Influenza
Conditions
Keywords
influenza infection, GSK Bio's influenza vaccine GSK2340272A
Brief summary
The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
Interventions
BIOLOGICALGSK investigational vaccine GSK2340272A
One or two intramuscular injections in the deltoid region of the non-dominant or the dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female aged 18 years or above at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment. * Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy 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. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial. * Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Presence of an axillary temperature \>= 37.5ºC, or acute symptoms greater than mild severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. * Diagnosed with cancer, or treatment for cancer, within the past 3 years. * Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above. * Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. * Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. * An acute evolving neurological disorder or history of Guillain-Barré syndrome. * Clinically or virologically confirmed influenza infection within 6 months preceding the study start. * Administration of any vaccines within 30 days before vaccination. * Any known or suspected allergy to any constituent of influenza vaccines; anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * Pregnant or lactating female * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies | At Day 21 | Seroconversion was defined as: For initially seronegative subjects \[antibody titer (below) \< 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age . |
| Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | At Day 21 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age . |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 21 | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Days 182 and 364 | Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post to vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age . |
| Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | At Days 0, 21 and 42 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age . |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Days 21 and 42 | GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age. |
| Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | At Days 0, 21, 42 and 182 | A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:8, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/Neth/602/09. The results for this assay were tabulated per age stratum. |
| Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | At Days 0, 21, 42 and 182 | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8. The results for this assay were tabulated per age stratum. |
| Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | At Days 21, 42 and 182 | Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:8 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09. The results were tabulated per age stratum. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-dose 1 vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum. |
| Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | At Days 0, 21 and 42 | A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-dose 1 vaccination period | Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (\>) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum. |
| Number of Days With Solicited General Symptoms | During the 7-day (Days 0-6) post-dose 1 vaccination period | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum. |
| Number of Subjects With Adverse Events of Specific Interest (AESIs) | During the entire study period (from Day 0 up to Day 364) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. The results were tabulated per age stratum. |
| Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | At Days 0, 21, 42, 182 and 364 | Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[AST\], total bilirubin \[BIL\], creatinine \[CRE\], blood urea nitrogen \[BUN\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and \> 60 years old. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 21 days after the first vaccination (Day 0 - Day 20) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Day 364) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The results were tabulated per age stratum. |
| Number of Days With Solicited Local Symptoms | During the 7-day (Days 0-6) post-dose 1 vaccination period | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Days 0, 21 and 42 | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. The results for this assay were tabulated per age stratum. |
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | At Days 21 and 42 | Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post to vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age . |
Countries
Belgium
Participant flow
Recruitment details
At Day 21, all subjects had received 1 dose of GSK2340272A vaccine and therefore no distinction was made between groups for the Day 21 analysis.
Participants by arm
| Arm | Count |
|---|---|
| GSK2340272A 2D Group Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21. | 138 |
| GSK2340272A 1D Group Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. | 102 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Migrated/moved from study area | 1 | 0 |
Baseline characteristics
| Characteristic | GSK2340272A 2D Group | GSK2340272A 1D Group | Total |
|---|---|---|---|
| Age, Continuous | 55.0 Years STANDARD_DEVIATION 18.2 | 53.6 Years STANDARD_DEVIATION 18.3 | 54.4 Years STANDARD_DEVIATION 18.2 |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 138 Participants | 102 Participants | 240 Participants |
| Sex: Female, Male Female | 68 Participants | 49 Participants | 117 Participants |
| Sex: Female, Male Male | 70 Participants | 53 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 138 |
| other Total, other adverse events | 89 / 102 | 126 / 138 |
| serious Total, serious adverse events | 6 / 102 | 10 / 138 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 38.71 Fold change |
| GSK2340272A 2D (>60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 13.86 Fold change |
Primary
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer (below) \< 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age .
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies | 63 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies | 53 Participants |
Primary
Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age .
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 65 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | 59 Participants |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age.
Time frame: At Day 182 and 364
Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 24.73 Fold change |
| GSK2340272A 2D (18-60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 10.4 Fold change |
| GSK2340272A 2D (>60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 4.3 Fold change |
| GSK2340272A 2D (>60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 10.45 Fold change |
| GSK2340272A 1D (18-60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 17.14 Fold change |
| GSK2340272A 1D (18-60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 7.6 Fold change |
| GSK2340272A 1D (>60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 5.31 Fold change |
| GSK2340272A 1D (>60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 2.9 Fold change |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the point estimated for GMFR was \> 2.5 in subjects 18 to 60 years old or \> 2 for subjects \> 60 years of age.
