Influenza
Conditions
Keywords
GSK Biologicals influenza vaccine GSK2321138A, influenza infection
Brief summary
This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.
Interventions
BIOLOGICALInfluenza vaccine GSK2321138A
intramuscular injections
BIOLOGICALFluarixTM
intramuscular injections
BIOLOGICALInfluenza vaccine GSK2604409A
intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * For non US countries: * \- Children, male or female, aged between 6 months and 17 years at the time of the first study vaccination. For US : * Children, male or female, aged between 3 and 17 years at the time of the first study vaccination * Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable. * Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history. * Written informed assent obtained from the subject if/as required by local regulations. * 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 urine pregnancy 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
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Routine registered childhood vaccinations are permitted. * Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) 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 three months prior to enrolment in this study or planned administration during the study period. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * History of seizures or progressive neurological disease. * History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * Concurrently participating in another clinical study, at any time during the study period in which the subject has been or will be exposed to an investigational or a non-investigational product . * History of hypersensitivity to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines * Acute disease and/or fever at the time of enrolment * Ongoing aspirin therapy * Pregnant or lactating female * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study * Child in Care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | At Day 28 (for primed subjects) and Day 56 (for unprimed subjects) | 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 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years. |
| Number of Seroprotected Subjects Against 4 Strains of Influenza. | At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). |
| Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Day 28 (for primed subjects) and Day 56 (for unprimed subjects) | MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). |
| Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | At Day 28 (for primed subjects) and Day 56 (for unprimed subjects) | MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 7-day (Days 0-6) follow-up period after any vaccination. | Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child \<6 years) or pain that prevented normal activity (Child \>6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | During the 7-day (Days 0-6) follow-up period after any vaccination. | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 28-day (Days 0-27) follow-up period after any 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | During the entire study period (Day 0 - Day 180) | MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed. |
| Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | During the entire study period (Day 0 - Day 180) | pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | During the entire study period (Day 0 - Day 180) | Serious adverse events (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. |
| Number of Days With Solicited Local Symptoms. | During the 7-day (Days 0-6) follow-up period after vaccination. | The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site. |
| Number of Days With Solicited General Symptoms | During the 7-day (Days 0-6) follow-up period after vaccination. | The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | During the 7-day (Days 0-6) follow-up period after any vaccination. | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C. |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | At Day 28 (for primed subjects) and Day 56 (for unprimed subjects) | 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 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years. |
Countries
Czechia, France, Germany, Philippines, United States
Participant flow
Recruitment details
Subjects were differentiated according to their priming status. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza in the last season or had received at least 1 dose prior to last season. Unprimed subjects had not.
Pre-assignment details
3015 subjects out of the 3027 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria. The treatment was stratified by age strata: 3-8 and 9-17 years. Another arm evaluates the GSK2321138A vaccine for children aged 6-17 and 18-35 months.
Participants by arm
| Arm | Count |
|---|---|
| GSK2321138A 1 Group Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. | 915 |
| Fluarix Group Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. | 912 |
| GSK2604409A Group Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. | 911 |
| GSK2321138A 2 Group Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28. | 277 |
| Total | 3,015 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 16 | 29 | 21 | 1 |
| Overall Study | Other | 2 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | GSK2321138A 1 Group | Fluarix Group | GSK2604409A Group | GSK2321138A 2 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 98.5 Months STANDARD_DEVIATION 44.4 | 98.2 Months STANDARD_DEVIATION 45.5 | 99.6 Months STANDARD_DEVIATION 44.2 | 22.1 Months STANDARD_DEVIATION 8.02 | 79.6 Months STANDARD_DEVIATION 35.53 |
| Sex: Female, Male Female | 443 Participants | 439 Participants | 440 Participants | 118 Participants | 1440 Participants |
| Sex: Female, Male Male | 472 Participants | 473 Participants | 471 Participants | 159 Participants | 1575 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 | 630 / 915 | 616 / 912 | 620 / 911 | 237 / 277 |
| serious Total, serious adverse events | 8 / 915 | 6 / 912 | 7 / 911 | 9 / 277 |
Outcome results
Primary
Number of Seroconverted Subjects 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 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 722 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 571 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 553 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 573 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 303 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 560 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 578 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 735 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 237 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 566 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 575 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 733 Participants |
| GSK2321138A 2 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 191 Participants |
| GSK2321138A 2 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 181 Participants |
| GSK2321138A 2 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 159 Participants |
| GSK2321138A 2 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 158 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 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, PRE | 21.6 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, PRE | 30.9 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, POST | 386.2 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, POST | 244.2 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, PRE | 29.0 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, POST | 569.6 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, POST | 228.8 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, PRE | 77.3 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, PRE | 24.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, POST | 227.3 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, PRE | 31.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, POST | 224.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, PRE | 31.4 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, PRE | 77.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, POST | 245.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, POST | 433.2 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, POST | 88.4 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, PRE | 84.7 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, POST | 422.3 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, POST | 643.3 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, PRE | 31.2 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, PRE | 22.1 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, POST | 234.0 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, PRE | 33.2 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, POST | 167.7 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, PRE | 12.3 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Cal/7/09, POST | 140.0 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, PRE | 8.6 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Vic/210/09, POST | 87.5 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, PRE | 9.0 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/60/08, POST | 86.4 titers |
