Trial Outcomes & Findings for Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults (NCT NCT02313155)
NCT ID: NCT02313155
Last Updated: 2016-02-17
Results Overview
Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Up to 21 days (Day 22) after vaccination
Results posted on
2016-02-17
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 13-December-2014 to 22-January-2015.
Healthy adult participants were randomized to receive a single dose of 0.5 milliliter (mL) of TAK-850 in 1 of the 2 treatment groups: TAK-850 subcutaneous injection and TAK-850 intramuscular injection.
Participant milestones
| Measure |
TAK-850 Subcutaneous Injection
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
TAK-850 Subcutaneous Injection
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults
Baseline characteristics by cohort
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.1 years
STANDARD_DEVIATION 3.50 • n=5 Participants
|
25.1 years
STANDARD_DEVIATION 4.08 • n=7 Participants
|
24.6 years
STANDARD_DEVIATION 3.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Height
|
165.9 centimeter (cm)
STANDARD_DEVIATION 8.83 • n=5 Participants
|
165.5 centimeter (cm)
STANDARD_DEVIATION 8.67 • n=7 Participants
|
165.7 centimeter (cm)
STANDARD_DEVIATION 8.71 • n=5 Participants
|
|
Weight
|
56.35 kilogram (kg)
STANDARD_DEVIATION 7.325 • n=5 Participants
|
58.19 kilogram (kg)
STANDARD_DEVIATION 7.610 • n=7 Participants
|
57.27 kilogram (kg)
STANDARD_DEVIATION 7.492 • n=5 Participants
|
|
Body Mass Index
|
20.41 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.457 • n=5 Participants
|
21.18 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.561 • n=7 Participants
|
20.79 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.552 • n=5 Participants
|
|
Influenza Infection Within 1 Year
Participant had influenza infection in 1 year (yr)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Influenza Infection Within 1 Year
Participant didnot have influenza infection in 1yr
|
55 participants
n=5 Participants
|
54 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 at Day1 (Predose) Titer
>=Minimum (Min) to <40 titer
|
40 participants
n=5 Participants
|
37 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 at Day1 (Predose) Titer
>=40 to <=Maximum (Max) titer
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
HI(Egg-derived) - A/H3N2 at Day1(Predose) Titer
>=Min to less than (<) 40 titer
|
48 participants
n=5 Participants
|
41 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
HI(Egg-derived) - A/H3N2 at Day1(Predose) Titer
>=40 to <=Max titer
|
7 participants
n=5 Participants
|
14 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
HI(Egg-derived) - Influenza B(B) at Day1(Predose) Titer
>=Min to < 40 titer
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
HI(Egg-derived) - Influenza B(B) at Day1(Predose) Titer
>=40 to <=Max titer
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days (Day 22) after vaccinationPopulation: Safety analysis set was defined as all participants who received vaccination with the study drug.
Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Injection site pain
|
7 participants
|
5 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Injection site redness
|
4 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Injection site swelling
|
4 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Injection site induration
|
2 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Injection site tenderness
|
29 participants
|
26 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Injection site ecchymosis
|
2 participants
|
1 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Pyrexia
|
2 participants
|
2 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Malaise
|
12 participants
|
10 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Chills
|
3 participants
|
3 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Fatigue
|
7 participants
|
8 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Headache
|
7 participants
|
3 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Sweaty
|
1 participants
|
0 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Myalgia
|
3 participants
|
3 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Arthralgia
|
4 participants
|
3 participants
|
|
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
Nausea
|
2 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Up to 21 days (Day 22) after vaccinationPopulation: Safety analysis set was defined as all participants who received vaccination with the study drug.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
34 participants
|
32 participants
|
PRIMARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroprotection rate as measured by HI antibody titer (egg-derived antigen) was defined as percentage of participants with the HI antibody titer of \>=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.
A/H1N1 strain
|
80.0 percentage of participants
Interval 67.027 to 89.57
|
88.9 percentage of participants
Interval 77.369 to 95.812
|
|
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.
A/H3N2 strain
|
49.1 percentage of participants
Interval 35.354 to 62.929
|
70.4 percentage of participants
Interval 56.391 to 82.022
|
|
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.