Time frame: At Days 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose was administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 and 42 days after the first vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 45.30 Fold change |
| GSK2340272A 2D (18-60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 38.62 Fold change |
| GSK2340272A 2D (>60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 13.32 Fold change |
| GSK2340272A 2D (>60y) Sub-Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 12.06 Fold change |
Secondary
Number of Days With Solicited General Symptoms
The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.
Time frame: During the 7-day (Days 0-6) post-dose 1 vaccination period
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue | 1.5 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches | 3.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating | 1.5 Days |
Secondary
Number of Days With Solicited General Symptoms
The number of days with any solicited general symptoms reported during the solicited post-vaccination period. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (\>60y) Sub-Group reported any temperature.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A vaccine and who filled in their symptom sheets.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue, Overall/dose | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache, Dose 1 | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache, Dose 2 | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache, Overall/dose | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 1 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 2 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain, Overall/dose | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 1 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 2 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches, Overall/dose | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating, Dose 1 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating, Dose 2 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating, Overall/dose | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering, Overall/dose | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature, Overall/dose | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 2 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | NA Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches, Overall/dose | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Fatigue, Overall/dose | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache, Dose 1 | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating, Dose 1 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache, Dose 2 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature, Overall/dose | NA Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Headache, Overall/dose | 1.5 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating, Dose 2 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 1 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering, Overall/dose | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain, Dose 2 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Sweating, Overall/dose | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Joint pain, Overall/dose | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | NA Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Muscle aches, Dose 1 | 2.5 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | 1.0 Days |
Secondary
Number of Days With Solicited Local Symptoms
The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.
Time frame: During the 7-day (Days 0-6) post-dose 1 vaccination period
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain | 3.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain | 2.5 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling | 2.0 Days |
Secondary
Number of Days With Solicited Local Symptoms
The number of days with any solicited local symptoms reported during the solicited post-vaccination period. This outcome included only subjects who received 2 doses of the study product and the results were tabulated per age stratum. No subjects from GSK2340272A 2D (18-60y) Sub-Group presented any redness post dose 1.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A and who filled in their symptom sheets.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness, Dose 2 | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain, Overall/dose | 3.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness, Overall/dose | 1.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling, Dose 1 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain, Dose 2 | 3.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling, Dose 2 | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness, Dose 1 | 0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling, Overall/dose | 2.0 Days |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain, Dose 1 | 3.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling, Overall/dose | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain, Dose 1 | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain, Dose 2 | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Pain, Overall/dose | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness, Dose 1 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness, Dose 2 | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling, Dose 1 | 2.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Swelling, Dose 2 | 1.0 Days |
| GSK2340272A 2D (>60y) Sub-Group | Number of Days With Solicited Local Symptoms | Redness, Overall/dose | 1.5 Days |
Secondary
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post to vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age .
Time frame: At Days 182 and 364
Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 63 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 50 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 28 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 52 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 42 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 32 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 21 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 15 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post to vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age .
Time frame: At Days 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose was administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days and 42 days after the first vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 21 | 47 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 42 | 46 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 21 | 38 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/2009 Strain of Influenza Disease | Flu A/CAL/7/2009, Day 42 | 39 Participants |
Secondary
Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09
Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:8 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09. The results were tabulated per age stratum.
Time frame: At Days 21, 42 and 182
Population: The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against the study vaccine antigen component at Day 182 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 21 | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 182 | 18 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 42 | 20 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 21 | 15 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 182 | 14 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 42 | 19 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 42 | 11 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 21 | 12 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 182 | 6 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 21 | 6 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 182 | 7 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 42 | 5 Participants |
Secondary
Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09
A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:8, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/Neth/602/09. The results for this assay were tabulated per age stratum.
Time frame: At Days 0, 21, 42 and 182
Population: The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 0 | 16 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 21 | 21 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 42 | 22 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 182 | 21 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 21 | 22 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 42 | 22 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 182 | 22 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 0 | 17 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 42 | 17 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 21 | 17 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 182 | 16 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 0 | 11 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 182 | 16 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 21 | 18 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 0 | 12 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Seropositive Subjects for Serum Neutralizing Antibodies Against Flu A/Netherlands (Neth)/602/09 | Flu A/Neth/602/09, Day 42 | 18 Participants |
Secondary
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum.
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose and 2 doses were administered and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 0 | 24 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 42 | 66 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 21 | 66 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 0 | 28 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 42 | 67 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 21 | 67 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 21 | 50 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 0 | 20 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 42 | 50 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 0 | 21 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 42 | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 21 | 47 Participants |
Secondary
Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum.
