Influenza
Conditions
Keywords
Drug Therapy
Brief summary
This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants
Detailed description
The primary objective of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of TAK-850 for 22 days in healthy Japanese adults
Interventions
DRUGTAK-850
TAK-850 injection
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2\. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3\. The participant is a healthy Japanese adult male or female. 4. The participant is aged 20 to 49 years, inclusive, at the time of informed consent. 5\. The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive, at the time of eligibility evaluation. 6\. If the participant is a female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
Exclusion criteria
* 1\. The participant has received any investigational compound within 4 months prior to the initial injection of study vaccine. 2\. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the initial injection of study vaccine. 3\. The participant has a history of influenza infection within 6 months prior to the initial injection of study vaccine 4. The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress. 5\. The participant has uncontrolled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine or other disorders, which may impact the ability of the participant to participate or potentially confound the study results. 6\. The participant has an oral temperature ≥37.5°C prior to the initial injection of study vaccine on Day 1. 7\. The participant has any medically diagnosed or suspected immune deficient condition. 8\. The participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to the initial injection of study vaccine. Such treatments include, but is not limited to, systemic or high dose inhaled corticosteroids (\>800 μg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation treatment or other immunosuppressive or cytotoxic drugs. 9\. The participant has received antipyretics within 4 hours prior to the initial injection of study vaccine. 10\. The participant has a history of Guillain- Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis) or convulsions. 11\. The participant has a functional or surgical asplenia. 12. The participant has a rash, other dermatologic conditions or tattoos which may interfere with the evaluation of injection site reaction as determined by the Investigator. 13\. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV). 14\. The participant has a known hypersensitivity to any component of TAK-850. 15. The participant has a history of severe allergic reactions or anaphylaxis. 16. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the initial injection of study vaccine or is unwilling to agree to abstain from alcohol and drugs throughout the study. 17\. The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the initial injection of study vaccine. 18\. The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to the initial injection of study vaccine. 19\. If female, the participant is pregnant or lactating or intending to become pregnant before signing informed consent, during, or within 1 month after participating in this study; or intending to donate ova during such time period. 20\. The participant has donated whole blood ?200 mL within 4 weeks (28 days), ≥400 mL within 12 weeks (84 days), ≥800 mL within 52 weeks (364 days), or blood components within 2 weeks (14 days) prior to the initial injection of study vaccine. 21\. The participant has abnormal (clinically significant) electrocardiogram (ECG) at the assessment prior to the initial injection of study vaccine. 22\. The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the initial injection of study vaccine, or the participant has the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the upper limits of normal. 23\. In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Injection Site and Systemic Adverse Events | For 22 days | Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT. |
| Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer | Day 22 | Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). |
| Seroconversion Rate of HI AntibodyTiter | Day 22 | Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of \< 10 achieving an HI antibody titer of ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). |
| Geometric Mean Fold Increase in HI Antibody Titer | Day 22 | Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT of Single Radial Hemolysis (SRH) Antibody Titer | Day 22 | GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. |
| Seroprotection Rate of SRH Antibody Titer | Day 22 | Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. |
| Geometric Mean Fold Increase in SRH Antibody Titer | Day 22 | Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline. |
| Seroconversion Rate of SRH Antibody Titer | Day 22 | Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. |
| Change From Baseline in Blood Pressure | Day 1 (Baseline), Day 8, Day 22 | For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created. |
| Change From Baseline in Safety Electrocardiogram (ECG) Parameters | Day 1 and Day 22 | The ECG data will be analyzed into 3 categories, 'normal', 'abnormal but not clinically significant' and 'abnormal clinically significant'. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS). |
| Geometric Mean Titer (GMT) of HI Antibody Titer | Day 22 | Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 23 March 2014 to 15 April 2014.
Pre-assignment details
Informed consent for the study was obtained from 64 subjects in total. All subjects who gave informed consent were screened for eligibility, and 55 of these subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| TAK-850 0.5 mL A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin \[HA\] antigen per strain) is injected into the deltoid muscle. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | TAK-850 0.5 mL |
|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 8.75 |
| Body Mass index (BMI) | 21.66 kg/m^2 STANDARD_DEVIATION 1.563 |
| Height | 164.8 cm STANDARD_DEVIATION 7.82 |
| Influenza Vaccination History Within 1 Year No | 55 Number of participants |
| Influenza Vaccination History Within 1 Year Yes | 0 Number of participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 30 Participants |
| Weight | 58.95 kg STANDARD_DEVIATION 7.185 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Geometric Mean Fold Increase in HI Antibody Titer
Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.
