence Interval 4.004 • Interval 17.833 to 26.284
|
20.30 titer
95% Confidence Interval 3.770 • Interval 16.868 to 24.422
|
SECONDARY outcome
Timeframe: Days 1 and 22Population: FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 1
|
12.6 percentage of participants
Interval 8.298 to 17.984
|
11.0 percentage of participants
Interval 7.023 to 16.18
|
|
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 22
|
54.3 percentage of participants
Interval 47.079 to 61.334
|
40.0 percentage of participants
Interval 33.155 to 47.146
|
|
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 1
|
38.7 percentage of participants
Interval 31.89 to 45.839
|
32.0 percentage of participants
Interval 25.596 to 38.947
|
|
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 22
|
66.8 percentage of participants
Interval 59.827 to 73.331
|
60.0 percentage of participants
Interval 52.854 to 66.845
|
|
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
B Strain-Day 1
|
19.6 percentage of participants
Interval 14.323 to 25.803
|
22.0 percentage of participants
Interval 16.464 to 28.386
|
|
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
B Strain-Day22
|
43.2 percentage of participants
Interval 36.23 to 50.408
|
46.0 percentage of participants
Interval 38.948 to 53.172
|
SECONDARY outcome
Timeframe: Baseline and Day 22Population: FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain
|
3.50 fold increase
95% Confidence Interval 4.066 • Interval 2.873 to 4.252
|
2.25 fold increase
95% Confidence Interval 3.539 • Interval 1.888 to 2.686
|
|
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain
|
2.49 fold increase
95% Confidence Interval 3.584 • Interval 2.082 to 2.975
|
2.54 fold increase
95% Confidence Interval 3.593 • Interval 2.122 to 3.031
|
|
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
B Strain
|
2.02 fold increase
95% Confidence Interval 3.046 • Interval 1.725 to 2.355
|
2.00 fold increase
95% Confidence Interval 2.831 • Interval 1.733 to 2.316
|
SECONDARY outcome
Timeframe: Baseline and Day 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain
|
24.1 percentage of participants
Interval 18.352 to 30.677
|
23.0 percentage of participants
Interval 17.358 to 29.461
|
|
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain
|
41.2 percentage of participants
Interval 34.294 to 48.385
|
42.0 percentage of participants
Interval 35.074 to 49.166
|
|
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
B Strain
|
43.2 percentage of participants
Interval 36.23 to 50.408
|
40.0 percentage of participants
Interval 33.155 to 47.146
|
SECONDARY outcome
Timeframe: Days 1 and 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
GMT of SRH Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 1
|
7.4041 titer
95% Confidence Interval 2.32428 • Interval 6.5806 to 8.33056
|
7.7958 titer
95% Confidence Interval 2.26942 • Interval 6.95397 to 8.73955
|
|
GMT of SRH Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 22
|
16.2670 titer
95% Confidence Interval 2.13276 • Interval 14.63265 to 18.08382
|
15.2566 titer
95% Confidence Interval 2.32297 • Interval 13.56496 to 17.1593
|
|
GMT of SRH Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 1
|
19.7055 titer
95% Confidence Interval 2.07033 • Interval 17.79947 to 21.81561
|
19.1990 titer
95% Confidence Interval 2.14468 • Interval 17.26128 to 21.35415
|
|
GMT of SRH Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 22
|
32.4796 titer
95% Confidence Interval 1.76234 • Interval 30.00608 to 35.15703
|
33.2751 titer
95% Confidence Interval 1.85480 • Interval 30.52867 to 36.26852
|
|
GMT of SRH Antibody Titer (Vero-Derived Antigen)
B Strain-Day 1
|
28.2050 titer
95% Confidence Interval 2.17963 • Interval 25.29425 to 31.45059
|
28.2142 titer
95% Confidence Interval 2.23368 • Interval 25.22323 to 31.55982
|
|
GMT of SRH Antibody Titer (Vero-Derived Antigen)
B Strain-Day 22
|
52.1647 titer
95% Confidence Interval 1.53822 • Interval 49.11712 to 55.40139
|
49.7468 titer
95% Confidence Interval 1.55670 • Interval 46.7697 to 52.91348
|
SECONDARY outcome
Timeframe: Days 1 and 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 1
|
17.1 percentage of participants
Interval 12.132 to 23.048
|
13.0 percentage of participants
Interval 8.671 to 18.465
|
|
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain-Day 22
|
33.7 percentage of participants
Interval 27.14 to 40.692
|
33.0 percentage of participants
Interval 26.53 to 39.983
|
|
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 1
|
38.2 percentage of participants
Interval 31.411 to 45.328
|
42.5 percentage of participants
Interval 35.556 to 49.67
|
|
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain-Day 22
|
71.9 percentage of participants
Interval 65.065 to 77.99
|
74.0 percentage of participants
Interval 67.342 to 79.932
|
|
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
B Strain-Day 1
|
65.3 percentage of participants
Interval 58.272 to 71.917
|
65.5 percentage of participants
Interval 58.469 to 72.063
|
|
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
B Strain-Day 22
|
92.5 percentage of participants
Interval 87.872 to 95.72
|
93.5 percentage of participants
Interval 89.141 to 96.494
|
SECONDARY outcome
Timeframe: Baseline and Day 22Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Outcome measures
