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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1166-6015 | Registry Identifier | UTN (WHO) | |
| JapicCTI-152807 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-850 0.5 mL injection (13-19 years of age) | Experimental | Single intramuscular injection of TAK-850 0.5 mL in participants aged 13-19 years |
|
| TAK-850 0.5 mL injection (3-12 years of age) | Experimental | Two intramuscular injections of TAK-850 0.5 mL in participants aged 3-12 years old. |
|
| TAK-850 0.25 mL injection (6-35 months of age) | Experimental | Two intramuscular injections of TAK-850 0.25 mL in participants aged 6-35 months old. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-850 0.5 mL injection | Drug | TAK-850 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 21 days after any vaccination |
| 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. | Up to 21 days after any vaccination |
| 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. | Up to 21 days after any vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
[Only for participants at the age of 6-35 months old]
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).
The participant has received any investigational compound within 4 months prior to the initial injection of study vaccine.
The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the initial injection of study vaccine.
The participant has a history of influenza infection within 6 months prior to the initial injection of study vaccine.
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.
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.
The participant has an armpit temperature ≥ 37.5°C prior to the initial injection of study vaccine on Day 1.
The participant has any medically diagnosed or suspected immune deficient condition.
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.
The participant has received antipyretics within 4 hours prior to the initial injection of study vaccine.
The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis) or convulsions.
The participant has a functional or surgical asplenia.
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.
The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
The participant has a known hypersensitivity to any component of TAK-850.
The participant has a history of severe allergic reactions or anaphylaxis.
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.
The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the initial injection of study vaccine.
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.
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.
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.
In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuou-ku | Tokyo | Japan | ||||
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 took part in the study at 2 investigative sites in Japan from 14 February 2015 to 2 May 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants who received at least 1 dose of study vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | TAK-850 0.5 mL: 3-12 Years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants 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. | Safety analysis set included all participants who received at least 1 dose of study vaccination. | Posted | Number | participants | Up to 21 days after any vaccination |
|
TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-850 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| TAK-850 0.25 mL injection | Drug | TAK-850 intramuscular injection |
|
| 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. |
| Day 22 (21 days after Vaccination) |
| 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. | Day 43 (21 days after Vaccination 2) |
| 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). | Day 22 (21 days after Vaccination) |
| 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). | Day 43 (21 days after Vaccination 2) |
| 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. | Day 22 (21 days after Vaccination) |
| 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. | Day 43 (21 days after Vaccination 2) |
| Day 22 (21 days after Vaccination 1) |
| 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). | Day 22 (21 days after Vaccination 1) |
| 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. | Day 22 (21 days after Vaccination 1) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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 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. | 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) | 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. | 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) |
| 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. | 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) |
| 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. | 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 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. | 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) | 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. | 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) |
| 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. | 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) |
| 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. | 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 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. | 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) | 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. | 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) |
| Setagaya-ku |
| Tokyo |
| Japan |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 Titer at Day 1(Pre-vaccination) | Number of participants with values of HI antibody titer for A/H1N1 strain pre-vaccination at Day 1 were reported. | Number | participants |
|
| Hemagglutination Inhibition (HI) (Egg-derived) - A/H3N2 Titer at Day 1 (Pre-vaccination) | Number of participants with values of HI antibody titer for A/H3N2 strain pre-vaccination at Day 1 were reported. | Number | participants |
|
| Hemagglutination Inhibition (HI) (Egg-derived) - B Titer at Day 1 (Pre-vaccination) | Number of participants with values of HI antibody titer for B strain pre-vaccination at Day 1 were reported. | Number | participants |
|
| Influenza Infection within 5 years | Number | participants |
|
| Administration of Antipyretics | Number | 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. | Safety analysis set included all participants who received at least 1 dose of study vaccination. | Posted | Number | participants | Up to 21 days after any vaccination |
|
|
|
| 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. | Safety analysis set included all participants who received at least 1 dose of study vaccination. | Posted | Number | participants | Up to 21 days after any vaccination |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after Vaccination) |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 43 (21 days after Vaccination 2) |
|
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|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after Vaccination) |
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| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 43 (21 days after Vaccination 2) |
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|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Day 22 (21 days after Vaccination) |
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|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Day 43 (21 days after Vaccination 2) |
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|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after Vaccination 1) |
|
|
|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (21 days after Vaccination 1) |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | Day 22 (21 days after Vaccination 1) |
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|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | 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) |
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|
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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|
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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|
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | 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) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | 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) |
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|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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|
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | 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) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | 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) |
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|
| 0 |
| 33 |
| 21 |
| 33 |
| EG001 | 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. | 1 | 33 | 29 | 33 |
| EG002 | 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. | 0 | 33 | 24 | 33 |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Injection site warmth | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Crying | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Irritability postvaccinal | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Molluscum contagiosum | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Injection site swelling |
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| Injection site induration |
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| Injection site tenderness |
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| Injection site ecchymosis |
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| Pyrexia |
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| Malaise |
|
| Chills |
|
| Fatigue |
|
| Headache |
|
| Sweaty |
|
| Myalgia |
|
| Nausea |
|
| Vomiting |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| B Strain (n=31, 31) |
|
| Title | Measurements |
|---|---|
|
| B Strain (n=31, 31) |
|
| Title | Measurements |
|---|---|
|
| B Strain (n=31, 31) |
|
| B Strain (n=32, 32) |
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| B Strain (n=32, 32) |
|
| B Strain (n=32, 32) |
|
| A/H1N1: 21 days after Vaccination 2 (n=31,31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32,32,33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) |
|
| B: 21 days after Vaccination 1 (n=32,32,33) |
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| B: 21 days after Vaccination 2 (n=31,31,0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29,31,0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32,32,33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29,31,0) |
|
| B: 21 days after Vaccination 1 (n=32,32, 33) |
|
| B: 21 days after Vaccination 2 (n=29,31,0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B:21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=31,31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=31, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| B: 21 days after Vaccination 1 (n= 32, 32, 33) |
|
| B:21 days after Vaccination 2 (n= 29, 31, 0) |
|
| A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0) |
|
| B: 21 days after Vaccination 1 (n=32, 32, 33) |
|
| B: 21 days after Vaccination 2 (n=29, 31, 0) |
|