Time frame: Day 22
Population: The full analysis set was used.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 0.5 mL | Geometric Mean Fold Increase in HI Antibody Titer | A/H1N1 strain | 14.74 Fold Change | 95% Confidence Interval 7.412 |
| TAK-850 0.5 mL | Geometric Mean Fold Increase in HI Antibody Titer | B strain7.14 | 7.14 Fold Change | 95% Confidence Interval 5.123 |
| TAK-850 0.5 mL | Geometric Mean Fold Increase in HI Antibody Titer | A/H3N2 strain | 6.71 Fold Change | 95% Confidence Interval 6.783 |
Primary
Number of Participants With Solicited Injection Site and Systemic Adverse Events
Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.
Time frame: For 22 days
Population: The safety analysis set, comprised the volunteers who received a single dose of 0.5 mL TAK-850, was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Arthralgia | 1 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Chills | 2 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Fatigue | 1 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Headache | 3 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Injection site pain | 9 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Injection site tenderness (Injection site pain) | 18 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Malaise | 9 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Injection site ecchymosis (haemorrhage) | 1 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Myalgia | 2 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Pyrexia | 1 participants |
| TAK-850 0.5 mL | Number of Participants With Solicited Injection Site and Systemic Adverse Events | Sweaty (Hyperhidrosis) | 1 participants |
Primary
Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer
Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Time frame: Day 22
Population: The full analysis set was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.5 mL | Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer | A/H1N1 strain Pre-vaccination (Day 1) | 34.5 Percentage of participants |
| TAK-850 0.5 mL | Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer | A/H1N1 strain 21 Days Post-vaccination (Day 22) | 81.8 Percentage of participants |
| TAK-850 0.5 mL | Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer | A/H3N2 strain Pre-vaccination (Day 1) | 63.6 Percentage of participants |
| TAK-850 0.5 mL | Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer | A/H3N2 strain 21 Days Post-vaccination (Day 22) | 87.3 Percentage of participants |
| TAK-850 0.5 mL | Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer | B strain Pre-vaccination (Day 1) | 20.0 Percentage of participants |
| TAK-850 0.5 mL | Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer | B strain 21 Days Post-vaccination (Day 22) | 76.4 Percentage of participants |
Primary
Seroconversion Rate of HI AntibodyTiter
Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of \< 10 achieving an HI antibody titer of ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Time frame: Day 22
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.5 mL | Seroconversion Rate of HI AntibodyTiter | A/H1N1 strain | 70.9 Percentage of participants |
| TAK-850 0.5 mL | Seroconversion Rate of HI AntibodyTiter | A/H3N2 strain | 52.7 Percentage of participants |
| TAK-850 0.5 mL | Seroconversion Rate of HI AntibodyTiter | B strain | 61.8 Percentage of participants |
Secondary
Change From Baseline in Blood Pressure
For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.
Time frame: Day 1 (Baseline), Day 8, Day 22
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 0.5 mL | Change From Baseline in Blood Pressure | Systolic blood pressure Day 1 | -1.2 mmHg | Standard Deviation 8.37 |
| TAK-850 0.5 mL | Change From Baseline in Blood Pressure | Systolic blood pressure Day 8 | -2.1 mmHg | Standard Deviation 9.23 |
| TAK-850 0.5 mL | Change From Baseline in Blood Pressure | Systolic blood pressure Day 22 | 0.7 mmHg | Standard Deviation 10.62 |
| TAK-850 0.5 mL | Change From Baseline in Blood Pressure | Diastolic blood pressure Day 1 | -2.0 mmHg | Standard Deviation 6.95 |
| TAK-850 0.5 mL | Change From Baseline in Blood Pressure | Diastolic blood pressure Day 8 | -2.7 mmHg | Standard Deviation 6.79 |
| TAK-850 0.5 mL | Change From Baseline in Blood Pressure | Diastolic blood pressure Day 22 | -2.4 mmHg | Standard Deviation 7.3 |
Secondary
Change From Baseline in Safety Electrocardiogram (ECG) Parameters
The ECG data will be analyzed into 3 categories, 'normal', 'abnormal but not clinically significant' and 'abnormal clinically significant'. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).
Time frame: Day 1 and Day 22
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | WNL at Day 1 and WNL at Day 22 | 55 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | WNL ay Day 1 and Abnormal, NCS at Day 22 | 0 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | WNL at Day 1 and Abnormal, CS at Day 22 | 0 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | Abnormal, NCS at Day 1 and Abnormal NCS at Day 22 | 0 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | Abnormal, NCS at Day 1 and Abnormal, CS at Day 22 | 0 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | Abnormal, CS at Day WNL at Day 22 | 0 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | Abnormal, CS at Day 1 and Abnormal, NCS at Day 22 | 0 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | Abnormal, NCS at Day 1 and WNL at Day 22 | 0 participants |
| TAK-850 0.5 mL | Change From Baseline in Safety Electrocardiogram (ECG) Parameters | Abnormal, CS at Day 1 and Abnormal, CS at Day 22 | 0 participants |
Secondary
Geometric Mean Fold Increase in SRH Antibody Titer
Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.
