Influenza Infection
Conditions
Keywords
Prevention
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.
Detailed description
The drug being tested in this study is called TAK-850, that is under development as a vaccine for influenza infection. This study will evaluate the safety and immunogenicity of TAK-850 in healthy Japanese children when given as an intramuscular injection. The study will enroll approximately 99 participants (33 per treatment group) to receive TAK-850 in open label fashion, The participants will be assigned to each treatment group as follows: * a single intramuscular injection of TAK-850/0.5 mL in 13 to 19 years old healthy Japanese children, * Two injections of TAK-850/0.5 mL in 3 to 12 years old healthy Japanese children, * Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children. The overall time to participate in this trial is 22 days (13-19 years old) or 43 days (6 months to 12 years old). Participants will make up to 2 visits (13-19 years old) or 3 visits (6 months to 12 years old) to the site.
Interventions
DRUGTAK-850 0.5 mL injection
TAK-850 injection
DRUGTAK-850 0.25 mL injection
TAK-850 intramuscular injection
Sponsors
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 19 Years
Healthy volunteers
Yes
Inclusion criteria
1. In the opinion of the investigator or the subinvestigator, the participant and/or his/her representative and his/her guardian is capable of understanding and complying with protocol requirements. 2. The participant's representative can sign and date a written, informed consent form prior to the initiation of any study procedures. 3. The participant is a healthy Japanese child. 4. The participant is aged 6 months to 19 years, inclusive, at the time of starting to receive the study vaccine. 5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent until 12 weeks after the administration.
Exclusion criteria
\[Only for participants at the age of 6-35 months old\] 1. The participant is a preterm newborn (gestational age was less than 37 weeks) or a low-birth-weight newborn (birth weight was less than 2500 g). 2. The participant has received any investigational compound within 4 months prior to the initial injection of study vaccine. 3. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the initial injection of study vaccine. 4. The participant has a history of influenza infection within 6 months prior to the initial injection of study vaccine. 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, 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 armpit temperature ≥ 37.5°C prior to the initial 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 the initial injection of study vaccine. Such treatments include, but are not limited to, systemic or high dose inhaled corticosteroids (\> 800 μg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation treatment or other immunosuppressive or cytotoxic drugs. 10. The participant has received antipyretics within 4 hours prior to the initial 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 as determined by the Investigator. 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 a known hypersensitivity to any component of TAK-850. 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 the initial injection of study vaccine or is unwilling to agree to abstain from alcohol and drugs throughout the study. 18. The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the initial 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 the initial injection of study vaccine. 20. 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. 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 the initial injection of study vaccine. 22. In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Up to 21 days after any vaccination | Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category. |
| Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Up to 21 days after any vaccination | Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category. |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 21 days after any vaccination | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, 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. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE. |
| Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group | Day 22 (21 days after Vaccination) | Seroprotection rate 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 for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40. |
| Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | Day 43 (21 days after Vaccination 2) | Seroprotection rate 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 second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40. |
| Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group | Day 22 (21 days after Vaccination) | Seroconversion rate 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 for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). |
| Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | Day 43 (21 days after Vaccination 2) | Seroconversion rate 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 second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). |
| Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group | Day 22 (21 days after Vaccination) | GMFI from baseline 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 for the age group of 13-19 years. |
| GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | Day 43 (21 days after Vaccination 2) | GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| GMT of HI Antibody Titer (Vero Antigen) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group | Day 22 (21 days after Vaccination 1) | Seroprotection rate 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 first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40. |
| Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of \>4 mm\^2), or achieving a SRH antibody titer of \>=25 mm\^2 (with baseline SRH antibody titer of \<=4 mm\^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| GMT of SRH Antibody Titer (Vero Antigen) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of \>=25 mm\^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | Day 22 (21 days after Vaccination 1) | Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). |
| GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | Day 22 (21 days after Vaccination 1) | GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years. |
| Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | 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 each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group. |
| Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of \>=25 mm\^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of \>4 mm\^2) or achieving a SRH antibody titer of \>=25 mm\^2 (with baseline SRH antibody titer of \<=4 mm\^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group) | GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| GMT of SRH Antibody Titer (Egg-Derived Antigen) | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
| Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group) | Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 2 investigative sites in Japan from 14 February 2015 to 2 May 2015.
Pre-assignment details
Healthy pediatric participants of age group 6 months-19 years were enrolled in 1 of the 3 treatment groups: TAK-850 0.25 milliliter (mL): 6 - 35 months; TAK-850 0.5 mL: 3-12 Years and TAK-850 0.5 mL: 13-19 Years.