| Measure |
TAK-850
n=199 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
A/H1N1 Strain
|
2.1970 fold increase
95% Confidence Interval 2.03685 • Interval 1.98906 to 2.42676
|
1.9570 fold increase
95% Confidence Interval 2.16354 • Interval 1.75737 to 2.17938
|
|
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
A/H3N2 Strain
|
1.6483 fold increase
95% Confidence Interval 1.71298 • Interval 1.52879 to 1.77705
|
1.7332 fold increase
95% Confidence Interval 1.71960 • Interval 1.60699 to 1.86926
|
|
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
B Strain
|
1.8495 fold increase
95% Confidence Interval 1.91583 • Interval 1.6881 to 2.02546
|
1.7632 fold increase
95% Confidence Interval 2.03032 • Interval 1.59739 to 1.94618
|
SECONDARY outcome
Timeframe: 22 DaysPopulation: Safety Analysis Set included all participants who received vaccination with study vaccine.
Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
Outcome measures
| Measure |
TAK-850
n=200 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Injection site pain
|
34.0 percentage of participants
|
39.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Injection site redness
|
23.5 percentage of participants
|
28.0 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Injection site swelling
|
15.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Injection site induration
|
7.0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Injection site ecchymosis
|
3.5 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Pyrexia
|
0.0 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Malaise
|
10.5 percentage of participants
|
11.0 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Chills
|
2.5 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Fatigue
|
10.5 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Headache
|
7.0 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Sweaty
|
0.5 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Myalgia
|
3.5 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Arthralgia
|
0.0 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Nausea
|
1.5 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Vomiting
|
0.5 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: 22 daysPopulation: Safety Analysis Set included all participants who received vaccination with study vaccine.
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
TAK-850
n=200 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
|
62.0 percentage of participants
|
64.0 percentage of participants
|
SECONDARY outcome
Timeframe: 22 DaysPopulation: Safety Analysis Set included all participants who received vaccination with study vaccine.
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Outcome measures
| Measure |
TAK-850
n=200 Participants
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 Participants
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Blood creatine phosphokinase increased
|
2.0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Protein urine present
|
0.5 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Blood bilirubin increased
|
0.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Liver function test abnormal
|
0.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
White blood cell count increased
|
0.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Alanine aminotransferase increased
|
0.0 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Blood glucose increased
|
0.0 percentage of participants
|
0.5 percentage of participants
|
Adverse Events
TAK-850
Serious events: 0 serious events
Other events: 117 other events
Deaths: 0 deaths
Influenza HA Vaccine
Serious events: 0 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-850
n=200 participants at risk
A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm.
|
Influenza HA Vaccine
n=200 participants at risk
A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
|
|---|---|---|
|
General disorders
Injection site pain
|
34.0%
68/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
39.5%
79/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site erythema
|
23.5%
47/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.0%
56/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site swelling
|
15.5%
31/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
40/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pruritus
|
9.5%
19/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.5%
31/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site warmth
|
8.5%
17/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.5%
29/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
10.5%
21/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.0%
22/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site induration
|
7.0%
14/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
20/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
7.0%
14/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.0%
18/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
10.5%
21/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
13/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.5%
7/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.5%
11/200 • 22 Days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER