Influenza Infection
Conditions
Keywords
Prevention
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in healthy Japanese adults
Detailed description
The drug being tested in this study is called TAK-850. This drug is being tested to evaluate the safety and immunogenicity of a single subcutaneous injection as compared to a single, intramuscular injection. A total of 110 healthy participants (55 per group) will take part in this study. Each participant will be randomly (like flipping a coin) assigned to receive one of the following : * A single injection of TAK-850, subcutaneously , or * A single injection of TAK-850, intramuscularly. Participants will make up to 3 visits to the study site. Total duration of this study is 22 days.
Interventions
DRUGSubcutaneous injection of TAK-850
TAK-850 0.5 mL, Subcutaneous injection
DRUGIntramuscular injection of TAK-850
TAK-850 0.5 mL, Intramuscular injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* In the opinion of the investigator or subinvestigator, 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/m\^2, 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 injection of study vaccine. 2\. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the injection of study vaccine. 3\. The participant has a history of influenza infection within 6 months prior to the 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 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 injection of study vaccine. Such treatments include, but is not limited to, systemic or high dose inhaled corticosteroids (\>800 mcg/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 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 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 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 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 injection of study vaccine. 21\. The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the 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. 22\. 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 Reporting Solicited Local and Systemic Adverse Events (AEs) | Up to 21 days (Day 22) after vaccination | 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. |
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Up to 21 days (Day 22) after vaccination | 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. |
| Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. | Day 22 (21 days after vaccination) | 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). |
| Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | Day 22 (21 days after vaccination) | 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). |
| Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Pre-vaccination, 21 Days After vaccination (Day 22) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2 | Day 22 (21 days after vaccination) | 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). |
| Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | Day 22 (21 days after vaccination) | 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). |
| GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Pre-vaccination, 21 Days after vaccination (Day 22) | 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. |
| GMT in SRH Antibody Titer (Egg-derived Antigen) | Day 22 (21 days after vaccination) | 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. |
| Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Day 22 (21 days after vaccination) | 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). |
| Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Day 22 (21 days after vaccination) | 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). |
| Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values | Baseline,up to 21 Days after drug administration (Day 22) | Laboratory values included hematology, biochemistry and urinalysis tests. |
| GMT in HI Antibody Titer (Cell Derived Antigen) | Day 22 (21 days after vaccination) | 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. |
| Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | Day 22 (21 days after vaccination) | 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). |
| Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Day 22 (21 days after vaccination) | 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). |
| GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Pre-vaccination, 21 Days After vaccination (Day 22) | 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. |
| GMT in SRH Antibody Titer (Cell Derived Antigen) | Day 22 (21 days after vaccination) | 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. |
| GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Pre-vaccination, 21 Days After vaccination (Day 22) | 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. |
| Change From Baseline in Blood Pressure | Baseline, Day 22 | Change from baseline in systolic and diastolic blood pressure was reported |
| Change From Baseline in Pulse | Baseline, Day 22 | Change from baseline in pulse was reported. |
| Change From Baseline in Body Temperature | Baseline, Day 22 | Change from baseline in body temperature (oral) was reported. |
| Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen) | Day 22 (21 days after vaccination) | 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. |
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 13-December-2014 to 22-January-2015.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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. | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | TAK-850 Subcutaneous Injection | TAK-850 Intramuscular Injection | Total |
|---|---|---|---|
| Age, Continuous | 24.1 years STANDARD_DEVIATION 3.5 | 25.1 years STANDARD_DEVIATION 4.08 | 24.6 years STANDARD_DEVIATION 3.82 |
| Body Mass Index | 20.41 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.457 | 21.18 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.561 | 20.79 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.552 |
| Height | 165.9 centimeter (cm) STANDARD_DEVIATION 8.83 | 165.5 centimeter (cm) STANDARD_DEVIATION 8.67 | 165.7 centimeter (cm) STANDARD_DEVIATION 8.71 |
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 at Day1 (Predose) Titer >=40 to <=Maximum (Max) titer | 15 participants | 18 participants | 33 participants |
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 at Day1 (Predose) Titer >=Minimum (Min) to <40 titer | 40 participants | 37 participants | 77 participants |
| HI(Egg-derived) - A/H3N2 at Day1(Predose) Titer >=40 to <=Max titer | 7 participants | 14 participants | 21 participants |
| HI(Egg-derived) - A/H3N2 at Day1(Predose) Titer >=Min to less than (<) 40 titer | 48 participants | 41 participants | 89 participants |
| HI(Egg-derived) - Influenza B(B) at Day1(Predose) Titer >=40 to <=Max titer | 30 participants | 30 participants | 60 participants |
| HI(Egg-derived) - Influenza B(B) at Day1(Predose) Titer >=Min to < 40 titer | 25 participants | 25 participants | 50 participants |
| Influenza Infection Within 1 Year Participant didnot have influenza infection in 1yr | 55 participants | 54 participants | 109 participants |
| Influenza Infection Within 1 Year Participant had influenza infection in 1 year (yr) | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Male | 28 Participants | 27 Participants | 55 Participants |
| Weight | 56.35 kilogram (kg) STANDARD_DEVIATION 7.325 | 58.19 kilogram (kg) STANDARD_DEVIATION 7.61 | 57.27 kilogram (kg) STANDARD_DEVIATION 7.492 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 55 | 32 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Intramuscular Injection | Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | A/H1N1 strain | 15.54 fold increase |
| TAK-850 Intramuscular Injection | Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | A/H3N2 strain | 4.40 fold increase |
| TAK-850 Intramuscular Injection | Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | B strain | 4.13 fold increase |
Primary
Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)
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.