Participants by arm
| Arm | Count |
|---|---|
| TAK-850 0.25 mL: 6-35 Months Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days. | 33 |
| TAK-850 0.5 mL: 3-12 Years Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days. | 33 |
| TAK-850 0.5 mL: 13-19 Years Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days. | 33 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | TAK-850 0.25 mL: 6-35 Months | TAK-850 0.5 mL: 3-12 Years | TAK-850 0.5 mL: 13-19 Years | Total |
|---|---|---|---|---|
| Administration of Antipyretics Antipyretics administered | 2 participants | 1 participants | 1 participants | 4 participants |
| Administration of Antipyretics Antipyretics not administered | 31 participants | 32 participants | 32 participants | 95 participants |
| Age, Customized 13-19 Years | 0 participants | 0 participants | 33 participants | 33 participants |
| Age, Customized 3-12 Years | 0 participants | 33 participants | 0 participants | 33 participants |
| Age, Customized 6-35 Months | 33 participants | 0 participants | 0 participants | 33 participants |
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 Titer at Day 1(Pre-vaccination) Greater Than or Equal to (>=) 40 Titer | 2 participants | 27 participants | 19 participants | 48 participants |
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 Titer at Day 1(Pre-vaccination) Less Than (<) 40 Titer | 31 participants | 6 participants | 14 participants | 51 participants |
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H3N2 Titer at Day 1 (Pre-vaccination) <40 Titer | 26 participants | 16 participants | 15 participants | 57 participants |
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H3N2 Titer at Day 1 (Pre-vaccination) >=40 Titer | 7 participants | 17 participants | 18 participants | 42 participants |
| Hemagglutination Inhibition (HI) (Egg-derived) - B Titer at Day 1 (Pre-vaccination) <40 Titer | 33 participants | 33 participants | 26 participants | 92 participants |
| Hemagglutination Inhibition (HI) (Egg-derived) - B Titer at Day 1 (Pre-vaccination) >=40 Titer | 0 participants | 0 participants | 7 participants | 7 participants |
| Influenza Infection within 5 years Infection did not occur | 31 participants | 17 participants | 26 participants | 74 participants |
| Influenza Infection within 5 years Infection occurred | 2 participants | 16 participants | 7 participants | 25 participants |
| Region of Enrollment Japan | 33 participants | 33 participants | 33 participants | 99 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 19 Participants | 50 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 14 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 33 | 29 / 33 | 24 / 33 |
| serious Total, serious adverse events | 0 / 33 | 1 / 33 | 0 / 33 |
Outcome results
Primary
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group
GMFI from baseline 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 for the age group of 13-19 years.
Time frame: Day 22 (21 days after Vaccination)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group | A/H1N1 Strain | 13.53 fold increase |
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group | A/H3N2 Strain | 3.66 fold increase |
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group | B Strain | 3.68 fold increase |
Primary
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.
Time frame: Day 43 (21 days after Vaccination 2)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=31, 31) | 14.23 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=31, 31) | 5.85 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=31, 31) | 1.32 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=31, 31) | 6.15 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=31, 31) | 4.73 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=31, 31) | 2.86 fold increase |
Primary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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 (example, 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. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.
Time frame: Up to 21 days after any vaccination
Population: Safety analysis set included all participants who received at least 1 dose of study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 24 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 29 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 24 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.
Time frame: Up to 21 days after any vaccination
Population: Safety analysis set included all participants who received at least 1 dose of study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site tenderness | 23 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Chills | 1 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site redness | 6 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Fatigue | 4 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site ecchymosis | 1 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Headache | 1 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site induration | 3 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Sweaty | 1 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Pyrexia | 3 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Myalgia | 3 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site swelling | 6 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Nausea | 0 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Malaise | 5 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Vomiting | 2 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site pain | 19 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Vomiting | 0 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site pain | 8 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site redness | 1 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site swelling | 3 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site induration | 2 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site tenderness | 18 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Injection site ecchymosis | 0 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Pyrexia | 1 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Malaise | 3 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Chills | 0 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Fatigue | 2 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Headache | 1 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Sweaty | 0 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Myalgia | 1 participants |
| TAK-850 0.5 mL: 13-19 Years | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group | Nausea | 1 participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.
Time frame: Up to 21 days after any vaccination
Population: Safety analysis set included all participants who received at least 1 dose of study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Injection site tenderness | 3 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Injection site ecchymosis | 4 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Pyrexia | 12 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Sweaty | 2 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Vomiting | 6 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Irritability postvaccinal | 2 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Crying abnormal | 2 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Inappetence | 3 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Somnolence | 5 participants |
| TAK-850 0.25 mL: 6-35 Months | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group | Sleeplessness | 2 participants |
Primary
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group
Seroconversion rate 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 for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Time frame: Day 22 (21 days after Vaccination)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group | A/H1N1 Strain | 66.7 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group | A/H3N2 Strain | 45.5 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group | B Strain | 45.5 percentage of participants |
Primary
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
Seroconversion rate 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 second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Time frame: Day 43 (21 days after Vaccination 2)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=31, 31) | 80.6 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=31, 31) | 58.1 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=31, 31) | 9.7 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=31, 31) | 71.0 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=31, 31) | 54.8 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=31, 31) | 45.2 percentage of participants |
Primary
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group
Seroprotection rate 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 for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.
Time frame: Day 22 (21 days after Vaccination)
Population: All participants included in the full analysis set (FAS) (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group | A/H1N1 Strain | 97.0 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group | A/H3N2 Strain | 93.9 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group | B Strain | 66.7 percentage of participants |
Primary
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
Seroprotection rate 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 second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.
Time frame: Day 43 (21 days after Vaccination 2)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=31, 31) | 87.1 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=31, 31) | 71.0 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=31, 31) | 9.7 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=31, 31) | 100 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=31, 31) | 90.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=31, 31) | 45.2 percentage of participants |
Secondary
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
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 each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in FAS (all participants who received at least 1 dose of study vaccination) who had available data for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32,32,33) | 8.78 titer |
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31,31, 0) | 88.96 titer |
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32,32,33) | 17.56 titer |
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | 66.90 titer |
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32,32,33) | 6.08 titer |
| TAK-850 0.25 mL: 6-35 Months | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=31,31,0) | 6.61 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=31,31,0) | 14.96 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32,32,33) | 583.71 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | 127.94 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32,32,33) | 16.82 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31,31, 0) | 773.95 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32,32,33) | 87.24 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31,31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32,32,33) | 133.14 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=31,31,0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32,32,33) | 558.32 titer |
| TAK-850 0.5 mL: 13-19 Years | Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32,32,33) | 28.58 titer |
Secondary
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years.
Time frame: Day 22 (21 days after Vaccination 1)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=32, 32) | 1.41 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=32, 32) | 1.58 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=32, 32) | 1.22 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=32, 32) | 5.36 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=32, 32) | 3.15 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=32, 32) | 3.22 fold increase |
Secondary
GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n=32, 32, 33) | 1.27 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 2 (n=31, 31, 0) | 1.28 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) | 6.40 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 1.72 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 1.02 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 2.30 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 16.17 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n=32, 32, 33) | 2.62 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 17.30 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) | 4.78 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 2 (n=31, 31, 0) | 2.99 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 3.67 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 2 (n=31, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 7.51 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 3.90 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n=32, 32, 33) | 3.21 fold increase |
Secondary
GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 1.2020 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 7.0652 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 1.5038 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 5.1163 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n=32, 32, 33) | 1.3443 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | B:21 days after Vaccination 2 (n=29, 31, 0) | 3.7658 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | B:21 days after Vaccination 2 (n=29, 31, 0) | 3.8880 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 2.4707 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 2.3363 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n=32, 32, 33) | 2.8400 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 2.9292 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 1.9682 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 2.0612 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | B:21 days after Vaccination 2 (n=29, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 2.7540 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n=32, 32, 33) | 1.8889 fold increase |
Secondary
GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 1.0000 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 1.2706 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 1.4480 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 4.9597 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n= 32, 32, 33) | 1.2209 fold increase |
| TAK-850 0.25 mL: 6-35 Months | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B:21 days after Vaccination 2 (n= 29, 31, 0) | 2.2979 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B:21 days after Vaccination 2 (n= 29, 31, 0) | 4.4759 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 3.8815 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 2.2506 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n= 32, 32, 33) | 3.6157 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 4.1427 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 1.7522 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 2.0947 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B:21 days after Vaccination 2 (n= 29, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | NA fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 3.0063 fold increase |
| TAK-850 0.5 mL: 13-19 Years | GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination | B: 21 days after Vaccination 1 (n= 32, 32, 33) | 2.6846 fold increase |
Secondary
GMT of HI Antibody Titer (Vero Antigen)
GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMT of HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 5.34 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 12.03 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 16.46 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) | 62.55 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 6.35 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=31, 31, 0) | 6.39 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=31, 31, 0) | 17.49 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 156.57 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) | 143.08 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 15.26 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 187.11 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 94.11 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 141.80 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=31, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 69.79 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 19.38 titer |
Secondary
GMT of SRH Antibody Titer (Egg-Derived Antigen)
GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 30.5555 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 9.8918 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 16.9727 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 5.1604 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 33.0272 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 6.3066 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 46.7134 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 41.4710 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 52.8247 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 83.8136 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 64.4700 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 36.4508 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 89.8328 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 52.9301 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 70.2017 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | NA titer |
Secondary
GMT of SRH Antibody Titer (Vero Antigen)
GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 4.0000 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 5.0822 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 12.2879 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 40.4564 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 6.5038 titer |
