Influenza Infection
Conditions
Keywords
Vaccine
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.
Detailed description
This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV. The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine. The study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * TAK-850 * Influenza HA vaccine All participants received one injection. This single center trial was conducted in Japan. The overall time to participate in this study was 22 days. Participants made multiple visits to the clinic, including a final visit 21 days after the vaccination for a follow-up assessment.
Interventions
BIOLOGICALTAK-850
TAK-850 subcutaneous injection
BIOLOGICALInfluenza HA vaccine
Influenza HA vaccine subcutaneous injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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 the eligibility evaluation. 6. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agreed to routinely use adequate contraception from signing of the informed consent throughout the duration of the study.
Exclusion criteria
1. The participant has received any investigational compound within 4 months prior to injection of study vaccine. 2. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to injection of study vaccine. 3. The participant has a history of influenza infection within 6 months prior to injection of study vaccine. 4. The participant has been vaccinated with TAK-850 before. 5. 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. 6. 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. 7. The participant has an oral temperature \>= 37.5 °C prior to injection of study vaccine on Day 1. 8. The participant has any medically diagnosed or suspected immune deficient condition. 9. 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 injection of study vaccine. Such treatments include systemic or high dose inhaled corticosteroids (\> 800 µg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation therapy, and other immunosuppressive and cytotoxic drugs. 10. The participant has received antipyretics within 4 hours prior to the injection of study vaccine. 11. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis), or convulsions. 12. The participant has a functional or surgical asplenia. 13. The participant has a rash, other dermatologic conditions, or tattoos which may interfere with the evaluation of injection site reaction. 14. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV). 15. The participant has known hypersensitivity to any component of TAK-850 or Influenza HA Vaccine. 16. The participant has a history of severe allergic reactions or anaphylaxis. 17. 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 injection of study vaccine or is unwilling to agree to abstain from excessive alcohol and drugs throughout the study. 18. The participant has received any blood products (blood transfusion or immunoglobulin) within 90 days prior to injection of study vaccine. 19. The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to injection of study vaccine. 20. If female, the participant is pregnant or lactating or intending to become pregnant before signing of informed consent, during treatment, or within 12 weeks after injection of study vaccine; or intending to donate ova during this time period. 21. 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 injection of study vaccine. 22. 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 laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the respective upper limits of normal. 23. In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | Baseline and Day 22 | Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10. |
| Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | Days 1 and 22 | Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | Baseline and Day 22 | Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. |
| GMT of SRH Antibody Titer (Egg-Derived Antigen) | Days 1 and 22 | GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. |
| Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | Days 1 and 22 | Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. |
| Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | Baseline and Day 22 | Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. |
| Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | Baseline and Day 22 | Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of \<10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. |
| GMT of HI Antibody Titer (Vero-Derived Antigen) | Days 1 and 22 | GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. |
| Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | Days 1 and 22 | Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. |
| Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | Days 1 and 22 | Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference. |
| Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | Baseline and Day 22 | Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. |
| GMT of SRH Antibody Titer (Vero-Derived Antigen) | Days 1 and 22 | GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. |
| Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | Days 1 and 22 | Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference. |
| Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | Baseline and Day 22 | Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. |
| Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | 22 Days | Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting. |
| Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 22 days | Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. |
| Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | 22 Days | The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs. |
| Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | Baseline and Day 22 | Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline. |
| Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | Baseline and Day 22 | Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline. |
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 24 September 2015 to 18 November 2015.
Pre-assignment details
Healthy Volunteers were enrolled equally in 1 of 2 groups, TAK-850 subcutaneous (SC) or Influenza hemagglutinin (HA) vaccine SC.
Participants by arm
| Arm | Count |
|---|---|
| TAK-850 A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm. | 200 |
| Influenza HA Vaccine A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. | 200 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Sponsor's Circumstances | 1 | 0 |
Baseline characteristics
| Characteristic | Influenza HA Vaccine | TAK-850 | Total |
|---|---|---|---|
| Age, Continuous | 31.5 years STANDARD_DEVIATION 9.46 | 31.2 years STANDARD_DEVIATION 9.61 | 31.4 years STANDARD_DEVIATION 9.52 |
| Age, Customized 20 to 29 years | 98 participants | 102 participants | 200 participants |
| Age, Customized 30 to 39 years | 47 participants | 46 participants | 93 participants |
| Age, Customized 40 to 49 years | 55 participants | 52 participants | 107 participants |
| Body Mass Index (BMI) | 20.86 kg/m^2 STANDARD_DEVIATION 1.752 | 21.10 kg/m^2 STANDARD_DEVIATION 1.912 | 20.98 kg/m^2 STANDARD_DEVIATION 1.835 |
| Gender Female | 95 Participants | 94 Participants | 189 Participants |
| Gender Male | 105 Participants | 106 Participants | 211 Participants |
| Height | 166.0 cm STANDARD_DEVIATION 8.32 | 166.3 cm STANDARD_DEVIATION 8.41 | 166.2 cm STANDARD_DEVIATION 8.35 |
| Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived)-A/H1N1 Strain Titer <40 | 65 participants | 74 participants | 139 participants |
| Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived)-A/H1N1 Strain Titer ≥40 | 135 participants | 125 participants | 260 participants |
| HI Antibody Titer (Egg-derived)-A/H3N2 Strain Titer <40 | 105 participants | 106 participants | 211 participants |
| HI Antibody Titer (Egg-derived)-A/H3N2 Strain Titer ≥40 | 95 participants | 93 participants | 188 participants |
| HI Antibody Titer (Egg-derived)-B Strain Titer <40 | 98 participants | 93 participants | 191 participants |
| HI Antibody Titer (Egg-derived)-B Strain Titer ≥40 | 102 participants | 106 participants | 208 participants |
| Influenza Infection within 1 Year No | 189 participants | 186 participants | 375 participants |
| Influenza Infection within 1 Year Yes | 11 participants | 14 participants | 25 participants |
| Region of Enrollment Japan | 200 participants | 200 participants | 400 participants |
| Weight | 57.69 kg STANDARD_DEVIATION 7.937 | 58.67 kg STANDARD_DEVIATION 8.918 | 58.18 kg STANDARD_DEVIATION 8.445 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 117 / 200 | 122 / 200 |
| serious Total, serious adverse events | 0 / 200 | 0 / 200 |
Outcome results
Primary
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 39.04 titer | 95% Confidence Interval 5.256 |
| TAK-850 | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 239.24 titer | 95% Confidence Interval 3.098 |
| TAK-850 | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 21.39 titer | 95% Confidence Interval 4.558 |
| TAK-850 | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 70.14 titer | 95% Confidence Interval 3.652 |
| TAK-850 | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 64.80 titer | 95% Confidence Interval 4.643 |
| TAK-850 | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 24.65 titer | 95% Confidence Interval 3.898 |
| Influenza HA Vaccine | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 84.93 titer | 95% Confidence Interval 5.496 |
| Influenza HA Vaccine | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 43.77 titer | 95% Confidence Interval 4.794 |
| Influenza HA Vaccine | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 65.89 titer | 95% Confidence Interval 4.197 |
| Influenza HA Vaccine | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 241.88 titer | 95% Confidence Interval 2.839 |
| Influenza HA Vaccine | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 25.34 titer | 95% Confidence Interval 4.211 |
| Influenza HA Vaccine | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 22.62 titer | 95% Confidence Interval 4.823 |
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.95% CI: [0.7984, 1.2253]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.95% CI: [0.5544, 1.05]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.95% CI: [0.8134, 1.3931]
Primary
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10.
Time frame: Baseline and Day 22
Population: Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 47.7 percentage of participants |
| TAK-850 | Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 31.2 percentage of participants |
| TAK-850 | Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | B Strain | 28.6 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 46.0 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 36.0 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) | B Strain | 26.0 percentage of participants |
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.95% CI: [-7.983, 11.415]
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.95% CI: [-13.974, 4.403]
Comparison: The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.95% CI: [-6.082, 11.32]
Secondary
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 6.13 fold increase | 95% Confidence Interval 5.496 |
| TAK-850 | Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 3.03 fold increase | 95% Confidence Interval 4.268 |
| TAK-850 | Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | B Strain | 2.85 fold increase | 95% Confidence Interval 3.399 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 5.53 fold increase | 95% Confidence Interval 5.353 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 3.75 fold increase | 95% Confidence Interval 4.861 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen) | B Strain | 2.60 fold increase | 95% Confidence Interval 3.356 |
Secondary
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
Population: FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 3.50 fold increase | 95% Confidence Interval 4.066 |
| TAK-850 | Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 2.49 fold increase | 95% Confidence Interval 3.584 |
| TAK-850 | Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | B Strain | 2.02 fold increase | 95% Confidence Interval 3.046 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 2.25 fold increase | 95% Confidence Interval 3.539 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 2.54 fold increase | 95% Confidence Interval 3.593 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen) | B Strain | 2.00 fold increase | 95% Confidence Interval 2.831 |
Secondary
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 2.0339 fold increase | 95% Confidence Interval 2.5478 |
| TAK-850 | Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | B Strain | 1.6305 fold increase | 95% Confidence Interval 1.81614 |
| TAK-850 | Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 2.5752 fold increase | 95% Confidence Interval 2.83602 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 2.1566 fold increase | 95% Confidence Interval 2.44635 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 2.3658 fold increase | 95% Confidence Interval 2.88645 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen) | B Strain | 1.6353 fold increase | 95% Confidence Interval 1.77973 |
Secondary
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Time frame: Baseline and Day 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 2.1970 fold increase | 95% Confidence Interval 2.03685 |
| TAK-850 | Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 1.6483 fold increase | 95% Confidence Interval 1.71298 |
| TAK-850 | Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | B Strain | 1.8495 fold increase | 95% Confidence Interval 1.91583 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 1.9570 fold increase | 95% Confidence Interval 2.16354 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 1.7332 fold increase | 95% Confidence Interval 1.7196 |
| Influenza HA Vaccine | Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen) | B Strain | 1.7632 fold increase | 95% Confidence Interval 2.03032 |
Secondary
GMT of HI Antibody Titer (Vero-Derived Antigen)
GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 7.41 titer | 95% Confidence Interval 2.395 |
| TAK-850 | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 25.88 titer | 95% Confidence Interval 4.297 |
| TAK-850 | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 15.93 titer | 95% Confidence Interval 3.549 |
| TAK-850 | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 39.65 titer | 95% Confidence Interval 4.449 |
| TAK-850 | GMT of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 10.74 titer | 95% Confidence Interval 2.826 |
| TAK-850 | GMT of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day 22 | 21.65 titer | 95% Confidence Interval 4.004 |
| Influenza HA Vaccine | GMT of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 10.13 titer | 95% Confidence Interval 2.721 |
| Influenza HA Vaccine | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 7.74 titer | 95% Confidence Interval 2.346 |
| Influenza HA Vaccine | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 37.19 titer | 95% Confidence Interval 5.313 |
| Influenza HA Vaccine | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 17.44 titer | 95% Confidence Interval 3.978 |
| Influenza HA Vaccine | GMT of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day 22 | 20.30 titer | 95% Confidence Interval 3.77 |
| Influenza HA Vaccine | GMT of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 14.67 titer | 95% Confidence Interval 3.722 |
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.95% CI: [1.1221, 1.9623]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.95% CI: [0.7806, 1.4564]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.95% CI: [0.8166, 1.3934]
Secondary
GMT of SRH Antibody Titer (Egg-Derived Antigen)
GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 32.4939 mm^2 | 95% Confidence Interval 2.98861 |
| TAK-850 | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 83.6792 mm^2 | 95% Confidence Interval 1.70398 |
| TAK-850 | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 23.6364 mm^2 | 95% Confidence Interval 2.99866 |
| TAK-850 | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 48.0742 mm^2 | 95% Confidence Interval 2.03848 |
| TAK-850 | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 45.6214 mm^2 | 95% Confidence Interval 2.00064 |
| TAK-850 | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 74.3848 mm^2 | 95% Confidence Interval 1.32537 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 46.3984 mm^2 | 95% Confidence Interval 1.8952 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 33.7752 mm^2 | 95% Confidence Interval 2.8508 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 53.5757 mm^2 | 95% Confidence Interval 1.87521 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 79.9046 mm^2 | 95% Confidence Interval 1.46596 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 75.8772 mm^2 | 95% Confidence Interval 1.32751 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 24.8424 mm^2 | 95% Confidence Interval 2.79368 |
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.95% CI: [0.9559, 1.1473]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.95% CI: [0.7862, 1.0241]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.95% CI: [0.9273, 1.0364]
Secondary
GMT of SRH Antibody Titer (Vero-Derived Antigen)
GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-850 | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 7.4041 titer | 95% Confidence Interval 2.32428 |
| TAK-850 | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 16.2670 titer | 95% Confidence Interval 2.13276 |
| TAK-850 | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 19.7055 titer | 95% Confidence Interval 2.07033 |
| TAK-850 | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 32.4796 titer | 95% Confidence Interval 1.76234 |
| TAK-850 | GMT of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 28.2050 titer | 95% Confidence Interval 2.17963 |
| TAK-850 | GMT of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 22 | 52.1647 titer | 95% Confidence Interval 1.53822 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 28.2142 titer | 95% Confidence Interval 2.23368 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 7.7958 titer | 95% Confidence Interval 2.26942 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 33.2751 titer | 95% Confidence Interval 1.8548 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 15.2566 titer | 95% Confidence Interval 2.32297 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 22 | 49.7468 titer | 95% Confidence Interval 1.5567 |
| Influenza HA Vaccine | GMT of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 19.1990 titer | 95% Confidence Interval 2.14468 |
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.95% CI: [0.9106, 1.2484]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.95% CI: [0.8686, 1.0969]
Comparison: The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.95% CI: [0.9622, 1.1427]
Secondary
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: 22 days
Population: Safety Analysis Set included all participants who received vaccination with study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-850 | Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 62.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 64.0 percentage of participants |
Secondary
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Time frame: 22 Days
Population: Safety Analysis Set included all participants who received vaccination with study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Blood glucose increased | 0.0 percentage of participants |
| TAK-850 | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Blood creatine phosphokinase increased | 2.0 percentage of participants |
| TAK-850 | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Protein urine present | 0.5 percentage of participants |
| TAK-850 | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Blood bilirubin increased | 0.5 percentage of participants |
| TAK-850 | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Liver function test abnormal | 0.5 percentage of participants |
| TAK-850 | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | White blood cell count increased | 0.5 percentage of participants |
| TAK-850 | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Alanine aminotransferase increased | 0.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Blood glucose increased | 0.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Liver function test abnormal | 0.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Blood creatine phosphokinase increased | 1.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Alanine aminotransferase increased | 0.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Protein urine present | 0.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | White blood cell count increased | 0.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Blood bilirubin increased | 0.0 percentage of participants |
Secondary
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
Time frame: 22 Days
Population: Safety Analysis Set included all participants who received vaccination with study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site ecchymosis | 3.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Chills | 2.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site swelling | 15.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 10.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site pain | 34.0 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Sweaty | 0.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Headache | 7.0 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Myalgia | 3.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Pyrexia | 0.0 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Arthralgia | 0.0 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site redness | 23.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 1.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 10.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Vomiting | 0.5 percentage of participants |