Time frame: Up to 21 days (Day 22) after vaccination
Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site tenderness | 29 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Chills | 3 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site redness | 4 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 7 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site ecchymosis | 2 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Headache | 7 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site induration | 2 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Sweaty | 1 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Pyrexia | 2 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Myalgia | 3 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site swelling | 4 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Arthralgia | 4 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Malaise | 12 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Nausea | 2 participants |
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site pain | 7 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Nausea | 4 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site pain | 5 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site redness | 0 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site swelling | 0 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site induration | 1 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site tenderness | 26 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Injection site ecchymosis | 1 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Pyrexia | 2 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Malaise | 10 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Chills | 3 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 8 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Headache | 3 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Sweaty | 0 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Myalgia | 3 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) | Arthralgia | 3 participants |
Primary
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
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.
Time frame: Up to 21 days (Day 22) after vaccination
Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-850 Subcutaneous Injection | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 34 participants |
| TAK-850 Intramuscular Injection | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 32 participants |
Primary
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H1N1 strain | 58.2 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H3N2 strain | 34.5 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | B strain | 34.5 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H1N1 strain | 64.8 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H3N2 strain | 50.0 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | B strain | 46.3 percentage of participants |
Comparison: A/H1N1 Strain95% CI: [-24.858, 11.592]
Comparison: A/H3N2 Strain95% CI: [-33.779, 2.87]
Comparison: B Strain95% CI: [-30.048, 6.547]
Primary
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. | A/H1N1 strain | 80.0 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. | A/H3N2 strain | 49.1 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. | B strain | 87.3 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. | A/H1N1 strain | 88.9 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. | A/H3N2 strain | 70.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. | B strain | 90.7 percentage of participants |
Secondary
Change From Baseline in Blood Pressure
Change from baseline in systolic and diastolic blood pressure was reported
Time frame: Baseline, Day 22
Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 Subcutaneous Injection | Change From Baseline in Blood Pressure | Systolic Blood Pressure: Baseline | 109.3 millimeter mercury (mmHg) | Standard Deviation 11.36 |
| TAK-850 Subcutaneous Injection | Change From Baseline in Blood Pressure | Systolic Blood Pressure: Change at Day 22 | -0.7 millimeter mercury (mmHg) | Standard Deviation 9.78 |
| TAK-850 Subcutaneous Injection | Change From Baseline in Blood Pressure | Diastolic Blood Pressure: Baseline | 63.8 millimeter mercury (mmHg) | Standard Deviation 7.5 |
| TAK-850 Subcutaneous Injection | Change From Baseline in Blood Pressure | Diastolic Blood Pressure: Change at Day 22 | 0.4 millimeter mercury (mmHg) | Standard Deviation 7.47 |
| TAK-850 Intramuscular Injection | Change From Baseline in Blood Pressure | Diastolic Blood Pressure: Change at Day 22 | 0.4 millimeter mercury (mmHg) | Standard Deviation 6.89 |
| TAK-850 Intramuscular Injection | Change From Baseline in Blood Pressure | Systolic Blood Pressure: Baseline | 112.2 millimeter mercury (mmHg) | Standard Deviation 10.93 |
| TAK-850 Intramuscular Injection | Change From Baseline in Blood Pressure | Diastolic Blood Pressure: Baseline | 66.3 millimeter mercury (mmHg) | Standard Deviation 8.57 |
| TAK-850 Intramuscular Injection | Change From Baseline in Blood Pressure | Systolic Blood Pressure: Change at Day 22 | -0.9 millimeter mercury (mmHg) | Standard Deviation 9.94 |
Secondary
Change From Baseline in Body Temperature
Change from baseline in body temperature (oral) was reported.