B strain
|
87.3 percentage of participants
Interval 75.52 to 94.726
|
90.7 percentage of participants
Interval 79.7 to 96.925
|
PRIMARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroconversion rate as measured by the HI antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline \>=10) or achieving an HI antibody titer of \>=40 (baseline \<10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
A/H1N1 strain
|
58.2 percentage of participants
Interval 44.106 to 71.345
|
64.8 percentage of participants
Interval 50.624 to 77.319
|
|
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
A/H3N2 strain
|
34.5 percentage of participants
Interval 22.237 to 48.581
|
50.0 percentage of participants
Interval 36.081 to 63.919
|
|
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
B strain
|
34.5 percentage of participants
Interval 22.237 to 48.581
|
46.3 percentage of participants
Interval 32.622 to 60.391
|
PRIMARY outcome
Timeframe: Pre-vaccination, 21 Days After vaccination (Day 22)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMFI in HI antibody titer (egg-derived antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
A/H1N1 strain
|
10.23 fold increase
Interval 5.939 to 17.616
|
15.54 fold increase
Interval 8.922 to 27.082
|
|
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
A/H3N2 strain
|
3.01 fold increase
Interval 2.003 to 4.53
|
4.40 fold increase
Interval 2.898 to 6.693
|
|
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
B strain
|
3.70 fold increase
Interval 2.632 to 5.192
|
4.13 fold increase
Interval 2.886 to 5.912
|
SECONDARY outcome
Timeframe: Baseline,up to 21 Days after drug administration (Day 22)Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
Laboratory values included hematology, biochemistry and urinalysis tests.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 22Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
Change from baseline in systolic and diastolic blood pressure was reported
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Change From Baseline in Blood Pressure
Systolic Blood Pressure: Baseline
|
109.3 millimeter mercury (mmHg)
Standard Deviation 11.36
|
112.2 millimeter mercury (mmHg)
Standard Deviation 10.93
|
|
Change From Baseline in Blood Pressure
Systolic Blood Pressure: Change at Day 22
|
-0.7 millimeter mercury (mmHg)
Standard Deviation 9.78
|
-0.9 millimeter mercury (mmHg)
Standard Deviation 9.94
|
|
Change From Baseline in Blood Pressure
Diastolic Blood Pressure: Baseline
|
63.8 millimeter mercury (mmHg)
Standard Deviation 7.50
|
66.3 millimeter mercury (mmHg)
Standard Deviation 8.57
|
|
Change From Baseline in Blood Pressure
Diastolic Blood Pressure: Change at Day 22
|
0.4 millimeter mercury (mmHg)
Standard Deviation 7.47
|
0.4 millimeter mercury (mmHg)
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: Baseline, Day 22Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
Change from baseline in pulse was reported.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Change From Baseline in Pulse
Pulse: Baseline
|
72.9 beats per minute
Standard Deviation 11.69
|
72.9 beats per minute
Standard Deviation 10.34
|
|
Change From Baseline in Pulse
Pulse: Change at Day 22
|
-2.3 beats per minute
Standard Deviation 11.35
|
-2.0 beats per minute
Standard Deviation 8.51
|
SECONDARY outcome
Timeframe: Baseline, Day 22Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
Change from baseline in body temperature (oral) was reported.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Change From Baseline in Body Temperature
Temperature: Baseline
|
36.71 degree celsius
Standard Deviation 0.305
|
36.72 degree celsius
Standard Deviation 0.311
|
|
Change From Baseline in Body Temperature
Temperature: Change at Day 22
|
-0.21 degree celsius
Standard Deviation 0.357
|
-0.20 degree celsius
Standard Deviation 0.388
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMT in HI antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)
A/H1N1 strain
|
143.30 titer
Interval 87.531 to 234.589
|
237.43 titer
Interval 156.037 to 361.284
|
|
Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)
A/H3N2 strain
|
21.91 titer
Interval 14.256 to 33.683
|
51.21 titer
Interval 32.446 to 80.835
|
|
Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)
B strain
|
82.56 titer
Interval 59.943 to 113.715
|
107.13 titer
Interval 78.013 to 147.122
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) was defined as percentage of participants with an SRH antibody titer of \>=25 mm\^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2
A/H1N1 strain
|
100.0 percentage of participants
Interval 93.513 to 100.0
|
100.0 percentage of participants
Interval 93.397 to 100.0
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2
A/H3N2 strain
|
67.3 percentage of participants
Interval 53.293 to 79.319
|
75.9 percentage of participants
Interval 62.359 to 86.514
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2
B strain
|