| GSK2321138A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Bri/3/07, PRE | 13.1 titers |
Secondary
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 18.0 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 7.9 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 7.9 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 7.4 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 7.2 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 7.9 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 2.9 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 17.4 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 2.7 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 7.5 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 7.6 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 19.2 fold change |
| GSK2321138A 2 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07 | 12.9 fold change |
| GSK2321138A 2 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09 | 10.4 fold change |
| GSK2321138A 2 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU A/California/7/09 | 11.7 fold change |
| GSK2321138A 2 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08 | 9.7 fold change |
Secondary
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.
Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 6-17 months | 8.2 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 18-35 months | 13.7 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 6-17 months | 7.3 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 18-35 months | 12.1 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 6-17 months | 6.9 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 18-35 months | 11.3 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 6-17 months | 9.5 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 18-35 months | 14.8 fold change |
Secondary
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 3-8 years | 17.2 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 9-17 years | 19.2 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 3-8 years | 8.4 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 9-17 years | 7.2 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 3-8 years | 8.8 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 9-17 years | 6.7 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 3-8 years | 8.8 fold change |
| GSK2321138A 1 Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 9-17 years | 5.6 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 3-8 years | 7.3 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 3-8 years | 3.1 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 9-17 years | 7.1 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 3-8 years | 8.8 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 9-17 years | 6.6 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 3-8 years | 17.2 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 9-17 years | 17.7 fold change |
| Fluarix Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 9-17 years | 2.5 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 3-8 years | 7.8 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 9-17 years | 23.3 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 3-8 years | 17.2 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 9-17 years | 7.1 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 3-8 years | 9.9 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 9-17 years | 2.4 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 3-8 years | 2.8 fold change |
| GSK2604409A Group | Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 9-17 years | 4.9 fold change |
Secondary
Number of Days With Solicited General Symptoms
The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\].
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Irritability, Dose 2 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 2 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 2 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Gastro., Dose 1 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 2 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Irritability, Dose 1 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 1 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Gastro., Dose 2 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 1 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 1 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Headache, Dose 1 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 1 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | 1.5 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Headache, Dose 2 | 1.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 2 | 3.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Headache, Dose 2 | 1.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Irritability, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Irritability, Dose 2 | 1.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 2 | 1.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 2 | 1.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | 1.5 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 2 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | 1.5 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Gastro., Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | 1.5 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Gastro., Dose 2 | 2.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Headache, Dose 1 | 1.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 1 | 1.0 days |
| Fluarix Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 2 | 1.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 2 | 1.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | 1.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Gastro., Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Gastro., Dose 2 | 1.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Headache, Dose 2 | 1.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Headache, Dose 1 | 1.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Irritability, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Irritability, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 2 | 1.5 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | 1.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 1 | 3.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Headache, Dose 2 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Headache, Dose 1 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Loss of appetite, Dose 2 | 3.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Gastro., Dose 2 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Gastro., Dose 1 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 1 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | 1.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 2 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 2 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 1 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Drowsiness, Dose 1 | 1.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 2 | NA days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Irritability, Dose 2 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Irritability, Dose 1 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | NA days |
Secondary
Number of Days With Solicited Local Symptoms.