Time frame: Baseline, Day 22
Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 Subcutaneous Injection | Change From Baseline in Body Temperature | Temperature: Baseline | 36.71 degree celsius | Standard Deviation 0.305 |
| TAK-850 Subcutaneous Injection | Change From Baseline in Body Temperature | Temperature: Change at Day 22 | -0.21 degree celsius | Standard Deviation 0.357 |
| TAK-850 Intramuscular Injection | Change From Baseline in Body Temperature | Temperature: Baseline | 36.72 degree celsius | Standard Deviation 0.311 |
| TAK-850 Intramuscular Injection | Change From Baseline in Body Temperature | Temperature: Change at Day 22 | -0.20 degree celsius | Standard Deviation 0.388 |
Secondary
Change From Baseline in Pulse
Change from baseline in pulse was reported.
Time frame: Baseline, Day 22
Population: Safety analysis set was defined as all participants who received vaccination with the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 Subcutaneous Injection | Change From Baseline in Pulse | Pulse: Baseline | 72.9 beats per minute | Standard Deviation 11.69 |
| TAK-850 Subcutaneous Injection | Change From Baseline in Pulse | Pulse: Change at Day 22 | -2.3 beats per minute | Standard Deviation 11.35 |
| TAK-850 Intramuscular Injection | Change From Baseline in Pulse | Pulse: Baseline | 72.9 beats per minute | Standard Deviation 10.34 |
| TAK-850 Intramuscular Injection | Change From Baseline in Pulse | Pulse: Change at Day 22 | -2.0 beats per minute | Standard Deviation 8.51 |
Secondary
Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)
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.
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen) | A/H3N2 strain | 21.91 titer |
| TAK-850 Subcutaneous Injection | Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen) | A/H1N1 strain | 143.30 titer |
| TAK-850 Subcutaneous Injection | Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen) | B strain | 82.56 titer |
| TAK-850 Intramuscular Injection | Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen) | A/H1N1 strain | 237.43 titer |
| TAK-850 Intramuscular Injection | Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen) | A/H3N2 strain | 51.21 titer |
| TAK-850 Intramuscular Injection | Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen) | B strain | 107.13 titer |
Secondary
GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: B strain | 3.67 fold increase |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: B strain | 2.84 fold increase |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: A/H1N1 strain | 9.12 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: A/H1N1 strain | 3.51 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Live-Vero antigen: A/H3N2 strain | 5.88 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: B strain | 3.45 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: A/H3N2 strain | 4.17 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Live-Vero antigen: B strain | 3.66 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: B strain | 3.74 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: A/H3N2 strain | 8.10 fold increase |
| TAK-850 Intramuscular Injection | GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Live-Vero antigen: A/H1N1 strain | 12.70 fold increase |
Secondary
GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: B strain | 1.7421 fold increase |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: B strain | 1.6128 fold increase |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: B strain | 1.5651 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: A/H1N1 strain | 3.4599 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: A/H3N2 strain | 2.4938 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Vero antigen: B strain | 1.7632 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Live-Vero antigen: A/H1N1 strain | 2.4059 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Live-Vero antigen: A/H3N2 strain | 2.2430 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | Live-Vero antigen: B strain | 1.8173 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: A/H1N1 strain | 3.1694 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination | MDCK antigen: A/H3N2 strain | 2.8178 fold increase |
Secondary
GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | A/H1N1 strain | 2.5435 fold increase |
| TAK-850 Subcutaneous Injection | GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | A/H3N2 strain | 1.7666 fold increase |
| TAK-850 Subcutaneous Injection | GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | B strain | 1.5867 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | A/H1N1 strain | 2.4169 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | A/H3N2 strain | 2.3687 fold increase |
| TAK-850 Intramuscular Injection | GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination | B strain | 1.6380 fold increase |
Secondary
GMT in HI Antibody Titer (Cell Derived Antigen)
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.
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 17.63 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 139.29 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 276.83 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 257.47 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 27.24 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 187.89 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 208.48 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 187.89 titer |
| TAK-850 Subcutaneous Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 17.52 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 210.85 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 20.72 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 32.05 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 37.40 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 424.41 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 320.00 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 168.43 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 381.77 titer |
| TAK-850 Intramuscular Injection | GMT in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 309.89 titer |
Secondary
GMT in SRH Antibody Titer (Cell Derived Antigen)
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.