100.0 percentage of participants
Interval 93.513 to 100.0
|
100.0 percentage of participants
Interval 93.397 to 100.0
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroconversion rate as measured by the SRH antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline \>4 mm\^2) or achieving an SRH antibody titer of \>=25 mm\^2 (baseline \<=4 mm\^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1 strain
|
58.2 percentage of participants
Interval 44.106 to 71.345
|
61.1 percentage of participants
Interval 46.879 to 74.08
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2 strain
|
41.8 percentage of participants
Interval 28.655 to 55.894
|
51.9 percentage of participants
Interval 37.837 to 65.657
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
B strain
|
38.2 percentage of participants
Interval 25.409 to 52.274
|
46.3 percentage of participants
Interval 32.622 to 60.391
|
SECONDARY outcome
Timeframe: Pre-vaccination, 21 Days after vaccination (Day 22)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMFI in SRH antibody titer (egg-derived antigen) as compared to baseline pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
A/H1N1 strain
|
2.5435 fold increase
Interval 1.98252 to 3.26315
|
2.4169 fold increase
Interval 1.87743 to 3.11144
|
|
GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
A/H3N2 strain
|
1.7666 fold increase
Interval 1.46398 to 2.13181
|
2.3687 fold increase
Interval 1.86326 to 3.01124
|
|
GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
B strain
|
1.5867 fold increase
Interval 1.37637 to 1.82926
|
1.6380 fold increase
Interval 1.42438 to 1.8837
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMT in SRH antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
GMT in SRH Antibody Titer (Egg-derived Antigen)
A/H1N1 strain
|
75.5840 titer
Interval 69.35268 to 82.3753
|
82.4482 titer
Interval 77.42068 to 87.80227
|
|
GMT in SRH Antibody Titer (Egg-derived Antigen)
A/H3N2 strain
|
28.9569 titer
Interval 23.40813 to 35.82096
|
34.0601 titer
Interval 27.64669 to 41.96127
|
|
GMT in SRH Antibody Titer (Egg-derived Antigen)
B strain
|
70.5747 titer
Interval 67.07223 to 74.26
|
73.2954 titer
Interval 69.23834 to 77.59029
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroprotection rate as measured by HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) was defined as percentage of participants with an HI antibody titer of \>=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
Vero antigen: A/H1N1 strain
|
41.8 percentage of participants
Interval 28.655 to 55.894
|
46.3 percentage of participants
Interval 32.622 to 60.391
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
Vero antigen: A/H3N2 strain
|
41.8 percentage of participants
Interval 28.655 to 55.894
|
55.6 percentage of participants
Interval 41.4 to 69.08
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
Vero antigen: B strain
|
60.0 percentage of participants
Interval 45.907 to 72.977
|
72.2 percentage of participants
Interval 58.356 to 83.545
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
Live-Vero antigen: A/H1N1 strain
|
92.7 percentage of participants
Interval 82.413 to 97.983
|
98.1 percentage of participants
Interval 90.108 to 99.953
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
Live-Vero antigen: A/H3N2 strain
|
96.4 percentage of participants
Interval 87.474 to 99.557
|
96.3 percentage of participants
Interval 87.253 to 99.548
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
Live-Vero antigen: B strain
|
96.4 percentage of participants
Interval 87.474 to 99.557
|
94.4 percentage of participants
Interval 84.611 to 98.839
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
MDCK antigen: A/H1N1 strain
|
90.9 percentage of participants
Interval 80.046 to 96.982
|
98.1 percentage of participants
Interval 90.108 to 99.953
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
MDCK antigen: A/H3N2 strain
|
92.7 percentage of participants
Interval 82.413 to 97.983
|
92.6 percentage of participants
Interval 82.107 to 97.945
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
MDCK antigen: B strain
|
98.2 percentage of participants
Interval 90.281 to 99.954
|
94.4 percentage of participants
Interval 84.611 to 98.839
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroconversion rate as measured by the HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline \>=10) or achieving an HI antibody titer of \>=40 (baseline HI \<10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H1N1 strain
|
41.8 percentage of participants
Interval 28.655 to 55.894
|
42.6 percentage of participants
Interval 29.235 to 56.792
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H3N2 strain
|
36.4 percentage of participants
Interval 23.814 to 50.437
|
50.0 percentage of participants
Interval 36.081 to 63.919
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
Vero antigen: B strain
|
34.5 percentage of participants
Interval 22.237 to 48.581
