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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1164-1969 | Registry Identifier | UTN (WHO) | |
| JapicCTI-142724 | Registry Identifier | JapicCTI |
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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
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 :
Participants will make up to 3 visits to the study site. Total duration of this study is 22 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-850 0.5 mL (subcutaneous) | Experimental | Single subcutaneous injection of TAK-850 |
|
| TAK-850 0.5 mL (Intramuscular) | Experimental | Single intramuscular injection of TAK-850 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous injection of TAK-850 | Drug | TAK-850 0.5 mL, Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 21 days (Day 22) after vaccination |
| 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. | Up to 21 days (Day 22) after vaccination |
| 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). | Day 22 (21 days after vaccination) |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values | Laboratory values included hematology, biochemistry and urinalysis tests. | Baseline,up to 21 Days after drug administration (Day 22) |
| Change From Baseline in Blood Pressure |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Senior VP Clinical Science | Takeda | Study Director |
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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 took part in the study at 1 investigative site in Japan from 13-December-2014 to 22-January-2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set was defined as all participants who received vaccination with the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | TAK-850 Intramuscular Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set was defined as all participants who received vaccination with the study drug. | Posted | Number | participants | Up to 21 days (Day 22) after vaccination |
|
Treatment-emergent AEs will be defined as any AEs, regardless of relationship to study drug, that occur or worsen after the dose of study drug and no more than 21 days after the study drug administration (up to Day 22).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Intramuscular injection of TAK-850 | Drug | TAK-850 0.5 mL, Intramuscular injection |
|
| Day 22 (21 days after vaccination) |
| 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. | Pre-vaccination, 21 Days After vaccination (Day 22) |
Change from baseline in systolic and diastolic blood pressure was reported |
| Baseline, Day 22 |
| Change From Baseline in Pulse | Change from baseline in pulse was reported. | Baseline, Day 22 |
| Change From Baseline in Body Temperature | Change from baseline in body temperature (oral) was reported. | Baseline, Day 22 |
| 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. | Day 22 (21 days after vaccination) |
| 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). | Day 22 (21 days after vaccination) |
| 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). | Day 22 (21 days after vaccination) |
| 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. | Pre-vaccination, 21 Days after vaccination (Day 22) |
| 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. | Day 22 (21 days after vaccination) |
| 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). | Day 22 (21 days after vaccination) |
| 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). | Day 22 (21 days after vaccination) |
| 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. | Pre-vaccination, 21 Days After vaccination (Day 22) |
| 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. | Day 22 (21 days after vaccination) |
| 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). | Day 22 (21 days after vaccination) |
| 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). | Day 22 (21 days after vaccination) |
| 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. | Pre-vaccination, 21 Days After vaccination (Day 22) |
| 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. | Day 22 (21 days after vaccination) |
TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Influenza Infection Within 1 Year | Number | participants |
|
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 at Day1 (Predose) Titer | Number of participants with values of HI antibody titer for A/H1N1 strain pre-dose at Day 1 were reported. Influenza A/Hemagglutinin Type 1 and Neuraminidase Type 1 (A/H1N1). Greater than or equal to (>=). Less than or equal to (<=). | Number | participants |
|
| HI(Egg-derived) - A/H3N2 at Day1(Predose) Titer | Number of participants with values of HI antibody titer for A/H3N2 strain pre-dose at Day 1 were reported. | Number | participants |
|
| HI(Egg-derived) - Influenza B(B) at Day1(Predose) Titer | Number of participants with values of HI antibody titer for B strain pre-dose at Day 1 were reported. | Number | participants |
|
| OG001 |
| 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. |
|
|
| 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. | Safety analysis set was defined as all participants who received vaccination with the study drug. | Posted | Number | participants | Up to 21 days (Day 22) after vaccination |
|
|
|
| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
|
|
|
| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
|
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| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Pre-vaccination, 21 Days After vaccination (Day 22) |
|
|
|
| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values | Laboratory values included hematology, biochemistry and urinalysis tests. | Safety analysis set was defined as all participants who received vaccination with the study drug. | Posted | Number | participants | Baseline,up to 21 Days after drug administration (Day 22) |
|
|
|
| Secondary | Change From Baseline in Blood Pressure | Change from baseline in systolic and diastolic blood pressure was reported | Safety analysis set was defined as all participants who received vaccination with the study drug. | Posted | Mean | Standard Deviation | millimeter mercury (mmHg) | Baseline, Day 22 |
|
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| Secondary | Change From Baseline in Pulse | Change from baseline in pulse was reported. | Safety analysis set was defined as all participants who received vaccination with the study drug. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Day 22 |
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| Secondary | Change From Baseline in Body Temperature | Change from baseline in body temperature (oral) was reported. | Safety analysis set was defined as all participants who received vaccination with the study drug. | Posted | Mean | Standard Deviation | degree celsius | Baseline, Day 22 |
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| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 (21 days after vaccination) |
|
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| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
|
|
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| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
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| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Pre-vaccination, 21 Days after vaccination (Day 22) |
|
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| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 (21 days after vaccination) |
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| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
|
|
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| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
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| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Pre-vaccination, 21 Days After vaccination (Day 22) |
|
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| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 (21 days after vaccination) |
|
|
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| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
|
|
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| 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). | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after vaccination) |
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|
| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Pre-vaccination, 21 Days After vaccination (Day 22) |
|
|
|
| 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. | Full analysis set was defined as participants who were randomized and received vaccination with the study drug. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 (21 days after vaccination) |
|
|
|
| 0 |
| 55 |
| 34 |
| 55 |
| EG001 | 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. | 0 | 55 | 32 | 55 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Chills | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site warmth | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| B strain |
|
| B strain |
|
A/H3N2 Strain
| Difference |
| -15.5 |
| 2-Sided |
| 95 |
| -33.779 |
| 2.870 |
Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C. |
| No |
| Superiority or Other |
| B Strain | Difference | -11.8 | 2-Sided | 95 | -30.048 | 6.547 | Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C. | No | Superiority or Other |
| B strain |
|
| Diastolic Blood Pressure: Baseline |
|
| Diastolic Blood Pressure: Change at Day 22 |
|
| B strain |
|
| B strain |
|
| B strain |
|
| B strain |
|
| B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|
| Vero antigen: B strain |
|
| Live-Vero antigen: A/H1N1 strain |
|
| Live-Vero antigen: A/H3N2 strain |
|
| Live-Vero antigen: B strain |
|
| MDCK antigen: A/H1N1 strain |
|
| MDCK antigen: A/H3N2 strain |
|
| MDCK antigen: B strain |
|