| TAK-850 | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site induration | 7.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Vomiting | 1.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site induration | 10.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Headache | 9.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site pain | 39.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site redness | 28.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site swelling | 20.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Injection site ecchymosis | 4.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Pyrexia | 0.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 11.0 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Chills | 4.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 6.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Sweaty | 1.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Myalgia | 5.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Arthralgia | 1.5 percentage of participants |
| Influenza HA Vaccine | Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 2.0 percentage of participants |
Secondary
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of \<10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Time frame: Baseline and Day 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | B Strain | 19.6 percentage of participants |
| TAK-850 | Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 40.2 percentage of participants |
| TAK-850 | Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 27.1 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | B Strain | 22.0 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 25.5 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 29.0 percentage of participants |
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.95% CI: [5.489, 23.577]
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.95% CI: [-10.614, 6.928]
Comparison: The analysis is difference of seroconversion rate between treatment groups for B-Strain.95% CI: [-10.346, 5.579]
Secondary
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.
Time frame: Baseline and Day 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 38.7 percentage of participants |
| TAK-850 | Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 50.8 percentage of participants |
| TAK-850 | Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | B Strain | 31.7 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain | 44.0 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain | 47.5 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen) | B Strain | 34.0 percentage of participants |
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.95% CI: [-3.02, 16.348]
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.95% CI: [-18.282, 0.901]
Comparison: The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.95% CI: [-11.461, 6.835]
Secondary
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \>4 mm\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\^2 achieving a SRH antibody titer of ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Time frame: Baseline and Day 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 24.1 percentage of participants |
| TAK-850 | Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 41.2 percentage of participants |
| TAK-850 | Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | B Strain | 43.2 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | B Strain | 40.0 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain | 23.0 percentage of participants |
| Influenza HA Vaccine | Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain | 42.0 percentage of participants |
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.95% CI: [-7.195, 9.423]
Comparison: The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.95% CI: [-10.369, 8.803]
Comparison: The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.95% CI: [-6.406, 12.757]
Secondary
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 53.3 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 81.4 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 62.8 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 95.5 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 46.7 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 77.9 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 47.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 51.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 97.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 76.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 78.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 67.5 percentage of participants |
Secondary
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 12.6 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 66.8 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 54.3 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 38.7 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 19.6 percentage of participants |
| TAK-850 | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day22 | 43.2 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 22.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 11.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 32.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 60.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | B Strain-Day22 | 46.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 40.0 percentage of participants |
Secondary
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 70.4 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 97.0 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 63.8 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 89.4 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 87.9 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 99.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 1 | 88.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 1 | 73.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 22 | 93.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1 Strain-Day 22 | 98.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | B Strain-Day 22 | 99.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2 Strain-Day 1 | 67.0 percentage of participants |
Secondary
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Time frame: Days 1 and 22
Population: FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 17.1 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 33.7 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 38.2 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 71.9 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 65.3 percentage of participants |
| TAK-850 | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 22 | 92.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 1 | 65.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 1 | 13.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 22 | 74.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H1N1 Strain-Day 22 | 33.0 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | B Strain-Day 22 | 93.5 percentage of participants |
| Influenza HA Vaccine | Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen) | A/H3N2 Strain-Day 1 | 42.5 percentage of participants |