Influenza
Conditions
Keywords
Influenza
Brief summary
This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.
Interventions
For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.
BIOLOGICALFluarix™ VB
For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.
BIOLOGICALFluarix™ YB
For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol. * A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. * Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject. * Written informed assent obtained from the subject if/as required by local regulations. * Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject * Has practiced adequate contraception for 30 days prior to vaccination, and * Has a negative pregnancy urine test on the day of vaccination, and * Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Child in care * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine. * Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Fever at the time of enrolment. * Acute disease at the time of enrolment. * Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Ongoing aspirin therapy. * Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. |
| Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. |
| Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. |
| Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. |
| Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | During the 7-day follow-up period (Days 0-6) after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects \< 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm). |
| Number of Days With Solicited Local Symptoms After Vaccination | During the 7-day follow-up period (Days 0-6) after vaccination | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling. |
| Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day follow-up period (Days 0-6) after vaccination | Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. |
| Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | During the 7-day follow-up period (Days 0-6) after vaccination | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite. |
| Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | During the 7-day follow-up period (Days 0-6) after vaccination | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering. |
| Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | During the 7-day follow-up period (Days 0-6) after vaccination | Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 28-day follow-up period (Day 0-27) after vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination. |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | During the entire study period (from Day 0 to Day 180) | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination | During the entire study period (from Day 0 to Day 180) | Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | During the entire study period (from Day 0 to Day 180) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. |
| Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day follow-up period (Days 0-6) after vaccination | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination. |
| Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. |
Countries
Canada, Mexico, Spain, Taiwan, United States
Participant flow
Recruitment details
A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.
Pre-assignment details
Unprimed Subjects - subjects aged 6 months to 8 years with no H1N1 vaccine or H1N1 infection in the last season, or with no seasonal influenza vaccine in the past or who had received only 1 dose for the first time in the last season - received a 2-dose vaccination course. Primed Subjects - all other subjects - received a 1-dose vaccination course.
Participants by arm
| Arm | Count |
|---|---|
| GSK2282512A 1 Group Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 932 |
| Victoria Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 929 |
| Yamagata Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 932 |
| GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age. | 301 |
| Total | 3,094 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 29 | 36 | 23 | 18 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 4 | 7 | 5 |
Baseline characteristics
| Characteristic | GSK2282512A 1 Group | Victoria Strain Fluarix Group | Yamagata Strain Fluarix Group | GSK2282512A 2 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 8.9 Years STANDARD_DEVIATION 4.21 | 8.9 Years STANDARD_DEVIATION 4.23 | 8.9 Years STANDARD_DEVIATION 4.17 | 1.2 Years STANDARD_DEVIATION 0.73 | 8.1 Years STANDARD_DEVIATION 4.6 |
| Sex: Female, Male Female | 434 Participants | 455 Participants | 464 Participants | 143 Participants | 1496 Participants |
| Sex: Female, Male Male | 498 Participants | 474 Participants | 468 Participants | 158 Participants | 1598 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 731 / 932 | 666 / 929 | 659 / 932 | 233 / 301 |
| serious Total, serious adverse events | 3 / 932 | 6 / 929 | 5 / 932 | 7 / 301 |
Outcome results
Primary
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Time frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H1N1, POST | 739 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H3N2, POST | 614 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Victoria, POST | 653 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Yamagata, POST | 659 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H3N2, POST | 590 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Victoria, POST | 622 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Yamagata, POST | 359 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H1N1, POST | 755 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Victoria, POST | 262 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H3N2, POST | 610 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Yamagata, POST | 644 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H1N1, POST | 750 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Yamagata, POST | 243 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H3N2, POST | 189 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | H1N1, POST | 220 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease | Victoria, POST | 219 Participants |
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Time frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 362.7 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 143.7 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 250.5 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 512.5 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 139.6 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 245.4 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 197.0 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 429.1 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 68.1 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 151.0 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 579.0 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 420.2 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 192.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 61.4 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 200.9 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 127.3 titer |
Secondary
Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination
Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.
Time frame: During the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 1 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 2 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 2 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 1 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 1 | 1.5 Days |
| Yamagata Strain Fluarix Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 2 | 1.0 Days |
| GSK2282512A 2 Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 1 | 1.0 Days |
| GSK2282512A 2 Group | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Fever, Dose 2 | 1.5 Days |
Secondary
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above
Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.
