Influenza
Conditions
Keywords
influenza infection, GSK Biologicals influenza vaccine GSK2321138A
Brief summary
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
Interventions
BIOLOGICALInfluenza vaccine GSK2321138A
One intramuscular injection
BIOLOGICALFluarixTM
One intramuscular injection
BIOLOGICALInfluenza vaccine GSK2604409A
One intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female 18 years of age or older at the time of the first vaccination * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study. * 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 dose of the 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 an influenza vaccine during the 6 months preceding entry into the study. * Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21. * Any contra-indication to intramuscular administration of the influenza vaccines. * History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Acute disease and/or fever at the time of enrolment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * History of chronic alcohol consumption and/or drug abuse. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study * Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | At Day 0 (D 0), and at Day 21 (D 21) | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | At Day 21 (D 21) | A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer \< 1:10 and a post-vaccination titer above or equal (\>=) 1:40, or a pre-vaccination HI antibody titer \>= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | At Day 21 (D 21) | Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using fold increase as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Within the 7-day (Days 0-6) follow-up period after vaccination | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Days With Solicited Local Symptoms | Within the 7-day (Days 0-6) follow-up period after vaccination | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day (Days 0-6) follow-up period after vaccination | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature \[axillary temperature above or equal to (\>=) 37.5 degrees Celsius (°C)\]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature \> 39°C. Related = symptom assessed as causally related to study vaccination. |
| Number of Seropositive Subjects Against 4 Strains of Influenza Disease | At Day 0 (D 0), and at Day 21 (D 21) | A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (\>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 21-day (Days 0-20) follow-up period after vaccination | Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | From the beginning of the study (Day 0) to study end (Day 180) | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | From the beginning of the study (Day 0) to study end (Day 180) | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | From the beginning of the study (Day 0) to study end (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. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination. |
| Number of Days With Solicited General Symptoms | Within the 7-day (Days 0-6) follow-up period after vaccination | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature \[defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)\]. |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | At Day 0 (D 0), and at Day 21 (D 21) | A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (\>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
Countries
Germany, Romania, South Korea, Spain, Taiwan, United States
Participant flow
Recruitment details
A total of 4659 subjects (all aged 18 years and older at the time of their first vaccination as part of this study) were enrolled in this study, of which 4656 were vaccinated. The study vaccine dose was not administrated but subject number was allocated for the other 3 subjects.
Pre-assignment details
Subjects receiving the GSK2321138A and Fluarix™ vaccines were followed in a double-blinded manner throughout the entire study period, from Day 0 to Day 180. Subjects receiving the GSK2604409A vaccine were followed in an open manner until Day 21 only.
Participants by arm
| Arm | Count |
|---|---|
| GSK2321138A Lot 1 Group Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 1,012 |
| GSK2321138A Lot 2 Group Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 1,013 |
| GSK2321138A Lot 3 Group Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 1,011 |
| Fluarix Group Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 1,010 |
| GSK2604409A Group Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 610 |
| Total | 4,656 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 | 3 | 3 | 1 |
| Overall Study | Lost to Follow-up | 7 | 8 | 6 | 4 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Unknown Completion Status | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 4 | 5 | 3 |
Baseline characteristics
| Characteristic | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.7 Years STANDARD_DEVIATION 17.9 | 58.0 Years STANDARD_DEVIATION 17.41 | 57.9 Years STANDARD_DEVIATION 17.8 | 58.1 Years STANDARD_DEVIATION 17.83 | 58.1 Years STANDARD_DEVIATION 17.92 | 58.0 Years STANDARD_DEVIATION 17.75 |
| Sex: Female, Male Female | 598 Participants | 578 Participants | 569 Participants | 548 Participants | 343 Participants | 2636 Participants |
| Sex: Female, Male Male | 414 Participants | 435 Participants | 442 Participants | 462 Participants | 267 Participants | 2020 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 485 / 1,008 | 472 / 1,003 | 482 / 1,004 | 500 / 1,003 | 275 / 607 |
| serious Total, serious adverse events | 28 / 1,012 | 20 / 1,013 | 22 / 1,011 | 26 / 1,010 | 1 / 610 |
Outcome results
Primary
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer \< 1:10 and a post-vaccination titer above or equal (\>=) 1:40, or a pre-vaccination HI antibody titer \>= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Time frame: At Day 21 (D 21)
Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 1396 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 1287 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 1046 Participants |
| GSK2321138A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 1112 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 276 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 467 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 335 Participants |
| Fluarix Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 398 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 313 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 371 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 252 Participants |
| GSK2604409A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 425 Participants |
Primary
Titers for 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. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Time frame: At Day 0 (D 0), and at Day 21 (D 21)
Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 314.7 Titer |
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 201.1 Titer |
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 34.0 Titer |
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 101.4 Titer |
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 14.7 Titer |
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 601.8 Titer |
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 404.6 Titer |
| GSK2321138A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 73.8 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 218.4 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 73.6 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 393.8 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 15.6 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 298.2 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 100.9 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 38.1 Titer |
| Fluarix Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 386.6 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 99.8 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 213.0 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 35.7 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 340.4 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 258.5 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 14.4 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 582.5 Titer |
| GSK2604409A Group | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 71.7 Titer |
Secondary
Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease
Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using fold increase as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Time frame: At Day 21 (D 21)
Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2321138A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 13.69 fold change |
| GSK2321138A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 9.28 fold change |
| GSK2321138A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 5.48 fold change |
| GSK2321138A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 5.93 fold change |
| Fluarix Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 3.84 fold change |
| Fluarix Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 13.92 fold change |
| Fluarix Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 5.37 fold change |
| Fluarix Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 7.84 fold change |
| GSK2604409A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 5.84 fold change |