|
48.1 percentage of participants
Interval 34.343 to 62.163
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H1N1 strain
|
54.5 percentage of participants
Interval 40.554 to 68.03
|
70.4 percentage of participants
Interval 56.391 to 82.022
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H3N2 strain
|
40.0 percentage of participants
Interval 27.023 to 54.093
|
50.0 percentage of participants
Interval 36.081 to 63.919
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: B strain
|
32.7 percentage of participants
Interval 20.681 to 46.707
|
38.9 percentage of participants
Interval 25.92 to 53.121
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H1N1 strain
|
45.5 percentage of participants
Interval 31.97 to 59.446
|
61.1 percentage of participants
Interval 46.879 to 74.08
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H3N2 strain
|
47.3 percentage of participants
Interval 33.653 to 61.196
|
57.4 percentage of participants
Interval 43.208 to 70.765
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
MDCK antigen: B strain
|
32.7 percentage of participants
Interval 20.681 to 46.707
|
33.3 percentage of participants
Interval 21.092 to 47.474
|
SECONDARY outcome
Timeframe: Pre-vaccination, 21 Days After vaccination (Day 22)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMFI in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Vero antigen: A/H1N1 strain
|
3.10 fold increase
Interval 2.101 to 4.57
|
3.51 fold increase
Interval 2.311 to 5.321
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Vero antigen: A/H3N2 strain
|
2.66 fold increase
Interval 1.872 to 3.791
|
4.17 fold increase
Interval 2.792 to 6.228
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Vero antigen: B strain
|
2.84 fold increase
Interval 2.069 to 3.891
|
3.74 fold increase
Interval 2.666 to 5.246
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Live-Vero antigen: A/H1N1 strain
|
7.95 fold increase
Interval 5.012 to 12.609
|
12.70 fold increase
Interval 7.823 to 20.614
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Live-Vero antigen: A/H3N2 strain
|
3.95 fold increase
Interval 2.684 to 5.812
|
5.88 fold increase
Interval 3.835 to 9.013
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Live-Vero antigen: B strain
|
3.19 fold increase
Interval 2.336 to 4.351
|
3.66 fold increase
Interval 2.717 to 4.92
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
MDCK antigen: A/H1N1 strain
|
5.95 fold increase
Interval 3.767 to 9.396
|
9.12 fold increase
Interval 5.74 to 14.505
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
MDCK antigen: A/H3N2 strain
|
5.52 fold increase
Interval 3.609 to 8.431
|
8.10 fold increase
Interval 4.931 to 13.315
|
|
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
MDCK antigen: B strain
|
3.67 fold increase
Interval 2.516 to 5.364
|
3.45 fold increase
Interval 2.483 to 4.796
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMT in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H3N2 strain
|
187.89 titer
Interval 132.545 to 266.336
|
309.89 titer
Interval 208.367 to 460.871
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H1N1 strain
|
17.52 titer
Interval 11.513 to 26.666
|
20.72 titer
Interval 13.374 to 32.096
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H3N2 strain
|
17.63 titer
Interval 11.714 to 26.54
|
32.05 titer
Interval 20.018 to 51.327
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
Vero antigen: B strain
|
27.24 titer
Interval 18.672 to 39.731
|
37.40 titer
Interval 26.335 to 53.102
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H1N1 strain
|
276.83 titer
Interval 192.61 to 397.866
|
424.41 titer
Interval 317.572 to 567.203
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H3N2 strain
|
208.48 titer
Interval 154.101 to 282.045
|
320.00 titer
Interval 225.694 to 453.713
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: B strain
|
139.29 titer
Interval 113.528 to 170.887
|
168.43 titer
Interval 125.641 to 225.795
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H1N1 strain
|
257.47 titer
Interval 171.653 to 386.187
|
381.77 titer
Interval 289.028 to 504.274
|
|
GMT in HI Antibody Titer (Cell Derived Antigen)
MDCK antigen: B strain
|
187.89 titer
Interval 151.967 to 232.298
|
210.85 titer
Interval 155.714 to 285.513
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroprotection rate as measured by SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) was defined as percentage of participants with a SRH antibody titer of \>=25 mm\^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
Vero antigen: A/H1N1 strain
|
76.4 percentage of participants
Interval 62.98 to 86.772
|
70.4 percentage of participants
Interval 56.391 to 82.022
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
Vero antigen: A/H3N2 strain
|
98.2 percentage of participants
Interval 90.281 to 99.954
|
100 percentage of participants
Interval 93.397 to 100.0
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