Time frame: During the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Fatigue, Dose 1 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Fatigue, Dose 2 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Gastrointestinal symptoms, Dose 1 | 1.5 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Gastrointestinal symptoms, Dose 2 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Headache, Dose 1 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Headache, Dose 2 | 1.5 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Joint pain at other location, Dose 1 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Joint pain at other location, Dose 2 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Muscle aches, Dose 1 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Muscle aches, Dose 2 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Shivering, Dose 1 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Shivering, Dose 2 | 1.5 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Shivering, Dose 2 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Fatigue, Dose 1 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Joint pain at other location, Dose 1 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Muscle aches, Dose 1 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Fatigue, Dose 2 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Headache, Dose 2 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Shivering, Dose 1 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Gastrointestinal symptoms, Dose 1 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Joint pain at other location, Dose 2 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Headache, Dose 1 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Gastrointestinal symptoms, Dose 2 | 1.5 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Muscle aches, Dose 2 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Gastrointestinal symptoms, Dose 2 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Headache, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Muscle aches, Dose 2 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Headache, Dose 2 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Joint pain at other location, Dose 1 | 1.5 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Joint pain at other location, Dose 2 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Shivering, Dose 1 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Fatigue, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Fatigue, Dose 2 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Muscle aches, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Gastrointestinal symptoms, Dose 1 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Shivering, Dose 2 | 2.0 Days |
Secondary
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age
Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.
Time frame: During the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 1 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 2 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 1 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 2 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 1 | 1.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 2 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 2 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 2 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 1 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 1 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 2 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 2 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 2 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 2 | 3.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 1 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 1 | 1.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 1 | 2.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Loss of appetite, Dose 2 | 2.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 2 | 2.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 2 | 2.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Drowsiness, Dose 1 | 2.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Irritability, Dose 1 | 2.0 Days |
Secondary
Number of Days With Solicited Local Symptoms After Vaccination
Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.
Time frame: During the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 1 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 2 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 1 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 2 | 2.0 Days |
| GSK2282512A 1 Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 2 | 2.5 Days |
| GSK2282512A 1 Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 1 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 1 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 1 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 2 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 2 | 1.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 2 | 2.0 Days |
| Victoria Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 2 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 1 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 2 | 2.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 1 | 1.0 Days |
| Yamagata Strain Fluarix Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 2 | 1.5 Days |
| GSK2282512A 2 Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 2 | 2.5 Days |
| GSK2282512A 2 Group | Number of Days With Solicited Local Symptoms After Vaccination | Redness, Dose 1 | 1.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 1 | 1.5 Days |
| GSK2282512A 2 Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 2 | 2.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited Local Symptoms After Vaccination | Pain, Dose 1 | 1.0 Days |
| GSK2282512A 2 Group | Number of Days With Solicited Local Symptoms After Vaccination | Swelling, Dose 2 | 3.0 Days |
Secondary
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.
Time frame: During the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 8 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 173 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 202 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related headache | 134 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any gastrointestinal symptoms | 80 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 6 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any joint pain at other location | 103 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related temperature | 16 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 222 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 joint pain at other location | 4 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any temperature | 26 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related joint pain at other location | 82 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 gastrointestinal symptoms | 9 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature | 5 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 45 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related gastrointestinal symptoms | 55 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 143 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 4 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any headache | 170 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 6 Participants |
| GSK2282512A 1 Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 55 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any temperature | 33 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 177 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 13 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 149 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any gastrointestinal symptoms | 82 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 gastrointestinal symptoms | 8 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related gastrointestinal symptoms | 51 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any headache | 171 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 9 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related headache | 134 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any joint pain at other location | 95 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 joint pain at other location | 5 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related joint pain at other location | 80 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 194 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 5 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 178 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 51 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 10 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 35 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature | 8 Participants |
| Victoria Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related temperature | 18 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 10 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 8 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related muscle aches | 170 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any headache | 157 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related temperature | 13 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 53 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related gastrointestinal symptoms | 37 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature | 2 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 4 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 gastrointestinal symptoms | 6 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 177 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 41 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 joint pain at other location | 1 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any gastrointestinal symptoms | 72 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related joint pain at other location | 67 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any joint pain at other location | 81 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 134 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any muscle aches | 193 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Related headache | 116 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Any temperature | 20 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 muscle aches | 9 Participants |
Secondary
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.