| GSK2604409A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 9.52 fold change |
| GSK2604409A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 3.60 fold change |
| GSK2604409A Group | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 14.88 fold change |
Secondary
Number of Days With Solicited General Symptoms
Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature \[defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)\].
Time frame: Within the 7-day (Days 0-6) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2321138A Group | Number of Days With Solicited General Symptoms | Fatigue | 2.0 Day |
| GSK2321138A Group | Number of Days With Solicited General Symptoms | Temperature | 1.0 Day |
| GSK2321138A Group | Number of Days With Solicited General Symptoms | Shivering | 2.0 Day |
| GSK2321138A Group | Number of Days With Solicited General Symptoms | Headache | 1.0 Day |
| GSK2321138A Group | Number of Days With Solicited General Symptoms | Gastr. | 2.0 Day |
| GSK2321138A Group | Number of Days With Solicited General Symptoms | Joint Pain | 2.0 Day |
| GSK2321138A Group | Number of Days With Solicited General Symptoms | Muscle Aches | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Muscle Aches | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Joint Pain | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Gastr. | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Fatigue | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Shivering | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Headache | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Temperature | 1.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Joint Pain | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Fatigue | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Gastr. | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Headache | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Muscle Aches | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Shivering | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Temperature | 1.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Headache | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Muscle Aches | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Gastr. | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Temperature | 1.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Shivering | 1.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Fatigue | 2.0 Day |
| Fluarix Group | Number of Days With Solicited General Symptoms | Joint Pain | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Headache | 1.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Temperature | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Shivering | 1.5 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Muscle Aches | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Gastr. | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Fatigue | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited General Symptoms | Joint Pain | 2.0 Day |
Secondary
Number of Days With Solicited Local Symptoms
Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.
Time frame: Within the 7-day (Days 0-6) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2321138A Group | Number of Days With Solicited Local Symptoms | Pain | 2.0 Day |
| GSK2321138A Group | Number of Days With Solicited Local Symptoms | Swelling | 2.0 Day |
| GSK2321138A Group | Number of Days With Solicited Local Symptoms | Redness | 2.0 Day |
| Fluarix Group | Number of Days With Solicited Local Symptoms | Redness | 2.5 Day |
| Fluarix Group | Number of Days With Solicited Local Symptoms | Pain | 2.0 Day |
| Fluarix Group | Number of Days With Solicited Local Symptoms | Swelling | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms | Redness | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms | Pain | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms | Swelling | 2.0 Day |
| Fluarix Group | Number of Days With Solicited Local Symptoms | Pain | 2.0 Day |
| Fluarix Group | Number of Days With Solicited Local Symptoms | Swelling | 2.0 Day |
| Fluarix Group | Number of Days With Solicited Local Symptoms | Redness | 1.0 Day |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms | Redness | 1.0 Day |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms | Pain | 2.0 Day |
| GSK2604409A Group | Number of Days With Solicited Local Symptoms | Swelling | 2.5 Day |
Secondary
Number of Seropositive Subjects Against 4 Strains of Influenza Disease
A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (\>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Time frame: At Day 0 (D 0), and at Day 21 (D 21)
Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 967 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 1738 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 1416 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 1783 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 1541 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 1795 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 1554 Participants |
| GSK2321138A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 1794 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 488 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 525 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 594 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 511 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 601 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 352 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 586 Participants |
| Fluarix Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 597 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 425 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 514 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 291 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 528 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 457 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 518 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 452 Participants |
| GSK2604409A Group | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 532 Participants |
Secondary
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (\>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Time frame: At Day 0 (D 0), and at Day 21 (D 21)
Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 514 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 1651 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 965 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 1751 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 1423 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 1788 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 1494 Participants |
| GSK2321138A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 1792 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 353 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 497 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 583 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 477 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 599 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 167 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 558 Participants |
| Fluarix Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 595 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 0 | 285 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 21 | 495 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1 Strain - D 0 | 139 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N2 Strain - D 21 | 517 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 0 | 441 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 21 | 513 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Victoria Strain - D 0 | 412 Participants |
| GSK2604409A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | Yamagata Strain - D 21 | 532 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within the 7-day (Days 0-6) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 26 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness (≥ 100 mm) | 0 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 13 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 24 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 377 Participants |
| GSK2321138A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling (≥ 100 mm) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness (≥ 100 mm) | 1 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 20 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 362 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 6 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling (≥ 100 mm) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 12 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 357 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 22 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness (≥ 100 mm) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling (≥ 100 mm) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 16 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 5 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 17 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 369 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 12 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness (≥ 100 mm) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 21 Participants |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling (≥ 100 mm) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling (≥ 100 mm) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 8 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 190 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness (≥ 100 mm) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 12 Participants |