The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 1 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 2 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 1 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 2 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 1 | 2.0 days |
| GSK2321138A 1 Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 2 | 2.0 days |
| Fluarix Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 2 | 2.0 days |
| Fluarix Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 2 | 2.0 days |
| Fluarix Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 1 | 2.0 days |
| Fluarix Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 2 | 2.0 days |
| Fluarix Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 2 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 1 | 2.0 days |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 1 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 1 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited Local Symptoms. | Swelling, Dose 2 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 2 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 2 | 2.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited Local Symptoms. | Pain, Dose 1 | 1.0 days |
| GSK2321138A 2 Group | Number of Days With Solicited Local Symptoms. | Redness, Dose 1 | 2.0 days |
Secondary
Number of Seroconverted Subjects 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 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 6-17 months | 43 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 18-35 months | 138 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 6-17 months | 37 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 18-35 months | 122 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 6-17 months | 36 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 18-35 months | 122 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 6-17 months | 52 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 18-35 months | 139 Participants |
Secondary
Number of Seroconverted Subjects 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 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 3-8 years | 447 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 9-17 years | 275 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 3-8 years | 367 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 9-17 years | 204 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 3-8 years | 364 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 9-17 years | 189 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 3-8 years | 376 Participants |
| GSK2321138A 1 Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 9-17 years | 197 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 3-8 years | 365 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 3-8 years | 203 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 9-17 years | 213 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 3-8 years | 367 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 9-17 years | 193 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 3-8 years | 468 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 9-17 years | 267 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 9-17 years | 100 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 3-8 years | 376 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 9-17 years | 276 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, 3-8 years | 457 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, 9-17 years | 199 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 3-8 years | 403 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 9-17 years | 83 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, 3-8 years | 154 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, 9-17 years | 163 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, PRE | 201 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, POST | 732 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, PRE | 228 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, POST | 721 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, PRE | 244 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, POST | 708 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, PRE | 454 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, POST | 779 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, POST | 733 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, PRE | 258 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, POST | 763 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, POST | 692 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, PRE | 462 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, POST | 748 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, PRE | 245 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, PRE | 218 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, PRE | 476 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, PRE | 267 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, POST | 721 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, PRE | 269 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, POST | 488 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, POST | 784 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, PRE | 202 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, POST | 744 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, PRE | 27 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/Victoria/210/09, POST | 125 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, POST | 155 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU A/California/7/09, PRE | 49 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, PRE | 18 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, POST | 175 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/3/07, PRE | 24 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza. | FLU B/Brisbane/60/08, POST | 140 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, PRE | 343 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, POST | 764 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, PRE | 381 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, POST | 775 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, PRE | 381 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, POST | 770 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, PRE | 565 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, POST | 785 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, POST | 790 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, PRE | 396 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, POST | 793 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, POST | 772 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, PRE | 575 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, POST | 800 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, PRE | 412 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, PRE | 404 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, PRE | 593 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, PRE | 409 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, POST | 773 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, PRE | 399 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, POST | 639 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, POST | 798 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, PRE | 353 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, POST | 778 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, PRE | 34 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/Victoria/210/09, POST | 169 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, POST | 187 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU A/California/7/09, PRE | 60 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, PRE | 28 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, POST | 212 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/3/07, PRE | 48 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLU B/Brisbane/60/08, POST | 167 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, PRE | 71 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, POST | 669 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, PRE | 103 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, POST | 597 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, PRE | 123 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, POST | 578 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, PRE | 300 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, POST | 730 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, POST | 607 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, PRE | 126 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, POST | 720 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, POST | 564 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, PRE | 324 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, POST | 597 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, PRE | 124 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, PRE | 92 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, PRE | 327 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, PRE | 121 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, POST | 599 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, PRE | 148 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, POST | 300 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, POST | 756 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, PRE | 79 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, POST | 690 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, PRE | 15 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/Victoria/210/09, POST | 82 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, POST | 122 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU A/California/7/09, PRE | 28 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, PRE | 9 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, POST | 129 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/3/07, PRE | 7 Participants |
| GSK2321138A 2 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | FLU B/Brisbane/60/08, POST | 83 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 229 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 135 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 24 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 444 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 380 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 165 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 286 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 47 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 33 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 217 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 259 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 75 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 349 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 410 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 48 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 70 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 278 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 92 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 32 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 155 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 442 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 250 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 301 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 212 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 357 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 169 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 385 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 60 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 263 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 66 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 56 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 36 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 66 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 428 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 22 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 262 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 87 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 390 