Time frame: During the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any temperature | 15 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related temperature | 6 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite | 0 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness | 46 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite | 21 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness | 34 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any irritability | 59 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness | 0 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature | 3 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability | 3 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related irritability | 45 Participants |
| GSK2282512A 1 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite | 40 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness | 3 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite | 41 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any irritability | 44 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite | 28 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any temperature | 16 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite | 6 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness | 47 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related irritability | 36 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability | 0 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness | 40 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related temperature | 10 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature | 5 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite | 3 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness | 51 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness | 1 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness | 42 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any irritability | 48 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability | 3 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related irritability | 45 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite | 35 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite | 24 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any temperature | 15 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature | 5 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related temperature | 6 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related irritability | 130 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 irritability | 14 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any drowsiness | 102 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any temperature | 27 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any irritability | 141 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related drowsiness | 93 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related temperature | 18 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature | 6 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 loss of appetite | 5 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any loss of appetite | 93 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 drowsiness | 7 Participants |
| GSK2282512A 2 Group | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related loss of appetite | 73 Participants |
Secondary
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 374 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 291 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 329 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 366 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 293 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 324 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 365 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 323 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 326 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 282 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 390 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 181 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 365 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 308 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 296 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 178 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 380 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 372 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 296 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 133 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 314 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 370 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 129 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 272 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 219 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 220 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 189 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 243 Participants |
Secondary
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.
Time frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, POST | 850 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, Day 0 | 295 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, POST | 838 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, POST | 869 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, Day 0 | 388 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, POST | 816 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 578 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, Day 0 | 480 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 583 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, Day 0 | 404 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, POST | 839 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, POST | 848 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, Day 0 | 496 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, Day 0 | 301 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, POST | 805 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, POST | 808 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, POST | 643 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, POST | 848 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, POST | 873 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 622 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, Day 0 | 324 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, Day 0 | 477 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, POST | 819 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, Day 0 | 400 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, POST | 250 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, Day 0 | 87 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H1N1, POST | 232 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, Day 0 | 7 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | H3N2, POST | 193 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, Day 0 | 28 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Victoria, POST | 228 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 22 Participants |
Secondary
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 161 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 405 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 209 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 379 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 144 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 398 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 205 Participants |
| GSK2282512A 1 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 419 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 445 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 450 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 134 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 437 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 244 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 440 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 373 Participants |
| Victoria Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 271 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 174 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 361 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 390 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 163 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 406 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 209 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 412 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 218 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 418 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 444 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 241 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 433 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 374 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 127 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 278 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 436 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 150 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 420 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 271 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 220 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 389 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 207 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 405 Participants |
| Yamagata Strain Fluarix (3-8 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 168 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 372 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 453 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 402 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 250 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 270 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 443 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 156 Participants |
| Yamagata Strain Fluarix (9-17 Years) Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 430 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 22 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 228 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 250 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 87 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 232 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 7 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 193 Participants |
| GSK2282512A 2 Group | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 28 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects \< 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
Time frame: During the 7-day follow-up period (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any pain | 637 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 pain | 35 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any redness | 57 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 redness | 1 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any swelling | 64 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 swelling | 1 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 swelling | 0 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 redness | 0 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any pain | 538 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any redness | 38 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 pain | 21 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any swelling | 40 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 pain | 26 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any redness | 36 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 redness | 0 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 swelling | 0 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any swelling | 39 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any pain | 542 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any swelling | 18 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 swelling | 1 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 pain | 6 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Grade 3 redness | 2 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any pain | 148 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Any redness | 24 Participants |
Secondary
Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination
Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.
Time frame: During the entire study period (from Day 0 to Day 180)
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2282512A 1 Group | Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination | 346 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination | 335 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination | 350 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination | 147 Participants |
Secondary
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination
Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (from Day 0 to Day 180)
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Any pIMD(s) | 0 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Related pIMD(s) | 0 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Related pIMD(s) | 0 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Any pIMD(s) | 1 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Related pIMD(s) | 0 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Any pIMD(s) | 1 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Related pIMD(s) | 0 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Any pIMD(s) | 0 Participants |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
Time frame: During the entire study period (from Day 0 to Day 180)
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 3 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 6 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 5 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 7 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 2 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.