Time frame: At Day 182 and 364
Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 67 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 67 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 65 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 68 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 44 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 46 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 41 Participants |
Secondary
Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. This outcome included only subjects who received one dose of the study product and the results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age .
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose was administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 and 42 days after the first vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 0 | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 21 | 48 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 42 | 47 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 0 | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 21 | 42 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 42 | 43 Participants |
Secondary
Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The results for this assay were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age.
Time frame: At Days 182 and 364
Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 65 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 53 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 37 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 61 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 44 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 34 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 182 | 28 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects Who Were Seroprotected (SPR ) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/California/7/2009, Day 364 | 22 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. The results were tabulated per age stratum.
Time frame: During the entire study period (from Day 0 up to Day 364)
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.
Time frame: During the 7-day (Days 0-6) post-dose 1 vaccination period
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 105 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 11 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 12 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 78 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 9 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. This outcome included only subjects who received two doses of the study product and the results were tabulated per age stratum.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A vaccine and who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 57 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 5 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 51 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 3 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 61 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 7 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 46 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 6 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 4 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 6 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 42 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 52 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 5 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature above (\>) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. This outcome inlcuded only subjects who received two doses of the study product and the results were tabulated per age stratum.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on a subset of subjects from the Total Vaccinated cohort (TVc), which included all subjects who received 2 doses of GSK2340272A vaccine and who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 24 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 21 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 23 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 22 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 12 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 10 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 19 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 14 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 13 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 12 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 11 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 19 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 19 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 11 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 11 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 18 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 18 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 11 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 11 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 29 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 27 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 29 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 28 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 16 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 26 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 23 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 22 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 21 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 19 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 18 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 3 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 15 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 19 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 13 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 14 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 12 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 18 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 11 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 9 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 9 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 6 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 12 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 7 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 10 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 2 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 16 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 2 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 22 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 9 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 15 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 26 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 15 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 12 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 20 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 25 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 12 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 13 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 20 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 7 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 13 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 13 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (\>) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. This outcome included all the subjects who received 1 dose of the study product and the assay results were tabulated per age stratum.
Time frame: During the 7-day (Days 0-6) post-dose 1 vaccination period
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects who filled in their symptom sheets. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 23 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 44 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 22 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 17 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 19 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 43 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 29 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 17 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 40 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 19 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 25 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 43 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 7 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 24 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 22 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 21 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain | 17 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain | 14 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 25 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 23 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 7 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 6 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 6 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 26 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. This outcome included all the subjects who received 1 dose of the study product and the results were tabulated per age stratum.
Time frame: Within 21 days after the first vaccination (Day 0 - Day 20)
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects. The results were tabulated for the pooled groups and per age stratum, because until Day 21 no distinction was made in terms of study groups, since all subjects had received 1 dose of GSK2340272A vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 53 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 24 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 31 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 14 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. The results were tabulated per age stratum.
Time frame: Within 84 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 83)
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 45 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 15 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 13 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 46 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 10 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 9 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 39 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 9 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 30 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 7 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 7 Participants |
Secondary
Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase \[ALT\], alkaline phosphatase \[AP\], aspartate aminotransferase \[AST\], total bilirubin \[BIL\], creatinine \[CRE\], blood urea nitrogen \[BUN\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and \> 60 years old.