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 34 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 209 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 82 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 174 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 283 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 126 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 150 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 473 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 177 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 57 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, PRE, 6-17 months | 5 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, POST, 6-17 months | 18 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, PRE, 18-35 months | 23 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, POST, 18-35 months | 104 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, PRE, 6-17 months | 3 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, POST, 6-17 months | 11 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, PRE, 18-35 months | 12 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, POST, 18-35 months | 71 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, PRE, 6-17 months | 0 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, POST, 6-17 months | 7 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, PRE, 18-35 months | 9 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, POST, 18-35 months | 76 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, PRE, 6-17 months | 1 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, POST, 6-17 months | 25 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, PRE, 18-35 months | 6 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, POST, 18-35 months | 104 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 156 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 453 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 71 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 279 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 130 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 446 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 72 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 275 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 145 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 430 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 99 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 278 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 233 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 480 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 221 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 299 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 462 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 68 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 286 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 395 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 140 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 441 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 297 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 118 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 128 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 235 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 471 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 292 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 90 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 292 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 177 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 227 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 119 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 446 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 248 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 61 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 77 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 291 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 141 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 275 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 202 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 190 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 150 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 493 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 464 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 286 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 280 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 228 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 6-17 months | 6 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 6-17 months | 45 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 18-35 months | 54 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 18-35 months | 142 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 6-17 months | 4 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 6-17 months | 39 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 18-35 months | 30 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 18-35 months | 130 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 6-17 months | 1 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 6-17 months | 38 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 18-35 months | 27 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 18-35 months | 129 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 6-17 months | 11 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 6-17 months | 61 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 18-35 months | 37 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 18-35 months | 151 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 253 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 469 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 137 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 295 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 206 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 477 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 128 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 298 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 217 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 478 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 164 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 292 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 315 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 485 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 250 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 300 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 496 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 135 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 304 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 465 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 218 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 489 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 307 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 178 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 234 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 266 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 491 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 301 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 170 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 302 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 277 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 309 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 167 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 481 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 329 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 123 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 140 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 295 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 230 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 292 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 261 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 269 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 232 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 503 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 487 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 378 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 291 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 264 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, PRE, 6-17 months | 6 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, POST, 6-17 months | 31 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, PRE, 18-35 months | 43 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/California/7/09, POST, 18-35 months | 124 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, PRE, 6-17 months | 4 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, POST, 6-17 months | 18 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, PRE, 18-35 months | 23 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Victoria/210/09, POST, 18-35 months | 107 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, PRE, 6-17 months | 0 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, POST, 6-17 months | 25 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, PRE, 18-35 months | 18 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/60/08, POST, 18-35 months | 115 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, PRE, 6-17 months | 4 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, POST, 6-17 months | 43 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, PRE, 18-35 months | 20 Participants |
| GSK2321138A 1 Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Brisbane/3/07, POST, 18-35 months | 132 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child \<6 years) or pain that prevented normal activity (Child \>6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 444 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 20 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 225 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 12 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 196 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 11 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 10 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 3 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 425 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 214 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 21 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 193 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 13 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 206 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 6 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 160 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 416 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 67 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 0 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 5 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 1 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 116 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 100 Participants |
Secondary
Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).
pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time frame: During the entire study period (Day 0 - Day 180)
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with any pIMD(s) | 0 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with related pIMD(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with related pIMD(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with any pIMD(s) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with any pIMD(s) | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with related pIMD(s) | 0 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with any pIMD(s) | 0 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). | Subjects with related pIMD(s) | 0 Participants |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Serious adverse events (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.
Time frame: During the entire study period (Day 0 - Day 180)
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 8 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 6 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 7 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 9 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.