Time frame: During the 28-day follow-up period (Day 0-27) after vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE(s) | 283 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE(s) | 44 Participants |
| GSK2282512A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE(s) | 40 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE(s) | 291 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE(s) | 47 Participants |
| Victoria Strain Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE(s) | 41 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE(s) | 35 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE(s) | 275 Participants |
| Yamagata Strain Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE(s) | 44 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AE(s) | 160 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AE(s) | 43 Participants |
| GSK2282512A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AE(s) | 24 Participants |
Secondary
Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 12.50 fold change |
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 7.02 fold change |
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 10.64 fold change |
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 13.23 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 6.09 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 9.65 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 12.12 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 8.91 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 9.75 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 6.82 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 14.20 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 3.49 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 12.52 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 7.94 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 9.28 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 3.26 fold change |
| Yamagata Strain Fluarix (3-8 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 14.56 fold change |
| Yamagata Strain Fluarix (3-8 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 14.11 fold change |
| Yamagata Strain Fluarix (3-8 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 7.29 fold change |
| Yamagata Strain Fluarix (3-8 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 2.85 fold change |
| Yamagata Strain Fluarix (9-17 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 8.27 fold change |
| Yamagata Strain Fluarix (9-17 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 14.29 fold change |
| Yamagata Strain Fluarix (9-17 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 2.44 fold change |
| Yamagata Strain Fluarix (9-17 Years) Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 5.63 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 14.61 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 11.95 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 10.94 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 24.92 fold change |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains
Time frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 12.31 fold change |
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 7.94 fold change |
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 10.12 fold change |
| GSK2282512A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 8.86 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 7.37 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 9.51 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 3.37 fold change |
| Victoria Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 13.31 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 2.63 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 7.78 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 8.78 fold change |
| Yamagata Strain Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 14.42 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 24.92 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 10.94 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 11.95 fold change |
| GSK2282512A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 14.61 fold change |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Time frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, Day 0 | 29.4 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 362.7 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, Day 0 | 18.1 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 143.7 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, Day 0 | 24.8 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 250.5 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 57.9 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 512.5 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 245.4 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, Day 0 | 25.8 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 429.1 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 197.0 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 58.4 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 139.6 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, Day 0 | 19.0 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, Day 0 | 32.2 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 65.9 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, Day 0 | 19.4 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 151.0 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, Day 0 | 25.8 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 68.1 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 579.0 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, Day 0 | 29.1 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 420.2 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, Day 0 | 5.6 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2, POST | 61.4 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, POST | 200.9 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, Day 0 | 16.8 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, Day 0 | 8.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, POST | 192.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata, Day 0 | 7.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria, POST | 127.3 titer |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 19.7 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 310.5 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 24.7 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 138.2 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 18.3 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 194.4 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 27.4 titer |
| GSK2282512A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 363.4 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 419.5 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 707.5 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 16.7 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 149.1 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 32.9 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 317.8 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 116.2 titer |
| Victoria Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 34.6 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 21.2 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 103.2 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 144.4 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 20.2 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 197.4 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 29.5 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 382.7 titer |
| Yamagata Strain Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 26.9 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 135.2 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 363.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 32.5 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 301.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 111.6 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 17.0 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 38.2 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 478.2 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 18.4 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 416.7 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 52.6 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 29.5 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 147.9 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 24.5 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 356.2 titer |
| Yamagata Strain Fluarix (3-8 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 20.2 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 86.6 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 787.1 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 139.6 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 35.4 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 34.2 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 490.3 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 18.6 titer |
| Yamagata Strain Fluarix (9-17 Years) Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 153.9 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, Day 0 | 7.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, POST | 127.3 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Yamagata, POST | 192.7 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, Day 0 | 16.8 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H1N1, POST | 200.9 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, Day 0 | 5.6 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | H3N2, POST | 61.4 titer |
| GSK2282512A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Victoria, Day 0 | 8.7 titer |