| TAK-850 0.25 mL: 6-35 Months | GMT of SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 10.8420 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 44.8583 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 26.8737 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 55.3238 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 35.8443 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 30.9216 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 40.3869 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 61.7091 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | NA titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 32.3664 titer |
| TAK-850 0.5 mL: 13-19 Years | GMT of SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 38.2075 titer |
Secondary
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Time frame: Day 22 (21 days after Vaccination 1)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=32, 32) | 6.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=32, 32) | 9.4 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=32, 32) | 15.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H1N1 Strain (n=32, 32) | 53.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | A/H3N2 Strain (n=32, 32) | 37.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group | B Strain (n=32, 32) | 46.9 percentage of participants |
Secondary
Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 0.0 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 32.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 21.9 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | 67.7 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 9.4 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=31, 31, 0) | 9.7 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=31, 31, 0) | 48.4 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 78.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | 54.8 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 28.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 87.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 43.8 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 42.4 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=31, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 69.7 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 42.4 percentage of participants |
Secondary
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of \>4 mm\^2) or achieving a SRH antibody titer of \>=25 mm\^2 (with baseline SRH antibody titer of \<=4 mm\^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32,32,33) | 6.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29,31,0) | 79.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32,32,33) | 18.8 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29,31,0) | 69.0 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32,32, 33) | 15.6 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=29,31,0) | 48.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=29,31,0) | 74.2 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32,32,33) | 81.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29,31,0) | 67.7 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32,32, 33) | 62.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29,31,0) | 90.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32,32,33) | 46.9 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29,31,0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32,32,33) | 42.4 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 2 (n=29,31,0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29,31,0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32,32,33) | 72.7 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen) | B: 21 days after Vaccination 1 (n=32,32, 33) | 42.4 percentage of participants |
Secondary
Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of \>4 mm\^2), or achieving a SRH antibody titer of \>=25 mm\^2 (with baseline SRH antibody titer of \<=4 mm\^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 18.8 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 0.0 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 72.4 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 24.1 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 10.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 12.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 87.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 75.0 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 40.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 58.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 56.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 64.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 57.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 51.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 54.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
Secondary
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group
Seroprotection rate 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 first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.
Time frame: Day 22 (21 days after Vaccination 1)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group | A/H1N1 Strain (n=32, 32) | 15.6 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group | A/H3N2 Strain (n=32, 32) | 28.1 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group | B Strain (n=32, 32) | 6.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group | B Strain (n=32, 32) | 46.9 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group | A/H1N1 Strain (n=32, 32) | 93.8 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group | A/H3N2 Strain (n=32, 32) | 75.0 percentage of participants |
Secondary
Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 3.1 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 32.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 28.1 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | 74.2 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | B: 21 days after Vaccination 1 (n=32, 32, 33) | 9.4 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | B: 21 days after Vaccination 2 (n=31, 31, 0) | 9.7 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | B: 21 days after Vaccination 2 (n=31, 31, 0) | 51.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 90.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | 87.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | B: 21 days after Vaccination 1 (n=32, 32, 33) | 34.4 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | 93.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 81.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 97.0 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | B: 21 days after Vaccination 2 (n=31, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 90.9 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40 | B: 21 days after Vaccination 1 (n=32, 32, 33) | 48.5 percentage of participants |
Secondary
Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of \>=25 mm\^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 9.4 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 79.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 28.1 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 79.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 15.6 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 48.3 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | B: 21 days after Vaccination 2 (n=29, 31, 0) | 87.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 90.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 93.5 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 78.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 100 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 78.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 97.0 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | B: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 100 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2) | B: 21 days after Vaccination 1 (n=32, 32, 33) | 97.0 percentage of participants |
Secondary
Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of \>=25 mm\^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Time frame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 0.0 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 10.3 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 34.4 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 86.2 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | B: 21 days after Vaccination 1 (n=32, 32, 33) | 15.6 percentage of participants |
| TAK-850 0.25 mL: 6-35 Months | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | B: 21 days after Vaccination 2 (n=29, 31, 0) | 27.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | B: 21 days after Vaccination 2 (n=29, 31, 0) | 83.9 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 75.0 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | 96.8 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | B: 21 days after Vaccination 1 (n=32, 32, 33) | 71.9 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | 87.1 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 90.6 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) | 97.0 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | B: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) | NA percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33) | 81.8 percentage of participants |
| TAK-850 0.5 mL: 13-19 Years | Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2 | B: 21 days after Vaccination 1 (n=32, 32, 33) | 81.8 percentage of participants |