Time frame: Day 22
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 0.5 mL | Geometric Mean Fold Increase in SRH Antibody Titer | A/H1N1 strain | 3.9106 Fold Change | 95% Confidence Interval 2.98684 |
| TAK-850 0.5 mL | Geometric Mean Fold Increase in SRH Antibody Titer | A/H3N2 strain | 3.9301 Fold Change | 95% Confidence Interval 2.75769 |
| TAK-850 0.5 mL | Geometric Mean Fold Increase in SRH Antibody Titer | B strain | 3.0851 Fold Change | 95% Confidence Interval 2.82759 |
Secondary
Geometric Mean Titer (GMT) of HI Antibody Titer
Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination
Time frame: Day 22
Population: The full analysis set was used.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.5 mL | Geometric Mean Titer (GMT) of HI Antibody Titer | A/H1N1 strain Pre-vaccination (Day 1) | 17.86 titer |
| TAK-850 0.5 mL | Geometric Mean Titer (GMT) of HI Antibody Titer | A/H1N1 strain 21 Days Post-vaccination (Day 22) | 263.22 titer |
| TAK-850 0.5 mL | Geometric Mean Titer (GMT) of HI Antibody Titer | A/H3N2 strain Pre-vaccination (Day 1) | 76.07 titer |
| TAK-850 0.5 mL | Geometric Mean Titer (GMT) of HI Antibody Titer | A/H3N2 strain 21 Days Post-vaccination (Day 22) | 510.11 titer |
| TAK-850 0.5 mL | Geometric Mean Titer (GMT) of HI Antibody Titer | B strain Pre-vaccination (Day 1) | 8.33 titer |
| TAK-850 0.5 mL | Geometric Mean Titer (GMT) of HI Antibody Titer | B 21 Days Post-vaccination (Day 22) | 59.49 titer |
Secondary
GMT of Single Radial Hemolysis (SRH) Antibody Titer
GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Time frame: Day 22
Population: The full analysis set was used.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.5 mL | GMT of Single Radial Hemolysis (SRH) Antibody Titer | A/H1N1 strain 21 Days Post-vaccination (Day 22) | 71.0170 mm^2 |
| TAK-850 0.5 mL | GMT of Single Radial Hemolysis (SRH) Antibody Titer | A/H3N2 strain Pre-vaccination (Day 1) | 7.8348 mm^2 |
| TAK-850 0.5 mL | GMT of Single Radial Hemolysis (SRH) Antibody Titer | A/H3N2 strain 21 Days Post-vaccination (Day 22) | 30.7917 mm^2 |
| TAK-850 0.5 mL | GMT of Single Radial Hemolysis (SRH) Antibody Titer | B strain Pre-vaccination (Day 1) | 32.8363 mm^2 |
| TAK-850 0.5 mL | GMT of Single Radial Hemolysis (SRH) Antibody Titer | B strain 21 Days Post-vaccination (Day 22) | 101.3016 mm^2 |
| TAK-850 0.5 mL | GMT of Single Radial Hemolysis (SRH) Antibody Titer | A/H1N1 strain Pre-vaccination (Day 1) | 18.1601 mm^2 |
Secondary
Seroconversion Rate of SRH Antibody Titer
Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Time frame: Day 22
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.5 mL | Seroconversion Rate of SRH Antibody Titer | A/H1N1 strain | 81.8 percentage of participants |
| TAK-850 0.5 mL | Seroconversion Rate of SRH Antibody Titer | A/H3N2 strain | 74.5 percentage of participants |
| TAK-850 0.5 mL | Seroconversion Rate of SRH Antibody Titer | B strain | 78.2 percentage of participants |
Secondary
Seroprotection Rate of SRH Antibody Titer
Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Time frame: Day 22
Population: The full analysis set was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.5 mL | Seroprotection Rate of SRH Antibody Titer | A/H1N1 strain Pre-vaccination (Day 1) | 50.9 percentage of participants |
| TAK-850 0.5 mL | Seroprotection Rate of SRH Antibody Titer | A/H1N1 strain 21 Days Post-vaccination (Day 22) | 92.7 percentage of participants |
| TAK-850 0.5 mL | Seroprotection Rate of SRH Antibody Titer | A/H3N2 strain Pre-vaccination (Day 1) | 16.4 percentage of participants |
| TAK-850 0.5 mL | Seroprotection Rate of SRH Antibody Titer | A/H3N2 strain 21 Days Post-vaccination (Day 22) | 81.8 percentage of participants |
| TAK-850 0.5 mL | Seroprotection Rate of SRH Antibody Titer | B strain Pre-vaccination (Day 1) | 72.7 percentage of participants |
| TAK-850 0.5 mL | Seroprotection Rate of SRH Antibody Titer | B strain 21 Days Post-vaccination (Day 22) | 100.0 percentage of participants |