Time frame: During the entire study period (Day 0 - Day 180)
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with Grade 3 MAE(s) | NA Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with any MAE(s) | 271 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with related MAE(s) | 2 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with related MAE(s) | 4 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with any MAE(s) | 278 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with Grade 3 MAE(s) | NA Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with Grade 3 MAE(s) | NA Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with any MAE(s) | 303 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with related MAE(s) | 4 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with related MAE(s) | 2 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with any MAE(s) | 171 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). | Subjects with Grade 3 MAE(s) | NA Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Headache | 8 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Fatigue | 129 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Muscle aches | 84 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Headache | 66 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Gastro. | 66 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Muscle aches | 4 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Joint Pain | 69 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Temperature | 25 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Muscle aches | 116 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Joint Pain | 2 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Temperature ≥37.5°C | 48 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Joint Pain | 44 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Gastro. | 7 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Temperature >39°C | 7 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Shivering | 27 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Gastro. | 31 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Fatigue | 95 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Shivering | 3 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Headache | 110 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Fatigue | 9 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Shivering | 44 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Temperature ≥37.5°C | 60 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Fatigue | 118 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Fatigue | 8 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Fatigue | 81 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Gastro. | 62 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Gastro. | 4 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Gastro. | 29 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Headache | 125 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Headache | 4 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Headache | 75 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Joint Pain | 63 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Joint Pain | 4 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Joint Pain | 43 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Muscle aches | 106 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Muscle aches | 8 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Muscle aches | 81 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Shivering | 31 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Shivering | 3 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Shivering | 23 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Temperature >39°C | 5 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Temperature | 30 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Headache | 5 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Fatigue | 4 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Muscle aches | 87 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Headache | 114 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Temperature | 32 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Shivering | 37 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Gastro. | 26 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Temperature >39°C | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Shivering | 1 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Gastro. | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Fatigue | 114 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Shivering | 22 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Joint Pain | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Gastro. | 52 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Joint Pain | 36 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Joint Pain | 51 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Fatigue | 76 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Any Muscle aches | 106 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Related Headache | 71 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Temperature ≥37.5°C | 47 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. | Grade 3 Muscle aches | 3 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature ≥37.5°C | 50 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Temperature | 24 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Loss of appetite | 3 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Drowsiness | 67 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Loss of appetite | 37 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Drowsiness | 44 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Irritability | 65 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Drowsiness | 5 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature >39°C | 4 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Irritability | 4 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Irritability | 44 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Loss of appetite | 59 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Drowsiness | 3 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Loss of appetite | 40 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Irritability | 56 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Loss of appetite | 24 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature ≥37.5°C | 51 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Loss of appetite | 3 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Drowsiness | 55 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Irritability | 37 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Irritability | 2 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Drowsiness | 31 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Temperature | 29 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature >39°C | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Loss of appetite | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Drowsiness | 59 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Drowsiness | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Drowsiness | 36 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Irritability | 53 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Irritability | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Irritability | 31 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Loss of appetite | 47 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Loss of appetite | 25 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature ≥37.5°C | 41 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature >39°C | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Temperature | 16 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Irritability | 81 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Irritability | 11 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Drowsiness | 84 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature ≥37.5°C | 81 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Irritability | 119 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Drowsiness | 57 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Temperature | 37 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Temperature >39°C | 18 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Loss of appetite | 12 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Any Loss of appetite | 83 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Grade 3 Drowsiness | 7 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. | Related Loss of appetite | 50 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Time frame: During the 28-day (Days 0-27) follow-up period after any vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 284 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 18 Participants |
| GSK2321138A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 20 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 305 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 19 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 37 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 26 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 308 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 23 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 167 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 5 Participants |
| GSK2321138A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 20 Participants |
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 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 6-17 months | 7.1 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 6-17 months | 56.2 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 18-35 months | 15.6 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 18-35 months | 208.3 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 6-17 months | 6.2 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 6-17 months | 43.8 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 18-35 months | 9.8 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 18-35 months | 118.2 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 6-17 months | 5.9 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 6-17 months | 40.2 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 18-35 months | 10.8 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 18-35 months | 120.7 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 6-17 months | 10.0 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 6-17 months | 93.5 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 18-35 months | 14.8 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 18-35 months | 216.3 titers |
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 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.
Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated 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) |
|---|---|---|---|
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 20.7 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 353.4 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 23.2 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 445.8 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 29.3 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 245.5 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 28.5 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 204.1 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 27.1 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 236.3 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 38.3 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 257.5 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 54.9 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 481.3 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 134.3 titers |
| GSK2321138A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 748.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 242.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 29.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 204.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 163.5 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 25.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 222.3 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 380.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 43.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 22.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 149.3 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 382.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 289.8 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 32.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 30.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 533.3 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 51.9 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 9-17 years | 44.7 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 3-8 years | 244.4 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 3-8 years | 57.6 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, PRE, 9-17 years | 162.8 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 9-17 years | 30.8 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 9-17 years | 797.9 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 3-8 years | 22.4 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, POST, 9-17 years | 217.5 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, PRE, 9-17 years | 21.5 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 9-17 years | 106.4 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, PRE, 3-8 years | 27.9 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/3/07, POST, 3-8 years | 566.7 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 3-8 years | 381.3 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU B/Bri/60/08, POST, 3-8 years | 79.2 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Vic/210/09, PRE, 3-8 years | 31.5 titers |
| GSK2604409A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. | FLU A/Cal/7/09, POST, 9-17 years | 502.0 titers |