Vero antigen: B strain
|
98.2 percentage of participants
Interval 90.281 to 99.954
|
100 percentage of participants
Interval 93.397 to 100.0
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
Live-Vero antigen: A/H1N1 strain
|
98.2 percentage of participants
Interval 90.281 to 99.954
|
100 percentage of participants
Interval 93.397 to 100.0
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
Live-Vero antigen: A/H3N2 strain
|
100 percentage of participants
Interval 93.513 to 100.0
|
100 percentage of participants
Interval 93.397 to 100.0
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
Live-Vero antigen: B strain
|
100 percentage of participants
Interval 93.513 to 100.0
|
100 percentage of participants
Interval 93.397 to 100.0
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
MDCK antigen: A/H1N1 strain
|
89.1 percentage of participants
Interval 77.753 to 95.89
|
94.4 percentage of participants
Interval 84.611 to 98.839
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
MDCK antigen: A/H3N2 strain
|
94.5 percentage of participants
Interval 84.877 to 98.861
|
98.1 percentage of participants
Interval 90.108 to 99.953
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
MDCK antigen: B strain
|
100 percentage of participants
Interval 93.513 to 100.0
|
100 percentage of participants
Interval 93.397 to 100.0
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
Seroconversion rate as measured by the SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline \>4 mm\^2) or achieving an SRH antibody titer of \>=25 mm\^2 (baseline \<=4 mm\^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H1N1 strain
|
61.8 percentage of participants
Interval 47.726 to 74.591
|
63.0 percentage of participants
Interval 48.742 to 75.709
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H3N2 strain
|
72.7 percentage of participants
Interval 59.038 to 83.862
|
77.8 percentage of participants
Interval 64.4 to 87.956
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
Vero antigen: B strain
|
45.5 percentage of participants
Interval 31.97 to 59.446
|
44.4 percentage of participants
Interval 30.92 to 58.6
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H1N1 strain
|
50.9 percentage of participants
Interval 37.071 to 64.646
|
46.3 percentage of participants
Interval 32.622 to 60.391
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H3N2 strain
|
38.2 percentage of participants
Interval 25.409 to 52.274
|
44.4 percentage of participants
Interval 30.92 to 58.6
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: B strain
|
34.5 percentage of participants
Interval 22.237 to 48.581
|
48.1 percentage of participants
Interval 34.343 to 62.163
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H1N1 strain
|
58.2 percentage of participants
Interval 44.106 to 71.345
|
61.1 percentage of participants
Interval 46.879 to 74.08
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H3N2 strain
|
47.3 percentage of participants
Interval 33.653 to 61.196
|
55.6 percentage of participants
Interval 41.4 to 69.08
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
MDCK antigen: B strain
|
34.5 percentage of participants
Interval 22.237 to 48.581
|
38.9 percentage of participants
Interval 25.92 to 53.121
|
SECONDARY outcome
Timeframe: Pre-vaccination, 21 Days After vaccination (Day 22)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMFI in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Vero antigen: A/H1N1 strain
|
2.8410 fold increase
Interval 2.27071 to 3.55446
|
3.4599 fold increase
Interval 2.68443 to 4.45933
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Vero antigen: A/H3N2 strain
|
2.2144 fold increase
Interval 1.90391 to 2.57562
|
2.4938 fold increase
Interval 2.09701 to 2.96573
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Vero antigen: B strain
|
1.7421 fold increase
Interval 1.49521 to 2.02974
|
1.7632 fold increase
Interval 1.51939 to 2.04622
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Live-Vero antigen: A/H1N1 strain
|
2.4134 fold increase
Interval 1.77374 to 3.28374
|
2.4059 fold increase
Interval 1.77115 to 3.26809
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Live-Vero antigen: A/H3N2 strain
|
2.0173 fold increase
Interval 1.5391 to 2.64419
|
2.2430 fold increase
Interval 1.69452 to 2.96898
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
Live-Vero antigen: B strain
|
1.7655 fold increase
Interval 1.42885 to 2.18152
|
1.8173 fold increase
Interval 1.49254 to 2.21278
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
MDCK antigen: A/H1N1 strain
|
2.6215 fold increase
Interval 2.03478 to 3.37729
|
3.1694 fold increase
Interval 2.38685 to 4.2084
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
MDCK antigen: A/H3N2 strain
|
2.6078 fold increase
Interval 1.98732 to 3.42193
|
2.8178 fold increase
Interval 2.10367 to 3.77438
|
|
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
MDCK antigen: B strain
|