Secondary
Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)
Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Time frame: From the beginning of the study (Day 0) to study end (Day 180)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Any MAE(s) | 688 Participants |
| GSK2321138A Group | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Related MAE(s) | 11 Participants |
| Fluarix Group | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Any MAE(s) | 216 Participants |
| Fluarix Group | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Related MAE(s) | 4 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Any MAE(s) | 52 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Related MAE(s) | 5 Participants |
Secondary
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Time frame: From the beginning of the study (Day 0) to study end (Day 180)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Any pIMD(s) | 1 Participants |
| GSK2321138A Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Related pIMD(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Any pIMD(s) | 1 Participants |
| Fluarix Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Related pIMD(s) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Any pIMD(s) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | 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. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.
Time frame: From the beginning of the study (Day 0) to study end (Day 180)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 28 Participants |
| GSK2321138A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 20 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 22 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 26 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 1 Participants |
| GSK2604409A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature \[axillary temperature above or equal to (\>=) 37.5 degrees Celsius (°C)\]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature \> 39°C. Related = symptom assessed as causally related to study vaccination.
Time frame: Within the 7-day (Days 0-6) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 45 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches | 117 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 9 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (> 39.0°C) | 0 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches | 5 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 5 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 109 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 37 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 163 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (≥ 37.5°C) | 19 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 31 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches | 165 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 67 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 6 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 11 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 96 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 87 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 3 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 152 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 64 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 10 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 92 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 107 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 63 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 3 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches | 130 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 154 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 4 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 34 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 162 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches | 2 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 8 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 32 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 2 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 84 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 5 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 54 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches | 172 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 19 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (≥ 37.5°C) | 21 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (> 39.0°C) | 0 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 16 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 51 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 118 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 74 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 98 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 8 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches | 109 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (> 39.0°C) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 38 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches | 156 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (≥ 37.5°C) | 8 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 171 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 155 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 48 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches | 7 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 32 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 8 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 6 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 70 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches | 195 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches | 8 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches | 137 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 185 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 50 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 5 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 3 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (≥ 37.5°C) | 12 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 97 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 104 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (> 39.0°C) | 0 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 7 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 61 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 8 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 65 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 30 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 2 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 132 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 6 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 35 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 164 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 1 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 80 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 6 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 26 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 36 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 19 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (≥ 37.5°C) | 9 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 19 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 57 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches | 61 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 48 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 90 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (> 39.0°C) | 0 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 4 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches | 98 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 29 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 64 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.
Time frame: Within the 21-day (Days 0-20) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicited AE(s) | 125 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicited AE(s) | 17 Participants |
| GSK2321138A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicited AE(s) | 11 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicited AE(s) | 12 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicited AE(s) | 120 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicited AE(s) | 20 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicited AE(s) | 16 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicited AE(s) | 134 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicited AE(s) | 27 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicited AE(s) | 138 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicited AE(s) | 26 Participants |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicited AE(s) | 7 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicited AE(s) | 2 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicited AE(s) | 92 Participants |
| GSK2604409A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicited AE(s) | 14 Participants |