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 53.3488 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 77.4468 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 77.3268 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 43.3793 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 51.4941 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 52.7714 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 75.9017 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 83.9627 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 29.2669 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 87.5052 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 33.3318 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 57.3376 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 54.3183 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 87.2200 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 79.7297 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 82.3667 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 51.8747 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 60.2234 titer |
Secondary
GMT in SRH Antibody Titer (Egg-derived Antigen)
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.
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Egg-derived Antigen) | A/H1N1 strain | 75.5840 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Egg-derived Antigen) | A/H3N2 strain | 28.9569 titer |
| TAK-850 Subcutaneous Injection | GMT in SRH Antibody Titer (Egg-derived Antigen) | B strain | 70.5747 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Egg-derived Antigen) | A/H1N1 strain | 82.4482 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Egg-derived Antigen) | A/H3N2 strain | 34.0601 titer |
| TAK-850 Intramuscular Injection | GMT in SRH Antibody Titer (Egg-derived Antigen) | B strain | 73.2954 titer |
Secondary
Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
Laboratory values included hematology, biochemistry and urinalysis tests.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-850 Subcutaneous Injection | Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values | 2 participants |
| TAK-850 Intramuscular Injection | Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values | 1 participants |
Secondary
Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 36.4 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 32.7 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 54.5 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 45.5 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 34.5 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 47.3 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 40.0 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 32.7 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 41.8 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 33.3 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 42.6 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 50.0 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 48.1 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 70.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 50.0 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 38.9 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 61.1 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 57.4 percentage of participants |
Secondary
Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 72.7 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 34.5 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 50.9 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 58.2 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 45.5 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 47.3 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 38.2 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 34.5 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 61.8 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: B strain | 38.9 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H1N1 strain | 63.0 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: A/H3N2 strain | 77.8 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Vero antigen: B strain | 44.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H1N1 strain | 46.3 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: A/H3N2 strain | 44.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | Live-Vero antigen: B strain | 48.1 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H1N1 strain | 61.1 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen) | MDCK antigen: A/H3N2 strain | 55.6 percentage of participants |
Secondary
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 strain | 58.2 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 strain | 41.8 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B strain | 38.2 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 strain | 61.1 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 strain | 51.9 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B strain | 46.3 percentage of participants |
Secondary
Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Vero antigen: A/H1N1 strain | 41.8 percentage of participants |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Vero antigen: B strain | 60.0 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | MDCK antigen: A/H1N1 strain | 90.9 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Vero antigen: A/H3N2 strain | 41.8 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | MDCK antigen: A/H3N2 strain | 92.7 percentage of participants |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | MDCK antigen: B strain | 98.2 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Live-Vero antigen: B strain | 96.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | MDCK antigen: B strain | 94.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Live-Vero antigen: B strain | 94.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Vero antigen: A/H1N1 strain | 46.3 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Vero antigen: A/H3N2 strain | 55.6 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Vero antigen: B strain | 72.2 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Live-Vero antigen: A/H1N1 strain | 98.1 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | Live-Vero antigen: A/H3N2 strain | 96.3 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | MDCK antigen: A/H1N1 strain | 98.1 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40 | MDCK antigen: A/H3N2 strain | 92.6 percentage of participants |
Secondary
Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | MDCK antigen: B strain | 100 percentage of participants |
| TAK-850 Subcutaneous Injection | 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 |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | MDCK antigen: B strain | 100 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | Vero antigen: A/H1N1 strain | 70.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | Vero antigen: A/H3N2 strain | 100 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | Vero antigen: B strain | 100 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | Live-Vero antigen: A/H1N1 strain | 100 percentage of participants |
| TAK-850 Intramuscular Injection | 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 |
| TAK-850 Intramuscular Injection | 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 |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | MDCK antigen: A/H1N1 strain | 94.4 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2 | MDCK antigen: A/H3N2 strain | 98.1 percentage of participants |
Secondary
Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2
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).
Time frame: Day 22 (21 days after vaccination)
Population: Full analysis set was defined as participants who were randomized and received vaccination with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2 | A/H1N1 strain | 100.0 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2 | A/H3N2 strain | 67.3 percentage of participants |
| TAK-850 Subcutaneous Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2 | B strain | 100.0 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2 | A/H1N1 strain | 100.0 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2 | A/H3N2 strain | 75.9 percentage of participants |
| TAK-850 Intramuscular Injection | Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2 | B strain | 100.0 percentage of participants |