1.6128 fold increase
Interval 1.3761 to 1.89014
|
1.5651 fold increase
Interval 1.35121 to 1.81284
|
SECONDARY outcome
Timeframe: Day 22 (21 days after vaccination)Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
GMT in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney \[MDCK\] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.
Outcome measures
| Measure |
TAK-850 Subcutaneous Injection
n=55 Participants
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=54 Participants
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H1N1 strain
|
29.2669 titer
Interval 24.46183 to 35.01576
|
33.3318 titer
Interval 27.94941 to 39.75064
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
Vero antigen: A/H3N2 strain
|
53.3488 titer
Interval 48.65362 to 58.49703
|
57.3376 titer
Interval 52.02305 to 63.19507
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
Vero antigen: B strain
|
51.4941 titer
Interval 47.87718 to 55.38425
|
54.3183 titer
Interval 50.64237 to 58.26095
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H1N1 strain
|
77.3268 titer
Interval 68.22339 to 87.64491
|
87.2200 titer
Interval 82.62689 to 92.06834
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: A/H3N2 strain
|
75.9017 titer
Interval 70.70835 to 81.47657
|
79.7297 titer
Interval 73.82638 to 86.105
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
Live-Vero antigen: B strain
|
77.4468 titer
Interval 73.26937 to 81.86249
|
82.3667 titer
Interval 78.50179 to 86.422
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H1N1 strain
|
43.3793 titer
Interval 36.13208 to 52.08009
|
51.8747 titer
Interval 46.86724 to 57.41712
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
MDCK antigen: A/H3N2 strain
|
52.7714 titer
Interval 45.49007 to 61.2181
|
60.2234 titer
Interval 52.03699 to 69.69772
|
|
GMT in SRH Antibody Titer (Cell Derived Antigen)
MDCK antigen: B strain
|
83.9627 titer
Interval 79.99444 to 88.12783
|
87.5052 titer
Interval 83.09898 to 92.14495
|
Adverse Events
TAK-850 Subcutaneous Injection
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
TAK-850 Intramuscular Injection
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-850 Subcutaneous Injection
n=55 participants at risk
TAK-850 0.5 mL (15 microgram \[mcg\] of hemagglutinin \[HA\] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
|
TAK-850 Intramuscular Injection
n=55 participants at risk
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.6%
2/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
7.3%
4/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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 pain
|
52.7%
29/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
50.9%
28/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
21.8%
12/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
18.2%
10/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
12.7%
7/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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%
8/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
14.5%
8/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
3.6%
2/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
Chills
|
5.5%
3/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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%
3/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
7.3%
4/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
7.3%
4/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
Pyrexia
|
3.6%
2/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
3.6%
2/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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 haemorrhage
|
3.6%
2/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
3.6%
2/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
Feeling hot
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
4/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
3.6%
2/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Investigations
White blood cell count increased
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
Arthralgia
|
7.3%
4/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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%
3/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
5.5%
3/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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%
3/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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
|
12.7%
7/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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%
3/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.8%
1/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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.
|
0.00%
0/55 • Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
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 Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER