Trial Outcomes & Findings for A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects (NCT NCT03370289)

NCT ID: NCT03370289

Last Updated: 2019-07-29

Results Overview

Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm\^2.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: Day 43 (21 days after the second vaccination)
• Results posted on: 2019-07-29

Participant Flow

Participants took part in the study at one investigative site in Japan, from 12 January 2018 to 28 February 2018.

Healthy volunteer were enrolled and vaccinated the study drug, BLB-750 at a 3-week interval (Day 1 and Day 22) in a treatment period of 43 days through intramuscular route.

Participant milestones

Measure	Overall (BLB-750 Vaccine) Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Overall Study STARTED	55
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Overall (BLB-750 Vaccine) Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Overall Study Screen Failure	1
Overall Study Sample Size Sufficient	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Age, Continuous	28.3 Years STANDARD_DEVIATION 4.52 • n=55 Participants
Sex: Female, Male Female	28 Participants n=55 Participants
Sex: Female, Male Male	27 Participants n=55 Participants
Region of Enrollment Japan	55 Participants n=55 Participants
Height	165.5 Centimeter (cm) STANDARD_DEVIATION 9.06 • n=55 Participants
Weight	58.43 Kilogram (kg) STANDARD_DEVIATION 7.567 • n=55 Participants
Body Mass Index (BMI)	21.29 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.657 • n=55 Participants
Single Radial Hemolysis (SRH) Antibody Titer	4.0 mm^2 STANDARD_DEVIATION 0.00 • n=55 Participants
Number of Participants who Had No Infection of Influenza within 1 Year prior to Study Start	55 Participants n=55 Participants

PRIMARY outcome

Timeframe: Day 43 (21 days after the second vaccination)

Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm^2.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination	32.7 Percentage of participants Interval 20.681 to 46.707

PRIMARY outcome

Timeframe: Day 43 (21 days after the second vaccination)

Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroconversion rate as SRH antibody titer is defined as the percentage of participants with a 50% or more increase in SRH antibody titer from baseline for those who have a baseline value >4 mm^2 or SRH antibody titer ≥25 mm^2 for those who have a baseline value ≤4 mm^2.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination	32.7 Percentage of participants Interval 20.681 to 46.707

PRIMARY outcome

Timeframe: Day 43 (21 days after the second vaccination)

Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Geometric Mean Fold Increase (GMFI) in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the Second Vaccination	3.5636 Fold change Interval 2.88968 to 4.39463

SECONDARY outcome

Timeframe: Day 22 (21 days after the first vaccination)

Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm^2.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination	10.9 Percentage of participants Interval 4.11 to 22.247

SECONDARY outcome

Timeframe: Day 22 (21 days after the first vaccination)

Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination. Seroconversion rate as SRH antibody titer is defined as the percentage of participants with a 50% or more increase in SRH antibody titer from baseline for those who have a baseline value >4 mm^2 or SRH antibody titer ≥25 mm^2 for those who have a baseline value ≤4 mm^2.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination	10.9 Percentage of participants Interval 4.11 to 22.247

SECONDARY outcome

Timeframe: Day 22 (21 days after the first vaccination)

Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
GMFI in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the First Vaccination	2.3319 Fold change Interval 1.87559 to 2.89931

SECONDARY outcome

Timeframe: Day 22, and Day 43 (21 days after the first and the second vaccination)

Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

GMT was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first and second vaccination.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 Days After Each Vaccination Day 22	9.3277 mm^2 Interval 7.50234 to 11.59725
Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 Days After Each Vaccination Day 43	14.2543 mm^2 Interval 11.5587 to 17.57854

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.

An Adverse Event (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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)	25 Participants

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.

Local reactions and systemic events were recorded using a diary.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Number of Participants With Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary	24 Participants

SECONDARY outcome

Timeframe: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination At 30 Minutes after the 1st Vaccination	-2.2 mmHg Standard Deviation 8.57
Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination Day 22 after the 1st Vaccination	3.2 mmHg Standard Deviation 10.73
Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination At 30 Minutes after the 2nd Vaccination	-3.3 mmHg Standard Deviation 11.19
Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination Day 22 after the 2nd vaccination	-4.2 mmHg Standard Deviation 11.06

SECONDARY outcome

Timeframe: Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination At 30 Minutes after the 1st Vaccination	-1.0 mmHg Standard Deviation 6.59
Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination Day 22 after the 1st Vaccination	0.4 mmHg Standard Deviation 11.53
Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination At 30 Minutes after the 2nd Vaccination	0.0 mmHg Standard Deviation 9.81
Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination Day 22 after the 2nd vaccination	-0.7 mmHg Standard Deviation 11.89

SECONDARY outcome

Timeframe: At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination At 30 Minutes after the 1st Vaccination	-4.7 Beats per minutes Standard Deviation 6.54
Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination Day 22 after the 1st Vaccination	5.5 Beats per minutes Standard Deviation 9.96
Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination At 30 Minutes after the 2nd Vaccination	-8.6 Beats per minutes Standard Deviation 7.20
Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination Day 22 after the 2nd vaccination	-0.4 Beats per minutes Standard Deviation 8.49

SECONDARY outcome

Timeframe: Baseline, At 30 minutes after the first vaccination, and at 30 minutes after the second vaccination

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination At 30 Minutes after the 1st Vaccination	-0.6 Breaths per minutes Standard Deviation 1.38
Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination At 30 Minutes after the 2nd Vaccination	-0.7 Breaths per minutes Standard Deviation 1.72

SECONDARY outcome

Timeframe: Baseline, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the first vaccination, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the second vaccination

Population: Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.

Outcome measures

Measure	Overall (BLB-750 Vaccine) n=55 Participants Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Mean Body Temperature at Specific Time Points After Vaccination Day 1 after the 1st Vaccination	36.70 degree Celsius Standard Deviation 0.356
Mean Body Temperature at Specific Time Points After Vaccination Day 2 after the 1st Vaccination	36.65 degree Celsius Standard Deviation 0.324
Mean Body Temperature at Specific Time Points After Vaccination Day 3 after the 1st Vaccination	36.73 degree Celsius Standard Deviation 0.329
Mean Body Temperature at Specific Time Points After Vaccination Day 4 after the 1st Vaccination	36.64 degree Celsius Standard Deviation 0.397
Mean Body Temperature at Specific Time Points After Vaccination Day 5 after the 1st Vaccination	36.71 degree Celsius Standard Deviation 0.293
Mean Body Temperature at Specific Time Points After Vaccination Day 6 after the 1st Vaccination	36.65 degree Celsius Standard Deviation 0.351
Mean Body Temperature at Specific Time Points After Vaccination Day 7 after the 1st Vaccination	36.69 degree Celsius Standard Deviation 0.288
Mean Body Temperature at Specific Time Points After Vaccination Day 1 after the 2nd Vaccination	36.70 degree Celsius Standard Deviation 0.363
Mean Body Temperature at Specific Time Points After Vaccination Day 2 after the 2nd Vaccination	36.65 degree Celsius Standard Deviation 0.322
Mean Body Temperature at Specific Time Points After Vaccination Day 3 after the 2nd Vaccination	36.65 degree Celsius Standard Deviation 0.377
Mean Body Temperature at Specific Time Points After Vaccination Day 4 after the 2nd Vaccination	36.64 degree Celsius Standard Deviation 0.374
Mean Body Temperature at Specific Time Points After Vaccination Day 5 after the 2nd Vaccination	36.60 degree Celsius Standard Deviation 0.403
Mean Body Temperature at Specific Time Points After Vaccination Day 6 after the 2nd Vaccination	36.72 degree Celsius Standard Deviation 0.361
Mean Body Temperature at Specific Time Points After Vaccination Day 7 after the 2nd Vaccination	36.67 degree Celsius Standard Deviation 0.304

Adverse Events

Overall (BLB-750 Vaccine)

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Overall (BLB-750 Vaccine) n=55 participants at risk Two doses of BLB-750 Qinghai reverse genetics (RG) strain at a vaccination dose of 0.5 mL (HA antigen level of 7.5 μg per strain) were injected into the upper arm muscle (the deltoid muscle) at 3-week intervals (Day 1 and Day 22) in a treatment period of 43 days.
Gastrointestinal disorders Abdominal pain	7.3% 4/55 • Up to Day 43 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	5.5% 3/55 • Up to Day 43 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 Dyspepsia	1.8% 1/55 • Up to Day 43 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 Vomiting	1.8% 1/55 • Up to Day 43 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 • Up to Day 43 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	16.4% 9/55 • Up to Day 43 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	14.5% 8/55 • Up to Day 43 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 • Up to Day 43 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	3.6% 2/55 • Up to Day 43 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 • Up to Day 43 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	1.8% 1/55 • Up to Day 43 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 • Up to Day 43 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	1.8% 1/55 • Up to Day 43 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 Viral upper respiratory tract infection	1.8% 1/55 • Up to Day 43 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	7.3% 4/55 • Up to Day 43 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	3.6% 2/55 • Up to Day 43 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	10.9% 6/55 • Up to Day 43 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 Dizziness	1.8% 1/55 • Up to Day 43 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 Somnolence	1.8% 1/55 • Up to Day 43 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	1.8% 1/55 • Up to Day 43 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

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

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