Time frame: At Days 0, 21, 42, 182 and 364
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Within | 66 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Within | 56 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Above | 12 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 56 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 12 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Within | 57 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Above | 11 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Within | 57 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Above | 10 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Within | 58 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Above | 9 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Within | 67 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Above | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 67 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Above | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Within | 65 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Above | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Within | 63 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Above | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Within | 63 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Above | 5 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 67 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 1 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Within | 63 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Above | 5 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Within | 62 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Above | 5 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Within | 63 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Above | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Within | 64 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Above | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Within | 64 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Above | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Within | 64 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Above | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Within | 65 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Above | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Within | 59 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Above | 8 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Within | 59 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Above | 9 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Within | 60 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Above | 8 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Within | 60 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Above | 8 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Within | 57 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Above | 10 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Within | 63 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Above | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Within | 66 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Above | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 66 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 2 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Within | 64 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Above | 4 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Within | 67 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Above | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Within | 67 Participants |
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Above | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Above | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Above | 2 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Within | 68 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Within | 65 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Above | 19 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Within | 51 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Above | 2 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Above | 13 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 59 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Within | 68 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Within | 66 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Within | 66 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Above | 18 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Within | 52 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Above | 4 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Within | 66 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Within | 57 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Within | 51 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 11 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Above | 4 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Above | 4 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Within | 67 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Within | 64 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Above | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Above | 6 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Above | 8 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Above | 10 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 69 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Within | 68 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Within | 63 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Above | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Above | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 67 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Above | 2 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Within | 58 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Within | 68 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Above | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Within | 66 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Above | 8 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Above | 4 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Within | 60 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Above | 12 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Within | 70 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 65 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Within | 59 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Within | 64 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Within | 67 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Above | 16 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Above | 5 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Within | 60 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Above | 4 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Within | 66 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Above | 18 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Above | 1 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Within | 65 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Below | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Within | 54 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Above | 3 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Unknown | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Within | 52 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Above | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Within | 50 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Within | 52 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Above | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Within | 47 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Above | 5 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 49 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 3 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Above | 2 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Within | 45 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Above | 7 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Within | 47 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Above | 5 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Within | 49 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Above | 3 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Within | 49 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Above | 3 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Within | 49 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Above | 3 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Within | 50 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Above | 2 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Within | 46 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Above | 6 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Within | 50 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Above | 2 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Within | 49 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Above | 3 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Above | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Within | 44 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Above | 8 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 45 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 7 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Within | 46 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Above | 6 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Within | 47 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Above | 5 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Within | 50 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Within | 47 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Above | 5 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Above | 2 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Within | 51 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Above | 1 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Within | 52 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 52 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Above | 3 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Within | 46 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Above | 5 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Within | 41 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Above | 5 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Within | 47 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 0 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Above | 3 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Within | 46 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Above | 9 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Within | 44 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 21 | Above | 4 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Above | 7 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Within | 45 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Within | 47 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Above | 9 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Above | 4 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Within | 44 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 0 | Above | 5 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 42 | Above | 6 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 182 | Within | 43 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Above | 6 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Within | 50 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Above | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 182 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Above | 1 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Above | 8 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Above | 5 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 182 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Within | 49 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Within | 45 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Within | 49 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 364 | Above | 1 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Above | 1 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Within | 42 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Within | 42 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Within | 43 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Within | 49 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 0 | Above | 8 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 21 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AP, Day 182 | Within | 45 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Within | 47 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Within | 41 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 42 | Above | 7 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Within | 48 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 182 | Within | 41 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 21 | Above | 9 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BUN, Day 364 | Within | 45 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 364 | Below | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | BIL, Day 0 | Unknown | 0 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | AST, Day 364 | Above | 2 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | ALT, Day 364 | Above | 3 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | CRE, Day 42 | Below | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The results were tabulated per age stratum.
Time frame: During the entire study period (from Day 0 up to Day 364)
Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2340272A 2D (>60y) Sub-Group | Number of Subjects With Serious Adverse Events (SAEs) | 10 Participants |
| GSK2340272A 1D (18-60y) Sub-Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| GSK2340272A 1D (>60y) Sub-Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. The results for this assay were tabulated per age stratum.
Time frame: At Day 182 and 364
Population: The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects for whom data concerning immunogenicity outcome measure and whom assay results for antibodies against the study vaccine antigen component at Day 182 and 364 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 214.8 Titers |
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 90.5 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 42.3 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 108.7 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 143.5 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 64.2 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 51.6 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 28.1 Titers |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10. The results for this assay were tabulated per age stratum.
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 1 dose and 2 doses were administrated and the assay results were available for antibodies against H1N1 antigen for blood sample taken 21 or 42 days after the first vaccine dose and 21 days after the second vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 8.8 Titers |
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 610.6 Titers |
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 339.1 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 10.3 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 345.8 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 142.7 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 388.6 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 8.6 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 331.2 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 9.7 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 117.1 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 129.3 Titers |
Secondary
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8. The results for this assay were tabulated per age stratum.
Time frame: At Days 0, 21, 42 and 182
Population: The analysis was performed on the ATP cohort for persistence at Day 182, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against the study vaccine antigen component at Day 182 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 11.9 Titers |
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 21 | 199.8 Titers |
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 42 | 326.8 Titers |
| GSK2340272A 2D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 182 | 128.7 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 21 | 169.7 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 42 | 309.5 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 182 | 96.7 Titers |
| GSK2340272A 2D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 16.9 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 42 | 136.7 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 21 | 199.1 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 182 | 55.2 Titers |
| GSK2340272A 1D (18-60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 12.6 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 182 | 65.3 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 21 | 83.5 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 21.3 Titers |
| GSK2340272A 1D (>60y) Sub-Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 42 | 86.7 Titers |